The Advanced Breast Template System is an applicator for interstitial 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 applicator acts to guide the radioactive source to the correct location or locations for treatment.

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. This device is used on male and female patients.

The Advanced Breast Template System is compatible with the following afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™.

The Advanced Breast Template System is CT compatible.

AI/ML Overview

The provided document describes the 510(k) submission for the Advanced Breast Template System, a remote controlled radionuclide applicator system used for HDR Brachytherapy in breast cancer treatment. This device is not an AI/ML powered device, therefore no information is available with respect to acceptance criteria or studies that prove an AI/ML device meets criteria.

However, the document does contain information regarding non-clinical performance data provided in support of the substantial equivalence determination for this device.

1. Table of acceptance criteria and the reported device performance:

Since this is not an AI/ML device, the concept of typical 'acceptance criteria' for AI model performance (like sensitivity, specificity, AUC) does not apply. Instead, the device met various performance and safety standards for medical devices.

Acceptance Criteria (Standards/Tests)	Performance/Finding
Biocompatibility Testing:
ISO 10993-1, ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization, Irritation)	Components categorized as medical device, surface device in contact with breached or compromised surfaces, prolonged contact duration (>24h to 30d). All tests performed.
In accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1 for: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subacute Toxicity, Implantation	All tests conducted, implying compliance with these standards for biocompatibility.
Sterilization Testing:
Validation/Efficacy Testing of Cleaning, Disinfection, Sterilization Cycles	Performed to assess effectiveness of provided procedures.
Evaluation of components after sterilization cycles (up to stated use life) for performance and damage	Performed and evaluated, implying satisfactory performance and no significant damage affecting safety or effectiveness.
Mechanical Testing:
CT Compatibility Tests and Analysis	Device is stated to be CT compatible, implying successful testing.
Declaration of Conformity:
ISO 10993-1, ISO 10993-5, ISO 10993-10, AAMI ANSI ST-79, AAMI ANSI ST-81, AAMI TIR-12, AAMI TIR-30, IEC 62366, EN ISO 17664	Declared conformity to all listed standards, indicating adherence to relevant safety and performance requirements.

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

Not Applicable. This is a medical device (hardware) submission, not an AI/ML software submission. Therefore, there are no "test sets" in the context of data for model evaluation. The "tests" refer to laboratory and engineering tests on the physical device and its materials.

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

Not Applicable. As this is not an AI/ML device, there are no test sets requiring expert ground truth establishment.

4. Adjudication method for the test set:

Not Applicable. No test sets requiring adjudication for 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:

Not Applicable. This device is not an AI assistant and therefore no MRMC studies comparing human readers with and without AI assistance were conducted.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

Not Applicable. No ground truth in the context of AI/ML performance evaluation was used. The "ground truth" for this device's safety and effectiveness comes from adherence to established engineering, material, and medical device standards (e.g., biocompatibility standards, sterilization efficacy, mechanical integrity).

8. The sample size for the training set:

Not Applicable. This is a physical medical device, not an AI/ML model, so there is no training set.

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

Not Applicable. No training set was used.

Summary

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

October 20, 2016

Varian Medical Systems, Inc. % Mr. Peter Coronado Director Global Regulatory Affairs 911 Hansen Wav PALO ALTO CA 94304

Re: K161540

Trade/Device Name: Advanced Breast Template System Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: September 12, 2016 Received: September 13, 2016

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-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.

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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/Resourcesfor You/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 yours.

Michael D.'Hara

For

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) K161540

Device Name Advanced Breast Template System

Indications for Use (Describe)

The Advanced Breast Template System is intended for use for cancer treatment of the breast wall using high dose rate HDR Brachytherapy.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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 Advanced Breast Template System

A partner for life

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).

l. SUBMITTER

Submitter's Name:	Varian Medical Systems3100 Hansen Way, m/s E-110Palo 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:	June 1, 2016

II. DEVICE

Name of Device:	Advanced Breast Template System
Common/Usual Name:	System, Applicator, Radionuclide, Remote-Controlled
Regulation Name:	Remote controlled radionuclide applicator system (21 CFR 892.5700)

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Regulatory Class: Class II Product Code: JAQ

PREDICATE DEVICE lll.

Name of Predicate: VariSource Breast Template System

510k Number: K023220

DEVICE DESCRIPTION IV.

The Advanced Breast Template System is compatible with the following afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™.

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The Advanced Breast Template System is CT compatible.

The device is 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.

V. INDICATIONS FOR USE

Indications for Use Statement: The Advanced Breast Template System is intended for use for cancer treatment of the breast or chest wall using high dose rate HDR Brachytherapy.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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

At a high level, the subject and predicate devices are based on the following same technological elements:

Ratchet assembly and other device components are fully biocompatible .
Application in interstitial brachytherapy treatments .
. Same anatomical treatment site/application
. Sterilized by user prior to use (and reuses)

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The following main differences exist between the subject and predicate devices:

Reworded indications for use
. Material change in the ratchet assembly
Validation of machine cleaning and sterilization parameters .
Added CT compatibility ●
Added GammaMed Afterloader compatibility

PERFORMANCE DATA VI.

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

Non-Clinical Tests:

Biocompatibility Testing:

The biocompatibility evaluation for the subject device 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 ●
Systemic Toxicity ●
Subacute Toxicity ●
Implantation ●

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

Sterilization Testing:

Sterilization testing was performed 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 safety or effectiveness.

. Validation/Efficacy Testing of Cleaning, Disinfection, Sterilization Cycles

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.

Software Verification and Validation Testing:

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

Mechanical and Acoustic Testing:

. CT Compatibility Tests and Analysis

Declaration of Conformity:

The following list are standards to which the subject device declares conformity:

. ISO 10993-1
ISO 10993-5
ISO 10993-10 ●

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AAMI ANSI ST-79 ●
AAMI ANSI ST-81
AAMI TIR-12
. AAMI TIR-30
IEC 62366 ●
EN ISO 17664 ●

Animal Study / Clinical Tests:

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

CONCLUSIONS VII.

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 device performs 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.