Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets

K152018 · Varian Medical Systems, Inc. · JAQ · Sep 11, 2015 · Radiology

Device Facts

• Record ID: K152018
• Device Name: Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Sep 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cleaning Cap is intended to close the lumens of applicator parts during the cleaning and disinfection process. New sterilized Cleaning Caps can be placed onto applicators during patient insertion if this is desired. The Leak Stop Buttons are intended to prevent liquid entering the applicator or source guide tube connector during implantation and treatment. They are also used for fixation of the individual channel marker clips. The Leak Stop Channel Marker Sets are intended for the individual numbering of the multiple channels in combination of avoiding liquid entering the applicator or source guide tube connectors.

Device Story

Brachytherapy applicator accessories; includes cleaning caps, leak stop buttons, and channel marker sets. Cleaning caps seal applicator lumens during cleaning/disinfection; can be used during patient insertion. Leak stop buttons and channel markers prevent blood/liquid ingress into source guide tube connectors during implantation and treatment. Channel markers provide individual channel numbering. Used in clinical settings (head/neck, GYN, breast, prostate brachytherapy) by oncology staff. Accessories are compatible with Varian applicator probes, tandems, or needles using ClickFit™ connectors. Devices facilitate safe handling and accurate treatment delivery by maintaining applicator integrity and preventing contamination.

Clinical Evidence

Bench testing only. No clinical data. Performance verified through verification and validation testing, including biocompatibility (irritation, sensitization, acute systemic injection) and cleaning validation. Conformance to ISO 10993 series and ISO 14971 standards demonstrated.

Technological Characteristics

Materials: Silicone. Compatibility: CT compatible, MR safe. Connectivity: Mechanical interface (ClickFit™ connector). Sterilization: Not specified, but intended for cleaning/disinfection. Standards: ISO 14971:2012, ISO 10993-1:2009, ISO 10993-10:2010, ISO 10993-12:2012.

Indications for Use

Indicated for use in brachytherapy treatment in areas such as head and neck, gynecological, breast, and prostate. Used for applicator cleaning/disinfection, preventing liquid ingress into source guide tube connectors during implantation/treatment, and channel identification.

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

• Plastic interstitial needles (K141624)

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

September 11, 2015

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

Re: K152018

Trade/Device Name: Varian Cleaning Caps, Leak Stop Buttons, Leak Stop Channel Marker Sets Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: July 14, 2015 Received: July 21, 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 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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K152018

Device Name

Cleaning Cap, Leak Stop Buttons & Leak Stop Channel Marker Sets

#### Indications for Use (Describe)

The Cleaning Cap is intended to close the lumens of applicator parts during and disinfection process. New sterilized Cleaning Caps can be placed onto applicators during patient insertion if this is desired.

The Leak Stop Buttons are intended to prevent liquid entering the applicator or source guide tube connector during implantation and treatment. They are also used for fixation of the individual channel marker clips.

The Leak Stop Channel Marker Sets are intended for the individual numbering of the multiple channels in combination of avoiding liquid entering the applicator or source guide tube connectors.

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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## Premarket Notification [510(k)] Summary Cleaning Caps, Leak Stop Channel Markers & Leak Stop Buttons

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

| I. Submitter's Name: | Varian Medical Systems, Inc.<br>3120 Hansen Way C-260<br>Palo Alto, CA 94304<br><br>Contact Name: Peter J. Coronado<br>Phone: [phone]<br>Fax: [phone]<br>Date: July 2015 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II. Trade Name: | Varian Cleaning Caps, Leak Stop Channel Marker Sets & Leak Stop Buttons |
| Common Name: | Cleaning Caps, Leak Stop Channel Marker Sets & Leak Stop Buttons |
| Classification Name: | Medical charged-particle radiation therapy system<br>21 CFR 892.5700, Class II<br>Product Code: JAQ |
| III. Predicate Device: | Plastic interstitial needles: K141624 |
| IV. Device Description: | The Cleaning Caps, the Leak Stop Buttons and Leak Stop Channel Marker Sets are brachytherapy applicator accessories. The Cleaning Cap is used to close the lumens of applicator parts during the cleaning and disinfection process. During treatment the Leak Stop Buttons and Leak Stop Channel Marker Sets prevent blood or liquid from entering the source guide tube connector. |
| V. Intended Use Statement: | The Cleaning Cap, the Leak Stop Channel Marker Sets and the Leak Stop Buttons are designed for brachytherapy treatment in areas such as the head and neck, gynecological, breast and prostate. |
| Indications for Use Statement | The Cleaning Cap is intended to close the lumens of applicator parts during the cleaning and disinfection process. New sterilized Cleaning Caps can be placed onto applicators during patient insertion if this is desired.<br><br>The Leak Stop Buttons are intended to prevent liquid entering the applicator or source guide tube connector during implantation and treatment. They are also used for fixation of the individual channel marker clips.<br><br>The Leak Stop Channel Marker Sets are intended for the individual numbering of the multiple channels in combination of avoiding liquid |

entering the applicator or source guide tube connectors.

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# Premarket Notification [510(k)] Summary Cleaning Caps, Leak Stop Channel Markers & Leak Stop Buttons

### VI. Technological Characteristics:

| FEATURE/<br>SPECIFICATION | PLASTIC INTERSTITIAL NEEDLES<br>510(k) ID # K141624 | CLEANING CAPS, LEAK STOP CHANNEL<br>MARKER SETS & LEAK STOP BUTTONS |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials: | Needles: PEEK/Titanium<br>Obturator/Mandrin: Stainless Steel<br>Cleaning Caps: Silicone<br>Leak Stop Channel Marker: Silicone<br>Leak Stop Buttons: Silicone | Cleaning Caps: Silicone<br>Leak Stop Channel Marker: Silicone<br>Leak Stop Buttons: Silicone |
| Compatibility with the<br>environment and other<br>devices | CT compatible, MR conditional for<br>1.5 and 3.0T | CT compatible; MR safe<br>Designed to be used with all Varian<br>applicator probes, tandems or needles<br>with the ClickFit™ connector. |
| Dimensions | Plastic needle:<br>• Diameter: 2 mm<br>• Length: 113, 200, 320mm<br>• Tip styles:<br>Sharp tip<br>Blunt tip (320mm length only)<br>Cleaning Caps:<br>• Diameter: 5.1mm<br>• Length: 13.5mm<br>Leak Stop Channel Marker:<br>• Diameter: 10.0mm<br>• Length: 2.0mm<br>Leak Stop Buttons:<br>• Diameter: 10.0mm<br>• Length: 2.0mm | Cleaning Caps:<br>• Diameter: 5.1mm<br>• Length: 13.5mm<br>Leak Stop Channel Marker:<br>• Diameter: 10.0mm<br>• Length: 2.0mm<br>Leak Stop Buttons:<br>• Diameter: 10.0mm<br>• Length: 2.0mm |
| Packing | Individual packaging for needles<br>Cleaning Caps: Pack of 25<br>Leak Stop Channel Marker:<br>• Sets contain packs of 25 (for<br>each channel);<br>• Sets are Channels 1-12,<br>Channels 13-24, and Channels<br>25-30<br>Leak Stop Buttons: Pack of 50 | Cleaning Caps: Pack of 25<br>Leak Stop Channel Marker:<br>• Sets contain packs of 25 (for each<br>channel);<br>• Sets are Channels 1-12, Channels 13-<br>24, and Channels 25-30<br>Leak Stop Buttons: Pack of 50 |

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## Premarket Notification [510(k)] Summary Cleaning Caps, Leak Stop Channel Markers & Leak Stop Buttons

| VII. Summary of performance<br>testing: | Results of verification and validation testing showed conformance to<br>applicable requirements specifications and assured hazard safeguards<br>functioned properly.<br>Biocompatibilty testing requirements for irritation, sensitization, and<br>acute systemic injection have been met.<br>Cleaning validation test requirements have been met. | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Standards conformance: | The Varian Cleaning Caps, Leak Stop Channel Marker Sets & Leak Stop<br>Buttons conform in whole or in part with the following standards:<br>IEC 62366:2007<br>ANSI/AAMI/ISO 10993-5:2009<br>ANSI/AAMI/ISO 10993-6:2007<br>ANSI/AAMI/ISO 10993-11:2010 | ISO 14971:2012<br>ISO 10993-1:2009<br>ISO 10993-10:2010<br>ISO 10993-12:2012 |
| Conclusion: | Based on the verification, validation and non-clinical 10993 standard<br>testing, the The Varian Cleaning Caps, Leak Stop Channel Marker Sets &<br>Leak Stop Buttons are as safe, effective and performs as well as or<br>better than the legally marketed device identified in section III above. | |