Advanced Breast Template System

K161540 · Varian Medical Systems, Inc. · JAQ · Oct 20, 2016 · Radiology

Device Facts

• Record ID: K161540
• Device Name: Advanced Breast Template System
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Oct 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Advanced Breast Template System is an interstitial brachytherapy applicator; guides radioactive sources to predefined locations within tumor or treatment area for HDR brachytherapy. Device consists of mechanical components, including a ratchet assembly, used to position sources for gamma ray delivery. Used in hospital environments by radiation oncologists, physicians, radiologists, dosimetrists, medical physicists, and nurses/technicians. Device is CT compatible; compatible with VariSource iX, VariSource 200, GammaMedplus iX, and GammaMedplus afterloaders. Applicator facilitates precise dose delivery to breast or chest wall; enables repeated use via steam sterilization. No software, electronics, or biologics involved.

Clinical Evidence

No clinical data or animal studies were included. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (cytotoxicity, sensitization, irritation, systemic/subacute toxicity, implantation), sterilization efficacy validation, and mechanical CT compatibility analysis.

Technological Characteristics

Mechanical interstitial brachytherapy applicator. Materials are biocompatible per ISO 10993-1. Designed for repeated use; steam sterilizable (pre-vacuum) per AAMI ANSI ST-79, ST-81, AAMI TIR-12, TIR-30, and EN ISO 17664. CT compatible. No electrical components, software, or firmware. Complies with IEC 62366.

Indications for Use

Indicated for cancer treatment of the breast or chest wall using high dose rate (HDR) brachytherapy in male and female patients.

Regulatory Classification

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.

Predicate Devices

• VariSource Breast Template System (K023220)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

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.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# 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)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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

Telephone: [phone] 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 Systems<br>3100 Hansen Way, m/s E-110<br>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: | [e-mail] |
| 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) |

{4}------------------------------------------------

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 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™.

{5}------------------------------------------------

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)

{6}------------------------------------------------

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 ●

{7}------------------------------------------------

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 ●

{8}------------------------------------------------

- 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.