TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA

{0}------------------------------------------------ K033230 # IV. 510(k) Summary This summary of safety and effectiveness is being submitted in accordance with This Sammary of Salesy and Medical Devices Act of 1990 and 21 CFR §807.92. #### Date Prepared A. October 3, 2003 #### General Information B. | Manufacturer: | Parallax Medical, Inc.<br>940 Disc Drive<br>Scotts Valley, CA 95066-4544 | |---------------|--------------------------------------------------------------------------| | Contact: | Linda Paul<br>Manager, Regulatory and Clinical | ager, Regulatory and Clinical Affairs (831) 439-0130, ext 251 (phone) (831) 439-1725 (fax) #### C. Device Information | Trade Name: | TRACERS® Ta Bone Cement Opacifier | |------------------------|-----------------------------------------------------------------| | Common Name: | Barium Sulfate with Tantalum | | Device Classification: | II | | Classification Name: | Accessory, Barium Sulfate, Methyl Methacrylate for Cranioplasty | | Product Code(s): | MYU | #### Predicate Device Identification D. The subject device is substantially equivalent to TRACERS® Bone Cement Opacifier (K023445). #### Intended Use E. TRACERS® Ta Bone Cement Opacifier is intended for use as an additive to Secour Acrylic Resin to provide radiopacity for imaging purposes. #### F. Product Description TRACERS® Ta Bone Cement Opacifier is an additive to be used with Secour Acrylic Resin (K994022) to provide radiopacity to the resin and assist in placement and visualization of the implant material. The TRACERS® Ta Bone Cement Opacifier is added to the Secour polymer (powder) prior to mixing with the Secour monomer (liquid). TRACERS Bone Cement Opacifier is comprised of USP Barium Sulfate and unalloyed Tantalum disks. #### Substantial Equivalence G. The subject device is equivalent in intended use, design, and technological characteristics to TRACERS® Bone Cement Opacifier (K023445). {1}------------------------------------------------ #### Summary H. Based on the information provided in this notification, the subject device is Based on the information provided in the notinstilling with the nechnological characteristics, and design. ### Signature of Preparer l. The 510(k) summary was prepared and submitted by the following Parallax Medical employee. Medical employee Kolo Paul Linda Paul Manager, Regulatory and Clinical Affairs {2}------------------------------------------------ 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 caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white. DEC 1 2 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Linda Paul Manager, Regulatory and Clinical Affairs Parallax Medical, Inc. 940 Disc Drive Scotts Valley, CA 95066 Re: K033230 Trade Name: TRACERS® Ta Bone Cement Opacifier Regulation Number: 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: MYU Dated: November 26, 2003 Received: November 28, 2003 Dear Ms. Paul: 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. 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 {3}------------------------------------------------ Page 2 -- Ms. Linda Paul 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) rms reter 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), rr you deente specifical of Compliance at (301) 594-4639. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark N. Melleman Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Statement of Indications for Use lll. # Indications for Use 510(k) Number (if known): K033230 TRACERS® Ta Bone Cement Opacifier Device Name: Indications for Use: TRACERS® Ta Bone Cement Opacifier is intended for use as an additive to Secour™ Acrylic Resin to provide radiopacity for imaging purposes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Prescription Use ✓ OR Over-The Counter Use **__** (Per 21 CFR 801.109) (Optional Format 1-2-96) Post Restorative K033230 Concurrence of CDRH, Office of Device Evaluation (ODE)