VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET

K111973 · Nucletron · JAQ · Sep 21, 2011 · Radiology

Device Facts

• Record ID: K111973
• Device Name: VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET
• Applicant: Nucletron
• Product Code: JAQ · Radiology
• Decision Date: Sep 21, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vaginal CT/MR Multi Channel Applicator Set is intended for gynecologic Brachytherapy treatment of the vagina, cervix and endometrium.

Device Story

Vaginal CT/MR Multi Channel Applicator Set; accessory to Nucletron afterloaders for gynecologic brachytherapy. Device consists of central and surface channels spaced around a cylinder; allows selective, individual loading of channels to sculpt radiation dose laterally for asymmetrically located tumors. Compatible with X-ray, CT, and MRI imaging; includes markers to assist in visualization of source path. Used in clinical settings by healthcare professionals to deliver targeted radiation to vagina, cervix, or endometrium. Enables precise dose distribution; improves treatment of complex tumor geometries.

Clinical Evidence

Bench testing only. Performance requirements met; device performance demonstrated to be equivalent to the predicate Miami Vaginal Applicator. Validation of sterilization processes and biocompatibility provided.

Technological Characteristics

Gynecological brachytherapy applicator; cylinder with central and surface channels. Materials modified for CT/MRI compatibility. Single-use components included. Compatible with Nucletron afterloaders.

Indications for Use

Indicated for gynecologic brachytherapy treatment of the vagina, cervix, and endometrium in patients requiring radiation therapy.

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

• Miami Vaginal Applicator (K083048)

Submission Summary (Full Text)

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K-111973

NUCLETRON B.V.

Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone [phone] Fax [phone]

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

# 510(k) Summary

June 29, 2011

## Submitter of 510(k):

| Company name: | Nucletron Corporation |
|----------------------|----------------------------------------------|
| Registration number: | 1121753 |
| Address: | 7021 Columbia Gateway Drive |
| | Suite 200 |
| | 21046 Columbia MD |
| Phone: | 443 545 2182 |
| Fax: | 443 769 1546 |
| Correspondent: | Michael Paul |
| | Regulatory Affairs/Quality Assurance Manager |

## New Device Name:

| Trade/Proprietary Name: | Vaginal CT/MR Multi Channel Applicator Set |
|-------------------------|------------------------------------------------------------|
| Common/Usual Name: | Gynecological Brachytherapy applicator |
| Classification Name: | Remote controlled radionuclide applicator system accessory |
| Classification: | 21Cfr892.5700 Class II |

SEP 2 1 2011

## Legally Marketed Device(s)

Our device is substantially equivalent to the legally marketed predicate device cited in the table below:

| Manufacturer | いたいというとなってきました。このことには無理問題がありませんです。まずはないと言えるという<br>levice<br>Company Controller Company Company<br>A . Portunities . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Comments . Co | 11 . 1<br>----------------------------------------------------------------------------------------------------- |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Nucletron | Miami<br>Anniicator | KOESONE |

## Description:

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The Vaginal CT/MR Multi Channel Applicator Set is a modification of the Miami Vaginal Applicator Set. It is intended for gynecologic brachytherapy of the vagina, cervix and endometrium. The applicator consists of a central channel and surface channels, which are equally spaced around the surface of the cylinder.

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The vaginal cylinder is several sizes, each diameter with a specified number of surface channels. The surface channels follow the shape of the cylinder's dome. By selectively and individually loading these channels, the dose can be directed laterally and sculpted to the required shape, for instance for treatment of asymmetrically located turnors.

The Vaginal CT/MR Multi Channel Applicator Set can be used in combination with X-ray, CT and MRI. Markers for the treatment channels are available to assist in visualization of the source path on the acquired images.

The devices are used as accessories to Nucletron afterloaders.

### Intended use:

The Vaginal CT/MR Multi Channel Applicator Set is intended for gynecologic Brachytherapy treatment of the vagina, cervix and endometrium.

### Summary of technological considerations:

Intended use, operating principle, design, performance and technological characteristics of the modified device are the same as or similar to the legally marketed device. The modified device can be used with CT and MRI through use of other materials. Some parts of the modified device are single use.

#### Summary of testing:

Validation of sterilization processes and biocompatibility is provided. Bench testing shows that the device meets its performance requirements, and that the device performance is equivalent to the Miami Vaginal Applicator Set.

#### Conclusion:

Nucletron considers the Vaginal CT/MR Multi Channel Applicator Set to be substantially equivalent to legally marketed predicate device through the data and information presented. No safety or effectiveness issues were identified.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002

Mr.Michael Paul Regulatory Affairs/Quality Assurance Manager Nucletron Corporation 7021 Columbia Gateway Drive, Suite 200 COLUMBIA MD 21046-2133

SEP 21 2011

Re: K111973

Trade/Device Name: Vaginal CT/MR Multi Channel Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: H Product Code: JAQ Dated: August 30, 2011 Received: August 31, 2011

Dear Mr. Paul:

We have reviewed vour 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR \$63); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR, Part 820). 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.

ff you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse evenis under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

<111973

510(k) Number (if known)

Device Name

Indications for Use

Vaginal CT/MR Multi Channel Applicator Set

The Vaginal CT/MR Multi Channel Applicator Set is intended for gynecologic Brachytherapy treatment of the vagina, cervix and endometrium.

Prescription Use __ X (Part 21 CFR 801 subpart D) AND/OR

Over-The-Counter Use_ (Part 21 CFR 801 subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

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Division of Radiological Devices Vitro Diagnostic Device Evaluation and Safety Office of In

510K KUU973