Bard Brachysource125 Implants Model # STM1251

Information for Use

TheraSeed® Palladium-103 Seeds, Sterile RADIONUCLIDE BRACHYTHERAPY SOURCE: Model 200

Sterile Presentation Prepared by: Model 200 Palladium-103 Seed Manufactured By: Bard Brachytherapy, Inc. Theragenics Corporation Carol Stream, IL 60188 USA Buford, GA 30518 www.bardmedical.com (770) 271-0233 800-977-6733

PK0304826 07/2016

Single Use Caution

Do not use if package is damaged. Do Not Re-sterilize

Caution: Federal law restricts this device Sterilized using irradiation to sale by or on the order of a physician. Only

Caution: After use, this product may Caution: Radioactive materials be a potential biohazard. Handle and dispose of in accordance with accepted Palladium-103 medical practice and applicable local, state and federal laws and regulations.

Use By

Serial Number Reference Number

DESCRIPTION See manufacturer’s Instructions for Use for the Palladium-103 seed and for any additional components included with the order. Presentation INDICATIONS Palladium-103 Seeds, Sterile are brachytherapy seeds containing Palladium- 103, provided sterile for implantation. Palladium-103 Seeds, Sterile See manufacturer’s Instructions for Use for the Palladium-103 seed and for can be provided in the following configurations per physician any additional components included with the order. request:

A. Loose within a screw-cap vial B. Loaded with BARD® SOURCELINK™ Connectors synthetic absorbable seeding spacer links or with CP Medical BioSpacer™ synthetic spacers in a requested patient-specific order within brachytherapy implant needles or in trays C. Loaded into Mick® cartridges (1-20 Palladium-103 brachytherapy seed implants per cartridge) designed for use with the Mick ® 200-TPV Applicator and with applicator implant needles or cartridges supplied for use by BARD. Please refer to the additional enclosed Instructions for Use for the Palladium-103 seed itself and for the Instructions for Use for the other presentation components assembled as part of the customer order for further information. All components are provided sterile. The customer should inspect the package contents prior to implantation to verify that the order has been properly prepared per the customer’s instructions.

Physical Characteristics

See manufacturer’s Instructions for Use for the Palladium-103 seed and for any additional components included with the order.

In-Vivo Characteristics

Information for Use

CONTRAINDICATIONS See manufacturer’s Instructions for Use for the Palladium-103 seed and for STERILIZATION any additional components included with the order. Palladium-103 Seeds, Sterile are supplied sterile. Loose seeds and seeds WARNINGS AND PRECAUTIONS loaded in Mick® cartridges may be resterilized per original manufacturer’s instructions. All other sterile presentations must not be resterilized. Warning: Brachytherapy seed implants contain radioactive materials. PATIENT INFORMATION

Brachytherapy seed implants, like all radioactive materials, must be BRACHYSOURCE® Seed Implants are radioactive. Prior to performing an handled with care. Appropriate safety measures should be used to minimize implant, patients should be informed about radiation safety procedures and exposure to clinical personnel. Personnel monitoring is required. Typically the expected time during which such precautions should be taken. See the a film badge or TLD dosimeter worn on the body and a ring badge(s) is manufacturer’s Instructions for Use for the Palladium-103 seed and for any adequate. Care should be taken to minimize radiation exposure to patients additional components included with the order for further information. and other individuals consistent with proper therapeutic management. During the implantation procedure, all practical steps should be employed ADMINISTRATION AND DOSAGE to maintain radioactive exposure as low as reasonably achievable. In circumstances such as surgery when protective barriers are not practical, Established practice should be followed for the calculation of the total operators must rely upon proper use of applicators, distance and speed to activity to be implanted, the evaluation of the radiation dose distribution minimize radiation exposure. Initiate radiation surveys on all components and the proper placement of the brachytherapy seed implants within the upon completion of the seed implant. tissue. The tumor volume, nature of the Palladium-103 seed and the previous radiation history of the tumor site should be considered for the Caution: Biohazard total activity calculation for any given treatment. Brachytherapy seed implants contain radioactive materials, so the effects of isotope decay After use, the brachytherapy seed implants and accessories are potential should be calculated within any treatment plan. See the manufacturer’s biohazards. Handle and dispose of in accordance with acceptable medical Instructions for Use for the Palladium-103 seed and for any additional practice and with applicable laws and regulations. components included with the order for further information. Caution: Restrictions on Use:

Brachytherapy seed implants and accessories should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclide brachytherapy sources and whose experience and training has been approved by the appropriate government authorities authorized to license the use of radioactive materials. Brachytherapy seed implants should be used in those facilities that have been approved by the appropriate government authorities authorized to license the use of radioactive materials.

Caution:

See manufacturer’s Instructions for Use for the Palladium-103 seed and for any components included with the order for additional warnings and precautions.

ADVERSE REACTIONS

LICENSING

The Illinois Emergency Management Agency (IEMA), Division of Nuclear Safety has approved Palladium-103 Seeds, Sterile for distribution to persons pursuant to 32Ill. Adm. Code, Sec. 330.260(a) and 32Ill. Adm. Code Sec. 335.7010, or under equivalent licenses of the NRC, an Agreement State and [outside the United States] to persons authorized by the appropriate authority. See manufacturer’s Instructions for Use for the Palladium-103 seed and for any additional components included with the order for further information.

BIOCOMPATIBILITY

LEAK TESTING

See manufacturer’s Instructions for Use for the Palladium-103 seed.

INSTRUCTIONS FOR USE

Palladium-103 Seeds, Sterile are supplied sterile. During the treatment procedure, the patient must be appropriately anesthetized. A qualified practitioner may place the Palladium-103 Seeds, Sterile throughout the tumor volume according to a treatment plan for geometric arrangement. See the manufacturer’s Instructions for Use for the Palladium-103 seed and for any additional components included with the order for further information.

Information for Use

ACCOUNTABILITY AND DISPOSAL

Palladium-103 is an accountable radioactive material. Brachytherapy seed implants containing Palladium-103 should be strictly controlled and stored in a locked safe. If any radioactive material cannot be accounted for, the loss must be reported to the appropriate licensing agency.

Records of receipt, storage and disposal of brachytherapy seed implants containing Palladium-103 must be maintained in accordance with requirements of the appropriate government regulatory agencies. When disposal is indicated, brachytherapy seed implants containing Palladium-103 should be transferred to an authorized radioactive waste disposal agency. Brachytherapy seed implants containing Palladium-103 should never be disposed of in normal waste.

Contact Bard Brachytherapy Customer Service, 800-977-6733 for assistance with questions regarding disposal of unused brachytherapy seed implants.

Bard, BrachySource and SourceLink are trademarks and/or registered trademarks of C. R. Bard, Inc. CP Medical and BioSpacer are trademarks of CP Medical Corporation. Mick is a registered trademark of Mick RadioNuclear Instruments, Inc. TheraSeed is a registered trademark of the Theragenics Corporation.