SEGMENTED VAGINAL APPLICATOR

K993472 · Mick Radio-Nuclear Instruments, Inc. · JAQ · Jan 12, 2000 · Radiology

Device Facts

• Record ID: K993472
• Device Name: SEGMENTED VAGINAL APPLICATOR
• Applicant: Mick Radio-Nuclear Instruments, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Jan 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mick Radio-Nuclear Instruments, Inc. Segmented Vaginal Applicators are intended for use in Brachytherapy. The delivery of intracavitoary 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 Segmented Vaginal Applicator meets these requirements by providing an system that can be adjusted in length and diameter to meet the dimensions of the treatment volume and by utilizing radio opaque markers for visualization.

Device Story

Segmented Vaginal Applicator; mechanical device for positioning sealed radioactive sources during intracavitary brachytherapy. System features adjustable length and diameter to accommodate treatment volume dimensions; includes radio-opaque markers for visualization under imaging. Used by clinicians in radiation oncology settings to deliver radiation therapy for vaginal cancer. Device provides stable delivery platform for isotopes (e.g., Cesium, Iridium, Iodine, Gold); facilitates precise dosimetry and localization of treatment volume. Benefits patient by enabling targeted internal radiation exposure to tumors.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and performance characteristics compared to the predicate device.

Technological Characteristics

Mechanical applicator system; adjustable length and diameter; incorporates radio-opaque markers for visualization. Materials are identical to predicate device. No electronic components, software, or energy sources.

Indications for Use

Indicated for the positioning of sealed radioactive sources in the intracavitary treatment of vaginal cancer using Low Dose Rate or High Dose Rate remote afterloading 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

• Mick Radio-Nuclear Instruments, Inc. Hilaris-Nori Endometrial Applicator (K871216/A)

Submission Summary (Full Text)

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# JAN 1 2 2000

K993472

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

### October 2, 1999

#### General Provisions 1.

Applicator Manual Radionuclide Applicator System Common/Usual Name:

Segmented Vaginal Applicator Proprietary Name:

Applicant Name and Address:

Mick Radio-Nuclear Instruments, Inc. 1470 Outlook Avenue Bronx, New York 10465

#### 2. Name of Predicate Devices:

- (1)

| Manufacturer | K Number |
|-----------------------------------------------------------------------------|-----------|
| Mick Radio-Nuclear Instruments, Inc. Hilaris-Nori<br>Endometrial Applicator | K871216/A |

l 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 I device according to 21 CFR 892.5650 .

#### 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.

#### ട. Intended Use and Device Description

The Mick Radio-Nuclear Instruments, Inc. Segmented Vaginal Applicators are intended The delivery of intracavitoary radiation therapy requires not for use in Brachytherapy. 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 The Mick Radio-Nuclear Segmented Vaginal Applicator meets these administered. requirements by providing an system that can be adjusted in length and diameter to meet the dimensions of the treatment volume and by utilizing radio opaque markers for visualization.

#### 6. Biocompatibility

No new issues of biocompatability 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 shows a black and white logo of the Department of Health & Human Services. The logo features the department's seal, which includes an abstract image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2000

Felix Mick President Mick Radio-Nuclear Instruments, Inc. P.O. Box 99 Bronx, New York 10465

Re:

K993472 Segmented Vaginal Applicator Dated: October 13, 1999 Received: October 14, 1999 Regulatory class: II 21 CFR 892.5700/Procode: 90 JAQ

Dear Mr. Mick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Dan Letizia

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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

993472

Device Name: Segmented Vaginal Applicator

Indications for Use:

The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modern era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors now are treated by internal exposure to radiation emitted from sealed radioactive sources. Two common modalities for this are Low Dose Rate and High Dose Rate remote afterloading (Brachytherapy). One common use of Brachytherapy is in the treatment of cancer of the vaginal process. The system described in this 510(k) has been developed to function as an applicator for the positioning of sealed sources in the intracavitary treatment of the vagina.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use: | <div> <img alt="Checkmark" src="checkmark.png"/> </div> | or | Over-The Counter Use: | (Per 21 CFR 801.109) |
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993472