Draft Guidance for Industry and FDA Staff

1 Draft Guidance for Industry and

2 FDA Staff

4 Surgical Masks - Premarket

5 Notification [510(k)] Submissions;

6 Draft Guidance for Industry and

7 FDA 8 9 DRAFT GUIDANCE 10 11 This guidance document is being distributed for comment purposes only. 12 Document issued on: [release date of FR Notice] 13 14 Comments and suggestions regarding this draft document should be submitted within __ days 15 of publication in the Federal Register of the notice announcing the availability of the draft 16 guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug 17 Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 18 be identified with the docket number listed in the notice of availability that publishes in the 19 Federal Register. 20 21 For questions regarding this draft document, please contact Chiu S. Lin, Ph.D. at 301-443-8913. 22 23 When final, this document supersedes “Draft Guidance for Industry and FDA 24 Reviewers on the Content and Format of Premarket Notification [510(k)] 25 Submissions for Surgical Mask” issued January 16, 1998 26 27 28 U.S. Department of Health and Human Services 29 Food and Drug Administration 30 Center for Devices and Radiological Health 31 32 Infection Control Devices Branch 33 Division of Anesthesiology, General Hospital, 34 Infection Control, and Dental Devices 2 3 Contains Nonbinding Recommendations 4 Draft - Not for Implementation 5 6 35 Office of Device Evaluation

7 8 Contains Nonbinding Recommendations 9 Draft - Not for Implementation 10 11 36 37 Preface 38 39Additional Copies 40 41Additional copies are available from the Internet at: http://www.fda.gov/cdrh/[specific 42address], or CDRH Facts-On-Demand. In order to receive this document via your fax 43machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 44from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, 45press 1 to order a document. Enter the document number (094) followed by the pound 46sign (#). Follow the remaining voice prompts to complete your request.

12 13 Contains Nonbinding Recommendations 14 Draft - Not for Implementation 15 16 47 Table of Contents 48 491. INTRODUCTION...... 1

502. BACKGROUND...... 2

513. THE CONTENT AND FORMAT OF AN ABBREVIATED 510(K) SUBMISSION...... 2

524. SCOPE...... 4

535. DEVICE DESCRIPTION...... 5

546. RISKS TO HEALTH...... 6

557. FLUID RESISTANCE...... 7

568. FILTRATION EFFICIENCY...... 8

579. DIFFERENTIAL PRESSURE (DELTA-P) TEST...... 8

5810. FLAMMABILITY TESTING...... 9

5911. LABELING...... 10

60APPENDIX I ABBREVIATIONS...... 11

61APPENDIX II. SUMMARY REPORT SAMPLE FORMATS...... 12 62

17 18 Contains Nonbinding Recommendations 19 Draft - Not for Implementation 20 21 64 Draft Guidance for Industry and FDA Staff 65

66 Surgical Masks - Premarket Notification 67 [510(k)] Submissions; Draft Guidance for 68 Industry and FDA 69 70 71 This draft guidance, when finalized, will represent the Food and Drug Administration's 72 (FDA's) current thinking on this topic. It does not create or confer any rights for or on 73 any person and does not operate to bind FDA or the public. You can use an alternative 74 approach if the approach satisfies the requirements of the applicable statutes and regula- 75 tions. If you want to discuss an alternative approach, contact the FDA staff responsible 76 for implementing this guidance. If you cannot identify the appropriate FDA staff, call the 77 appropriate number listed on the title page of this guidance. 78

791. Introduction 80FDA has developed this draft guidance document to assist industry in preparing premarket 81notification submissions for surgical masks. The device is intended to be worn by operating 82room personnel during surgical procedures to protect both the surgical patients and the operating 83room personnel from the transfer of microorganisms, body fluids, and particulate material. 21 84CFR §878.4040. 85 86This draft guidance is issued for comment purposes only. FDA previously issued a draft 87guidance entitled “Draft Guidance for Industry and FDA Reviewers on the Content and 88Format of Premarket Notification [510(k)] Submissions for Surgical Mask” on January 16, 891998; however no notice of availability was published in the Federal Register. We are seeking to 90correct that error by issuing the document again for comment with a notice of availability in the 91Federal Register. FDA will consider the comments received and make every effort to issue the 92guidance for implementation in a reasonable time after the comment period has closed. 93 94FDA's guidance documents, including this guidance, do not establish legally enforceable 95responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should 96be viewed only as recommendations, unless specific regulatory or statutory requirements are 97cited. The use of the word should in Agency guidances means that something is suggested or 98recommended, but not required.

22 1 23 Contains Nonbinding Recommendations 24 Draft - Not for Implementation 25 26 99

1002. Background 101A manufacturer who intends to market a device of this generic type should (1) conform to the 102general controls of the Federal Food, Drug & Cosmetic Act (the Act), including the 103premarket notification requirements described in 21 CFR 807 Subpart E, (2) address the 104specific risks to health associated with surgical masks identified in this guidance and, (3) 105obtain a substantial equivalence determination from FDA prior to marketing the device. (See 106also 21 CFR 807.85). 107 108This guidance document identifies the classification regulations and product codes for the 109surgical masks (Refer to Section 4). In addition, other sections of this guidance document list 110the risks to health identified by FDA and describe measures that, if followed by manufacturers 111and combined with the general controls, will generally address the risks associated with these 112surgical masks and lead to a timely premarket notification [510(k)] review and clearance. 113 114This document supplements other FDA documents regarding the specific content requirements 115of a premarket notification submission. You should also refer to 21 CFR 807.87 and "How to 116Prepare a 510(k) Submission" on FDA Device Advice at 117http://www.fda.gov/cdrh/devadvice/314.html. 118 119Under “The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial 120Equivalence in Premarket Notifications; Final Guidance,” 121http://www.fda.gov/cdrh/ode/parad510.html, a manufacturer may submit a Traditional 510(k) or 122has the option of submitting either an Abbreviated 510(k) or a Special 510(k). FDA believes an 123Abbreviated 510(k) provides the least burdensome means of demonstrating substantial 124equivalence for a new device, particularly once FDA has issued a guidance document. 125Manufacturers considering modifications to their own cleared devices may lessen the regulatory 126burden by submitting a Special 510(k). 127

1283. The Content and Format of an Abbreviated 510(k) Sub- 129 mission 130An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 131807.87, including the proposed labeling for the device sufficient to describe the device, its 132intended use, and the directions for its use. In an Abbreviated 510(k), FDA may consider the 133contents of a summary report to be appropriate supporting data within the meaning of 21 CFR 134807.87(f) or (g); therefore, we recommend that you include a summary report. The report should 135describe how this guidance document was used during the device development and testing and 136should briefly describe the methods or tests used and a summary of the test data or description of 137the acceptance criteria applied to address the risks identified in this document, as well as any

27 2 28 Contains Nonbinding Recommendations 29 Draft - Not for Implementation 30 31 138additional risks specific to your device. This section suggests information to fulfill some of the 139requirements of 807.87 as well as some other items that we recommend you include in an 140Abbreviated 510(k). 141 142 Coversheet 143 The coversheet should prominently identify the submission as an Abbreviated 510(k) and cite 144 the title of this guidance document. 145 146 Proposed labeling 147 Proposed labeling should be sufficient to describe the device, its intended use, and the 148 directions for its use. (Refer to Section 11 for specific information that we recommend you 149 include in labeling.) 150 151 Summary report 152 We recommend that the summary report contain: 153 154  Description of the device and its intended use. We recommend that the description 155 include a complete discussion of the performance specifications and, when 156 appropriate, detailed, labeled drawings of the device. (Refer to Section 5 for specific 157 information that we recommend you include in the device description for devices of 158 the types covered by this guidance document.) You should also submit an 159 "indications for use" enclosure.1 160 161  Description of device design requirements. 162 163  Identification of the Risk Analysis method(s) used to assess the risk profile in general 164 as well as the specific device’s design and the results of this analysis. (Refer to 165 Section 6 for the risks to health generally associated with the use of this device that 166 FDA has identified.) 167 168  Discussion of the device characteristics that address the risks identified in this 169 guidance document, as well as any additional risks identified in your risk analysis. 170 171  A brief description of the test method(s) you have used or intend to use to address 172 each performance aspect identified in Sections 7-10 of this guidance document. If 173 you follow a suggested test method, you may cite the method rather than describing 174 it. If you modify a suggested test method, you may cite the method but should 175 provide sufficient information to explain the nature of and reason for the

321 Refer to http://www.fda.gov/cdrh/ode/indicate.html for the recommended format. 33 34 3 35 Contains Nonbinding Recommendations 36 Draft - Not for Implementation 37 38 176 modification. For each test, you may either (1) briefly present the data resulting from 177 the test in clear and concise form, such as a table, or (2) describe the acceptance 178 criteria that you will apply to your test results.2 (See also 21 CFR 820.30, Subpart C - 179 Design Controls for the Quality System Regulation.) 180 181  If any part of the device design or testing relies on a recognized standard, (1) a 182 statement that testing will be conducted and meet specified acceptance criteria before 183 the product is marketed, or (2) a declaration of conformity to the standard.3 Please 184 note that testing must be completed before submitting a declaration of conformity to a 185 recognized standard. (21 USC 514(c)(2)(B)). For more information, refer to the FDA 186 guidance, Use of Standards in Substantial Equivalence Determinations; Final 187 Guidance for Industry and FDA, http://www.fda.gov/cdrh/ode/guidance/1131.html. 188 189If it is not clear how you have addressed the risks identified by FDA or additional risks identified 190through your risk analysis, we may request additional information about aspects of the device’s 191performance characteristics. We may also request additional information if we need it to assess 192the adequacy of your acceptance criteria. (Under 21 CFR 807.87(l), we may request any 193additional information that is necessary to reach a determination regarding substantial 194equivalence.) 195 196As an alternative to submitting an Abbreviated 510(k), you can submit a Traditional 510(k) that 197provides all of the information and data required under 21 CFR 807.87 and described in this 198guidance. A Traditional 510(k) should include all of your methods, data, acceptance criteria, and 199conclusions. Manufacturers considering modifications to their own cleared devices should 200consider submitting Special 510(k)s. 201

2024. Scope 203The scope of this document is limited to the following devices described in 21 CFR 204§878.4040(b) class II, product codes: 205 392 If FDA makes a substantial equivalence determination based on acceptance criteria, the subject 40device should be tested and shown to meet these acceptance criteria before being introduced into 41interstate commerce. If the finished device does not meet the acceptance criteria and, thus, 42differs from the device described in the cleared 510(k), FDA recommends that submitters apply 43the same criteria used to assess modifications to legally marketed devices (21 CFR 807.81(a)(3)) 44to determine whether marketing of the finished device requires clearance of a new 510(k). 45 463 See Required Elements for a Declaration of Conformity to a Recognized Standard (Screening 47Checklist for All Premarket Notification [510(K)] Submissions), 48http://www.fda.gov/cdrh/ode/reqrecstand.html. 49 50 4 51 Contains Nonbinding Recommendations 52 Draft - Not for Implementation 53 54 206 FXX Surgical Mask 207 MSH Surgical N95 Respirator 208 209Surgical Mask 210The surgical masks referenced in this guidance document include masks that are labeled as a 211surgical, laser, isolation, dental or medical procedure masks with or without a face shield. 212 213Surgical N95 Respirator 214We recommend that surgical masks with respirator performance features (Surgical N95 215Respirator) also be certified by National Institute of Occupational Safety and Health (NIOSH) as 216a respirator. 217

2185. Device Description 219We recommend that you identify your device by regulation and product code and compare your 220device with the predicate device using a tabular format as shown in the example below. We 221recommend that you provide information to show how the new device is both similar to and 222different from the legally marketed device. Side by side comparisons, whenever possible, are 223desirable. We also recommend that you describe how any differences may affect the 224comparative safety and performance of the new device. 225 226 Device and Predicate Device Descriptions Predicate (with 510(k) Your Device Description number, if available) Materials Specifications and dimensions Mask style Design features NIOSH certification number (where applicable) 227 228We recommend that you include the following descriptive information in the comparison table: 229 230 Material Composition 231 We recommend that you describe the material composition of the mask. A description of 232 material composition may include the following:

233 55 5 56 Contains Nonbinding Recommendations 57 Draft - Not for Implementation 58 59 234  materials your device is made of, e.g., polypropylene 235  weave, e.g., spunbonded, meltblown, or spunbonded 236  metals, for example used in nose features 237  colorants 238  elastic materials, e.g., used in ear loops 239  foam and other anti-fog materials, if any 240  face shield materials, if any 241 242 Specifications and Dimensions 243 We recommend that you provide the following information about your device and any add- 244 on features such as a face shield or wrap-around visor:

245 246  size 247  dimensions 248  tensile strength 249  other specifications relevant to user needs, e.g., impact resistance 250 251 Design features 252 We recommend that you describe the design features of your mask, such as:

253 254  tie-on or ear loops 255  elastic on the side for blow-by prevention 256  face shield attached 257 258 Mask Styles 259 We recommend that you identify the style of your mask, e.g., duck bill, flat pleated, cone 260 shaped. 261

2626. Risks to Health 263In the table below, FDA has identified the risks to health generally associated with the use of the 264surgical masks addressed in this document. The measures recommended to mitigate these 265identified risks are given in this guidance document, as shown in the table below. You should 266also conduct a risk analysis, prior to submitting your premarket notification, to identify any other 267risks specific to your device. The premarket notification should describe the risk analysis 268method. If you elect to use an alternative approach to address a particular risk identified in this 269document, or have identified risks additional to those in this document, you should provide 270sufficient detail to support the approach you have used to address that risk. 271

60 6 61 Contains Nonbinding Recommendations 62 Draft - Not for Implementation 63 64 Identified risk Recommended mitigation measures

Inadequate fluid resistance Section 7

Inadequate bacterial filtration efficiency Section 8

Inadequate air exchange (differential Section 9 pressure)

Flammability Section 10 272 273Surgical masks include parts that have prolonged contact with intact skin. We recommend that 274you evaluate the biocompatibility of the materials in these parts as described in the standard ISO- 27510993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for limited 276contact devices, contacting intact skin. We also recommend that you document the results in 277your design history file as a part of the Quality Systems Requirements (21 CFR 820.30). You 278should select tests appropriate for the duration and level of contact with your device. If identical 279materials are used in a predicate device with the same type and duration of skin contact, you may 280identify the predicate device in lieu of performing biocompatibility testing. 281 282For a surgical mask that is also an N95 Respirator and certified by NIOSH as a respirator, 283you may submit the NIOSH certification number in lieu of filter effciency performance 284(Section 8) and differential pressure (Section 9). 285

2867. Fluid Resistance 287Fluid resistance is the ability of the mask’s material to inhibit the penetration of blood and body 288fluids. We recommend that you evaluate the fluid resistance of your device using the standard 289listed below. 290 291  ASTM F 1862-00a: Standard Test Method for Resistance of Surgical Mask to Penetration 292 by Synthetic Blood 293 294 According to ASTM F 1862-00a, surgical masks are tested on a pass/fail basis at three 295 velocities corresponding to the range of human blood pressure (80, 120, 160 mm Hg). 296 Surgical masks that show passing results at these pressures exhibit fluid resistance. 297 Surgical masks that show passing results at higher velocities are more fluid resistant. 298

2998. Filtration Efficiency 300For surgical masks that are not certified N95 Respirators, we recommend that you evaluate filter 65 7 66 Contains Nonbinding Recommendations 67 Draft - Not for Implementation 68 69 301efficiency performance and bacterial filtration efficiency. For surgical masks that are certified 302N95 Respirators, you may submit your NIOSH certification number in lieu of this information. 303 Filter Efficiency Performance 304 We recommend that you conduct a particle challenge study using 0.1-Micron Polystyrene 305 Latex Spheres. This in vitro test challenges the mask with unneutralized 0.1-micron 306 polystyrene latex spheres and measures penetration. The use of latex spheres provides an 307 appropriately rigorous test for evaluating a submicron efficiency performance. 308 309 Bacterial Filtration Efficiency 310 Bacterial Filtration Efficiency (BFE) is a measure of the ability of the mask’s material to 311 prevent the passage of aerosolized bacteria. BFE is expressed in the percentage of a known 312 quantity that does not pass the mask material at a given aerosol flow rate. We recommend 313 that you evaluate the fluid resistance of your device using one of the test methods or 314 standards listed below. 315 316  Bacterial Penetration (aerosol filtration) - Mil- M369454C, Military Specifications: 317 Surgical Mask, disposable (June 12, 1975). 318 319  Modified Greene and Vesley Method: Method for evaluation of bacterial filtration 320 efficiency of surgical masks. J Bacteriol 83:663-667. (1962). 321 322  ASTM F2101-01 Standard Test Method for Evaluating the Bacterial Filtration 323 Efficiency (BFE) of surgical masks using a Biological Aerosol of Staphylococcus 324 aureus. 325

3269. Differential Pressure (Delta-P) Test 327For surgical masks that are not certified N95 Respirators, we recommend that you evaluate 328differential pressure. For surgical masks that are certified N95 Respirators, you may submit your 329NIOSH certification number in lieu of this information. 330Differential Pressure (Delta-P) is the measured pressure drop across a surgical facemask 331material. Delta-P determines the resistance of the surgical facemask’s material to air flowing 332through the mask. Pressure drop also relates to the breathability and comfort of the surgical 333mask. We recommend demonstrating Delta-P according to either of the following standards: 334 335  MIL-M-36945C 4.4.1.1.1 Method 1 Military Specifications: Surgical Mask, 336 disposable (June 12, 1975) 337 338We recommend reporting Delta-P using the comfort scale shown in the table below. 339

70 8 71 Contains Nonbinding Recommendations 72 Draft - Not for Implementation 73 74 340Comfort Scale used in Delta-P testing Score Perception Above 5.0 hot 4.0 to 5.0 very warm 3.0 to 4.0 warm 2.0 to 3.0 cool 1.0 to 2.0 very cool 341

34210. Flammability Testing 343We recommend using one of the standards below to determine the flammability by class. 344 345  CPSC CS-191-53 Flammability Test Method (16 CFR 1610) Flammability Test Method 346 347  NFPA Standard #702-1980: Standard for the use of inhalation anesthetics.4 348 349  UL 2154: Test that measures the level of atmospheric oxygen required to propagate 350 flame when ignition is caused by an electrosurgery unit or laser. Higher levels of oxygen 351 required for flame propagation indicate materials which are more flame resistant for 352 electrosurgery or laser procedures. 353 354We recommend that Class 1 and Class 2 flammability materials be used in surgical masks 355intended for use in the operating room. 356 357FDA believes that devices with a Class 4 rating are not appropriate for use in the operating room. 358There are many potential ignition sources in the operating room, including surgical lasers, 359electrosurgical units, endoscopic fiberoptics, and high-energy electro-medical devices. All 360materials will burn if a high intensity heat source is applied to them, especially in the presence of 361elevated oxygen levels. 362

36311. Labeling 364The premarket notification should include labeling in sufficient detail to satisfy the requirements 365of 21 CFR 807.87(e). The following suggestions are aimed at assisting you in preparing labeling

754 In the past, an NFPA test method is used to assess flame-spread rate in textile. Although this 76document was removed from NFPA’s list of "active" standards in 1987, the test is still 77referenced by many applicants. 78 9 79 Contains Nonbinding Recommendations 80 Draft - Not for Implementation 81 82 366that satisfies the requirements of 21 CFR 807.87(e).5 367 368 Intended Use 369 We recommend that you clearly state the intended use of your device, and identify whether it 370 is a combination surgical mask N95 Respirator. We recommend that you also describe the 371 indications for use, such as whether the mask is an isolation mask, procedure mask, or dental 372 face mask. 373 374 We also recommend that you include whether your device is intended as a single use and 375 disposable device. 376 377 Warning 378 379 For Class 3 flammability surgical mask materials, we recommend that you include a 380 flammability warning, such as one of the following examples: 381 382 This device does not meet 16 CFR 1610, NFPA, or CPSC flammability standards. 383 384 This device may burn when used in the presence of high intensity heat source or 385 flammable gas. 386

835 Although final labeling is not required for 510(k) clearance, final labeling must comply with 84the requirements of 21 CFR 801 before a medical device is introduced into interstate commerce. 85In addition, final labeling for prescription medical devices must comply with 21 CFR 801.109. 86Labeling recommendations in this guidance are consistent with the requirements of part 801 and 87section 809.10. 88 89 10 90 Contains Nonbinding Recommendations 91 Draft - Not for Implementation 92 93

387Appendix I Abbreviations 388 ASTM American Society for Testing and Materials CDC Centers for Disease Control and Prevention CDRH Center for Devices and Radiological Health CFR Code of Federal Regulations CPSC Consumer Products Safety Commission DSMICA Division of Small Manufacturers, International and Consumer Assistance ISO International Organization for Standardization NFPA National Fire Protection Association NIOSH National Institute of Occupational Safety and Health ODE Office of Device Evaluation OSHA Occupational Safety and Health Administration SMDA Safe Medical Devices Act of 1990 UL Underwriters Laboratory, Inc.

94 11 95 Contains Nonbinding Recommendations 96 Draft - Not for Implementation 97 98

389Appendix II. Summary Report Sample Formats 390You may use the following formats, as applicable to your device, for your summary report. 391Your acceptance criteria may be based on the performance characteristics of a legally marketed 392predicate. If possible, you should provide the 510(k) number for the predicate. We recommend 393that the predicate device(s) you choose be as close in intended use, design, and technology to the 394new surgical mask as possible. 395 396For surgical masks that are not certified N95 Respirators we recommend the format below. Acceptance Criteria or Performance Characteristics Test Method Results Fluid Resistance Performance (mmHg) Filter Efficiency Performance (microns) Bacterial Filtration Efficiency Performance (%) Differential Pressure (Delta-P)

Flammability class

397 398For surgical masks that are certified N95 Respirators Acceptance Criteria or Performance Characteristics Test Method Results Fluid Resistance Performance (mmHg)

Flammability class

99 12 100 Contains Nonbinding Recommendations 101 Draft - Not for Implementation 102 103 400Surgical Mask Guidance 401 402Drafted: F. Marshall 2/26/01 403Commented: C. Lin 4/19/02 404Revised: F. Marshall 6/22/01 405Commented: T. Ulatowski 7/27/01 406Revised: F. Marshall 8/3/01 407Commented: C. Lin 9/1/01 408Revised: F. Marshall 9/7/01 409Edited: C. Lin 9/19/01 410Revised: F, Marshall 11/21/01 411Edited: C. Lin 1/12/-02 412Revised: F. Marshall 2/22/02 413Edited: C. Lin 6/16/02 414Revised F. Marshall 7/26/02 415Edited: C. Lin 8/26/02 416Revised: F. Marshall 9/23/02 417Edited: C. Lin 9/30/02 418Revised: F. Marshall 10/17/02 419Edited: T. Ulatowski 10/23/02 420Edited: T. Ulatowski 12/4/02 421Revised: F. Marshall 12/5/02 422Final: F. Marshall 1/30/03 423Final : Hawthorne 3/3/03 424 425 426 427 428 429 430 431 432

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