HDR CT COMPATIBLE SPLIT RING APPLICATOR

K063382 · Mick Radio-Nuclear Instruments, Inc. · JAQ · Dec 26, 2006 · Radiology

Device Facts

• Record ID: K063382
• Device Name: HDR CT COMPATIBLE SPLIT RING APPLICATOR
• Applicant: Mick Radio-Nuclear Instruments, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Dec 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HDR CT Compatible Split Ring type applicator is indicated for use in any case where high dose rate brachytherapy of the cervix or uterus is an accepted clinical practice.

Device Story

HDR CT Compatible Split Ring Applicator functions as positioning device for HDR remote after-loader sealed sources; used in treatment of cervical or uterine cancer. Device provides stable, reproducible, and predictable geometry for radioactive source placement during radiation therapy. Operated by clinical staff in oncology settings; enables precise dosimetry via remote control. Benefits patient by ensuring accurate radiation delivery to target tissue while maintaining stable applicator positioning.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Remote controlled radionuclide applicator system. Designed for CT compatibility to facilitate precise source positioning. Materials are identical to predicate devices. Class II device (21 CFR 892.5700).

Indications for Use

Indicated for patients requiring high dose rate (HDR) brachytherapy for cancer of the cervix or uterus.

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

• CT HDR Tandem / Ring Applicator with Rectal Retractor (K030110)
• HDR Tandem/Ring Applicator with Rectal Retractor (K011657)
• H.A.M. Applicator (K961601)

Submission Summary (Full Text)

{0}------------------------------------------------

K 0633882

DEC 26 2006

Appendix 1

.

510(k) Summary

1

:

-

{1}------------------------------------------------

K166382

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

### November 2, 2006

#### General Provisions 1.

| Common/Usual Name: | Remote Controlled Radionuclide Applicator System |
|--------------------|--------------------------------------------------|
| Proprietary Name: | HDR CT Compatible Split Ring Applicator |

Applicant Name and Address:

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

#### Name of Predicate Devices: 2.

(1)

l

| Device | Manufacturer | K Number |
|----------------------------------------------------------|-----------------------------------------|----------|
| CT HDR Tandem / Ring<br>Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments,<br>Inc. | K030110 |
| HDR Tandem/Ring Applicator<br>with Rectal Retractor | Mick Radio-Nuclear Instruments,<br>Inc | K011657 |
| H.A.M. Applicator | Mick Radio-Nuclear Instruments,<br>Inc | K961601 |

statement made in conjunction with this submission regarding Any 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).

{2}------------------------------------------------

K1063382

#### 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.

#### న. Intended Use and Device Description

The HDR CT Compatible Split Ring Applicator presented in this 510(k) notification has been developed to function for the positioning of HDR Remote After-Loader sealed sources in the treatment of cancer of the cervix or uterus. The design of these systems is similar to that of the predicate devices listed below.

| Device | Manufacturer | K Number |
|----------------------------------------------------------|-----------------------------------------|----------|
| CT HDR Tandem / Ring<br>Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments,<br>Inc. | K030110 |
| HDR Tandem/Ring Applicator<br>with Rectal Retractor | Mick Radio-Nuclear Instruments,<br>Inc | K011657 |
| H.A.M. Applicator | Mick Radio-Nuclear Instruments,<br>Inc | K961601 |

The delivery of radiation therapy via high dose rate Brachytherapy treatment of the cervix or uterus requires not only a stable system for precise dosimetry but also a reproducible and predictable geometry for positioning of the radioactive source under remote control. The HDR CT Compatible Split Ring Applicator is designed to act as such a device.

#### 6. Biocompatibility

No new issues of biocompatibility 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.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

JAN 31 2007

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: K063382

Trade/Device Name: HDR CT Compatible Split Ring Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: November 2, 2006 Received: November 8, 2006

Dear Mr. Mick:

This letter corrects our substantially equivalent letter of December 26, 2006.

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 (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

Image /page/3/Picture/13 description: The image is a black and white logo. The logo is circular and contains the text "1906 - 2006" at the top. Below the text is the acronym "FDA" in large, bold letters. Below the acronym is the word "Centennial" in a cursive font. There are two stars below the word "Centennial". The text "FDA in your corner for a century" surrounds the circle.

*Protecting and Promoting Public Health*

{4}------------------------------------------------

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.

This letter will allow you to continue marketing your device as described in your Section 510(k) I mis lotter will and in you to containtial equivalence of your device to a legally premium of needicate 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 [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 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,

David G. Ingram

for

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{5}------------------------------------------------

### Indications for Use

510(k) Number: To be assigned \< 063382

Device Name: HDR CT Compatible Split Ring Applicator

### Indications for Use:

The HDR CT Compatible Split Ring type applicator is indicated for use in any case where high The HDK CI Compatible Spin King type applicator is marcated in the cervice is an accepted clinical practice.

## Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use:_

or

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

David R. Lyman

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

CT Compatible Split Ring Applicator - 510(K)