Therapeutic Products Programme Programme des produits thérapeutiques OUR MISSION: To ensure that the drugs, medical devices, NOTRE MISSION: Faire en sorte que les médicaments, lesmatériels and other therapeutic products available in Canada are safe, médicaux et les autres produits thérapeutiques disponibles au Canada effective and of high quality. soient sûrs, efficaces et de haute qualité. Therapeutic Products Programme Keyword Index To Assist Manufacturers In Verifying The Class of Medical Devices For more information please contact: Don Boyer Licensing Services Division Medical Devices Bureau 1605 Statistics Canada Main Building, Postal Locator: 0301H1 Tunney’s Pasture, Ottawa, Ontario K1A 0L2 phone: (613) 957-7090 fax: (613) 954-7666 e-mail: [email protected] Therapeutic Products Programme Medical Device Keyword Index DRAFT Introduction The Medical Device Keyword Index was prepared to assist manufacturers in verifying the device class for products after application of the Classification Rules for Medical Devices of the Medical Devices Regulations. The Index should also be used in conjunction with the guidance document “Guidance For The Risk Based Classification System, GD006/RevDR-MDB.” Please note that this document is provided as a guide and that in the event of any discrepancy between this guide and the Classification Rules for Medical Devices of the Medical Devices Regulations, the latter shall prevail. What is a Keyword Index? The Medical Device Keyword Index is an alphabetical listing of all the words which appear in all the short descriptors for all the device groups that have been identified by the Medical Devices Bureau. It contains synonyms and industry words that are commonly used to describe the products in these device groups. The listing consists of the following four fields: Keyword, Preferred Name Code or PNC, Risk Class, and Description, in the following order and format: Keyword Pref Name (PNC) Risk Class Description Pump 80FRN 3 Pump, Infusion Definitions Keyword means all the words which appear in the short descriptors for all the generic device groups as well as synonyms and industry words that are commonly used to describe these device groups. PNC or Preferred Name Code is a five digit alpha numeric code (2-numeric and 3-alpha) which represents a device group. The three letters designate the specific device group and the two numbers represent the medical specialty in which it is routinely, but not necessarily exclusively, used. These codes are harmonized with the USFDA as much as is feasible. 73 - Anaesthesiology 80 - General Hospital & Personal Use 90 - Radiology 79 - General & Plastic Surgery 84 - Neurology 74 - Cardiovascular 85 - Obstetrics & Gynaecology 76 - Dental 86 - Ophthalmology 77 - Ear, Nose and Throat 87 - Orthopaedics 78 - Gastroenterology & Urology 89 - Physical Medicine File: KWINDXV2.WPD January 14, 2000 Page 1 of 2 Therapeutic Products Programme Medical Device Keyword Index DRAFT Risk Class is a number from 1 to 4, with 4 representing the highest risk classifiction, determined by the Medical Devices Bureau as representative of the majority of products currently on the database and assigned this device group code (PNC). Description is a string of two or more words that defines a device group. Electronic Formats of the Keyword Index The electronic version of the Keyword Index database contains over 10,000 lines of information and is presented in PDF format. How to use the Keyword Index Instructions: Copy the PDF file to your computer. To search for a device group in the PDF file, go to Tools / Find and enter either the Keyword, PNC or Description you are searching for in the “Find What” field. It must be noted that the device class assigned to a device group is only indicative of what class the majority of this type of device will be. It is not an exact determination. It is the responsibility of each manufacturer to use the Classification Rules for Medical Devices of the Medical Devices Regulations to determine the class of a specific device. e.g. tracheostomy tube (73BTO) The majority of these devices are Class II by rule 2(1). However, if a manufacturer claims the device can be left in place for longer than 30 days, the device class becomes Class III, by rule 2(3). File: KWINDXV2.WPD January 14, 2000 Page 2 of 2 Date: 2000/01/20 Medical Device Keyword Index Page 1 of Pages 144 Keyword Pref Risk Description Name Class 6MM 74DSY 4 PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER 74DYF PROSTHESIS, VASCULAR GRAFT, OF LESS THAN 6MM DIAMETER A-V 78KNR 2 ADAPTER, A-V SHUNT OR FISTULA 78FIQ 3 CANNULA, A-V SHUNT ABBEY 79RHW 1 HOLDER, NEEDLE, OTHER ABDOMINAL 89EXP 1 BELT, ABDOMINAL 80FSD BINDER, ABDOMINAL 78SCC TROCAR, ABDOMINAL 85HEE 3 CHAMBER, DECOMPRESSION, ABDOMINAL ABDUCTION 87AMM 1 IMMOBILIZER, HIP, POST-OP, ABDUCTION 89IOZ SPLINT, ABDUCTION, CONGENITAL HIP DISLOCATION 87WUU SPLINT, ABDUCTION, SHOULDER ABLATION 74AAF 4 SUCTION ABLATION CATHETER SYSTEM (SAC) ABORTION 85KNB 1 INSTRUMENT, DESTRUCTIVE, FETAL, OBSTETRIC 85HHI 2 SYSTEM, ABORTION, VACUUM ABRASIVE 76EJR 1 AGENT, POLISHING, ABRASIVE, ORAL CAVITY 76EHJ DISK, ABRASIVE 76EHL POINT, ABRASIVE ABSORBABLE 79LMG 3 ABSORBABLE HEMOSTATIC AGENTS NON-COLLAGEN BASED 74AAQ ANASTOMOSIS DEVICE FOR MICROVASCULAR SURGERY 85MCN BARRIER, ABSORBABLE, ADHESION 79ACN CLIP, LIGATING ABSORBABLE 87MAI FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE 86HQJ IMPLANT, ABSORBABLE, (SCLERAL BUCKLING METHOD) 87MNU STAPLE, ABSORBABLE 79GAK SUTURE, ABSORBABLE 79GAM SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID 79LMF 4 ABSORBABLE HEMOSTATIC AGENTS, COLLAGEN BASED ABSORBENT 80FOR 1 APPLICATOR, ABSORBENT TIPPED 80FRL MEDICAL, ABSORBENT FIBER 73CBL 2 ABSORBENT, CARBON-DIOXIDE ABSORBER 73BSF 2 ABSORBER, CARBON-DIOXIDE ABSORPTION 79KOZ 1 BEADS, HYDROPHILIC, FOR WOUND EXUDATE ABSORPTION 73BSF 2 ABSORBER, CARBON-DIOXIDE AC 76EFD 1 AMALGAMATOR, DENTAL, AC-POWERED 80FNL BED, AC-POWERED ADJUSTABLE HOSPITAL 86HJO BIOMICROSCOPE, SLIT-LAMP, AC-POWERED 86HKI CAMERA, OPHTHALMIC, AC-POWERED 86HME CHAIR, OPHTHALMIC, AC-POWERED 86HPQ HEADLAMP, OPERATING, AC-POWERED 86HLM INSTRUMENT, MEASURING, LENS, AC-POWERED 86HLQ KERATOSCOPE, AC-POWERED 80FNG LIFT, PATIENT, AC POWERED 79HRM MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC 86HLI OPHTHALMOSCOPE, AC-POWERED 86HOO PERIMETER, AC-POWERED 86HLG PUPILLOMETER, AC-POWERED 86HKL RETINOSCOPE, AC-POWERED 86HOK SCREEN TANGENT, PROJECTION AC-POWERED 86HOM SCREEN, TANGENT, AC-POWERED (CAMPIMETER) 86HMF STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC 86HJQ STEREOSCOPE, AC-POWERED 87JEA TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED 79JCX 2 APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED 86HRG ENGINE, TREPHINE, ACCESSORIES, AC-POWERED 76EKX HANDPIECE, DIRECT DRIVE, AC-POWERED 87HWE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND 86HNO KERATOME, AC-POWERED 86HPO MAGNET, AC-POWERED 86HIX MAXWELL SPOT, AC-POWERED 79GEY MOTOR, SURGICAL INSTRUMENT, AC-POWERED 86HRD STERILIZER, SOFT LENS, THERMAL AC POWERED 73BXM STIMULATOR, NERVE, AC-POWERED 86HKX TONOMETER, AC-POWERED 86HRO UNIT, ELECTROLYSIS, AC-POWERED, OPHTHALMIC 86HQE 3 INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED AC-POWERED 76EFD 1 AMALGAMATOR, DENTAL, AC-POWERED 80FNL BED, AC-POWERED ADJUSTABLE HOSPITAL 86HJO BIOMICROSCOPE, SLIT-LAMP, AC-POWERED 86HKI CAMERA, OPHTHALMIC, AC-POWERED 86HME CHAIR, OPHTHALMIC, AC-POWERED 86HPQ HEADLAMP, OPERATING, AC-POWERED 86HLM INSTRUMENT, MEASURING, LENS, AC-POWERED Date: 2000/01/20 Medical Device Keyword Index Page 2 of Pages 144 Keyword Pref Risk Description Name Class 86HLQ KERATOSCOPE, AC-POWERED 80FNG LIFT, PATIENT, AC POWERED 79HRM MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC 86HLI OPHTHALMOSCOPE, AC-POWERED 86HOO PERIMETER, AC-POWERED 86HLG PUPILLOMETER, AC-POWERED 86HKL RETINOSCOPE, AC-POWERED 86HOK SCREEN TANGENT, PROJECTION AC-POWERED 86HOM SCREEN, TANGENT, AC-POWERED (CAMPIMETER) 86HMF STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC 86HJQ STEREOSCOPE, AC-POWERED 85HDD TABLE, OBSTETRICAL, AC POWERED (AND ACCESSORIES) 87JEA TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED 79JCX 2 APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED 86HRG ENGINE, TREPHINE, ACCESSORIES, AC-POWERED 76EKX HANDPIECE, DIRECT DRIVE, AC-POWERED 87HWE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND 86HNO KERATOME, AC-POWERED 86HPO MAGNET, AC-POWERED 86HIX MAXWELL SPOT, AC-POWERED 79GEY MOTOR, SURGICAL INSTRUMENT, AC-POWERED 86HRD STERILIZER, SOFT LENS, THERMAL AC POWERED 73BXM STIMULATOR, NERVE, AC-POWERED 86HKX TONOMETER, AC-POWERED 86HRO UNIT, ELECTROLYSIS, AC-POWERED, OPHTHALMIC 86HQE 3 INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED ACCELERATOR 90IYE 3 ACCELERATOR, LINEAR, MEDICAL ACCESS 78LTH 3 GRAFT, VASCULAR ACCESS 80LMP PORT & CATHETER, SUBCUTANEOUS, INTRASPINAL 74QHK 4 KIT, CATHETERIZATION, CARDIAC ACCESSORIES 78FEB 1 ACCESSORIES, CLEANING, FOR ENDOSCOPE 80WQD ACCESSORIES, LASER 79FWZ ACCESSORIES, OPERATING ROOM, TABLE 78FEM ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT 89ILZ ACCESSORIES, TRACTION 87HXF ACCESSORIES, TRACTION (CART, FRAME, CORD, WEIGHT) 89KNO ACCESSORIES, WHEELCHAIR 79FTA LIGHT, SURGICAL, ACCESSORIES 79HRM MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC 80KCT PACK, STERILIZATION WRAPPER, BAG AND ACCESSORIES 79GDR SAW, MANUAL AND ACCESSORIES 79KQM SURGICAL CAMERAS AND ACCESSORIES 85HDD TABLE, OBSTETRICAL, AC POWERED (AND ACCESSORIES) 85HHP TABLE, OBSTETRICAL, MANUAL (AND ACCESSORIES) 87JEA TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED 87JEB