HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR

K011657 · Mick Radio-Nuclear Instruments, Inc. · JAQ · Aug 27, 2001 · Radiology

Device Facts

• Record ID: K011657
• Device Name: HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
• Applicant: Mick Radio-Nuclear Instruments, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Aug 27, 2001
• 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 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 HDR Tandem/Ring Applicator with Rectal Retractor meets these requirements.

Device Story

HDR Tandem/Ring Applicator with Rectal Retractor is a mechanical accessory for remote afterloading brachytherapy systems (e.g., Varisource, Gammamed). Device facilitates intra-cavitary radiation therapy by providing a stable delivery path for radioactive sources (Iridium-192) to treat cervical cancer. Physician places applicator in the vaginal cavity; rectal retractor component allows for anatomical positioning to minimize radiation dose to the rectum. Device utilizes varying intrauterine tube lengths to optimize clinical delivery. No electronic or software components; purely mechanical device used in clinical settings to guide radiation source placement.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and performance characteristics compared to the predicate device. Bench testing only.

Technological Characteristics

Mechanical brachytherapy applicator. Materials are identical to the predicate device. Features include a tandem/ring configuration, rectal retractor, and interchangeable intrauterine tubes of varying diameters. Non-powered, non-electronic, standalone mechanical device.

Indications for Use

Indicated for patients requiring high dose rate (HDR) remote afterloading brachytherapy for the treatment of cancer, specifically cancer of the cervix. Used as an accessory to deliver radiation via sealed radioactive sources (e.g., Iridium-192) to tumors within the body.

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 Corporation Ring Applicator - Complete Set (K953946)

Reference Devices

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

Submission Summary (Full Text)

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KO1165-7

# AUG 2 7 2001

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

May 25, 2001

#### General Provisions 1.

Remote Controlled Radionuclide Applicator System Common/Usual Name:

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)
l

| Manufacturer | K Number |
|---------------------------------------------------------|----------|
| Nucletron Corporation Ring Applicator - Complete<br>Set | 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 .

#### Performance Standards 4.

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 ડ.

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

#### Biocompatibility 6.

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

#### Summary of Substantial Equivalence 7.

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 the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three overlapping wing shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

AUG 2 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K011657 HDR Tandem/Ring Applicator with rectal retractor (Brachytherapy Applicator) Dated: May 25, 2001 Received: May 29, 2001 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 is w marked in the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate submand of the May 28, 1976, the enactered to the Medical Device Amendments, or to devices that have been reclassified in occordance 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 II (Special Controls) or 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 equivalient determination assumes compliance with the Current Good Manufacturing Practice requirements, 600 to 09: I r backlain.) of the Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic as so round in and Quality Dystem to and will verify such assumptions. Failure to comply with the GMP regulation may Qu 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

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

[phone] Other Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-659. 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, 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

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## Indications for Use

510(k) Number: To be assigned

K011657

Device Name: HDR Tandem/Ring Applicator with Rectal Retractor

### 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 application of Brachytherapy is in the treatment of cancer of the cervix. 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 HDR Tandem/Ring Applicator with Rectal Retractor is placed in the vicinity of the vagina just as described for the predicate device (Nucletron Ring Applicator, K953946) and with a rectal retractor and varying intrauterine tube length diameters, clinical needs can be best optimized along with minimization of dose to the rectum.

Nancy C. broadon

(Division Sign-Off)
Division of Imaging and Radiation
and Radiological Devices
510(k) Number K011657

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:_X

or

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