CENTERING INTRALUMINAL APPLICATOR

K082653 · Varian Medical Systems, Inc. · JAQ · Oct 10, 2008 · Radiology

Device Facts

• Record ID: K082653
• Device Name: CENTERING INTRALUMINAL APPLICATOR
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Oct 10, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Varian transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.

Device Story

Centering Intraluminal Applicator functions as part of a high-dose-rate (HDR) remote afterloading brachytherapy system. Device utilizes a single Iridium-192 radioactive source; source is enclosed within a wire/cable driven through coupling catheters, transfer guide tubes, and source guide tubes from the afterloader into the patient. System is used in clinical settings for cancer treatment; operated by trained medical professionals. Applicator ensures precise positioning of the radioactive source within the target anatomy. Output is the delivery of therapeutic radiation to cancerous tissue; assists clinicians in localized tumor treatment while sparing surrounding healthy tissue.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Remote-controlled radionuclide applicator system; utilizes Iridium-192 radioactive source; includes coupling catheters, transfer guide tubes, and source guide tubes for source delivery; Class II device (21 CFR 892.5700).

Indications for Use

Indicated for the treatment of cancer via intracavitary, interstitial, intralumenal, and intraoperative irradiation in patients requiring brachytherapy.

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

• GammaMed Plus High Does Rate Remote Afterloading System (K983436)

Submission Summary (Full Text)

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OCT 1 0 2008

K082653

### 510(k) Summary

The information below is provided for the Modifications to the Centering Intraluminal Applicators, following the format of 21 CFR 807.92 ..

#### Submitter:

Varian Medical Systems 3100 Hansen Way M/S E-110 Palo Alto, CA 94304-1129 Contact Name: Ms. Vy Tran Phone: [phone] Fax: [phone] Email: [e-mail] Date summary was prepared: September 11, 2008

### Name of the Device:

Trade/Proprietary Name: Common or Usual Name: Classification Name:

Centering Intraluminal Applicator Centering Intraluminal Applicator Centering Intraluminal Applicator System, Applicator, Radionuclide, Remote - Controlled 21 CFR 892.5700 Class II Product Code: JAQ

## Predicate Device to claim substantial equivalence:

K983436 - GammaMed Plus High Does Rate Remote Afterloading System

### Description of the Device:

Varian's High Dose Rate BrachyTherapy Afterloaders use a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites.

The radioactive source is enclosed within a wire/cable which is driven via coupling catheters /Transfer Guide Tubes / Source Guide Tubes from the Applicator in to the patient.

#### Intended Use Statement:

The intended use of the Varian transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.

#### Summary of the Technological Characteristics:

The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate device. The chart is located in Tab 7 of this submission.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract representation of a human form or a caduceus, rendered in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2008

Ms. Vy Tran Senior Director, Corporate Regulatory Affairs Varian Medical Systems, Incorporated 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K082653

Trade/Device Name: Centering Intraluminal Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: September 11, 2008 Received: September 12, 2008

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 such 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.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | | 240-276-0115 |
|----------------|---------------------------------|--|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | | 240-276-0120 |
| Other | | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

logu M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K082653

# Device Name: Centering Intraluminal Applicator

Indications For Use:

The indications for use of the Varian transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

(Optional Format 3-10-98)

Armi'th Khan

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