VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET

K080934 · Nucletron Corporation · JAQ · May 28, 2008 · Radiology

Device Facts

• Record ID: K080934
• Device Name: VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET
• Applicant: Nucletron Corporation
• Product Code: JAQ · Radiology
• Decision Date: May 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vienna Ring CT/MR Applicator is intended for use with Nucletron remote afterloading equipment for gynaecological brachytherapy procedures.

Device Story

The Vienna Ring CT/MR Applicator is a gynecological brachytherapy applicator used with Nucletron remote afterloading equipment. It features a ring tube modified with nine guide holes to allow the placement of interstitial titanium needles, enabling asymmetric dose distribution. The device is constructed from composite fiber tubing to ensure CT/MR compatibility and minimize imaging artifacts. Titanium needles are used for treating carcinoma in areas lacking a natural lumen or cavity. The applicator is operated by clinicians in a clinical setting to deliver radiation therapy. It functions as a template for needle placement, allowing for precise interstitial access while maintaining standard ring-based treatment geometry. The device benefits patients by providing enhanced dose control and the ability to treat complex gynecological tumors.

Clinical Evidence

No clinical data. Bench testing only, focusing on CT/MR compatibility and mechanical integration of the interstitial needle sets.

Technological Characteristics

Composite fiber tubing construction for CT/MR compatibility; titanium interstitial needles; nine guide holes in ring tube for needle placement; compatible with Nucletron remote afterloading systems. No software or electronic components.

Indications for Use

Indicated for patients undergoing gynaecological brachytherapy procedures requiring remote afterloading equipment, including cases where interstitial needles are needed for carcinoma treatment where no lumen or cavity is available.

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 (K953946)
• Interstitial Needle Sets (K953946)

Submission Summary (Full Text)

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K080934

MAY 2 8 2008

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NUCLETRON B.V.

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

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Special 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<br>Columbia, MD 21046 |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4198 |
| Correspondent: | Lisa Dimmick<br>Director Assurance & Regulatory Affairs |

#### Modified Device Name:

| Trade/Proprietary Name: | Vienna Ring CT/MR Applicator |
|-------------------------|-------------------------------------------------------|
| Common/Usual Name: | JAQ, Remote controlled radionuclide applicator system |
| Classification Name: | 90 (Radiology) |
| Classification: | 21CFR892.5700 Class II |

#### Legally Marketed Device(s)

Legally Marketed Device(of
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:

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|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
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#### Description:

The Vienna Ring CT/MR Applicator is based on the Ring CT/MR Applicator set enhanced The Vienna Ring C Thin Applicator is bacul of the ring tube (seven holes for part number 189.699).
with the addition of nine guide holes in the ring tube (seven holes in the with the addition of mine guide notes in the ting table (sessing the ring tube as a
r These guide holes allow placement of interstitial titanium needles The addition These guide noies allow placentent of interstition international of the ring tube. The addition of needle template while still manitating the troutinent on the dose distribution.
interstitial needles makes it possible to achieve asymmetric altern the standare . The intersitial needles makes it poolible to the ring and are parallel to the tandem. The

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applicator is fully CT/MR compatible. Its design uses composite fiber tubing, 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 Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artifacts on the acquired images.

The device is the same as the legally marketed predicate device cited. The only change is that the applicator allows placement of pre-bent Titanium Needle Sets which are based on the predicate stainless steet Interstitial Needle Sets (K953946).

#### Intended use:

The modified device has the same intended use as the legally marketed predicate device cited:

The Vienna Ring CT/MR Applicator is intended for use with Nucletron remote afterloading equipment for gynaecological brachytherapy procedures

#### Summary of technological considerations:

The Vienna Ring CT/MR Applicator is substantially equivalent to the cleared predicate device, Ring CT/MR Applicator Set, 510(k)#: K953946. The Titanium Needle Sets the Vienna Ring CT/MR Applicator is compatible with are substantial equivalent to the Interstitial Needles Setst, 510(k)#: K953946.

01-04-2008
Date

Name: Bick van Waes Title: Vice President Nucletron B.V. Veenendaal, The Netherlands

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2008

Ms. Lisa Dimmick Director Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046-2133

Re: K080934

Trade/Device Name: Vienna Ring CT/MR Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: April 2, 2008 Received: April 2, 2008

Dear Ms. Dimmick:

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.

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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); 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 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 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.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Nancy Brogdon

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 Statement

510(k) Number

K080934

Device Name

Indications for Use

Vienna Ring CT/MR Applicator

The Vienna Ring CT/MR Applicator is intended for use with Nucletron The Vienna Ring equipment for gynaecological brachytherapy procedures.

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

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

Prescription Use (Per 21 CFR 801.109) ાર

Over-The-Counter Use_

Aonni M. Wham

(Division Division of Reproductive. Abdomin and Radiological Devi 510(k) Number.