VARIAN INTERSTITIAL TITANIUM NEEDLES

K093291 · Varian Medical Systems, Inc. · JAQ · Nov 17, 2009 · Radiology

Device Facts

• Record ID: K093291
• Device Name: VARIAN INTERSTITIAL TITANIUM NEEDLES
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Nov 17, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Interstitial Needles are used with Varian High Dose Rate Afterloaders.

Device Story

Device consists of family of closed-ended interstitial needles and associated obturators. Used in conjunction with high dose rate (HDR) brachytherapy afterloading devices. Needles available in 17 or 18 gauge O.D. and lengths of 113mm, 200mm, 250mm, and 320mm. Obturators inserted into needles to provide stiffness during implantation and between radiation therapy fractions. Provided unsterile; require steam sterilization by user. Used in clinical settings by medical professionals to facilitate delivery of radiation therapy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Closed-ended interstitial needles and obturators. Materials: Titanium. Dimensions: 17G or 18G O.D.; lengths 113mm, 200mm, 250mm, 320mm. Sterilization: Steam sterilization (user-performed).

Indications for Use

Indicated for use with Varian High Dose Rate (HDR) afterloaders for interstitial brachytherapy procedures.

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

• Varian Interstitial Needles (K073133)

Submission Summary (Full Text)

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## Premarket Notification 510(k) Summary

| Submitter's Name: | Varian Medical Systems, Inc.<br>3100 Hansen Way, E-110<br>Palo Alto, CA 94304<br>Contact Name: Vy Tran<br>Phone: [phone]<br>Fax: [phone]<br>Date: October 2009 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Varian Interstitial Needles |
| Classification Name: | System, Applicator, Radionuclide, Remote - Controlled<br>21 CFR 892.5700, Class II, JAQ |
| Common/Usual Name: | Varian Interstitial Needles |
| Predicate Devices: | Varian Interstitial Needles, K073133 |

NOV 1 7 2009## Device Description:

The device is a family of closed-ended, interstitial needles and associated obturators to be used in conjunction with a high dose rate (HDR) brachytherapy afterloading device. The needles are available in either 17 gauge O.D. or 18 gauge O.D. and in lengths of 113mm, 200 mm, 250mm and 320mm. The associated obturators are inserted into needles to stiffen the needles during implantation of the needles into the patient and to stiffen the needles between radiation therapy fractions. The obturators are available in lengths of 113mm, 200 mm, 250mm and 320mm. The needles are provided unsterile with instructions for steam sterilization. The obturators are provided unsterile with instructions for steam sterilization.

| Statement of | |
|----------------------|-------------------------------------------------------------------------------|
| Indications for Use: | The Interstitial Needles are used with Varian High Dose<br>Rate Afterloaders. |

Technological Characteristics:

Refer to the Substantial Equivalence Comparison Chart.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Vy Tran Corporate Vice President, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

NOV 1 7 2009

Re: K093291

Trade/Device Name: Interstitial Titanium Needles Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: October 16, 2009 Received: October 21, 2009

Dear Ms. Tran:

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.

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

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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.

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/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Indications for Use |
|---------------------|
|---------------------|

| 510(k) Number (if known): | K093291 |
|---------------------------|-------------------------------|
| Device Name: | Interstitial Titanium Needles |
| Indications for Use: | |

The Interstitial Needles are used with Varian High Dose Rate Afterloaders.

| Prescription Use (Part 21 CFR 801 Subpart D) | <div>X</div> | AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) | |
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|----------------------------------------------|--------------|--------|---------------------------------------------|--|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helena

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(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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