The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vaqina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

Device Description

The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

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 intended patient population includes adult female patients whose cancer can be treated using HDR brachytherapy, as determined by the prescribing physician. The subject device is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

The key performance characteristics of this applicator set are as follows:

. The ability to customize the relative depth of the tandem and ovoids, as well as adapt to different anatomies with three tandem angles (15°, 30°, 45°) and a movable cervical stop.
3.5 mm diameter intrauterine tandems allow for easy insertion into the cervical channel helping provide maximum patient comfort.
The tandems and the pivot assembly are made from strong, lightweight titanium.
Four different ovoid sizes to allow for varying anatomy.
. Channel marking on the intrauterine tandems and colpostat tandems for easy identification.
. Ability to image the patient using CT imaging.
Ability to image the patient using MR imaging.
Optional interstitial ovoids for more complex cases with guide tubes to allow for the needles to be preloaded outside of the patient and locked into place.
. Compatible with cervical sleeves to allow easy multiple fraction and help provide maximum patient comfort and eliminate the risk of perforation.
Can be manually or machine cleaned, disinfected and steam sterilizable.
Can be securely connected to the BRAVOS Afterloader System and GammaMedeplus iX series afterloader.
Suitable for patient contact for a period of less than 30 days

AI/ML Overview

This document is a 510(k) Premarket Notification for the Titanium Flexible Geometry FSD Applicator Set (GM11013400). It does not describe an AI/ML powered device. The information provided focuses on the substantial equivalence to a predicate device through non-clinical performance testing. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, standalone algorithm performance, AI training/test sets, expert ground truth establishment, etc.) are not applicable to this submission.

Here is the information that can be extracted relevant to the performance and acceptance criteria for this medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests Conducted	Reported Device Performance (Summary)
Biocompatibility	ISO 10993-1 and applicable parts	Compatibility of skin-contact component material meets biocompatibility requirements.
Magnetic Resonance (MR) Compatibility	ASTM F2503-23 (Marking)	MR Conditional; complies with standards for marking, RF induced heating, magnetically induced displacement force, torque, and image artifacts.
	ASTM F2182-19e2 (RF Heating)
	ASTM F2052-21 (Displacement Force)
	ASTM F2213-17 (Torque)
	ASTM F2119-07 (2013) (Image Artifacts)
Cleaning, Disinfection, Sterilization	Demonstrated effectiveness for components and specified number of uses	Testing conducted to demonstrate effective sterilization and multi-use capability.
Human Factors/Usability	IEC 62366 (Human Factors Validation Study)	Device performs well as intended for intended users, uses, and use environments.
Mechanical & Acoustic Testing	Formal Design Verification & Validation Testing (21 CFR §820, ISO 13485, ISO 14971)	Device performs as intended; conformance to applicable requirements and hazard safeguards.
Safety & Efficacy	Conformance to FDA-recognized consensus standards (various ISO and EN ISO standards, e.g., ISO 13485, ISO 14971, ISO 10993, IEC 60601)	Demonstrated through verification and validation, meeting safety and performance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. This submission concerns a physical medical device (applicator set), not an AI/ML model for data-driven analysis. Performance testing likely involved physical prototypes or units, but specific "sample sizes" in the context of data analysis are not presented.
Data Provenance: Not applicable in the context of clinical data used for AI/ML development. The testing described is non-clinical (biocompatibility, MR compatibility, cleaning/sterilization, mechanical, human factors).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth as typically defined for AI/ML (e.g., expert labels on medical images) is not relevant for the type of device and testing described. The "ground truth" for this device's performance is established by objective engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication is typically for resolving discrepancies in expert labels for AI/ML ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI-powered device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an AI-powered device.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on objective engineering standards, regulatory requirements, and validated test methods. This includes:
- Compliance with ISO 10993 for biocompatibility.
- Compliance with ASTM standards for MR compatibility.
- Demonstrated effectiveness for cleaning, disinfection, and sterilization.
- Usability verification through human factors studies (IEC 62366).
- Verification and validation against design specifications and risk management (21 CFR §820, ISO 13485, ISO 14971).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device.

Summary

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March 3, 2025

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, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Varian Medical Systems, Inc. Lynn Allman Senior Director, Regulatory Affairs 3100 Hansen Way Palo Alto, California 94304

Re: K243939

Trade/Device Name: Titanium Flexible Geometry FSD Applicator Set (GM11013400) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAO Dated: December 19, 2024 Received: December 20, 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/cdrb/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.

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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 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.

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 Re"). 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 mediation-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

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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,

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)

K243939

Device Name

Titanium Flexible Geometry FSD Applicator Set (GM11013400)

Indications for Use (Describe)

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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K243939

Premarket Notification - 510(k) Summary

Traditional 510(k) Submission for Titanium Flexible Geometry FSD 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

ll. Device Information

Proprietary Name: Titanium Flexible Geometry FSD Applicator Set Classification Name: Remote Controlled Radionucleotide Applicator System Regulation Number: §892.5700 Product Code: JAQ

lll. Predicate Device

Titanium Fletcher-Style Applicator Set Defined Geometry (K241853)

IV. Device Description

The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

The key performance characteristics of this applicator set are as follows:

. The ability to customize the relative depth of the tandem and ovoids, as well as adapt to different anatomies with three tandem angles (15°, 30°, 45°) and a movable cervical stop.
3.5 mm diameter intrauterine tandems allow for easy insertion into the cervical channel helping provide maximum patient comfort.
The tandems and the pivot assembly are made from strong, lightweight titanium.
Four different ovoid sizes to allow for varying anatomy.

510(k) Summary

Traditional 510(k) Application Titanium Flexible Geometry FSD Applicator Set

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Image /page/5/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.

. Channel marking on the intrauterine tandems and colpostat tandems for easy identification.
. Ability to image the patient using CT imaging.
Ability to image the patient using MR imaging.
Optional interstitial ovoids for more complex cases with guide tubes to allow for the needles to be preloaded outside of the patient and locked into place.
. Compatible with cervical sleeves to allow easy multiple fraction and help provide maximum patient comfort and eliminate the risk of perforation.
Can be manually or machine cleaned, disinfected and steam sterilizable.
Can be securely connected to the BRAVOS Afterloader System and GammaMedeplus iX series afterloader.
Suitable for patient contact for a period of less than 30 days

V. Intended Use

The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

VI. Comparison of Technological Characteristics with the Predicate Device

FEATURE AND/ORSPECIFICATION OF NEWDEVICE	Predicate Device:GM11006200 TitaniumFletcher-Style Applicator SetDefined Geometry (K241853)	Subject Device: GM11013400Titanium Flexible GeometryFSD Applicator Set	Comparison
Intended use	The Titanium Fletcher-styleApplicator Set DefinedGeometry is intended for usefor cancer treatment of theuterus, cervix, paracervix,endometrium and vaginawhen performing HDR or PDRbrachytherapy.	The Titanium FlexibleGeometry FSD Applicator Setwith the optional interstitialovoids is intended for cancertreatment of the uterus,cervix, paracervix,endometrium and vagina, withintracavitary or with acombination of intracavitaryand interstitial HDRbrachytherapy.	Similar, as both devices areintended for brachytherapycancer treatment in the sameanatomical areas. The subjectdevice is not indicated for usewith PDR brachytherapy.
Indications for Use	The Titanium Fletcher-styleApplicator Set DefinedGeometry is indicated for usefor cancer treatment of theuterus, cervix, paracervix,endometrium and vagina usingHDR or PDR brachytherapy.	The Titanium FlexibleGeometry FSD Applicator Setwith the optional interstitialovoids is intended for cancertreatment of the uterus,cervix, paracervix,endometrium and vagina, withintracavitary or with acombination of intracavitaryand interstitial HDRbrachytherapy.	Similar, as both devices areintended for brachytherapycancer treatment in the sameanatomical areas. The subjectdevice is not indicated for usewith PDR brachytherapy.
Device Classification	Class II, IAQ	Class II, IAQ	Same
FEATURE AND/ORSPECIFICATION OF NEWDEVICE	Predicate Device:GM11006200 TitaniumFletcher-Style Applicator SetDefined Geometry (K241853)	Subject Device: GM11013400Titanium Flexible GeometryFSD Applicator Set	Comparison
Intended Patient Population	Adult female patients forwhich brachytherapy isdetermined to be anappropriate treatment by aprescribing physician	Adult female patients forwhich brachytherapy isdetermined to be anappropriate treatment by aprescribing physician	Same
Compatible Afterloader	GammaMedplus iX AfterloaderSeriesBRAVOS Afterloader SystemVariSource Afterloader Series	GammaMedplus iX AfterloaderSeriesBRAVOS Afterloader System	Similar, the subject device isnot indicated for use with theVariSource afterloader series
Performance Characteristics	Device is made ofbiocompatible, sturdy, andlightweight components,which are marked foridentification.Users can adjust componentsof the device and select from avariety of sizing for a range ofanatomical sizes.	Device is made ofbiocompatible, sturdy, andlightweight components,which are marked foridentification.Users can adjust componentsof device and select from avariety of sizing for a range ofanatomical sizes.	Similar, there are differences inthe design and optionalaccessories as detailed inComponents and Design (&Optional Accessories).
Components and Design (&Optional Accessories)	Rigid design / definedgeometry	Adjustable design / flexiblegeometry	Similar, the primary differenceis in the type of orientationangles available and adjustabledesign of the subject device.Both sets provide applicatorsfor brachytherapy treatmentfor the same anatomicalregion.
	Pair of titanium colpostatprobes (left and right):	Pair of titanium colpostattandems (left and right):
	Titanium intrauterine probewith cervical stop 30°,Length: 40mm, 60mm, 80mm(optional 30mm, 50mm,70mm)Diameter: 3mm	Titanium intrauterine tandemswith cervical stop with 15°, 30°and 45° curved;Length: AdjustableDiameter: 3.5mm
	Ovoids and mini-ovoids:Dimensions: 16, 20, 25, 30 mm	Ovoids and mini-ovoids:Dimensions: 16, 20, 25 and30mm;
	Titanium central clampingmechanismAllen Key	Titanium Tandem PivotAssembly, Locking Nut,Cervical Stop;
	Cleaning Caps	Cleaning Caps
	Optional Components:Fixation for 3-channelapplicatorsTitanium rectal retractor	Optional Components:Ovoid/cervical stop set screwInterstitial ovoids with fixationfor guide tubes

Table 1: Comparison of Subject Device to Predicate Device

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Image /page/7/Picture/0 description: This image is a table comparing the features and specifications of a new device to a predicate device. The predicate device is the GM11006200 Titanium Fletcher-Style Applicator Set Defined Geometry (K241853), and the subject device is the GM11013400 Titanium Flexible Geometry FSD Applicator Set. The table compares the materials, packing, sterility, sterilization method, biocompatibility, anatomical sites, compatibility with the environment and other devices, and where the devices are used.

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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".

Magnetic Resonance Testing (MR):

MR Compatibility testing was completed, and documentation was provided to FDA in support of the substantial equivalence determination. The subject device is MR Conditional and complies 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
ASTM F2182-19e2 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
. ASTM F2052-21: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2213-17: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
. ASTM F2119-07 (2013): Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

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 subject device 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.

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Standard/ CS	Standard/ CS Title
EN ISO 13485:2016	Quality management systems. Requirements for regulatory purposes
EN ISO 14971:2019+All:2021	Medical devices - Application of risk management to medical devices (ISO14971:2019)
EN ISO 15223-1:2021	Medical devices - Symbols to be used with medical device labels, labelling andinformation to be supplied - Part 1: General requirements
EN ISO 20417:2021	Information supplied by the manufacturer of medical devices
EN ISO 62366-1:2015+Al:2020	Application of Usability Engineering to Medical Devices
EN ISO 11737-2:2020	Sterilization of medical devices - Microbiological methods - Part 2: Tests ofsterility performed in the definition, validation and maintenance of asterilization process
EN ISO 17664-1:2021	Processing of health care products-Information to be provided by the medicaldevice manufacturer for the processing of medical devices.
EN ISO 11607-1:2020	Packaging for terminally sterilized medical devices - Part 1: Requirements formaterials, 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 formedical devices
EN ISO 10993-1:2020	Biological evaluation of medical devices -- Part 1: Evaluation and testing within arisk management process.
EN ISO 10993-2:2022	Biological evaluation of medical devices. - Part 2: Animal welfare requirements
EN ISO 10993-5:2009	Biological evaluation of medical devices - part 5: Tests for in vitro cytotoxicity
EN ISO 10993-6:2016	Biological evaluation of medical devices - Part 6: Tests for local effects afterimplantation
EN ISO 10993-10:2021	Biological evaluation of medical devices - Part 10: Tests for irritation and skinsensitization
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 andreference materials
EN ISO 10993-17:2023	Biological evaluation of medical devices - Part 17: Establishment of allowablelimits for leachable substances
EN ISO 10993-18:2020	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
EN ISO 60601-1:2006/A1:2013	Medical Electrical Equipment Part 1- General Requirements For Safety andessential performance
EN ISO 60601-2-17:2015	Medical electrical equipment - Part 2-17: Particular requirements for the basicsafety and essential performance of automatically-controlled brachytherapyafter loading equipment

VIII. Determination of Substantial Equivalence to the Predicate

Subject Device: Titanium Flexible Geometry FSD Applicator Set Predicate device: Titanium Fletcher-Style Applicator Set Defined Geometry (K241853)

1. Is the predicate device legally marketed?

510(k) Summary Traditional 510(k) Application Titanium Flexible Geometry FSD Applicator Set

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Yes, the predicate device received 510(k) Clearance under K241853 and since then has been legally marketed in the United States.

2. Do the devices have the same intended use?

Yes, with both devices, users are able to perform brachytherapy cancer treatment where indicated under the direction of clinical professionals. Both devices can be used with HDR brachytherapy.

3. Do the devices have the same technological characteristics?

No, There are differences in the flexibility and configurability that the subject device provides relative to the predicate that addresses varying patient anatomy. However, they are both patient-contacting applicator sets that are intended for use in the same anatomical region. The material composition, general design (Fletcher-Style), and device/environment compatibility is similar between the devices.

4. Do the different technological characteristics of the devices raise different questions of safety and effectiveness?

No, these differences do not raise different questions of safety and effectiveness. As demonstrated within this 510(k) submission, these differences raise similar questions relating to usability and performance. These considerations of safety and effectiveness were also applicable to the predicate device, as there are similar configurable elements which can be used to accommodate varying patient anatomy.

5a. Are the methods acceptable?

Yes, these verification and validation methods are similar to those applied to the predicate device and are well established and acceptable for the purpose of evaluation, either through the use of voluntary consensus or having been utilized in other 510(k) clearances. Test results demonstrate conformance to applicable requirements specifications and assure hazard safeguards function properly.

5b. Do the data demonstrate substantial equivalence?

Yes, the overall verification and validation testing for the Titanium Flexible Geometry FSD Applicator Set demonstrates that the device requirements and risk control measures perform as intended at a level similar to the predicate.

Varian believes the major technological characteristics are substantially equivalent to the predicate device and the differences do not raise new questions of safety and effectiveness compared to the predicate.

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 Titanium Flexible Geometry FSD Applicator Set to be as safe and effective as the predicate and therefore 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.