The Kelowna GYN Templates are 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.

Device Description

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

The devices do not contain or consist of software/firmware. The devices do not contain any biologics or drug components. The devices have patient-contacting materials. The devices are designed for repeated use. No parts of the system are provided sterile. The devices can be steam sterilized with common parameters using pre-vacuum sterilization. These devices are used on both female and male patients.

The Kelowna GYN and Crook Prostate Templates are compatible with the following Varian Afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™.

The Kelowna GYN and Crook Prostate Templates are CT compatible.

The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.

AI/ML Overview

The provided document details a 510(k) premarket notification for the "Kelowna GYN and Crook Prostate Templates," which are applicator accessories for brachytherapy. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.

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

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Implied)	Reported Device Performance and Results
Biocompatibility	Meet standards for medical devices in contact with breached surfaces and prolonged contact duration (ISO 10993-1).	Cytotoxicity, Sensitization, Irritation, System Toxicity, Subacute Toxicity, and Implantation tests were conducted. The components are categorized as a medical device, surface device in contact with breached or compromised surfaces and prolonged contact duration (>24h to 30d) according to ISO 10993-1. (Implied: All tests passed).
Sterilization	Effectiveness of cleaning, disinfection, and sterilization procedures; device performance and safety/effectiveness after repeated sterilization cycles.	Validation/Efficacy Testing of Cleaning, Disinfection, and Sterilization Cycles; Verification of the Suitability of Applicator Design and Material for the Stated Use Life and Reprocessing Cycles were performed. (Implied: All tests passed and demonstrated effectiveness and suitability).
Mechanical/Acoustic	Compatibility with CT imaging; adherence to applicator design specifications.	CT Compatibility Tests and Analysis; Verification and Validation Testing for Applicator Design Specifications were conducted. (Implied: Demonstrated CT compatibility and adherence to specifications).
General Comparison to Predicate	Must perform comparably to the predicate device (GammaMed Plus High Dose Rate Remote Afterloading System, K983436) for its intended use and indications.	The non-clinical tests support the safety and effectiveness, and validation/verification testing demonstrates that the subject devices perform comparably to the predicate device, meeting the intended use. The device shares the same intended use (brachytherapy for cancer) and compatible afterloader series as the predicate. Different designs and materials (PEEK, Titanium vs. PPSU, Stainless Steel) are used but are considered biocompatible and suitable.

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

The document does not specify exact sample sizes for the individual non-clinical tests (biocompatibility, sterilization, mechanical) beyond stating that "testing was conducted" or "components were subjected." It is common for these types of tests to use a statistically adequate number of samples as per the relevant standards, but the specific numbers are not disclosed.

The data provenance is retrospective non-clinical bench testing and analysis, as indicated by the "Non-Clinical Tests" section. There is no mention of human subject data or data from a specific country of origin, as the testing relates to the device's physical and material properties.

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

This information is not applicable or provided in the document. The "ground truth" for non-clinical performance data like biocompatibility, sterilization efficacy, and mechanical properties is typically established by adherence to international standards (e.g., ISO 10993, AAMI TIRs) and validated by laboratory testing following established protocols. The expertise lies in the execution and interpretation of these standardized tests by qualified laboratory personnel, rather than expert consensus on medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable or provided. Adjudication methods are typically used in clinical studies or image-based evaluations where multiple human readers assess data and discrepancies need to be resolved. For non-clinical bench testing, the results are objectively measured against defined criteria within the test protocols.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes physical medical devices (applicators for brachytherapy) and their non-clinical performance. It does not involve AI, software, or human interpretation of images or data that would necessitate an MRMC study.

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

No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for these non-clinical tests is based on:

Established International Standards: For biocompatibility (ISO 10993 series), sterilization (AAMI and ISO standards), and mechanical properties (internal design specifications validated through testing).
Objective Measurements: Laboratory test results measured against predefined acceptance limits set by these standards and engineering specifications.

There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense, as this is a pre-market notification for a physical device demonstrating substantial equivalence through bench testing.

8. The sample size for the training set

This information is not applicable or provided. There is no "training set" as this device does not involve machine learning or artificial intelligence.

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

This information is not applicable or provided. As there is no training set, there is no ground truth established for one.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 31, 2017

Varian Medical Systems, Inc. % Mr. Peter Coronado Director. Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304

Re: K162533

Trade/Device Name: Kelowna Gyn and Crook Prostate Templates Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: August 14, 2017 Received: August 18, 2017

Dear Mr. Coronado:

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 (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. 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.

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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael D. O'Hara

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162533

Device Name

Kelowna GYN and Crook Prostate Templates

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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A partner for life

Varian Medical Systems, Inc. Corporate Headquarters 3100 Hansen Way Palo Alto, CA 94304-1038

Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com

510k Summary

510(k) Submission for the Kelowna GYN and Crook Prostate Templates

As required by 21 CFR 807.92, Reference: FDA's Guidance Document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (June 2014).

SUBMITTER l.

Submitter's Name:	Varian Medical Systems3100 Hansen Way,Palo Alto CA 94304-1038
Contact Name:	Peter J. Coronado
Position:	Director, Regulatory Affairs
Phone:	1.650.424.6230
Fax:	1.650.646.9200
Email:	submissions.support@varian.com
Date Prepared:	August 25, 2016

II. DEVICE

Name of Devices:	Kelowna GYN and Crook Prostate Templates
Common/Usual Name:	System, Applicator, Radionuclide, Remote-Controlled
Regulation Name:	Remote controlled radionuclide applicator system (21 CFR 892.5700)
Regulatory Class:Product Code:	Class IIJAQ

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PREDICATE DEVICE lll.

GammaMed Plus High Dose Rate Remote Name of Predicate: Afterloading System

510k Number: K983436

DEVICE DESCRIPTION IV.

The Kelowna GYN and Crook Prostate Templates are compatible with the following Varian Afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™.

The Kelowna GYN and Crook Prostate Templates are CT compatible.

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The associated components of the Kelowna GYN and Crook Prostate Templates include:

Product Number	Component List	Associated510(k)	Refer ISD
GM11012200	Kelowna GYN Template for 2.0 mm needles, includinglocking collets (pack of 25) and needle collet wrench
GM11012210	Kelowna GYN Template for 16 gauge (1.65 mm) needles,including locking collets (pack of 25) and needle colletwrench
GM11012220	Kelowna GYN Template for 17 gauge (1.47 mm) needles,including locking collets (pack of 25) and needle colletwrench		KelownaGYN andCrook
GM11012230	Crook Prostate Template for 2.0 mm needles, B-K labelling,including locking collets (pack of 25) and needle colletwrench	This 510(k)	ProstateTemplates
GM11012240	Crook Prostate Template for 17 gauge (1.47 mm) needles, B-K labelling, including locking collets (pack of 25)and needle collet wrench
GM11012250	Crook Prostate Template for 2.0 mm needles, Siemenslabelling, including locking collets (pack of 25) and needlecollet wrench
GM11012260	Crook Prostate Template for 17 gauge (1.47 mm) needles,Siemens labelling, including locking collets (pack of 25) andneedle collet wrench

INDICATIONS FOR USE V.

Indications for Use Statement: 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.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both subject and predicate devices are intended for use in the treatment of cancer through interstitial brachytherapy.

	CLEARED DEVICEFEATURE/SPECIFICATION	NEW / MODIFIED DEVICE	NEW / MODIFIED DEVICE
FEATURE AND/ORSPECIFICATION	510(K) K983436 GAMMAMEDPLUS HIGH DOSE RATEREMOTE AFTERLOADINGSYSTEM(GM11004650 PROSTATE ANDPERINEAL IMPLANTTEMPLATEDSET IS LISTED INATTACHMENT B, PAGE 11)	KELOWNA GYN TEMPLATES	CROOK PROSTATE TEMPLATES
Intended use	The intended use of theGammaMed Plus transportablehigh-dose-rate remotelycontrolled afterloadingbrachytherapy device is for thetreatment of cancer byintracavitary, interstitial,intralumenal and intraoperativeirradiation.	The Kelowna GYN Templatesare intended for interstitialbrachytherapy treatments forgynecological and rectal/analcancer using HDR an PDRbrachytherapy.	The Crook Prostate Templatesare intended for interstitialprostate cancer using HDR orPDR brachytherapy.
Indication foruse	The intended use of theGammaMed Plus transportablehigh-dose-rate remotelycontrolled afterloadingbrachytherapy device is for thetreatment of cancer byintracavitary, interstitial,intralumenal and intraoperativeirradiation.	The Kelowna GYNTemplates are intended forinterstitial brachytherapytreatments for gynecologicaland rectal/anal cancer usingHDR and PDR brachytherapy.	The Crook Prostate Templatesare intended for interstitialprostate cancer using HDR orPDR brachytherapy.
ApplicatorDesign	Various Plates (Templates) with10 x 10mm hole geometrypattern;Cylinder, length 130mm, Ø24.9mm;Needle: length 200mm,Ø1.65mm;Needle stopper/holder for1.65mm needles;Pipe screw driver	Kelowna GYN Templates for16 gauge, 17 gauge and Ø 2mm needlesDosimetry based holegeometry pattern;Locking collets for fixation ofneedles;Needle collet wrench tosecurely affix the needles	Crook Prostate Templatesfor 17 gauge and Ø 2 mmneedles5 x 5 mm hole geometry pattern;Locking collets for fixation ofneedles;Needle collet wrench to securelyaffix the needles
CompatibleAfterloader	GammaMed Plus AfterloaderSeries	GammaMed Plus AfterloaderSeries	GammaMed Plus AfterloaderSeries
	GammaMed 12i(t)	VariSource Afterloader Series	VariSource Afterloader Series
Component List	Base plate for 1.65mm steel needles Cover plate II without cylinder hole, with fixation screws Cover plate III with centered cylinder hole with fixation screws Cover plate IV with de-centered cylinder hole, with fixation screws Cylinder, length 130mm, 24.9mm diameter Base plate filling piece for needles Cover plate filling piece for cylinder with fixation screws Needle stopper for 1.56mm needles Pipe screwdriver Stainless Steel needle, 200mm, 1.65mm diameter Sterilization plugs (pack of 25) Cleaning caps, white (pack of 20)	Kelowna GYN Template for Ø 2.0 mm needles, including locking collets (pack of 25) and needle collet wrench Kelowna GYN Template for 16 gauge (1.65 mm) needles, including locking collets (pack of 25) and needle collet wrench Kelowna GYN Template for 17 gauge (1.47 mm) needles, including locking collets (pack of 25) and needle collet wrench	Crook Prostate Template for Ø 2.0 mm needles, B-K labelling, including locking collets (pack of 25) and needle collet wrench Crook Prostate Template for 17 gauge (1.47 mm) needles, B-K labelling, including locking collets (pack of 25) and needle collet wrench Crook Prostate Template for 2.0 mm needles, Siemens labelling, including locking collets (pack of 25) and needle collet wrench
	Channel marker clips, code 1-12 Channel marker clips, coded 13-24 Leak stop buttons, non-sterile, pack of 50
Materials	Template: PPSUNeedle stopper: Stainless SteelScrew Driver: Stainless Steel	Template: PEEKLocking collets: TitaniumNeedle collet wrench: Stainless Steel	Template: PEEKLocking collets: TitaniumNeedle collet wrench: Stainless Steel
Packing	Individual	Individual	Individual
Sterility	Provided in non-sterile conditionSterilized by user prior to use	Provided in non-sterile conditionSterilized by user prior to use	Provided in non-sterile conditionSterilized by user prior to use
CleaningMethod	Manual cleaning	Manual cleaningMachine cleaning	Manual cleaningMachine cleaning
Sterilizationmethod	Steam Sterilization	Steam Sterilization	Steam Sterilization
Biocompatibility	Fully biocompatible	Fully biocompatible	Fully biocompatible
Anatomical sites	Pelvic, vaginal, female urethral,cervical, prostatic and rectal	Pelvic	Pelvic
Compatibilitywith ImagingEnvironment	CT Compatible	CT compatible	CT compatible
SupportingAccessories	Required:interstitial accessory kitOptional:screws for cover platesource guide tube support16G stainless steelneedle, 113mm trocar	Required:Ø 2.0 mm Plastic Interstitial Needles (K141624) 17G (1.47mm) Titanium and Stainless Steel Interstitial Needles (K160815) 16G (1.65mm) Titanium and Stainless Steel Interstitial Needles (K160815) Optional: 25mm diameter cylinders of the Universal	Required:Ø 2.0 mm Plastic Interstitial Needles (K141624) 17 gauge (1.47mm) Titanium and Stainless Steel Interstitial Needles (K160815) Optional: Bard (Amertek) adapter Blue locking collets for Ø 2.0 mm needles
	point	Segmented Cylinder Applicator Set and Universal Stump Applicator Set
	Source guide tube with locking mechanism for 180mm needles	Blue locking collets for Ø 2.0 mm needles Locking collets for 16 G and 17 G needles Needle collet wrench	Locking collets for 16 G and 17 G needles Needle collet wrench
Where used	Brachytherapy treatment room	Brachytherapy treatment room	Brachytherapy treatment room

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VI. PERFORMANCE DATA

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

Non-Clinical Tests:

Biocompatibility Testing:

The biocompatibility evaluation for the subject devices was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. This included the following tests:

Cytotoxicity ●
. Sensitization
Irritation ●
System Toxicity ●
Subacute Toxicity ●
Implantation

According to ISO 10993-1 the components of the Kelowna GYN and Crook Prostate Templates are categorized as a medical device, surface device in contact with breached or compromised surfaces and prolonged contact duration (>24h to 30d). (B).

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Sterilization Testing:

Sterilization testing for the subiect devices were 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 safety or effectiveness.

. Validation/Efficacy Testing of Cleaning, Disinfection, and Sterilization Cycles
Verification of the Suitability of Applicator Design and Material for the Stated Use Life and Reprocessing Cycles

Electrical Safety and Electromagnetic Compatibility (EMC):

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

Software Verification and Validation Testing:

This item is not applicable to the subject devices; 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:

. CT Compatibility Tests and Analysis
Verification and Validation Testing for Applicator Design Specifications .

Declaration of Conformity:

The following list are standards to which the subject devices conformity:

. AAMI TIR-12:2010
AAMI TIR-30:2011
ANSI/AAMI ST-79:2010/A2:2011/A3:2012/A4:2013 (R 2014) ●
ANSI/AAMI ST-81:2004/(R)2010
IEC 62366 ●
ISO 10993-1:2009 ●

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ISO 10993-5:2009 ●
ISO 10993-10:2009
ISO 17664:2004
ISO 17665-1: 2006
ISO 14937:2009/(R)2013 .

Animal Study / Clinical Tests:

No animal studies or clinical tests have been included in this submission in support of the substantial equivalence determination.

VII. CONCLUSIONS

The results of the non-clinical tests support the safety and effectiveness of the device under the specified use conditions. Varian believes that the validation and verification testing demonstrates that the subject devices perform comparably to the predicate device, meeting the intended use.

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.