PROGUIDE NEEDLE SET

K060349 · Nucletron Corporation · JAQ · Mar 10, 2006 · Radiology

Device Facts

• Record ID: K060349
• Device Name: PROGUIDE NEEDLE SET
• Applicant: Nucletron Corporation
• Product Code: JAQ · Radiology
• Decision Date: Mar 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Proguide Needle Set is intended for interstitial Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR.

Device Story

Proguide Needle Set functions as an accessory to Nucletron mHDR remote afterloading equipment for interstitial brachytherapy. Needles are inserted into the treatment area using standard interstitial techniques; CT markers are inserted for visualization. Radiographic images determine applicator location for treatment planning. Needles connect to the afterloader via transfer tubes, creating a closed system to prevent radioactive source contact with body fluids. The system does not control the afterloader; it provides a path for the radioactive source. Clinical staff verify attachment; a check cable run ensures path patency and proper connection before the radioactive source steps through the needle to deliver radiation. Post-treatment, needles are disconnected and removed. Used in clinical settings by trained medical staff.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Interstitial brachytherapy needle set; closed system design; EtO sterilized; compatible with Nucletron mHDR remote afterloading equipment.

Indications for Use

Indicated for patients undergoing interstitial brachytherapy procedures using Nucletron mHDR remote afterloading equipment.

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

• Proguide Needle Set (K953946)

Submission Summary (Full Text)

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MAR 1 0 2006

Image /page/0/Picture/1 description: The image shows the word "Nucletron" in bold, black font, next to a square logo. The logo contains a black circle with two white circles on either side of it. The logo and the word "Nucletron" are aligned horizontally.

#### NUCLETRON B.V.

Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O. Box 930 The Netherlands K060349 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: | 410-312-4197 |
| Correspondent: | Lisa Dimmick<br>Director Assurance & Regulatory Affairs |

#### Modified Device Name:

| Trade/Proprietary Name: | Proguide Needle Set |
|-------------------------|------------------------------------------------------------------|
| Common/Usual Name: | Remote Afterloading for Intracavitary Brachytherapy applications |
| 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 | ------------------<br>510/k) |
|--------------|--------------------------------------------------------------------------------------------------|--------------------------------|
| Nucletron R. | and the state of the first company for the first and the below the first<br>000000<br>Progring . | KORROJE<br>N A REAL C LIBERT & |

#### Description:

The Proguide Needle Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR and is intended for interstitial Brachytherapy procedures.

The Proguide Needle is inserted into the treatment area, using standard interstitional techniques. CT markers are inserted into the Proguide Needles for visualisation.

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Radiographic images are obtained to determine the precise location of the applicator within the body. This information is then used for Brachytherapy treatment planning purposes.

The Proguide treatment needle is attached to the afterloader (treatment head), using transfer tubes. The Proguide treatment needles are a closed system to prevent the radioactive source from coming in contact with body fluids. The treatment catheter does not control the treatment unit; it strictly provides a treatment path for the radioactive source. The afterloader and the clinical staff verify that the applicator is properly attached prior to treatment. When the applicator is attached, a check cable run is performed to ensure that the applicator is properly attached and that there are no obstructions, which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver the prescribed dose of radiation. After the treatment the Proquide treatment needles are disconnected from the attached transfer tubes, and removed from the implant.

The device is the same as the legally marketed predicate device cited. The only change is that the device is EtO sterilized by the manufacturer, instead of being sterilized by the hospital.

The Proguide Needle Set is used as an accessory to the Nucletron microSelectron,

#### Intended use:

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

Proguide Needle Set is intended for interstitial Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR.

#### Summary of technological considerations:

The Proguide Needle Set is substantially equivalent to the cleared predicate device, Proguide Needle Set, 510(k)#: K953946.

Wi-ll S

Name: Wilco van der Lugt Title: Basiness Segment Manager Nucletron B.V. Veenendaal, The Netherlands

27-01-2006
Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K060349

MAR 1 0 2006

Trade/Device Name: Proguide Needle Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: January 27, 2006 Received: February 15, 2006

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 (Premarket Approval), 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 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 (OS) 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 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" (21 CFR 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/industrv/support/index.html.

Sincerely yours.

Nancy C. Brigdon

Naney 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

,

Device Name Proguide Needle Set The Proguide Needle Set is intended for interstitial Brachytherapy Indications for procedures involving the Nucletron remote afterloading equipment: mHDR. Use

### 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)

OR

Over-The-Counter Use_

David A. Syam
(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _