CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR

K030110 · Mick Radio-Nuclear Instruments, Inc. · JAQ · Apr 3, 2003 · Radiology

Device Facts

• Record ID: K030110
• Device Name: CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
• Applicant: Mick Radio-Nuclear Instruments, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Apr 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor 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 CT HDR Tandem/Ring Applicator with Rectal Retractor meets these requirements.

Device Story

The CT HDR Tandem/Ring Applicator with Rectal Retractor is a mechanical device used in brachytherapy for the uterus and cervix. It provides a stable delivery system for intra-cavitary radiation therapy, facilitating visualization and localization of the applicator within the treatment volume. The device is used by clinicians in a clinical setting to ensure precise dosimetry during radiation delivery. It does not involve electronic processing or software.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical applicator for remote controlled afterloading brachytherapy. Constructed from materials previously used in medical devices. No electronic components, software, or energy sources.

Indications for Use

Indicated for High Dose Rate (HDR) irradiation of the uterus and cervix.

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

• Mick Radio-Nuclear HDR Tandem/Ring Applicator with Rectal Retractor (K011657)

Submission Summary (Full Text)

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APR - 3 2003

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

January 30, 2003

#### 1. General Provisions

Common/Usual Name: Remote Controlled Radionuclide Applicator System

CT HDR Tandem/Ring Applicator with Rectal Retractor Proprietary Name:

Applicant Name and Address:

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

#### Name of Predicate Devices: 2.

- (1)

| Manufacturer | K Number |
|------------------------------------------------------------------------|----------|
| Mick Radio-Nuclear HDR Tandem/Ring Applicator<br>with Rectal Retractor | K011657 |

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.

#### 5. Intended Use and Device Description

The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor 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 CT HDR Tandem/Ring Applicator with Rectal Retractor 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, and has the same intended use and performance characteristics to the predicate devices. It utilizes materials that are already in use in other medical 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 Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 2003

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

Re: K030110 Trade/Device Name: CT HDR Tandem/Ring Applicator with Rectal Retractor Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: 90 JAQ Dated: January 9, 2003 Received: January 13, 2003

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 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 the 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" (21CFR Part 807.97) you may obtain. 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 yours.

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

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510(k) Number: To be assigned

Device Name: CT HDR Tandem/Ring Applicator with Rectal Retractor

### Indications for Use:

The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is indicated for High Dose Rate irradiation of the uterus and cervix.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Usc:

Over-The Counter Use: ____ (Per 21 CFR 801.109)

David A. Legnon

or

(Division Sign-Off) Division of Reproductive and Radiological Devi 510(k) Number