CURAY CUSTOM SEED ARRAY

{0}------------------------------------------------ FEB 2 8 2006 BioLucent. Inc. 510(k) Submission CuRay™ Custom Seed Array K 053595 ## 4. 510(k) Summary of Safety and Effectiveness | Device Name: | CuRay™ Custom Seed Array | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Device Model Number: | CSA-xx | | Classification Name: | Radionuclide Brachytherapy Source (KXK)<br>21 CFR, 892.5730 | | Device Classification: | Class II | | Predicate devices: | TheraLoad (K043596)<br>SeedLink (K023073)<br>Readi-Strand (K023179)<br>RAPID-Strand (K030594)<br>Nag Brachyflex Catheters (Cook, Inc.) | | Manufacturer: | BioLucent, Inc.<br>6 Journey, Suite 325<br>Aliso Viejo, CA 92656 | | Establishment Registration<br>Number: | 2032338 | | Official Contact: | Sheryl Higgins<br>BioLucent, Inc.<br>6 Journey, Suite 325<br>Aliso Viejo, CA 92656<br>Phone: (949) 349-1380 (x101) | #### Intended Use: CuRay Custom Seed Array is a sterile, custom loaded, brachytherapy seed assembly intended to treat localized tumors such as tumors of the head, neck, lung, pancreas, breast, uterus, cervix and prostate. It can be used either as primary treatment or for residual disease after excision of the primary tumor or for recurring tumors. It may also be used concurrent with or at the completion of other treatment modalities such as external beam radiation therapy or chemotherapy. {1}------------------------------------------------ ## Device Description: The CuRay Custom Seed Array is an integral assembly containing radionuclide source seeds, spacers, and markers which are custom loaded according to a prescribed treatment plan. The CuRay Custom Seed Array is provided sterile and is a single use device. #### Technological Characteristics Summary The CuRay Custom Seed Array is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics. ## Performance Data Summary I erformance testing was conducted on the CuRay Custom Seed Array 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 CuRay Custom Seed Array is determined to be substantially equivalent to existing legally marketed devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 8 2006 Ms. Shervl W. Higgins Director of Engineering BioLucent, Inc. 6 Journey, Suite 325 ALISO VIEJO CA 92656 Re: K053595 Trade/Device Name: CuRay Custom Seed Array Regulation Number: 21 CFR §892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: December 21, 2005 Received: December 23, 2005 Dear Ms. Higgins: 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 (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. {3}------------------------------------------------ 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### 3. Indications for Use Statement # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): Kr 3 5 5 15 Device Name: CuRay Custom Seed array Indications for Use: CuRay Custom Seed Array is a sterile, custom loaded, brachytherapy seed assembly intended to treat localized tumors such as tumors of the head, neck, lung, pancreas, breast, uterus, cervix and prostate. It can be used either as primary treatment or for residual disease after excision of the primary tumor or for recurring tumors. It may also be used concurrent with or at the completion of other treatment modalities such as external beam radiation therapy or chemotherapy. #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) | |------------------------------------------|----|--------------------------------------------------| |------------------------------------------|----|--------------------------------------------------| | | <div style="text-align:center;">Nancy C Brogdon</div> | |--|-------------------------------------------------------| | | (Division Sign-Off) | Division of Reproductive, Abdominal, and Radiological Devices | 510(k) Number | K053595 | |---------------|---------| |---------------|---------| Confidential