Heyman Packing Applicator Set

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 17, 2016 Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304 Re: K160045 Trade/Device Name: Hevman Packing Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: November 3, 2016 Received: November 4, 2016 Dear Mr. Coronado: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K160045 Device Name Heyman Packing Applicator Set Indications for Use (Describe) Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Corporate Headquarters 3100 Hansen Way Palo Alto, CA 94304-1038 Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com # 510k Summary # 510(k) Submission for Heyman Packing Applicator Set As required by 21 CFR 807.92, Reference: FDA's Guidance Document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (June 2014). #### l. SUBMITTER | Submitter's Name: | Varian Medical Systems<br>3100 Hansen Way, m/s E-110<br>Palo Alto CA 94304-1038 | |-------------------|---------------------------------------------------------------------------------| | Contact Name: | Peter J. Coronado | | Position: | Director, Regulatory Affairs | | Phone: | 1.650.424.6230 | | Fax: | 1.650.646.9200 | | Email: | submissions.support@varian.com | | Date Prepared: | Thursday January 07, 2016 | #### II. DEVICE | Name of Device: | Heyman Packing Applicator Set | |--------------------|-----------------------------------------------------------------------| | Common/Usual Name: | System, Applicator, Radionuclide,<br>Remote-controlled | | Regulation Name: | Remote controlled radionuclide applicator<br>system (21 CFR 892.5700) | | Regulatory Class: | Class II | | Product Code: | JAQ | {4}------------------------------------------------ #### PREDICATE DEVICE . Name of Predicate: GammaMed Plus High Dose Rate Remote Afterloading System 510k Number: K983436 This predicate has not been subject to a design-related recall. K152018 (Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets) is used as a reference device for this submission. #### IV. DEVICE DESCRIPTION The Heyman Packing Applicator Set consists of various sized Heyman-capsules which may be connected to compatible brachytherapy afterloaders via guide tubes. The set also includes a number of associated accessories for sterilization (Cleaning Cap, Leak Stop Button, and Leak Stop Channel Marker Sets). The Heyman Packing Applicator Set is intended for cancer treatment of the endometrium using HDR or PDR brachytherapy. The Heyman Packing Applicator Set is an applicator for intracavitary Brachytherapy. The applicator acts to quide the radioactive source to the correct location or locations for treatment. The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization. This device is used on female patients. The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel. {5}------------------------------------------------ | Product Number | Component List | Associated<br>510(k) Number | |----------------|---------------------------------------------------------------|-----------------------------| | GM11005280 | Heyman-capsule, 4mm diameter x<br>17.5mm length, with mandrin | This 510(k) | | GM11005110 | Heyman-capsule, 6mm diameter x<br>17.5mm length, with mandrin | | | GM11005040 | Heyman-capsule, 8mm diameter x<br>17.5mm length, with mandrin | | | GM11010510 | Leak Stop Channel Marker Set, 1 - 12 | Cleared under<br>K152018 | | GM11003810 | Leak stop button, pack of 50 | | | GM11010770 | Cleaning Cap, dark blue (pack of 25) | | The associated accessories include: #### INDICATIONS FOR USE V. Indications for Use Statement: The Heyman Packing Applicator Set is indicated for cancer treatment of the endometrium using HDR or PDR brachytherapy. ### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Both the subject and predicate devices are intended for use in the treatment of cancer through intracavitary brachytherapy. The subject device is based on a subset of applicator accessories from the predicate device. {6}------------------------------------------------ At a high level, the subject and predicate devices are based on the following same technological elements: - Biocompatible Heyman-capsules of various sizes . - Application in intracavitary brachytherapy treatments ● - . Same anatomical treatment site/application - Sterilized by user prior to use (and reuses) . The following main differences exist between the subject and predicate devices: - Material change in the probe connect of the Heyman-capsule - . Validation of machine cleaning and the associated accessories - . Heyman capsules for the subject device are MR conditional - Added VariSource afterloader compatibility . #### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. # Non-Clinical Tests: ## Biocompatibility Testing: The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. This included the following tests: - . Cytotoxicity - Sensitization ● {7}------------------------------------------------ - Irritation - Systemic Toxicity ● - Subacute Toxicity ● - . Implantation The Heyman Packing Applicator Set is a surface device in contact with mucosal membrane and prolonged contact duration of 24 hours up to 30 days. ## Sterilization Testing: Sterilization testing was performed for the subject device was conducted to assess the effectiveness of the provided cleaning, disinfection, and sterilization procedures for the device. Furthermore, the components of the subject set were subjected to sterilization cycles up to the stated use life and evaluated for performance and any damage that might affect safety or effectiveness. - . Validation/Efficacy Testing of Cleaning, Disinfection, Sterilization Cycles - . Verification of the Suitability of Applicator Design and Material for the Stated Use Life and Reprocessing Cycles ## Electrical Safety and Electromagnetic Compatibility (EMC): This item is not applicable to the subject device. No electrical safety and electromaqnetic compatibility tests have been included in this submission in support of the substantial equivalence determination. ## Software Verification and Validation Testing: This item is not applicable to the subject device; the device does not contain or consist of software/firmware. No software verification and validation testing has been included in this submission in support of the substantial equivalence determination. ## Mechanical and Acoustic Testing: - MRI Safety Tests and Analysis ● {8}------------------------------------------------ - CT Compatibility Tests and Analysis ● - Validation with the VariSource afterloader series # Animal Study / Clinical Tests: No animal studies or clinical tests have been included in this submission in support of the substantial equivalence determination. # VIII. CONCLUSIONS The results of the non-clinical tests support the safety and effectiveness of the device under the specified use conditions. Varian believes that the validation and verification testing demonstrates that the subject device performs comparably to the predicate device, meeting the intended use.