UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,

K091154 · Nucletron Corporation · JAQ · May 18, 2009 · Radiology

Device Facts

• Record ID: K091154
• Device Name: UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,
• Applicant: Nucletron Corporation
• Product Code: JAQ · Radiology
• Decision Date: May 18, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the device is gynecological brachytherapy procedures for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.

Device Story

Applicator set for gynecological brachytherapy; used with Nucletron microSelectron afterloaders. Device features guiding holes in ring or ovoid components allowing insertion of Proguide needles into tumors. Enables asymmetric dose distribution; facilitates treatment of carcinoma where no lumen or cavity exists. Constructed from polymers to minimize CT/MR imaging distortion. Optional MR line markers (Teflon tubes with fluid) used for visualization during imaging, removed prior to treatment. Operated by clinicians in clinical settings. Output is physical guidance for radiation source delivery; assists in precise dose distribution for cancer treatment.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Polymer construction for CT/MR compatibility; guiding holes for interstitial needle placement; accessory to remote-controlled afterloader systems. Optional Teflon MR line markers. No electronic or software components.

Indications for Use

Indicated for gynecological brachytherapy procedures for cancer treatment of the cervix and endometrium, including interstitial brachytherapy via optional needles.

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

• Ring CT/MR Applicator Set and Standard CT/MR Applicator set (k983341)

Reference Devices

• Proguide needles (k060349)
• Vienna Ring CT/MR Applicator Set

Submission Summary (Full Text)

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Page 24
April, 2009

Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold, black font next to a square graphic. The graphic contains a black circle with two white circles on either side of it, all enclosed in a black square. The word "Nucletron" is positioned to the right of the graphic.

NUCLETRON B.V.

Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal MAY 18 200gthe Netherlands Phone [phone] [phone] Fax

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

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c)

## Submitter of 510(k):

| Company name: | Nucletron Corporation |
|------------------------------------------------|--------------------------|
| Registration number: | 1121753 |
| Address: | 8671 Robert Fulton Drive |
| Columbia, MD 21046 | |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Elaina Colby |
| Manager Quality Assurance & Regulatory Affairs | |

## New Device Name:

| Trade/Proprietary Name: | Interstitial Ring CT/MR Applicator Set &<br>Utrecht Interstitial Fletcher CT/MR Applicator Set |
|-------------------------|------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Gynecological Brachytherapy applicator |
| Classification Name: | Remote controlled radionuclide applicator system accessory |
| Classification: | 21Cfr892.5700 Class II |

#### Legally Marketed Device(s)

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

| Manufacturer | Device | 510(k) # |
|--------------|----------------------------------------------------------------|----------|
| Nucletron BV | Ring CT/MR Applicator Set and Standard CT/MR<br>Applicator set | k983341 |

## Description:

The Interstitial Ring CT/MR Applicator Set is based on the Ring CT/MR Applicator Set enhanced with the addition of nine guiding holes in the ring tube (seven holes for part number 110.130). These guide holes allow placement of guiding tubes through which Proguide needles (k060349) can be inserted into the tumor. The addition of interstitial needles makes it possible to achieve asymmetric alteration of the dose distribution. The needles are inserted

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#### Special 510(k) Utrecht Interstitial Fletcher CT/MR and Interstitial Ring CT/MR Applicator

Page 30 - April, 2009

..

perpendicular to the ring and are parallel to the tandem. The applicator is fully CT/MR compatible. The device is composed of polymers, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available.

The device is similar to the legally marketed predicate device Vienna Ring CT/MR Applicator Set. The difference between this device and the Vienna Ring CT/MR Applicator Set is that this device allows the use of Proguide needles instead of the titanium needles used with the Vienna Ring CT/MR Applicator Set

The Utrecht Interstitial Fletcher CT/MR Applicator Set is based on the legally marketed predicate device Standard CT/MR Applicator Set enhanced with five similar guiding holes in each ovoid as the guiding holes in the ring of the Interstitial Ring CT/MR Applicator Set. These guiding holes allow placement of guiding tubes through which Proguide needles (k060349) can be inserted into the tumor. The addition of interstitial needles makes it possible to achieve asymmetric alteration of the dose distribution. The needles are inserted perpendicular to the ovoids. The applicator is fully CT/MR compatible. The device is composed of polymers, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available.

The MR line markers are optional devices that can make the channels of the Nucletron CT/MR applicators visible using magnetic resonance imaging. The markers consist of a thin Teflon tube that can be filled with an appropriate fluid that is clearly visible on magnetic resonance images.

The tubes are inserted before imaging in the channels of the CT-MR applicator and are removed before the treatment of the patient.

The devices are used as accessories to the Nucletron microSelectron Afterloaders

## Intended use:

The intended use of the device is gynecological brachytherapy procedures for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.

## Summary of technological considerations:

The Interstitial Ring CT/MR Applicator Set and the Utrecht Interstitial Fletcher CT/MR Applicator Set are substantially equivalent to the cleared predicate devices, Ring CT/MR Applicator Set and Standard CT/MR Applicator set, k983341

Name: Dick van Waes Title: Business Manager Nucletron B.V. Veenendaal, The Netherlands

09-04-2009
Date

KC91154

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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 eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

MAY 18 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elaina M. Colby Manager, Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046-2133

Re: K091154

Trade/Device Name: Interstitial Ring CT/MR Applicator Set & Utrecht Interstitial Fletcher CT/MR Applicator Set

Regulation Number: 21 CFR 892.5700

Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: April 20, 2009 Received: April 21, 2009

Dear Ms. Colby:

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.

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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

[phone] (Gastroenterology/Renal/Urology) 21 CFR 876.xxx (Obstetrics/Gynecology) [phone] 21 CFR 884.xxx [phone] 21 CFR 892.xxx (Radiology) [phone] Other

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

[signature]

Janine M. Morris Acting 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 (if known)

K091154

Device Name

Interstitial Ring CT/MR Applicator Set & Utrecht Interstitial Fletcher CT/MR Applicator Set

Indications for Use

The intended use of the device is gynecological brachytherapy procedures for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy ..

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)

| (Division Sign-Off) |
|---------------------|
|---------------------|

Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K091154 |
|---------------|---------|
|---------------|---------|

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