UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET

K141490 · Varian Medical Systems, Inc. · JAQ · Sep 26, 2014 · Radiology

Device Facts

• Record ID: K141490
• Device Name: UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Sep 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are indicated for use for cancer treatment of the vagina, vaginal stump and rectum using HDR or PDR brachytherapy.

Device Story

Intracavitary applicators designed for use with GammaMed Plus, VariSource 200, and IX afterloaders; deliver high dose rate (HDR) or pulsed-dose-rate (PDR) brachytherapy for gynecological and rectal cancers. Applicators inserted into body cavities by physicians in brachytherapy treatment rooms. Device guides radioactive source to target tumor site; positional accuracy verified via CT or MRI. Benefits include localized radiation delivery to cancerous tissue while sparing surrounding healthy anatomy. Non-sterile, reusable devices; sterilized via steam.

Clinical Evidence

No clinical data. Bench testing only. Testing confirmed device functionality with specified afterloaders, mechanical durability over lifetime cycles, positional accuracy of radioactive source, radiation resistance of materials, and effectiveness of steam sterilization. Usability assessed per IEC 62366:2007.

Technological Characteristics

Intracavitary applicators for HDR/PDR brachytherapy. Materials: PPSU (cylinder), PEEK (guiding tube/probe), Titanium. Dimensions: Segmented cylinder diameters 20-40mm; Stump applicator diameters 20-35mm. MR conditional and CT compatible. Sterilization: Steam (132-134°C). Compatible with GammaMed Plus, VariSource 200, and IX afterloaders.

Indications for Use

Indicated for cancer treatment of the vagina, vaginal stump, and rectum using HDR or PDR brachytherapy in patients requiring intracavitary radiation therapy.

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

• Intracavitary Brachytherapy Applicators (K033371)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human profiles facing to the right.

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

September 26, 2014

Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304

Re: K141490

Trade/Device Name: Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: August 15, 2014 Received: August 18, 2014

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 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

510(k) Number (if known) K141490

Device Name

GM11011100 - Universal Segmented Cylinder Applicator Set GM11011160 - Universal Stump Applicator Set

#### Indications for Use (Describe)

The Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are indicated for use for cancer treatment of the vaginal stump and rectum using HDR or PDR brachytherapy.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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

## GM11011100 Universal Segmented Cylinder Applicator Set GM11011160 Universal Stump 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<br>Phone: [phone]<br>Fax: [phone] |
| | Date: 04 June 2014 |
| Proprietary Name: | Universal Segmented Cylinder Applicator Set<br>Universal Stump 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: | K033371 Intracavitary Brachytherapy Applicators<br>(11-00415 Segmented Cylinder Set, 11-00416 Stump Applicator Set) |
| Device Description: | The applicator sets in this submission are designed to be used with the GammaMed Plus<br>afterloader series, Varisource 200 and IX afterloaders to deliver high dose rate (HDR) and<br>pulsed-dose-rate (PDR) brachytherapy treatment for gynecological and rectal<br>applications. The intracavitary applicators will be used for the treatment of cancerous<br>tumors, and are designed to be inserted into a body cavity. |
| Intended Use<br>Statement | The Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set<br>are indicated for use for cancer treatment of the vagina, vaginal stump and rectum using<br>HDR or PDR brachytherapy. |
| Indications for Use<br>Statement | The Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set<br>are indicated for use for cancer treatment of the vagina, vaginal stump and rectum using<br>HDR or PDR brachytherapy. |

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## Technological Characteristics:

| | Segmented Applicator Cylinder Set and<br>Stump Applicator Set (K033371) | Universal Segmented Cylinder Applicator<br>Set and Universal Stump Applicator Set |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible Afterloader | Varian Afterloader (GammaMed and<br>VariSource) | GammaMed Plus afterloader series<br>Varisource 200 and IX afterloader |
| Intended use | 11-00415 Segmented Cylinder Set<br>Segmented Cylinder Set is developed to<br>treat cancer of the vagina and the vaginal<br>stump. It is also suitable to treat rectal<br>cancer. The applicator set is MR and CT<br>compatible. The maximum implantation<br>time for this applicator is 2 days. | The Universal Segmented Cylinder<br>Applicator Set and the Universal Stump<br>Applicator Set are indicated for use for<br>cancer treatment of the vagina, vaginal<br>stump and rectum using HDR or PDR<br>Brachytherapy. |
| | 11-00416 Stump Applicator Set<br>Stump Applicator Set is developed for<br>post-operative irradiation of the vaginal<br>stump. The flexible applicator probe has a<br>connector made of titanium, so that<br>position checks can be made using CT or<br>MRI. The maximum implantation time for<br>this applicator is 30 days. | |
| Indications for Use | The applicators will be used with the<br>VariSource High Dose Rate Afterloaders to<br>deliver brachytherapy treatment for<br>gynecological and rectal applications. The<br>applicators will be used in medical<br>intracavitary for treatment of cancerous<br>tumors. | The Universal Segmented Cylinder<br>Applicator Set and the Universal Stump<br>Applicator Set are indicated for use for<br>cancer treatment of the vagina, vaginal<br>stump and rectum using HDR or PDR<br>Brachytherapy. |
| Design | Segmented Cylinder:<br>Cylinder segment dimension: diameters<br>20, 25, 30, 35 mm; length 30 mm<br>Front segment: 2 front segments for<br>vaginal wall and vaginal stump treatment<br>Front segment dimension: diameters 20,<br>25, 30, 35 mm; length 20 – 27.5 mm<br>Guiding tube: straight ø 6.4 mm; length<br>228 mm<br>Applicator probe: ø 3.2 mm; inner length<br>320 mm; flexible with blocking washer | Segmented Cylinder:<br>Cylinder segment dimension: diameters<br>20, 25, 30, 35, 40 mm; length 30 mm<br>Front segment: 1 front segment for vaginal<br>wall and vaginal stump treatment<br>Front segment dimension: diameter 20,<br>25, 30, 35, 40 mm; length 50 – 60 mm<br>Guiding tube & applicator probe: straight<br>rigid ø 3.2 mm; length 200 and 250 mm |
| | Stump Applicator:<br>Cylinder dimension: diameters 20, 23, 26,<br>30, 35 mm; length 140 mm<br>Applicator probe dimension:<br>ø 3.2 mm;<br>inner length 320 mm | Stump Applicator:<br>Cylinder dimension: diameters 20, 25, 30,<br>35 mm; length 140 mm<br>Applicator probe dimension: ø 3.2 mm;<br>inner length 200 and 250 mm |

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| Materials | Segmented Cylinder:<br>Cylinder: PPSU plastic white<br>Guiding tube: PEEK plastic natural<br>Applicator probe: FEP, Titanium | Segmented Cylinder:<br>Cylinder: PPSU plastic white<br>Guiding tube & applicator probe: PEEK<br>plastic natural, Titanium |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| | Stump Applicator:<br>Cylinder: PPSU plastic white<br>Applicator probe: PVDF, Titanium | Stump Applicator: Cylinder: PPSU plastic<br>white<br>Applicator probe: PEEK plastic natural,<br>Titanium |
| Packing | Individual | Individual |
| Sterility | Provided non-sterile | Provided non-sterile |
| Sterilization method | Steam sterilization<br>134 °C for 5 minutes<br>121 °C for 15 minutes | Steam sterilization<br>132 °C for 4 min<br>134 °C for 3 min<br>134 °C for 5 min |
| Biocompatibility | Full biocompatibility | Full biocompatibility |
| Anatomical sites | Segmented Cylinder:<br>Vaginal, rectum | Segmented Cylinder:<br>Vaginal, rectum |
| | Stump Applicator: Vaginal | Stump Applicator: Vaginal, rectum |
| Compatibility with the<br>environment and other<br>devices | Segmented Cylinder:<br>CT compatible<br>MR conditional | Segmented Cylinder:<br>CT compatible<br>MR conditional |
| | Stump Applicator:<br>CT compatible<br>MR conditional | Stump Applicator:<br>CT compatible<br>MR conditional |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |

### 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
- . 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. Varian considers to be safe and effective and to perform as well or better than the predicate.