CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406

K033828 · Mick Radio-Nuclear Instruments, Inc. · JAQ · Feb 2, 2004 · Radiology

Device Facts

• Record ID: K033828
• Device Name: CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406
• Applicant: Mick Radio-Nuclear Instruments, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Feb 2, 2004
• 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 Compatible Intrauterine Sleeve is intended for use as an accessory to the cervical applicators used in High Dose Rate (HDR) Brachytherapy as described for the predicate device. The intended use and design of this system is the similar to that of the predicate device (Varian Medical Systems, Inc. Cervical Sleeve, K955844). Fractionated HDR Brachytherapy of the Cervix requires repeated insertion of the applicator during treatment. Use of the CT Compatible Intrauterine Sleeves allows the user to repeatedly insert non-curved tandems without repeated delivery of anesthesia to the patient and helps prevent the possibility of uterine penetration by the tandems.

Device Story

The CT Compatible Intrauterine Sleeve is a mechanical accessory for cervical applicators used in HDR brachytherapy. It functions as a guide or sleeve for non-curved tandems during fractionated radiation treatment. By remaining in place, it allows for repeated insertion of the tandem without requiring repeated anesthesia for the patient and reduces the risk of uterine perforation. It is used in a clinical setting by healthcare providers performing brachytherapy procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical accessory for cervical applicators; designed for use with non-curved tandems. Materials are biocompatible and previously used in medical devices. No energy source or software components.

Indications for Use

Indicated for patients undergoing fractionated High Dose Rate (HDR) Brachytherapy for cervical cancer. Used as an accessory for cervical applicators with non-curved tandems to facilitate repeated insertion, avoid repeated anesthesia, and prevent uterine perforation.

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

• Varian Medical Systems, Inc.; Cervical Sleeve (K955844)

Submission Summary (Full Text)

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## FEB - 2 2004

K033828
Page 1 of 2

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

October 30, 2003

#### General Provisions 1.

Remote Controlled Radionuclide Applicator System Common/Usual Name:

CT Compatible Intrauterine Sleeve 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 |
|-----------------------------------------------|----------|
| Varian Medical Systems, Inc.; Cervical Sleeve | K955844 |

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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K03822
Page 2 of 2

#### Classification 3.

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

#### Performance Standards 4.

Performance standards for accessories to applicators for remote controlled afterloading 1 or ormanoe atablished by the FDA under Section 514 of the FDA under Section 514 of the Food, Drug and Cosmetic Act.

#### Intended Use and Device Description ട്.

The Mick Radio-Nuclear Instruments, Inc. CT Compatible Intrauterine Sleeve is intended for use as an accessory to the cervical applicators used in High Dose Rate (HDR) Brachytherapy as described for the predicate device. The intended use and design of this system is the similar to that of the predicate device (Varian Medical Systems, Inc. Cervical Sleeve, K955844). Fractionated HDR Brachytherapy of the Cervix requires repeated insertion of the applicator during treatment. Use of the CT Compatible Intrauterine Sleeves allows the user to repeatedly insert non-curved tandems without repeated delivery of anesthesia to the patient and helps prevent the possibility of uterine penetration by the tandems.

#### 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, and has the same intended use and performance characteristics to the predicate device. 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 shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 2004

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

Re: K033828 Trade/Device Name: CT Compatible Intrauterine Sleeve Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: 90 JAQ Dated: November 12, 2003 Received: December 11, 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 such 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 I'DA'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. Brogden

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

KO33828

Device Name: CT Compatible Intrauterine Sleeve

### 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 This accessory for cervical applicators is designed as an accessory for any Cervical cervix. Applicator that has a non-curved tandem. Use of the Intrauterine Sleeve aids in repeated insertion of the cervical applicator during fractionated treatments, eliminating repeated use of anesthesia and prevents the possibility of uterine perforation.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

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

David A. Symm

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

or

CT Compatible Intrauterine Sleeve - 510(k)