HDR MIAMI APPLICATOR

K020176 · Mick Radio-Nuclear Instruments, Inc. · JAQ · Apr 8, 2002 · Radiology

Device Facts

• Record ID: K020176
• Device Name: HDR MIAMI APPLICATOR
• Applicant: Mick Radio-Nuclear Instruments, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Apr 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mick Radio-Nuclear Instruments, Inc. HDR Miami Applicator is intended for use in Brachytherapy. The delivery of intra-cavitary radiation therapy requires not only proper visualization and localization of the applicator within the treatment volume, but precise dosimetry and a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear HDR Miami Applicator meets these requirements.

Device Story

The HDR Miami Applicator is a mechanical accessory for remote-controlled afterloading brachytherapy systems (Varisource, Gammamed). It functions as a stable delivery system for Iridium-192 radioactive sources. The device is placed intra-cavitarily in the vicinity of the cervix via the vagina. It features interchangeable diameter sleeves and intrauterine tubes to optimize treatment geometry and minimize mucosal radiation dose. It is operated by clinicians in a clinical setting to facilitate precise dosimetry and radiation delivery for cancer treatment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical brachytherapy applicator; includes interchangeable sleeves and intrauterine tubes. Materials are identical to the predicate device. No energy source or software components; purely mechanical device.

Indications for Use

Indicated for use as an accessory to the Varisource System and Gammamed System using Iridium-192 radioactive sources to treat cancer in various body sites. Specifically designed for placement in the vicinity of the cervix via the vagina for intra-cavitary 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

• Nucletron Miami Vaginal Applicator (K953946)

Reference Devices

• Varisource System (K952913)
• Gammamed System (K891131/A)

Submission Summary (Full Text)

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# APR = 8 2002

## Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act

December 30, 2001

### 1. General Provisions

Common/Usual Name: Remote Controlled Radionuclide Applicator System

Proprietary Name:

HDR Miami Applicator

Applicant Name and Address:

Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue Mount Vernon, New York 10550

#### 2. Name of Predicate Devices:

- (1)

| Manufacturer | K Number |
|------------------------------------|----------|
| Nucletron Miami Vaginal Applicator | K953946 |

Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, " ... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).

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#### 3. Classification

This device is classified as a class II device according to 21 CFR 892.5700 .

#### 4. Performance Standards

Performance standards for applicators for remote controlled afterloading brachytherapy have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

#### Intended Use and Device Description న్.

The Mick Radio-Nuclear Instruments, Inc. HDR Miami Applicator is intended for use in Brachytherapy. The delivery of intra-cavitary radiation therapy requires not only proper visualization and localization of the applicator within the treatment volume, but precise dosimetry and a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear HDR Miami Applicator meets these requirements.

Biocompatibility 6.

No new issues of biocompataibility are raised with regard to this device.

#### 7. Summary of Substantial Equivalence

This device is similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### APR = 8 2002

Re: K020176

Mr. Felix Mick President Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue MOUNT VERNON NY 10550

Trade/Device Name: HDR Miami Applicator HDR Brachytherapy Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system

Regulatory Class: II Product Code: 90 JAQ Dated: January 7, 2002 Received: January 18, 2002

Dear Mr. Mick:

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); 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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This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon 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: To be assigned

KO 20176

Device Name: HDR Miami Applicator

Indications for Use:

This applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K891131/A) which uses a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites. The Miami Applicator is placed in the vicinity of the cervix via the vagina just as described for the predicate device (Nucletron Miami Vaginal Applicator, K953946) and different diameter sleeves and interuterine tubes, can be optimized to best meet the clinical needs of the patient along with minimization of dose to the mucosa.

*Prescription Use* ✓

Yurid A. Stepanov

(Division Sign Division of Rep and Radiologic 510(k) Numb