The Flexible Fixation Device for gynecological applicators is intended for cancer treatment of the vagmal stump. cervix, uterus, endometrium or rectum using HDR or PDR Brachytherapy.

Device Description

The Flexible Fixation Device for Gynecological Applicators is an accessory used to hold an applicator in place, to prevent movement of the applicator during the imaging (standard radiograph, CT and/or MR technique) and treatment process for HDR and PDR brachytherapy.

The key performance characteristics of the device are as follows:

Fixation rings for cylinders of various diameters (20 mm - 40 mm); and fixation straps (500 mm/150 mm, 1050 mm /350 mm, 1700 mm/500 mm)

CT compatible -
-MR safe
-Fixation rings are sterilizable and released for 250 reuses
-Fixation plate rings are sterilizable and released for 50 reuses
-The fixation straps are qualified for 50 textile laundering cycles
-Suitable for patient contact—on intact skin—for a period of less than 30 day

Fixation straps are fixed in slots of the fixation plate and around the waist of the fixation ring is attached onto an applicator which then is inserted into the patient. The flexible fixation plate is attached over the applicator and clamped in the fixation ring. The applicator is connected to an afterloader. This combination places the remote-controlled radioisotope treatment source (brachytherapy source) nearby the target tissue. The applicator guides the radioactive source to the correct location or locations for treatment.

The fixation rings for cylinders of ø 20, 23-, 26-, 30-, 35-, and 40-mm diameter, in combination with the flexible fixation plate, provide a mount for the respective cylinder applicator. The flexible fixation plate for gynecological applicators has a smaller and a larger teardrop-shaped holes for the different fixation rings. It also provides several slots for the fixation straps. The fixation straps of different lengths (500 mm/150 mm, 1050 mm/350 mm/500 mm) can be fixed at the fixation plate through the slots of the plate using hook-and-loop fasteners. Multiple straps in suitable lengths can be combined and fixated around the patient's waist and if necessary, additionally around the shoulders.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the "Flexible Fixation Device for Gynecological Applicators," and its substantial equivalence to a predicate device. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical effectiveness. The document focuses on non-clinical testing and regulatory compliance.

Here's an analysis of what is and is not in the document based on your request:

1. A table of acceptance criteria and the reported device performance

Not provided in the document. The document lists "key performance characteristics" of the device, but these are descriptive features (e.g., fixation ring diameters, CT compatibility, MR safety, sterilization reuses, laundering cycles, patient contact duration), not quantifiable performance metrics with acceptance criteria and reported values in the way one would find for an AI/diagnostic device's accuracy. The "Summary of Performance Testing" section lists types of tests conducted (biocompatibility, cleaning/disinfection/sterilization, human factors validation, mechanical/acoustic testing), but does not provide specific acceptance criteria or quantitative results.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. This device is a physical accessory, not a diagnostic algorithm that processes data or images. Therefore, there's no "test set" in the context of diagnostic performance, nor data provenance in terms of country of origin or retrospective/prospective data collection. The "tests" mentioned are for physical device characteristics and safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. As above, there's no diagnostic "test set" requiring expert ground truth establishment.

4. Adjudication method for the test set

Not applicable/Not provided. No diagnostic performance test set is described.

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

Not applicable. This device is a physical fixation device, not an AI software or assistance tool for human readers.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used

Not applicable/Not provided. Since there's no diagnostic performance being evaluated, there's no "ground truth" in that sense. The "ground truth" for the non-clinical tests would be defined by the standards and specifications that the device must meet (e.g., successful sterilization, structural integrity after mechanical stress).

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided.

Summary of available information:

The document describes a "Flexible Fixation Device for Gynecological Applicators," an accessory for brachytherapy. The submission is a Traditional 510(k), indicating the manufacturer believes the device is substantially equivalent to a legally marketed predicate device.

The "Summary of Performance Testing (Non-Clinical Testing)" section states that the following tests were conducted to demonstrate safety and effectiveness:

Biocompatibility Testing: Complied with ISO 10993-1 and applicable parts.
Cleaning, Disinfection and Sterilization Testing: Demonstrated effective sterilization and specified number of reuses/laundering cycles.
Human factors validation study: Conducted according to IEC 62366 to verify device performs as intended for users, uses, and environments.
Mechanical and Acoustic Testing: Formal design verification and validation testing demonstrating the device performs as intended, in accordance with FDA Quality System Regulation, ISO 13485, and ISO 14971.

The device also utilized several harmonized consensus standards for its design and evaluation (listed in the document).

Conclusion:

Based on the provided text, the device is a physical medical accessory, and the regulatory filing focuses on demonstrating its physical performance, safety (e.g., biocompatibility, sterilization, mechanical integrity), and substantial equivalence to a predicate device through non-clinical testing. It does not involve diagnostic accuracy, AI, or human-in-the-loop performance, which are the typical contexts for the robust performance criteria and study details requested in your prompt. Therefore, most of the requested information is not applicable or present in this specific document.

Summary

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May 9, 2024

Image /page/0/Picture/1 description: The image shows the logo of 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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

Varian Medical Systems, Inc % Dr. Lynn Allman Sr. Director, Regulatory Affairs 3100 Hansen Way PALO ALTO, CA 94304

Re: K240495

Trade/Device Name: Flexible Fixation Device for Gynecological Applicators Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: February 20, 2024 Received: February 20, 2024

Dear Dr. 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

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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,

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

510(k) Number (if known) K240495

Device Name

Flexible Fixation Device for Gynecological Applicators

Indications for Use (Describe)

The Flexible Fixation Device for gynecological applicators is intended for cancer treatment of the vagmal stump. cervix, uterus, endometrium or rectum using HDR or PDR Brachytherapy.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Premarket Notification - 510(k) Summary

Traditional 510(k) Submission for Flexible Fixation Device for Gynecological Applicators

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: April 23, 2024

II. Device Information

Proprietary Name: The Flexible Fixation Device for Gynecological Applicators Classification Name: Remote Controlled Radionucleotide Applicator System Regulation Number: §892.5700 Product Code: JAQ

III. Predicate Device

Shielded Applicator Set, Cervical Stop (K151657)

IV. Device Description

The key performance characteristics of the device are as follows:

Fixation rings for cylinders of various diameters (20 mm - 40 mm); and fixation straps (500 mm/150 mm, 1050 mm /350 mm, 1700 mm/500 mm)

CT compatible -
-MR safe
-Fixation rings are sterilizable and released for 250 reuses
-Fixation plate rings are sterilizable and released for 50 reuses
-The fixation straps are qualified for 50 textile laundering cycles
-Suitable for patient contact—on intact skin—for a period of less than 30 day

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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.

V. Intended Use

The Flexible Fixation Device for gynecological applicators is intended for cancer treatment of the vagina, vaginal stump, cervix, uterus, endometrium or rectum using HDR or PDR Brachytherapy.

VI. Comparison of Technological Characteristics with the Predicate Device

Featureand/orSpecification	Predicate Device: ShieldedApplicator Set, Cervical StopK151657(GM11001960 Flexible Fixationdevice for GynecologicalApplicators is listed as anoptional accessory of theShielded Applicator Set)	Subject Device: FlexibleFixation Device forGynecological Applicators	Comparison
Intended Use	The Shielded Applicator Set isintended for cancer treatment ofthe vagina, vaginal stump orrectum where partial shielding isrequired using HDR or PDRBrachytherapy.	The Flexible Fixation Devicefor gynecological applicators isintended for cancer treatmentof the vagina, vaginal stump,cervix, uterus, endometriumor rectum using HDR or PDRBrachytherapy.	A separateintended usestatement is nowdefined for theFlexible FixationDevice forGynecologicalApplicators.
Indicationsfor Use	The Shielded Applicator Set isintended for cancer treatment ofthe vagina, vaginal stump orrectum where partial shielding isrequired using HDR or PDRBrachytherapy. The FlexibleFixation Device is a clinical useaccessory for the fixation ofgynecological applicators.	The Flexible Fixation Devicefor gynecological applicators isindicated for cancer treatmentof the vagina, vaginal stump,cervix, uterus, endometriumor rectum using HDR or PDRBrachytherapy.	A separateintended usestatement is nowdefined for theFlexible FixationDevice forGynecologicalApplicators.
CompatibleAfterloader	VariSource iX™VariSource 200™GammaMedplus iX™GammaMedplus 3/24 iX™BRAVOS Afterloader System	VariSource iX™VariSource 200™GammaMedplus iX™GammaMedplus 3/24 iX™BRAVOS Afterloader System	No Change

CompatibleApplicators	Shielded Applicator SetStump Applicator Set with CTCylindersVaginal Applicator Set with CTCylindersSegmented Cylinder Applicator SetCervix Applicator SetSegmented Cervix Applicator SetApplicators used with the OptionalComponent:Ring Applicator Set 45°Ring Applicator Set 60°Ring Applicator Set 90°	Shielded Applicator SetUniversal Stump Applicator SetUniversal Segmented CylinderApplicator SetUniversal Multi-channel CylinderSetUniversal Interstitial CylinderSetApplicators used with theOptional Components:Ring Applicator Set 45°Ring Applicator Set 60°Ring Applicator Set 90°3D Interstitial Ring ApplicatorSet 60° (without needle use)3D Interstitial Ring ApplicatorSet 90° (without needle use)	The cylinderapplicators havebeen updated tothe newUniversal family.The same rangeof diameters iscovered with theaddition of some40 mm diametercylinders.The Interstitialring applicatorshave beenadded. Withoutneedle use theyare equivalent tothe ring sets.
OptionalComponents	Clamping screw of the fixation ringBracket for ring applicator forflexible fixation GYN	Clamping screw of the fixationringBracket for ring applicator forflexible fixation GYN	No Change
Design	Cylinder:- Ø 20, 23, 26, 30, 35mm- length 140mmApplicator probe:- Ø 3.0mm, straight- length 320mmTungsten Alloy Shielding:- 90°, 180°- Length 122.5mmMarking Screw (shielded)- 0°, 90°, 2 x 90°, 180°, 270°Clamping Nut for marking screwClamping screw for probe, 3 mmPlexiglass Filler Piece, 90° BlueCleaningFixation Ring for Cylinder:	Fixation Ring for Cylinder:Ø 20, 23, 26, 30, 35, 40 mmFlexible Fixation Plate forgynecological applicatorsFixation strap:- 500mm/150mm- 1050mm/350mm- 1700mm/500mm	No Change
Materials	The Shielded Applicator Set- Shielding - Tungsten Alloy	- Fixation ring for cylinder -PPSU	Change inmaterial of the
	- Marking Screw, Clampingnut/Screw andapplicator probe - StainlessSteel- Cylinder - PMMA- Cleaning cap - SiliconeThe Flexible Fixation Device- Fixation ring for cylinder -PPSU- Flexible fixation plate - PVC- Fixation strap - Cotton/PA	- Flexible fixation plate -Silicone- Fixation strap - Cotton/PA	flexible fixationplate from PVC tosilicone.
Environment	The Shielded Applicator Set is aclinical use accessory for thefixation of gynecologicalapplicators.CT image compatible and MR-Safe.	The Flexible Fixation Device isa clinical use accessory for thefixation of gynecologicalapplicators.CT image compatible and MR-Safe.	No Change

Table 1: Comparison of Subiect Device to Predicate Device

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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".

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:

The Flexible Fixation Device for Gynecological Applicators 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.

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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.

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 17664-2:2021	Processing of health care products - Information to be provided by the medical devicemanufacturer for the processing of medical devices –Part 2: Non-critical medicaldevices
EN ISO 11138-1:2017	Sterilization of health care products –Biological indicators – Part 1: Generalrequirements
EN ISO 11138-3:2017	Sterilization of health care products –Biological indicators – Part 3: Biological indicatorsfor moist heat sterilization processes
EN ISO 11138-7:2019	Sterilization of health care products –Biological indicators – Part 7: Guidance for theselection, use and interpretation of results
EN ISO 11607-1:2019	Packaging for terminally sterilized medical devices –Part 1: Requirements for materials,sterile barrier systems and packaging systems
EN ISO 11737-1:2018+A1:2021	Sterilization of medical devices – Microbiological methods – Part 1: Determination of apopulation of microorganisms on products
EN ISO 11737-2:2019	Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterilityperformed in the definition, validation and maintenance of a sterilization process
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
ISO/TS 17665-2:2009	Sterilization of health care products –Moist heat –Part 2: Guidance on the applicationof ISO 17665-1
ISTA 3A (2018)	General Simulation Performance Tests for packaged-products weighing 150 lb. (70 kg)or less (standard, small, flat or elongated)
EN ISO 10993-1:2018	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
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 10993-12:2021	Biological evaluation of medical devices –Part 12: Sample preparation and referencematerials
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

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EN ISO 10993-2:2022 Biological evaluation of medical devices. —Part 2: Animal welfare requirements

VIII. Determination of Substantial Equivalence to the Predicate

The Flexible Fixation Device for Gynecological Applicators was previously sold as an optional accessory for the Shielded Applicator set in K151657. 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 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 Flexible Fixation Device for Gynecological Applicators 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.