Varian Cervical Sleeves

K172675 · Varian Medical Systems, Inc. · JAQ · May 16, 2018 · Radiology

Device Facts

• Record ID: K172675
• Device Name: Varian Cervical Sleeves
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: May 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Varian Cervical Sleeves are intended for use for treatment of any case where high dose irradiation with an intrauterine tandem is an acceptable clinical practice.

Device Story

Varian Cervical Sleeves are brachytherapy applicator accessories; used for insertion into cervix prior to radiation treatment. Device guides radioactive source to correct locations; can be sutured in place for series of treatments. Presence of sleeve prevents uterine wall perforation by distal end of tandem. Used in clinical settings by healthcare professionals. Benefits include improved guidance of radioactive source and reduced risk of tissue perforation during high dose rate brachytherapy.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation testing conducted per 21 CFR 820, ISO 13485, and ISO 14971. Biocompatibility testing (irritation, sensitization, acute systemic injection) performed per ANSI/AAMI/ISO 10993-1. Cleaning validation requirements met.

Technological Characteristics

Material: Low density polyethylene with BaSO4 for CT contrast. MR safe. Dimensions, biocompatibility, and sterility consistent with predicate. Standards: ISO 14971:2007, ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2002, ISO 10993-12:2012, ISO 11138-1:2006, ISO 11737-2:2009, AAMI/ANSI ST79:2010, AAMI/ANSI ST81:2004, ISO 14161:2009, IEC 62366:2007.

Indications for Use

Indicated for patients requiring high dose irradiation via intrauterine tandem where such clinical practice is acceptable. No specific age or gender restrictions provided, though implied for gynecological oncology patients.

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

• Cervical sleeves (K955844)

Submission Summary (Full Text)

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May 16, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K172675

Trade/Device Name: Varian Cervical Sleeves Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: April 19, 2018 Received: April 19, 2018

Dear Mr. Coronado:

We have reviewed vour 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 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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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone

(1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. 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)

K172675

Device Name

Cervical Sleeves

Indications for Use (Describe)

The Varian Cervical Sleeves are intended for use for treatment of any case where high dose irradiation with an intrauterine tandem is an acceptable clinical practice.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Premarket Notification [510(k)] Summary Cervical sleeves

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

- Varian Medical Systems, Inc. I. Submitter's Name: 3120 Hansen Way C-260 Palo Alto, CA 94304 Contact Name: Peter J. Coronado Phone: [phone] Fax: [phone] Date: August 2017 II. Trade Name: Varian Cervical Sleeves
Common Name: Cervical sleeves

Classification Name: Remote controlled radionuclide applicator system 21 CFR 892.5700, Class II Product Code: JAQ

- III. Predicate Device: Cervical sleeves: K955844
- IV. Device Description: Varian Cervical Sleeves are brachytherapy applicator accessories. The cervical sleeves are used for insertion into the cervix prior to treatment and acts to guide the radioactive source to the correct locations for treatment. The sleeve can be sutured in place and left for a series of treatments. Presence of the sleeve helps to insure against perforation of the uterine wall by the distal end of the tandem.
- The Varian Cervical Sleeves are intended for use for treatment of any case V. Intended Use Statement: where high dose irradiation with an intrauterine tandem is an acceptable clinical practice.

Indications for Use The Varian Cervical Sleeves are intended for use for treatment of any case Statement where high dose irradiation with an intrauterine tandem is an acceptable clinical practice.

### VI. Technological Characteristics:

The differences between the cleared predicate device and this device are:

- · Low density polyethylene (with BaS04 for CT contrast) material;
- · MR safe compatibility

The similarities are:

- · Indications and Intended Use;
- · Use location;
- · Dimensions, Biocompatibility, Sterility, Sterilization & Packaging

VII. Summary of Hardware verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management performance

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# Premarket Notification [510(k)] Summary Cervical sleeves

| <b>testing:</b> | System standard, ISO 14971 Risk Management Standard and the other FDA<br>recognized consensus standards listed below. Test results showed conformance<br>to applicable requirements specifications and assured hazard safeguards<br>functioned properly.<br>Biocompatibilty testing requirements in conformance with ANSI/AAMI/ ISO 10993<br>1 “Biological Evaluation of Medical Devices - Part 1” for irritation, sensitization,<br>and acute systemic injection have been met.<br>Cleaning validation test requirements have been met. | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| <b>Standards<br/>conformance:</b> | The Varian Cervical Sleeves conform in whole or in part with the following<br>standards: | |
| | ISO 14971:2007 | ISO 15223:2012 |
| | ISO 10993-1:2009 | ISO 10993-5:2009 |
| | ISO 10993-10:2002 | ISO 10993-12:2012 |
| | ISO 11138-1:2006 | ISO 11737-2:2009 |
| | AAMI/ANSI ST79:2010 +A2:2011 | AAMI/ANSI ST81:2004 +R2010 |
| | ISO 14161:2009 | IEC 62366:2007 |
| <b>Conclusion:</b> | Based on the verification, validation and non-clinical 10993 standard testing, the<br>Varian Cervical Sleeves are as safe, effective and performs as well as or better | |

than the legally marketed device identified in section III above.