Surface Applicator Set

K162018 · Varian Medical Systems, Inc. · JAQ · Feb 28, 2017 · Radiology

Device Facts

• Record ID: K162018
• Device Name: Surface Applicator Set
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Feb 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surface Applicator Set is intended for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR Brachytherapy.

Device Story

Surface Applicator Set is a brachytherapy accessory used to guide radioactive sources to treatment sites. Device functions as a physical guide for HDR brachytherapy, ensuring source placement aligns with predefined treatment plans for small skin tumors or superficial diseases like keloids. Used in brachytherapy treatment rooms by clinical staff. Applicator does not contact patient directly; requires sterile plastic envelope or surgical foil. Device is non-sterile, reusable (up to 500 times), and compatible with GammaMedplus series afterloaders. By accurately positioning the radioactive source, the device enables precise radiation delivery to the target area, facilitating effective treatment of superficial lesions.

Clinical Evidence

No clinical data. Bench testing only. Testing evaluated suitability for 500 uses and 100 cleaning cycles; results met all pre-defined acceptance criteria.

Technological Characteristics

Materials: Tungsten, stainless steel, hard PVC. Principle: Mechanical guide for HDR brachytherapy radioactive source. Form factor: Surface cone insets (round/oval) and shielding with vertical source entrance. Connectivity: None (mechanical). Sterilization: Delivered non-sterile; requires sterile barrier (envelope/foil) for use. Reusability: 500 uses, 100 cleaning cycles.

Indications for Use

Indicated for treatment of small skin tumors or superficial diseases (e.g., keloid formations) in patients requiring HDR 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

• Surface Applicator Set with Leipzig-style Cone (K123815)

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

February 28, 2017

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

Re: K162018

Trade/Device Name: Surface Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: February 9, 2017 Received: February 10, 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-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. 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) K162018

Device Name Surface Applicator Set

Indications for Use (Describe)

The Surface Applicator Set is intended for treatment of small skin tumours or other superficial disease (such as keloid formations) with 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. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel [phone] www.varian.com

# Premarket Notification [510(k)] Summary

### Surface Applicator Set

The following information is provided following the format of 21 CFR 807.92(c).

| Submitter's Name: | Varian Medical Systems, Inc.<br>3100 Hansen Way E-110<br>Palo Alto, CA 94304 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado |
| | Phone: [phone] |
| | Fax: [phone] |
| | Date: February 9, 2017 |
| Proprietary Name: | Surface Applicator Set |
| Classification Name: | Remote controlled radionuclide applicator system<br>21 CFR 892.5700, Class II<br>Product Code: JAQ |
| Common/Usual<br>Name: | Remote controlled radionuclide applicator system |
| Predicate Devices: | Surface Applicator Set with Leipzig-style Cone (K123815) |
| Device Description: | The Surface Applicator Set is an applicator for Brachytherapy. Brachytherapy is a form of<br>radiotherapy using Gamma rays from a radioactive source placed at locations close to or<br>within a tumor or other treatment area to a predefined treatment plan. The treatment<br>plan defines the positions and times for the source to ensure the correct dose for the<br>treatment area. The applicator acts to guide the radioactive source to the correct<br>location or locations for treatment. |
| Intended Use<br>Statement | The Surface Applicator Set is intended for treatment of small skin tumours or other<br>superficial disease (such as keloid formations) with HDR Brachytherapy. |
| Indications for Use<br>Statement | The Surface Applicator Set is intended for treatment of small skin tumours or other<br>superficial disease (such as keloid formations) with HDR Brachytherapy. |

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## Technological Characteristics:

| FEATURE AND/OR<br>SPECIFICATION OF<br>NEW/MODIFIED DEVICE | SURFACE APPLICATOR SET WITH LEIPZIG-<br>STYLE CONE<br>(K123815) | MODIFIED DEVICE –<br>SURFACE APPLICATOR SET |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible Afterloader | GammaMedplus Series | GammaMedplus Series |
| Intended Use | The Surface Applicator Set with Leipzig-<br>style cone-GM11010080<br>is indicated for treatment of small skin<br>tumours or other superficial disease<br>(such as keloid formations) with HDR<br>brachytherapy. | The Surface Applicator Set<br>is intended for treatment of small skin<br>tumours or other superficial disease<br>(such as keloid formations) with HDR<br>Brachytherapy. |
| Indications for Use | The Surface Applicator Set with Leipzig-<br>style cone-GM11010080<br>is indicated for treatment of small skin<br>tumours or other superficial disease<br>(such as keloid formations) with HDR<br>brachytherapy. | The Surface Applicator Set<br>is intended for treatment of small skin<br>tumours or other superficial disease<br>(such as keloid formations) with HDR<br>Brachytherapy. |
| Design/Component list | Shielding for tubus with a vertical source<br>entrance:<br>• Ø 10-25 mm and Ø 30-45 mm<br>with fixation<br><br>Surface cone inset set:<br>• Ø30, 35, 40 mm round<br><br>Sterilization Plug GM11009960 and<br>Leak Stop Button GM11003810 | Shielding for the cone with a<br>vertical source entrance:<br>• Ø 10-25 mm and Ø 30-45 mm<br>with fixation<br><br>Surface cone inset set:<br>• Ø15, 20, 25, 30, 35, 40 mm<br>round<br>• Ø 30 x 20 mm and Ø 45 x 25<br>mm oval<br><br>Cleaning Caps (K152018) |
| Materials | • Surface cone inset:<br>Tungsten/hard PVC<br>• Leipzig Style Cone: Tungsten/<br>Stainless Steel | • Surface cone inset: Tungsten/hard<br>PVC<br>• Shielding for cones with fixation:<br>Tungsten/Stainless steel |
| Packing | Individual | Individual |
| Sterility | Delivered in non-sterile condition. | Delivered in non-sterile condition. |
| Sterilization method | Device is not sterilized. | Device is not sterilized. |
| Repeated Use | 500 times | 500 times |
| Cleaning cycles | 100 | 100 |
| Biocompatibility | N/A. The use of a sterile plastic envelope<br>or surgical foil is required to prevent any<br>parts of the applicator from having body<br>contact | N/A. The use of a sterile plastic<br>envelope or surgical foil is required to<br>prevent any parts of the applicator from<br>having body contact |
| Anatomical sites | Skin | Skin |
| Compatible with CT or<br>MR | No | No |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |

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#### Performance Data:

Bench testing was performed to evaluate the suitability of the applicator sets repeated use for up to 500 times and 100 cleaning cycles. Non-clinical testing showed the test articles met the pre-defined acceptance criteria, thereby demonstrating that the device performs as intended.

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

#### Conclusions

The non-clinical data support the safety of the device and the bench testing demonstrates that the Surface Applicator Set performs as intended. Varian therefore considers Surface Applicator Set to be safe and effective and to perform at least as well as the predicate device.