BIOLUCENT APPLICATOR, MODEL RTA-XX

K061241 · Biolucent, Inc. · JAQ · Jul 28, 2006 · Radiology

Device Facts

• Record ID: K061241
• Device Name: BIOLUCENT APPLICATOR, MODEL RTA-XX
• Applicant: Biolucent, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Jul 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioLucent Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

Device Story

BioLucent Applicator is an expandable cylindrical device with radially positioned catheters; inserted into target volume during brachytherapy. Functions as accessory to remote afterloading equipment; provides pathways for delivery of prescribed radiation dose to treatment area. Single-use, sterile device. Used by clinicians in clinical settings. Benefits patient by facilitating precise radiation delivery.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Expandable cylindrical applicator with multiple radially positioned catheters. Single-use, sterile. Functions as an accessory to remote afterloading brachytherapy equipment.

Indications for Use

Indicated for use as an accessory to remote afterloading equipment for brachytherapy procedures to provide pathways for radiation dose delivery to a treatment area.

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

• NoviSad Rectal Applicator (Nucletron, B.V.)
• Wright Vaginal Cuff Applicator (K980601)
• Comfort Catheters (K032372)
• H.A.M. Applicator (K961601)

Submission Summary (Full Text)

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| 1. 510(k) Summary of Safety and Effectiveness | | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | K061241 | |
| Device Name: | BioLucent Applicator | JUL 2 8 2006 |
| Device Model Numbers: | RTA-06<br>RTA-08<br>RTA-10 | |
| Classification Name: | Remote Controlled Radionuclide Applicator System<br>(JAQ),<br>21 CFR, 892.5700 | |
| Device Classification: | Class II | |
| Predicate devices: | NoviSad Rectal Applicator (Nucletron, B.V.)<br>Wright Vaginal Cuff Applicator (K980601)<br>Comfort Catheters (K032372)<br>H.A.M. Applicator (K961601) | |
| Manufacturer: | BioLucent, Inc.<br>6 Journey, Suite 325<br>Aliso Viejo, CA 92656 | |
| Establishment Registration Number: | 2032338 | |
| Official Contact: | Sheryl Higgins<br>BioLucent, Inc.<br>6 Journey, Suite 325<br>Aliso Viejo, CA 92656<br>Phone: [phone] (x101) | |

#### Intended Use:

The BioLucent Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

#### Device Description:

The BioLucent Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The BioLucent Applicator is provided sterile and is a single use device.

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### Technological Characteristics Summary

The BioLucent Applicator is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics.

### Performance Data Summary

Performance testing was conducted on the BioLucent Applicator to demonstrate the integrity, suitability and substantial equivalence of the device.

### Conclusion:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the BioLucent Applicator is determined to be substantially equivalent to existing legally marketed devices

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 2 8 2006

Mr. J. David Campbell Director of Operations BioLucent, Inc. 6 Journey, Suite 325 ALISO VIEJO CA 92656

Re: K061241

Trade/Device Name: BioLucent Applicators Model RTA-06, RTA-08 and RTA-10 Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: June 27, 2006 Received: June 28, 2006

Dear Mr. Campbell:

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.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo in a bold, sans-serif font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The logo appears to be a commemorative emblem for the centennial of the FDA.

oting Public

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Page 2 -

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrlvindustry/support/index.html.

Sincerely yours,

Nancy C.Bogdon
Nancy C. Bogdon

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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## 3. Indications for Use Statement

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K ob 124 /

Device Name:

BioLucent Applicator

Indications for Use:

The BioLucent Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

# (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 (Optional Format 1-2-96)

(Division Sign-Off)

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