Heyman Packing Applicator Set (GM11004580)

{0}------------------------------------------------ August 30, 2024 Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Varian Medical Systems, Inc. Lynn Allman Sr. Director, Regulatory Affairs 3100 Hansen Way Palo Alto, California 94304 Re: K241386 Trade/Device Name: Heyman Packing Applicator Set (GM11004580) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: July 29, 2024 Received: July 30, 2024 Dear Lynn Allman: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming {1}------------------------------------------------ product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Lora Werner Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K241386 Device Name Heyman Packing Applicator Set (GM11004580) Indications for Use (Describe) The 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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Submitter's Name Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304 > Contact Name: Lynn, Allman, PhD., Senior Director Regulatory Affairs Phone: (650) 424-5369 E-mail: submissions.support@varian.com Date Prepared: May 15th, 2024 #### II. Device Information Proprietary Name: Heyman Packing Applicator Set (GM11004580) Classification Name: Remote Controlled Radionucleotide Applicator System Regulation Number: §892.5700 Product Code: JAQ #### III. Predicate Device Heyman Packing Applicator Set (K160045) #### 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 an applicator for intracavitary Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide 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. The Heyman Packing Applicator Set includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Varian logo, with the word "Varian" in bold, sans-serif font. Below the logo, in a smaller font size, is the text "A Siemens Healthineers Company". The logo is simple and modern, with a focus on the company name and its affiliation with Siemens Healthineers. The key performance characteristics of this applicator set are as follows: - Simulates the classic Heyman packing technique ● - 4 mm, 6 mm, and 8 mm diameter capsules for optimal packing of the uterine cavity - . Mandrins stabilize the applicators during insertion - CT Compatible - . MR Safe-without mandrins inserted - Material is biocompatible for intracavitary use - . Leak stop channel markers allow for channel number coding - Reusable and steam sterilizable - Compatibility with all Varian afterloader systems - Suitable for patient contact for a period of less than 30 days #### V. Intended Use The Heyman Packing Applicator Set is intended for use when performing HDR or PDR brachytherapy. #### VI. Indications for Use The Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy. #### VII. Comparison of Technological Characteristics with the Predicate Device ### Table 1: Comparison of Subject Device to Predicate Device | FEATURE AND/OR<br>SPECIFICATION OF<br>NEW/MODIFIED DEVICE | CLEARED DEVICE<br>FEATURE/SPECIFICATION<br>510(k) ID # K160045<br>HEYMAN PACKING APPLICATOR SET | NEW / MODIFIED DEVICE NAME<br>HEYMAN PACKING APPLICATOR<br>SET (GM11004580) | COMPARISON | |------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Compatible<br>Afterloader | GammaMedplus Afterloader<br>series<br>VariSource Afterloader series | GammaMedplus<br>Afterloader series<br>VariSource Afterloader<br>Series<br>BRAVOS Afterloader System | Device is compatible with<br>the BRAVOS Afterloader<br>System, it is just now being<br>included in the labelling for<br>completeness. | | Intended use | The Heyman Packing<br>Applicator Set is intended for<br>cancer treatment of the<br>endometrium. | The Heyman Packing<br>Applicator Set is intended<br>for use when performing<br>HDR or PDR brachytherapy. | The intended use was<br>amended to accurately<br>reflect the use of the<br>packing applicator set for<br>general HDR or PDR<br>brachytherapy procedures.<br>The indications for use<br>remain the same which<br>ensures that the device is<br>being used appropriately<br>for the therapeutic<br>indication for which it is<br>intended The indication for | | | | | use statement has not<br>changed and limits the<br>clinical use of the set to<br>endometrial cancer using<br>HDR or PDR brachytherapy.<br>Furthermore, the risk<br>review for the Heyman<br>Packing Applicator Set did<br>not identify any new risks as<br>a result of this change; | | Indications for Use | The Heyman Packing<br>Applicator Set is indicated for<br>use for treating endometrial<br>cancer using HDR or PDR<br>brachytherapy. | No change | Same | | Design | Heyman capsules:<br>- 320 mm length<br>- various capsule<br>- diameters of 4mm,<br>6mm and 8mm and<br>length of 17.5 mm<br>Mandrin:<br>- 320 mm length | No change | Same | | Materials | Heyman capsules: PEEK,<br>Titanium<br>Mandrin: Stainless Steel | Heyman capsules: PEEK<br>Mandrin: Stainless Steel | This change has not<br>identified any new or<br>increased biocompatibility<br>or safety concerns and does<br>not impact the performance<br>specifications of the subject<br>device. | | Packing | Individual | No change | Same | | Sterility | Provided non-sterile | No change | Same | | Sterilization<br>method | Manual and Machine<br>Cleaning, Disinfection, and<br>Steam Sterilization | Manual or machine cleaning<br>and disinfection.<br>Steam sterilization with<br>common parameters using<br>Pre-vacuum sterilization. | These changes were<br>cumulatively made as part<br>of a process improvement<br>initiative and is used to<br>emphasize proper<br>sterilization of the subject<br>device. This does not<br>impact the risk profile of<br>the subject device. | | Biocompatibility | Fully biocompatible | No change | Same | | Anatomical sites | Endometrium | No change | Same | | Compatibility with<br>the environment<br>and other devices | CT compatible<br>MR-Conditional | CT compatible<br>MR-Safe | This change was made to<br>enhance the usability and<br>flexibility of use in the<br>intended population | | Where used | Brachytherapy treatment<br>room | No change | Same | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the logo is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern, and the text clearly identifies Varian as part of the Siemens Healthineers group. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is written in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern. #### VIII. Summary of Performance Testing (Non-Clinical Testing) The following performance data was provided in support of the substantial equivalence determination. ### Biocompatibility Testing: The compatibility of the skin-contact component material in the finished product meets the biocompatibility requirements. The Biological Evaluation Tests are in compliance with the standards of ISO 10993-1 and its applicable parts, "Biological Evaluation of Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process". ### Magnetic Resonance Testing (MR): MR Compatibility testing was completed, and documentation was provided to FDA in support of the substantial equivalence determination. The Heyman Packing Applicator Set is MR Safe and comply with the following MR standard: - ASTM F2503-23 (2023 ED): Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment ### Cleaning, Disinfection and Sterilization Testing: Cleaning, disinfection and sterilization testing was conducted to demonstrate the device components may be sterilized effectively (as appropriate) and the device can be used and sterilized for the specified number of times. A human factors validation study was conducted according to the standard IEC 62366 to verify that the device performs well as intended for the intended users, uses, and use environments. ### Mechanical and Acoustic Testing: The Heyman Packing Applicator Set has undergone formal design verification and design validation testing. Design verification and design validation testing demonstrates that the device performs as intended. Design verification and design validation testing was performed according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System Standard, and ISO 14971 Risk Management Standard. ### Use of Consensus Standards: The following list of FDA-recognized, voluntary consensus standards were utilized in the design and evaluation of the subject device's safety and efficacy. ### 510(k) Summary {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern. | Standard / CS | Standard / CS Title | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | EN ISO 13485:2016 | Quality management systems. Requirements for regulatory purposes | | EN ISO<br>14971:2019+A11:2021 | Medical devices - Application of risk management to medical devices (ISO 14971:2019) | | EN ISO 15223-1:2021 | Medical devices - Symbols to be used with medical device labels, labelling and<br>information to be supplied - Part 1: General requirements | | EN ISO 20417:2021 | Information supplied by the manufacturer of medical devices | | EN 62366-1:2015+A1:2020 | Application of Usability Engineering to Medical Devices | | EN ISO 17664-1:2021 | Processing of health care products-Information to be provided by the medical device<br>manufacturer for the processing of medical devices | | EN ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the<br>development, validation and routine control of a sterilization process for medical devices | | EN ISO 10993-1:2020 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk<br>management process. | | EN ISO 10993-2:2022 | Biological evaluation of medical devices. - Part 2: Animal welfare requirements | | EN ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity<br>and reproductive toxicity | | EN ISO 10993-5:2009 | Biological evaluation of medical devices - part 5: Tests for in vitro cytotoxicity | | EN ISO 10993-10:2023 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin<br>sensitization | | EN ISO 10993-11:2018 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | | EN ISO 10993-12:2021 | Biological evaluation of medical devices - Part 12: Sample preparation and reference<br>materials | | EN ISO 10993-17:2009 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for<br>leachable substances | | EN ISO 10993-<br>18:2020+A1:2023 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical<br>device materials within a risk management process | | EN ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for irritation | | EN 60601-1:2006/A1:2013 | Medical Electrical Equipment Part 1- General Requirements For Safety and essential<br>performance | | EN 60601-2-17:2015 | Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and<br>essential performance of automatically-controlled brachytherapy after loading<br>equipment | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is black and white. #### IX. Determination of Substantial Equivalence to the Predicate The Heyman Packing Applicator Set was originally marketed as MR Conditional, but has now completed the testing to be classified as MR Safe. The intended use was amended to accurately reflect the use of the packing applicator set for general HDR or PDR brachytherapy procedures. The indications for use remain the same which ensures that the device is being used appropriately for the therapeutic indication for which it is intended. The indication for use statement has not changed and limits the clinical use of the set to endometrial cancer using HDR or PDR brachytherapy. Furthermore, the risk review for the Heyman Packing Applicator Set did not identify any new risks as a result of this change. There are no changes in the design or principle of operation of the devices. Varian believes the major technological characteristics are substantially equivalent to the predicate device. The results of verification and validation as well as conformance to relevant safety standards demonstrate that the device meets the safety and performance criteria. Varian considers the Heyman Packing Applicator Set to be substantially equivalent to the predicate device.