SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE

K123815 · Varian Medical Systems, Inc. · JAQ · Mar 11, 2013 · Radiology

Device Facts

• Record ID: K123815
• Device Name: SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Mar 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surface Applicator Set with Leipzig-style cone-GM11010080 is indicated for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR brachytherapy.

Device Story

Surface Applicator Set with Leipzig-style Cone is a brachytherapy accessory used in hospital treatment rooms. It guides a radioactive source from an HDR afterloader (GammaMedplus or VariSource series) to a precise location on the patient's skin. The device consists of a Leipzig-style cone with a horizontal source entrance and various cone insets (30-45 mm). It is operated by radiation oncologists, physicists, and technicians. The device does not contact the patient directly; a sterile plastic envelope or surgical foil is required. By ensuring accurate source positioning according to a predefined treatment plan, it enables targeted radiation delivery to small skin tumors or superficial lesions, potentially benefiting patients by providing localized radiotherapy.

Clinical Evidence

No clinical tests included. Bench testing only: verified functional compatibility with afterloaders, mechanical durability over lifetime cycles, positional accuracy of the radioactive source, and material resistance to radiation exposure. Usability assessed per IEC 62366:2007.

Technological Characteristics

Materials: Tungsten, Stainless Steel, PVC. Design: Leipzig-style cone with horizontal source entrance; cone insets (30-45 mm). Energy source: External (HDR radioactive source via afterloader). Connectivity: None (mechanical accessory). Sterilization: Non-sterile (requires sterile barrier).

Indications for Use

Indicated for treatment of small skin tumors or superficial diseases (e.g., keloids) via HDR brachytherapy. No specific age or gender restrictions.

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 as part of GammaMedplus HDR remote afterloader system (K983436)

Submission Summary (Full Text)

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# PREMARKET NOTIFICATION

### 510(k) Summary

### Surface Applicator Set with Leipzig-style Cone

### As required by 21 CFR 807.92

MAR 1 1 2013

| Submitter's Name: | Varian Medical Systems<br>911 Hansen Way, M/S C-260<br>Palo Alto CA94304 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado<br>Phone: [phone]<br>Fax:[phone]<br>Date: 30 November 2012 |
| Proprietary Name: | GM11010080 Surface Applicator Set with Leipzig-style Cone |
| Classification Name: | Remote controlled radionuclide applicator system<br>21CFR892.5700<br>Class II |
| Common/Usual Name: | Surface Applicator Set(s), Surface Applicator |
| Predicate Devices: | Surface Applicator as part of GammaMedplus HDR remote<br>afterloader system. K983436. |
| Device Description: | The Surface Applicator Set with Leipzig-style Cone is a<br>Brachytherapy applicator set. Brachytherapy is a form of<br>radiotherapy using Gamma rays from a radioactive source placed<br>at locations close to or within a tumour to a predefined treatment<br>plan. The treatment plan defines the positions and times for the<br>source to ensure the correct dose for the treatment area. The<br>applicator acts to guide the radioactive source to the correct<br>location or locations for treatment..<br>The devices are intended to be used by trained and qualified<br>personnel such as Radiation Oncologists, Physicians, Radiologists,<br>Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology<br>Technicians/Radiographers in a hospital environment. |
| Indications for Use: | The Surface Applicator Set with Leipzig-style cone-GM11010080 is<br>indicated for treatment of small skin tumours or other superficial<br>disease (such as keloid formations) with HDR brachytherapy. |

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# Technological Characteristics of the device compared with the predicate device:

| | Surface Applicator | GM11010080 Surface<br>Applicator Set with Leipzig-<br>style Cone |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate<br>Device<br>Clearance<br>Number: | GammaMedplus Afterloader system<br>with applicators and accessories<br>K983436 | N/A |
| Compatible<br>Afterloader | GammaMedplus<br>GammaMed 12i(t) | GammaMedplus series<br>VariSource Series |
| Intended use | The intended use of the GammaMed<br>Plus transportable high-dose-rate<br>remotely controlled afterloading<br>brachytherapy device is for the<br>treatment of cancer by intracavitary,<br>interstitial, intraluminal and<br>intraoperative irradiation. | The Surface Applicator Set with<br>Leipzig-style Cone is intended for<br>the treatment of small skin tumours<br>or other superficial disease (such as<br>keloid formations) with HDR<br>brachytherapy. |
| Indications for<br>Use | The intended use of the GammaMed<br>Plus transportable high-dose-rate<br>remotely controlled afterloading<br>brachytherapy device is for the<br>treatment of cancer by intracavitary,<br>interstitial, intraluminal and<br>intraoperative irradiation. | The Surface Applicator Set with<br>Leipzig-style Cone is intended for<br>the treatment of small skin tumours<br>or other superficial disease (such as<br>keloid formations) with HDR<br>brachytherapy. |
| Target<br>population | No specific population | No specific population |
| Design | Shielding for tubus with a vertical<br>source entrance: | Leipzig-style Cone with a horizontal<br>source entrance: |
| | Ø 10-25 mm and Ø 30-45 mm with<br>fixation | Ø 30-45 mm, with holder and guide |
| | Surface tubus inset set:<br>Ø10-25 mm, round<br>Ø30-45 mm, round<br>Ø30-45 mm, oval | Surface cone inset:<br>Ø 30 mm, 35 mm, 40 mm, 45 mm,<br>round |
| Materials | Shielding: Tungsten / Stainless Steel<br>Surface tubus insets:<br>Tungsten / PVC | Leipzig-style Cone:<br>Tungsten / Stainless Steel<br>Surface cone insets:<br>Tungsten / PVC |
| Packing | individual | individual |
| Sterility | Non sterile | Non sterile |
| Sterilization<br>method | Devices are not sterilized. | Devices are not sterilized. |
| Biocompatibility | N/A. The use of a sterile plastic<br>envelope or surgical foil is required to<br>prevent any parts of the applicator<br>from having body contact. | N/A. The use of a sterile plastic<br>envelope or surgical foil is required<br>to prevent any parts of the applicator<br>from having body contact. |
| Anatomical sites | skin | skin |
| Where used | Brachytherapy Treatment Room | Brachytherapy Treatment Room |

:

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Non Clinical Tests Berich Testing has been performed to demonstrate . that the device functions correctly with the specified afterloaders; . that the device can withstand the number of cycles of use that it will experience in its lifetime; that the device enables the radioactive source to be ● located to the accuracy required, . that 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; . that 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. Varian considers the devices to be safe and effective and to perform as well or better than the predicate

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

March 11, 2013

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

Re: K123815

Trade/Device Name: Surface Applicator Set with Leipzing-style Cone Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: November 30, 2012 Received: December 12, 2012

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 vour 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 (OS) 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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#### Page 2-Mr. Coronado

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm

Sincerely yours.

Michael D'Hara

for

Janine M Morris 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 Form

510(k) Number (if known): K123815

Device Name: Surface Applicator Set with Leipzig-style Cone.

Indications for Use:

GM110010080 Surface Applicator Set with Leipzig-style Cone.

The Surface Applicator Set with Leipzig-style cone-GM11010080 is indicated for treatment of small short of the superficial disease (such as keloid formations) with HDR brachnerapy.
skin tumours or other superficial disease (such as keloid formations) with HDR brachytherap

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED. NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Offision Sign-Off ffice of In Vitro Diagnostic Device Safety 510/k)

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