The Kelowna GYN and Crook Prostate Templates are applicators for Brachytherapy. 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 the correct dose for the treatment area. The applicators act to guide the radioactive source to the correct location or locations for treatment.

The key performance characteristics of Kelowna GYN and Crook Prostate Templates are as follows:

Constructed of polyetheretherketone (PEEK), Titanium and stainless steel
Used when performing HDR or PDR brachytherapy within a CT environment
Accommodate the organization of interstitial implants; used with interstitial needles
Provide for individual needle collet fixation
Can be manually or machine cleaned; steam sterilizable
Suitable for re-use
Suitable for patient contact for a period of less than 30 days
MR conditional and suitable for use during MR imaging for MRI systems of 1.5T or 3.0T if used with Varian interstitial plastic needles

AI/ML Overview

The provided text describes the regulatory clearance of the "Kelowna GYN and Crook Prostate Templates" by Varian Medical Systems. The device is a brachytherapy applicator system. The submission (K232949) is a 510(k) premarket notification, indicating it's a submission for a device substantially equivalent to an already marketed device, not a novel device requiring extensive clinical trials for efficacy.

The core of this submission is a change in the device's MR compatibility from "MR unsafe" to "MR conditional" when used with specific Varian interstitial plastic needles, along with minor updates to compatible afterloaders and optional accessories.

Therefore, the "study that proves the device meets the acceptance criteria" primarily refers to non-clinical performance testing related to these changes, particularly MR compatibility and general device safety and functionality.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a brachytherapy applicator system, the "acceptance criteria" are generally related to the device's physical and functional performance, biocompatibility, sterilization, and MR compatibility, rather than specific diagnostic or therapeutic sensitivity/specificity metrics typically found in AI/imaging device clearances. The document reports that the device meets these criteria, implying successful completion of the tests.

Acceptance Criteria (Test Category)	Reported Device Performance
Biocompatibility	"The biocompatibility evaluation for the subject device was conducted according to ISO 10993-1 'Biological Evaluation of a Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process.' This includes the following tests: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subacute Toxicity." (Implies successful completion as the device was cleared.)
Sterilization Effectiveness & Durability	"Sterilization testing for the subject device was conducted to assess the effectiveness of the provided cleaning, disinfection, and sterilization procedures for the device. Furthermore, the components of the subject set were subjected to sterilization cycles up to the stated use life and evaluated for performance and any damage that might affect the safety or effectiveness." (Implies successful completion as the device was cleared.)
MR Compatibility (Primary Focus of Submission)	"MR Compatibility testing was completed, and documentation was provided to FDA in support of the substantial equivalence determination. The Kelowna GYN and Crook Prostate Templates are MR Conditional when used with Varian interstitial plastic needles and comply with the following MR standards: ASTM F2052-21 (Displacement Force), ASTM F2213-17 (Torque), ASTM F2182-19e2 (RF Induced Heating), ASTM F2119-07 (MR Artifacts)." (Device successfully demonstrated MR Conditional status adhering to specific ASTM standards.)
Mechanical & Design Performance	"The Kelowna GYN and Crook Prostate Templates have undergone formal design verification and design validation testing. Design verification and design validation testing demonstrates that the Kelowna GYN and Crook Prostate Templates 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." (Implies successful performance in accordance with quality and risk management standards.)
Electrical Safety & EMC	"This item is not applicable to the subject device. No electrical safety and electromagnetic compatibility tests have been included in this submission in support of the substantial equivalence determination." (No performance reported as not applicable.)
Software Verification & Validation	"This item is not applicable to the subject device. The devices do not contain or consist of software/firmware. No software verification and validation testing have been included in this submission in support of the substantial equivalence determination." (No performance reported as not applicable.)
Substantial Equivalence	"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. 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 Kelowna GYN and Crook Prostate Templates to be as safe and effective as the predicate and to perform at least as well as the predicate device (K162533)." (Overall conclusion based on all non-clinical tests.)

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

The document pertains to a physical medical device (applicators for brachytherapy) and does not involve AI or imaging "test sets" in the conventional sense for diagnostic algorithms. The testing described (biocompatibility, sterilization, MR compatibility, mechanical/design) uses physical samples of the device and materials, not patient data sets. Therefore, the questions about "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable in the context of this device's non-clinical testing.

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

Not applicable. This device is not an AI/imaging algorithm requiring ground truth annotation by experts. The "ground truth" for the non-clinical tests is established by objective measurements and standardized protocols (e.g., meeting specific force limits in MR environment, sterility assurance levels).

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

Not applicable. No expert adjudication process is described or relevant for the non-clinical tests conducted.

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 is not an AI-assisted diagnostic or therapeutic imaging device involving human readers or interpretation of medical cases.

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

Not applicable. This device does not have an AI algorithm component.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests described:

Biocompatibility: Ground truth is defined by the toxicological response observed in standardized in vitro and in vivo assays as per ISO 10993.
Sterilization: Ground truth is established by microbiological challenge tests demonstrating lethal effects on microorganisms and material integrity limits.
MR Compatibility: Ground truth is defined by quantitative measurements (e.g., displacement force, temperature rise, artifact size) meeting the limits specified in the relevant ASTM standards for "MR Conditional" labeling.
Mechanical & Design Performance: Ground truth is the device's adherence to engineering specifications and functional requirements under defined test conditions.

8. The Sample Size for the Training Set

Not applicable. This device does not use an AI algorithm that requires a training set.

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

Not applicable. This device does not use an AI algorithm that requires a training set with established ground truth.

Summary

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February 1, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K232949

Trade/Device Name: Kelowna GYN and Crook Prostate Templates Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: December 20, 2023 Received: December 20, 2023

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

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Indications for Use

510(k) Number (if known) K232949

Device Name Kelowna GYN and Crook Prostate Templates

Indications for Use (Describe)

The Kelowna GYN Templates are intenstitial brachytherapy treatments for gynecological and rectal/anal cancer using HDR or PDR brachytherapy.

The Crook Prostate Templates are interstitial brachytherapy treatments for prostate cancer 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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Image /page/3/Picture/1 description: The image contains the logo for Varian Medical Systems. The logo consists of the word "Varian" in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller font size. The logo is simple and modern.

Premarket Notification - 510(k) Summary

Kelowna GYN and Crook Prostate Templates

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: 20 September 2023

II. Device Information

Proprietary Name: Kelowna GYN and Crook Prostate Templates Classification Name: Remote Controlled Radionucleotide Applicator System Regulation Number: §892.5700 Product Code: JAQ

lll. Predicate Device

Kelowna GYN and Crook Prostate Templates (K162533)

IV. Device Description

The key performance characteristics of Kelowna GYN and Crook Prostate Templates are as follows:

Constructed of polyetheretherketone (PEEK), Titanium and stainless steel ●
Used when performing HDR or PDR brachytherapy within a CT environment
Accommodate the organization of interstitial implants; used with interstitial needles ●
Provide for individual needle collet fixation
Can be manually or machine cleaned; steam sterilizable
Suitable for re-use
Suitable for patient contact for a period of less than 30 days
MR conditional and suitable for use during MR imaging for MRI systems of 1.5T or 3.0T if ● used with Varian interstitial plastic needles

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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, sans-serif font. The logo is black and white.

V. Intended Use/Indications for Use

The Kelowna GYN Templates are intended for interstitial brachytherapy treatments for gynecological and rectal/anal cancer using HDR or PDR brachytherapy.

The Crook Prostate Templates are intended for interstitial brachytherapy treatments for prostate cancer using HDR or PDR brachytherapy.

VI. Comparison of Technological Characteristics with the Predicate Device

The major change addressed in this 510(k) is the change from MR unsafe to MR conditional when the templates are used with Varian interstitial plastic needles.

The change to the MR compatibility resulted in updates to 2 existing risk items. MR risks are now applicable resulting in updated warnings in the IFU.

Minor changes include:

Addition of the BRAVOS afterloader system to the Compatible Afterloaders
Addition of the 'Universal Multi-channel Cylinder Set' and 'Universal Interstitial Cylinder Set' to the Optional Accessories

One risk item was updated to include a warning within the IFU re: the use of third-party applicators and afterloaders.

The device comparison table below demonstrates the substantial equivalence of the subject Kelowna GYN and Crook Prostate Templates to the predicate Kelowna GYN and Crook Prostate Templates (K162533). The differences between the subject and predicate are indicated in yellow fill. The indications for use and the intended use of the subject device are the same as the predicate device.

Feature and/or specification	Predicate Device:Kelowna GYN and Crook ProstateTemplatesK162533	Subject Device:Kelowna GYN and CrookProstate Templates	Comparison
Intended Use/ Indications forUse	The Kelowna GYN Templates areintended for interstitialbrachytherapy treatments forgynecological and rectal/analcancer using HDR or PDRbrachytherapy.The Crook Prostate Templates areintended for interstitialbrachytherapy treatments forprostate cancer using HDR or PDRbrachytherapy.	The Kelowna GYN Templates areintended for interstitialbrachytherapy treatments forgynecological and rectal/analcancer using HDR or PDRbrachytherapy.The Crook Prostate Templatesare intended for interstitialbrachytherapy treatments forprostate cancer using HDR orPDR brachytherapy.	Same
Compatible Afterloader	GammaMedplus iXGammaMedplusVariSource iXVariSource 200	GammaMedplus iXGammaMedplusVariSource iXVariSource 200Bravos Afterloader system	Now compatible withBravos AfterloaderSystem

Table 1. Comparison of Subject Device to Predicate Device

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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 written in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller font.

Feature and/or specification	Predicate Device:Kelowna GYN and Crook ProstateTemplatesK162533	Subject Device:Kelowna GYN and CrookProstate Templates	Comparison
Optional Accessories	Universal Cylinder Applicator Familyas cleared in K141490	Universal Cylinder ApplicatorFamily as cleared in K193240	Substantially the same.Addition of UniversalMulti-Channel CylinderSet and UniversalInterstitial Cylinder setas cleared in K193240
Compatibility with ImagingEnvironment	CT compatibleMR Unsafe	CT compatibleMR Conditional	MR compatibility hasbeen updated to indicateMR conditional if usedwith Varian interstitialplastic needles

Table 1. Comparison of Subject Device to Predicate Device

VII. Summary of Performance Testing (Non-Clinical Testing)

The following performance data was provided in support of the substantial equivalence determination.

Biocompatibility Testing:

The biocompatibility evaluation for the subject device was conducted according to ISO 10993-1 'Biological Evaluation of a Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process." This includes the following tests:

. Cytotoxicity
Sensitization
Irritation
Acute Systemic Toxicity
Subacute Toxicity

Sterilization Testing:

Sterilization testing for the subject device was conducted to assess the effectiveness of the provided cleaning, disinfection, and sterilization procedures for the device. Furthermore, the components of the subject set were subjected to sterilization cycles up to the stated use life and evaluated for performance and any damage that might affect the safety or effectiveness.

Electrical Safety and Electromagnetic Compatibility (EMC):

This item is not applicable to the subject device. No electrical safety and electromagnetic compatibility tests have been included in this submission in support of the substantial equivalence determination.

Magnetic Resonance Testing (MR):

MR Compatibility testing was completed, and documentation was provided to FDA in support of the substantial equivalence determination. The Kelowna GYN and Crook Prostate Templates are MR Conditional when used with Varian interstitial plastic needles and comply with the following MR standards:

ASTM F2052-21 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment

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Image /page/6/Picture/0 description: The image shows the word "varian" in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller font. The text is black and the background is white.

ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices 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
ASTM F2119-07 Standard Test Method for Evaluation of MR Artifacts from Passive Implants

Software Verification and Validation Testing:

This item is not applicable to the subject device. The devices do not contain or consist of software/firmware. No software verification and validation testing have been included in this submission in support of the substantial equivalence determination.

Mechanical and Acoustic Testing:

●

The Kelowna GYN and Crook Prostate Templates have undergone formal design verification and design validation testing. Design verification and design validation testing demonstrates that the Kelowna GYN and Crook Prostate Templates 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.

Table 2. Applicable Standards
Standard
ANSI AAMI ST98:2022	ISO 10993-5	ASTM F2182-19e2
ANSI AAMI ST79:2017	ISO 10993-10	ASTM F2119-07
ISO 174664-1	ISO 10993-11	ASTM D4332-14
ISO 11138-1	ISO 10993-12	ISO 13485:2016
ISO 11607-1	ISO 10993-18	ISO 14971:2019
ISO 11737-2	ASTM F2052-21	ISO 15223-1:2021
ISO 17665-1	ASTM F2213-17	IEC 62366-1
ISO 10993-1

Table 2. Applicable Standards

No animal or clinical studies were conducted.

VIII. Determination of Substantial Equivalence to the Predicate Device

The Intended Use and indications for use are the predicate device. Further, there are no changes in the materials 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. 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 Kelowna GYN and Crook Prostate Templates to be as safe and effective as the predicate and to perform at least as well as the predicate device (K162533).

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.