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 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 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 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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Catheter Surface Flap Applicator Set (GM11011830)". This document is not a study proving a device meets acceptance criteria for an AI/ML algorithm. Instead, it's a submission to the FDA to demonstrate substantial equivalence to a predicate device, primarily focusing on materials, design, and intended use as an applicator for brachytherapy.

Therefore, I cannot extract the requested information because the document does not contain details about:

Acceptance criteria for an AI/ML device's performance.
A study involving a test set, training set, ground truth experts, or MRMC studies for an AI/ML algorithm.
Any mention of AI or machine learning.

The document discusses non-clinical performance testing for a physical medical device, including biocompatibility, cleaning/disinfection/sterilization, human factors validation, and mechanical/acoustic testing. These are typical tests for a physical medical device, not an AI/ML software device.

Summary

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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"

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(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

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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

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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)

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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.

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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.

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

Featureand/orSpecification	Predicate Device:GammaMed plus HighDose Rate RemoteAfterloading System(K983436)	Subject Device: CatheterSurface Flap Applicator Set	Comparison
Intended Use	The intended use ofthe GammaMed Plustransportable high-dose-rate remotedlycontrolled afterloadingbrachytherapy device isfor the treatment ofcancer by intracavitary,interstitial,intralumenal andintraoperativeirradiation.	The Catheter Surface FlapApplicator Set is intendedfor use for skin cancertreatment using HDR or PDRbrachytherapy.	Changed - Device will now beregistered as an individualproduct (in the last 510(k)the Catheter Surface Flapwas an accessory ofK983436). Accordingly theintended use statement isupdated to be more specificto the applicator set, ratherthan the Afterloader withwhich it is used.This applicator's action isexactly the same for High DoseRadiation (HDR) treatment andPulse Dose Rate (PDR)treatment. The only differencewith the HDR and PDRtreatments are fractionsdelivered and some activitylevel. Both treatments deliverthe source from the afterloader,through the source guide tubeto the catheter surface flap andto the patient treatmentlocation.
Indicationsfor Use	The intended use ofthe GammaMed Plus	The Catheter Surface FlapApplicator Set is intended	Changed - Device will now beregistered as an individual

	transportable high-dose-rate remotedlycontrolled afterloadingbrachytherapy device isfor the treatment ofcancer by intracavitary,interstitial,intralumenal andintraoperativeirradiation.	for use for skin cancertreatment using HDR or PDRbrachytherapy.	product (in the previous510(k) the Catheter SurfaceFlap was an accessory ofK983436).
CompatibleAfterloader	GammaMedplus SeriesVariSource Series (200and iX)	GammaMedplus SeriesBRAVOS Afterloader System	Changed - removal ofVariSource and addition ofBRAVOS
	The comparison below compares the principal components of the subject device to the relevant accessories of theK983436 predicate device. Refer to bolded text for the differences between components that are the subject ofthis submission. Leak Stop Channel Marker Set and Cleaning Caps are covered in K152018. Mould probe withmandrin is covered in K241764.
Design	Catheter Flap:200 mm x 290 mm x 10mm40 channels2 mm channeldiameter5 mm distancebetween eachchannel	Catheter Flap:200 mm x 290 mm x 10mm38 channels2 mm channel diameter5 mm distance betweeneach channelHollow Pattern Design	Changed - Now includesupdated Catheter Flapcomponent.
	Mould probe withmandrin:ø 1.8 mm, 320 mmlength	Mould probe MR Safe withmandrin:ø 1.8 mm, 320 mm length	Updated Mould Probe (nowMR Safe) covered inK241764.
	Fixation Button,radiopaque, pack of100, non-sterile:3 mm lengthOuter diameter 4.2mmInner diameter 1.2 mm	Fixation Button, pack of10x10, sterile:3 mm lengthOuter diameter 4.2 mmInner diameter 1.4 mmLeak Stop Channel MarkerSet:2 mm lengthOuter diameter 10 mmInner diameter 1 mmCleaning Caps:11 mm lengthOuter diameter 5.07 mmInner diameter 2.03 mm	Now includes sterile fixationbuttons as componentswhich differ in shorehardness and inner diameter.Now includes Leak StopChannel Marker Set andCleaning Caps as componentsof the set (separately clearedK152018).
Materials	Catheter Flap: Silicone(ALPA-SIL CLASSICKomponente A+B)	Catheter Surface Flap:Silicone (75% Sorta Clear 18and 25% of ECOflex Gel)	Changed – The Flap materialis changed from ALPA-SILCLASSIC Komponente A+B to
	Mould probe: PA,TitaniumMandrin: StainlessSteelFixation Button: PVC	Mould probe: PA, PEEKMandrin: Stainless SteelFixation Button: PVCLeak Stop Channel Markers:SiliconeCleaning caps: Silicone	Sorta Clear 18 and 25% ofECOflex Gel in order to havea biocompatible applicator.
Environment	Brachytherapytreatment room	Brachytherapy treatmentroom	No Change

Table 1: Comparison of Subject Device to Predicate Device

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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/ISO14971:2019	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 themanufacturer – Part 1: General requirements
EN ISO 20417: 2021	Information supplied by the manufacturer of medical devices
IEC 62366-1:2015+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 / AAMIST79:2017(R)2022	Comprehensive guide to steam sterilization and sterility assurance in health carefacilities
ISO 17664-1:2021	Processing of health care products - Information to be provided by the medical devicemanufacturer for the processing of medical devices -Part 1: Critical and semi-criticalmedical devices
EN ISO 11607-1:2020	Packaging for terminally sterilized medical devices -Part 1: Requirements for materials,sterile barrier systems and packaging systems
EN ISO 17665-1:2006	Sterilization of health care products - Moist heat - Part 1: Requirements for thedevelopment, validation and routine control of a sterilization process for medicaldevices
ISTA 3A (2018)	General Simulation Performance Tests for packaged-products weighing 150 lb. (70 kg)or less (standard, small, flat or elongated)
EN ISO 10993-1:2020	Biological evaluation of medical devices -- Part 1: Evaluation and testing within a riskmanagement 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 skinsensitization
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 referencematerials
ISO 10993-18:2020/AMD 1:2022	Biological evaluation of medical devices -- Part 18: Chemical characterization ofmedical 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 safetyand essential performance of automatically-controlled brachytherapy after loadingequipment
ASTM F2503-23	Standard Practice for Marking Medical Devices and Other Items for Safety in theMagnetic Resonance Environment
ASTM D4332-22	Standard Practice for Conditioning Containers, Packages, or Packaging Components forTesting
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 forleachable substances

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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.

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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.

Regulation Number and Section

§ 892.5700 Remote controlled radionuclide applicator system.

(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.