Catheter Surface Flap Applicator Set (GM11011830)

{0}------------------------------------------------ October 29, 2024 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size. Varian Medical Systems Lynn Allman Sr. Director Regulatory Affairs 3100 Hansen Way Palo Alto, California 64304 ## Re: K241965 Trade/Device Name: Catheter Surface Flap Applicator Set (GM11011830) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: October 2, 2024 Received: October 2, 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 (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" {1}------------------------------------------------ (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 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 (OS) 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-regulatory {2}------------------------------------------------ assistance/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, Locon Weidner 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 Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K241965 Device Name Catheter Surface Flap Applicator Set (GM11011830) Indications for Use (Describe) The Catheter Surface Flap Applicator Set is intended for use for skin cancer treatment using HDR or PDR brachytherapy. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/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. # Premarket Notification – K241965 510(k) Summary Traditional 510(k) Submission for Catheter Surface Flap Applicator Set #### l. 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: July 3, 2024 #### II. Device Information Proprietary Name: Catheter Surface Flap Applicator Set (GM11011830) Classification Name: Remote Controlled Radionucleotide Applicator System Regulation Number: §892.5700 Product Code: JAQ #### lll. Predicate Device GammaMedplus High Dose Rate Remote Afterloading System (K983436) #### IV. Device Description The Catheter Surface Flap Applicator Set qualifies as a medical device as it is used on human beings for the purpose of cancer treatment. The key performance characteristics of this applicator set are as follows: - Surface applicator intended for the treatment of skin cancers. - A 10mm thick flap allowing for up to 38 channels spaced at 5 mm allows for a large uniform ● treatment. - Hollow pattern design and semi translucent material provides good visibility of the treatment area. - The material high flexibility allows the applicator to conform closely to complex patient anatomies such as when treating nose or ear lesions. - Silicone material gives excellent biocompatibility and durability. - Single patient multiple use. - The Catheter Surface Flap is MR and CT compatible. - Patient-contacting parts constructed of silicone and Polyvinylchloride; suitably for patient contact for a period up to 24 hours. The Catheter Surface Flap Applicator Set is an applicator for 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. The treatment plan defines the positions and {5}------------------------------------------------ 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 fixation buttons are used for locking the mould probes in place after insertion in the catheter surface flap. Some of these are supplied in the fixation button kits but they are also available to be purchased separately as spares. As spares, they are packed in sterile pouches, with 10 pieces per pouch and sold as pack of 10 pouches respectively. #### V. Indications for Use The Catheter Surface Flap Applicator Set is intended for use for skin cancer treatment using HDR or PDR brachytherapy. #### VI. Comparison of Technological Characteristics with the Predicate Device | Feature<br>and/or<br>Specification | Predicate Device:<br>GammaMed plus High<br>Dose Rate Remote<br>Afterloading System<br>(K983436) | Subject Device: Catheter<br>Surface Flap Applicator Set | Comparison | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The intended use of<br>the GammaMed Plus<br>transportable high-<br>dose-rate remotedly<br>controlled afterloading<br>brachytherapy device is<br>for the treatment of<br>cancer by intracavitary,<br>interstitial,<br>intralumenal and<br>intraoperative<br>irradiation. | The Catheter Surface Flap<br>Applicator Set is intended<br>for use for skin cancer<br>treatment using HDR or PDR<br>brachytherapy. | Changed - Device will now be<br>registered as an individual<br>product (in the last 510(k)<br>the Catheter Surface Flap<br>was an accessory of<br>K983436). Accordingly the<br>intended use statement is<br>updated to be more specific<br>to the applicator set, rather<br>than the Afterloader with<br>which it is used.<br><br>This applicator's action is<br>exactly the same for High Dose<br>Radiation (HDR) treatment and<br>Pulse Dose Rate (PDR)<br>treatment. The only difference<br>with the HDR and PDR<br>treatments are fractions<br>delivered and some activity<br>level. Both treatments deliver<br>the source from the afterloader,<br>through the source guide tube<br>to the catheter surface flap and<br>to the patient treatment<br>location. | | Indications<br>for Use | The intended use of<br>the GammaMed Plus | The Catheter Surface Flap<br>Applicator Set is intended | Changed - Device will now be<br>registered as an individual | | | | | | | | transportable high-<br>dose-rate remotedly<br>controlled afterloading<br>brachytherapy device is<br>for the treatment of<br>cancer by intracavitary,<br>interstitial,<br>intralumenal and<br>intraoperative<br>irradiation. | for use for skin cancer<br>treatment using HDR or PDR<br>brachytherapy. | product (in the previous<br>510(k) the Catheter Surface<br>Flap was an accessory of<br>K983436). | | Compatible<br>Afterloader | GammaMedplus Series<br>VariSource Series (200<br>and iX) | GammaMedplus Series<br>BRAVOS Afterloader System | Changed - removal of<br>VariSource and addition of<br>BRAVOS | | | The comparison below compares the principal components of the subject device to the relevant accessories of the<br>K983436 predicate device. Refer to bolded text for the differences between components that are the subject of<br>this submission. Leak Stop Channel Marker Set and Cleaning Caps are covered in K152018. Mould probe with<br>mandrin is covered in K241764. | | | | Design | Catheter Flap:<br>200 mm x 290 mm x 10<br>mm<br>40 channels<br>2 mm channel<br>diameter<br>5 mm distance<br>between each<br>channel | Catheter Flap:<br>200 mm x 290 mm x 10<br>mm<br><b>38 channels</b><br>2 mm channel diameter<br>5 mm distance between<br>each channel<br><b>Hollow Pattern Design</b> | Changed - Now includes<br>updated Catheter Flap<br>component. | | | Mould probe with<br>mandrin:<br>ø 1.8 mm, 320 mm<br>length | Mould probe MR Safe with<br>mandrin:<br>ø 1.8 mm, 320 mm length | Updated Mould Probe (now<br>MR Safe) covered in<br>K241764. | | | Fixation Button,<br>radiopaque, pack of<br>100, non-sterile:<br>3 mm length<br>Outer diameter 4.2<br>mm<br>Inner diameter 1.2 mm | Fixation Button, pack of<br>10x10, <b>sterile:</b><br>3 mm length<br>Outer diameter 4.2 mm<br>Inner diameter <b>1.4 mm</b><br><br>Leak Stop Channel Marker<br>Set:<br>2 mm length<br>Outer diameter 10 mm<br>Inner diameter 1 mm<br><br>Cleaning Caps:<br>11 mm length<br>Outer diameter 5.07 mm<br>Inner diameter 2.03 mm | Now includes sterile fixation<br>buttons as components<br>which differ in shore<br>hardness and inner diameter.<br><br>Now includes Leak Stop<br>Channel Marker Set and<br>Cleaning Caps as components<br>of the set (separately cleared<br>K152018). | | Materials | Catheter Flap: Silicone<br>(ALPA-SIL CLASSIC<br>Komponente A+B) | Catheter Surface Flap:<br>Silicone (75% Sorta Clear 18<br>and 25% of ECOflex Gel) | Changed – The Flap material<br>is changed from ALPA-SIL<br>CLASSIC Komponente A+B to | | | Mould probe: PA,<br>Titanium<br>Mandrin: Stainless<br>Steel<br>Fixation Button: PVC | Mould probe: PA, PEEK<br>Mandrin: Stainless Steel<br>Fixation Button: PVC<br>Leak Stop Channel Markers:<br>Silicone<br>Cleaning caps: Silicone | Sorta Clear 18 and 25% of<br>ECOflex Gel in order to have<br>a biocompatible applicator. | | Environment | Brachytherapy<br>treatment room | Brachytherapy treatment<br>room | No Change | Table 1: Comparison of Subject Device to Predicate Device {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, sans-serif font. The logo is in black and white. {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, sans-serif font. The logo is black and white. #### VII. 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". ## 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. 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: Catheter Surface Flap 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. | ANSI/AAMI/ISO<br>14971:2019 | Medical devices – Applications of risk management to medical devices | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | EN ISO 15223-1:2021 | Medical devices – Symbols to be used with the information to be supplied by the<br>manufacturer – Part 1: General requirements | | EN ISO 20417: 2021 | Information supplied by the manufacturer of medical devices | | IEC 62366-<br>1:2015+A1:2020 | Application of Usability Engineering to Medical Devices | | ANSI/AAMI ST98:2022 | Cleaning Validation of health care products -cleaning process for medical devices | | ANSI / AAMI<br>ST79:2017(R)2022 | Comprehensive guide to steam sterilization and sterility assurance in health care<br>facilities | | 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 -Part 1: Critical and semi-critical<br>medical devices | | EN ISO 11607-1:2020 | Packaging for terminally sterilized medical devices -Part 1: Requirements for materials,<br>sterile barrier systems and packaging systems | | 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<br>devices | | ISTA 3A (2018) | General Simulation Performance Tests for packaged-products weighing 150 lb. (70 kg)<br>or less (standard, small, flat or elongated) | | EN ISO 10993-1:2020 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk<br>management process. | | EN ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | | EN ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin<br>sensitization | | ISO 10993-11:2017 | 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 | | ISO 10993-18:2020/<br>AMD 1:2022 | Biological evaluation of medical devices -- Part 18: Chemical characterization of<br>medical device materials within a risk management process | | EN ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for irritation | | IEC 60601-2-17:2013 | Medical electrical equipment - Part 2-17: Particular requirements for the basic safety<br>and essential performance of automatically-controlled brachytherapy after loading<br>equipment | | ASTM F2503-23 | Standard Practice for Marking Medical Devices and Other Items for Safety in the<br>Magnetic Resonance Environment | | ASTM D4332-22 | Standard Practice for Conditioning Containers, Packages, or Packaging Components for<br>Testing | | EN ISO 10993-2:2022 | Biological evaluation of medical devices. -Part 2: Animal welfare requirements | | EN ISO 10993-17:2023 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for<br>leachable substances | {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 font. The logo is simple and professional. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is 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 in black and white. #### VIII. Determination of Substantial Equivalence to the Predicate Catheter Surface Flap Applicator Set was previously sold as an accessory for the GammaMedplus High Dose Rate Remote Afterloading System (K983436). 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 as well as conformance to relevant safety standards demonstrate that the device meets the safety and performance criteria. Varian considers the Catheter Surface Flap Applicator Set to be substantially equivalent to the predicate device.