3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90

K150839 · Varian Medical Systems, Inc. · JAQ · Jul 17, 2015 · Radiology

Device Facts

• Record ID: K150839
• Device Name: 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Jul 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 3D Interstitial Ring Applicator Sets (60° and 90°) and the Ring Applicator Sets (45°, 60° and 90°) are intended for use for cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy.

Device Story

Applicator sets for intracavitary or intracavitary/interstitial brachytherapy; guides radioactive source to predefined locations within tumor/treatment area based on treatment plan; used in brachytherapy treatment rooms; operated by clinical staff; device enables precise radiation delivery to vagina, cervix, and uterus; PEEK and titanium construction; MR conditional (1.5T/3T) and CT compatible; non-sterile, steam-sterilizable; compatible with GammaMedplus iX and GammaMedplus afterloaders.

Clinical Evidence

No clinical tests included. Bench testing only: verified afterloader compatibility, mechanical durability, positional accuracy of radioactive source, material radiation resistance, sterilization effectiveness, and usability per IEC 62366:2007.

Technological Characteristics

Materials: PEEK, Titanium. Sensing/Actuation: Mechanical guide for radioactive source. Energy: Gamma radiation (via external afterloader). Form factor: Ring applicators (26mm, 30mm) and intrauterine tandems (30-80mm lengths). Connectivity: None (mechanical). Sterilization: Steam (132°C/134°C). Standards: IEC 62366:2007 (usability).

Indications for Use

Indicated for cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy.

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

• Mick Radio Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator With Rectal Ring Retractor (K030110)

Submission Summary (Full Text)

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

July 17, 2015

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

Re: K150839

Trade/Device Name: 3D Interstitial Ring Applicator Sets (60° and 90°) and the Ring Applicator Sets (45°, 60° and 90°) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: June 18, 2015 Received: June 19, 2015

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 [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 O'Hara

For

Robert Ochs. Ph.D. Acting 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) K150839

#### Device Name

3D Interstitial Ring Applicator Sets (60° and 90°) and the Ring Applicator Sets (45°, 60° and 90°)

Indications for Use (Describe)

The 3D Interstitial Ring Applicator Sets (60° and the Ring Applicator Sets (45°, 60° and 90°) are intended for use for cancer treatment of the vagina, cervix, and uterus 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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## PREMARKET NOTIFICATION

## 510(k) Summary

## Remote Controlled Radionuclide applicator System

# As required by 21 CFR 807.92

| Submitter's Name: | Varian Medical Systems<br>3100 Hansen Way, m/s E-110<br>Palo Alto CA94304<br><br>Contact Name: Peter J. Coronado<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | March 27th 2015 |
| Proprietary Name: | 3D Interstitial Ring Applicator Set 60°<br>3D Interstitial Ring Applicator Set 90°<br>Ring Applicator Set 45°<br>Ring Applicator Set 60°<br>Ring Applicator Set 90° |
| Classification Name: | Remote controlled radionuclide applicator system<br>21CFR892.5700<br>Class II |
| Common/Usual Name: | Remote controlled radionuclide applicator system |
| Predicate Devices: | The Mick Radio Nuclear Instruments, Inc. CT HDR Tandem/Ring<br>Applicator With Rectal Ring Retractor (K030110) |
| Device Description: | The 3D Interstitial Ring Applicator Sets (60° and 90°), are<br>applicators for intracavitary or intracavitary/interstitial<br>brachytherapy. Brachytherapy is a form of radiotherapy using<br>Gamma rays from a radioactive source placed at locations close to<br>or within a tumor or other treatment area to a predefined<br>treatment plan. The treatment plan defines the positions and<br>times for the source to ensure the correct dose for the treatment<br>area. The applicator acts to guide the radioactive source to the<br>correct location or locations for treatment.<br><br>The Ring Applicator Sets (45°, 60° and 90°), are applicators for<br>intracavitary brachytherapy. Brachytherapy is a form of<br>radiotherapy using Gamma rays from a radioactive source placed<br>at locations close to or within a tumor or other treatment area to |

a predefined treatment plan. The treatment plan defines the

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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.

Indications for Use: The 3D Interstitial Ring Applicator Sets (60° and 90°) and the Ring Applicator Sets (45°, 60° and 90°) are intended for use for cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy.

#### Technological Characteristics:

| FEATURE AND/OR SPECIFICATION<br>OF NEW/MODIFIED DEVICE | 510(k) ID K030110<br>CT HDR Tandem/Ring Applicator<br>WITH RECTAL RETRACTOR | 3D INTERSTITIAL RING APPLICATOR SETS (60° AND 90° )<br>AND<br>RING APPLICATOR SETS (45°, 60° AND 90°) |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible Afterloader | GammaMed plus<br>GammaMed 12i(t)<br>VariSource | GammaMedplus iX<br>GammaMedplus |
| Intended use | High dose rate Brachytherapy<br>treatment of the uterus and<br>cervix | The 3D Interstitial Ring Applicator Sets 60° and 90°)<br>and the Ring Applicator Sets (45°, 60° and 90°) are<br>intended for use for cancer treatment of the vagina,<br>cervix, and uterus using HDR or PDR brachytherapy. |
| Indications for Use | The Mick Radio-Nuclear<br>Instruments, Inc. CT HDR<br>Tandem/Ring Applicator with<br>Rectal Retractor is indicated for<br>High Dose Rate irradiation of the<br>uterus and cervix | The 3D Interstitial Ring Applicator Sets (60° and 90°)<br>and the Ring Applicator Sets (45°, 60° and 90°) are<br>intended for use for cancer treatment of the vagina,<br>cervix, and uterus using HDR or PDR brachytherapy. |
| Design | Ring applicators 30°, 45°, and 60°;<br>32mm diameter<br>Intrauterine tandems 30°, 45°,<br>and 60°; 20mm, 40mm, 60mm,<br>and 80mm lengths | 3D interstitial ring applicators Sets (60° and 90°)<br>30mm diameter Intrauterine tandems 60°and, 90°;<br>30mm, 40mm, 50mm, 60mm, 70mm, and 80mm<br>lengths<br>3D interstitial ring applicators and intrauterine<br>tandems in sets possess holes to allow for needle<br>application.<br>Ring applicators Sets (45°,60°and 90°)<br>(same as predicate, angle measured from different<br>position); 26mm, and 30mm diameter<br>Intrauterine tandems 45°,60°, and 90°; 30mm,<br>40mm, 50mm, 60mm, 70mm, and 80mm lengths |
| Materials | Stainless Steel, PPSU, PEEK,<br>Titanium | PEEK, Titanium |
| Packing | Individual | Individual |
| Sterility | Provided non sterile | Provided non sterile |
| Sterilization method | Steam sterilization<br>15 minutes @ 121°C<br>5 minutes @ 134°C<br>18 minutes @ 134°C | Steam sterilization<br>4 minutes @ 132°C<br>3 minutes @ 134°C<br>5 minutes @ 134°C |
| Biocompatibility | Full biocompatibility | Full biocompatibility |
| Anatomical sites | Uterus, cervix | Uterus, cervix, vagina |
| Compatibility with the<br>environment and other<br>devices | CT compatible | CT compatible<br>MR conditional for 1.5 and 3 Tesla |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |

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Non Clinical Tests Bench Testing has been performed to demonstrate that

- the device functions correctly with the specified afterloaders; .
- the device can withstand the number of cycles of use that it will experience in its lifetime;
- . the device enables the radioactive source to be located to the accuracy required,
- . the device is constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
- . the device may be sterilized effectively

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- . the device can be used and sterilized for the specified number of times
- the positional accuracy of the source within the applicator is adequate.

Usability was assessed to the requirements of IEC 62366:2007. Results of Bench Testing showed conformance to applicable requirements and specifications

Clinical Tests No clinical tests have been included in this pre-market submission.

Conclusions All the tests that were performed met the applied pass criteria. Body of testing provides evidence that the devices are safe and effective to perform as well or better than the predicate.