POIINT OF CARE STRANDING SYSTEM, MODE 1004-00

{0}------------------------------------------------ # THERAGENICS CORPORATION® K072296 # 510(k) SUMMARY OF SAFETY & EFFECTIVENESS SEP 2 6 2007 | Device Name: | Point of Care Stranding System | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Device Model Number: | 1004-00 | | Classification Name: | Radionuclide Brachytherapy Source (KXK) | | Device Classification: | Class II | | Predicate Devices: | TheraStrand (K040339)<br>CP Spacer (K013964)<br>MICK 200-TPV Applicator (K890341)<br>Bard Sourcelink (K041576) | | Manufacturer: | Theragenics Corporation®<br>5203 Bristol Industrial Way<br>Buford, GA 30518 USA | | Establishment<br>Registration Number: | 1037598 | | Official Contact: | Betsy Cortelloni<br>RA/QS Manager<br>Theragenics Corporation®<br>5203 Bristol Industrial Way<br>Buford, GA 30518<br>Phone: 770-271-0233 | Intended Use: The Point of Care Stranding System provides a method for the physician to custom confiqure and assemble sterile TheraSeed® strands in the operating room at the time of the implant procedure. The Point of Care System may also be used to custom load sterile I-Seed in non-stranded configurations. Device Description: The Point of Care Stranding System is designed to facilitate intra-operative treatment planning by providing a means of joining sterile TheraSeed® sources with sterile spacers of varying lengths to form the desired strand configuration. The device also facilitates transfer of the sterile strand either directly into a CP Medical brachytherapy needle, or via a transfer tube into a MICK style applicator needle. The device system consists of the following components: Assembly Device, Seed Magazine, Spacer Cartridges, Stylet, and Transfer Tube (optional). Substantial Equivalence Comparison: The application (linking process) of the Point of Care Stranding System is substantially equivalent to the Bard Quick-Link (K041576). Both systems use a press-fit concept. The Bard system presses seeds into the end of a bioabsorbable "sleeve" or link (SourceLink) to form the seed array. The Point of Care System presses solid bioabsorbable spacers into the concave endcups of TheraSeed® to link alternating seed-spacer pairs. {1}------------------------------------------------ Design Verification: Design verification of the Point of Care Stranding System was accomplished through bench testing including validation of manufacturing processes, verification of device and component performance, sterilization and package validations. The testing demonstrated the functional performance of the device in accordance with the design specifications. Additionally, User Validation was conducted to verify that the device could be successfully used to assemble, transfer, and implant the strand while maintaining strand integrity. Conclusion: The results of verification testing confirmed that design inputs were achieved and the cumulative test results demonstrated the functionality, safety and effectiveness of the Point of Care Stranding System and its components, as well as its substantial equivalence to the predicate device and methodology. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "U.S. Department of Health & Human Services". The symbol in the center is a stylized representation of a human figure with outstretched arms, possibly symbolizing care and support. The logo is in black and white and appears to be from an official government source. # DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 SEP 26 2007 Ms. Betsy Cortelloni RA/OS Manager Theragenics Corporation 5203 Bristol Industrial Way BUFORD GA 30518 Re: K072296 Trade/Device Name: Point of Care Stranding System Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: August 16, 2007 Received: August 17, 2007 ### Dear Ms. Cortelloni: 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 shows a circular logo with the text "1906-2006" at the top. Below the text is the abbreviation "PA" in a stylized font. Underneath "PA" is the word "Centennial" in a cursive font. At the bottom of the logo are three stars. The logo appears to be a commemorative emblem for a centennial celebration. roloting and Premoting Publio Hoalth {3}------------------------------------------------ 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html. Sincerely yours, Nancy Chrogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ ## INDICATIONS FOR USE FORM Page 1 of 510(K) number (if known): K072296 Device Name: Point of Care Stranding System #### Indications for Use: The Point of Care Stranding System provides a method for the physician to custom configure and assemble sterile TheraSeed® strands in the operating room at the time of the implant procedure. The Point of Care System may also be used to custom load sterile I-Seed in non-stranded configurations. #### (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 CFRR 801.109). OR Over-The-Counter Use (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _