BONE CEMENT RADIO-OPACIFIER

{0}------------------------------------------------ K032388 OCT 3 1 2003 Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The graphic is made up of several curved lines that resemble the wings of a bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font. Cardinal Health 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Bone Cement Radio-Opacifier | Sponsor: | Cardinal Health<br>1500 Waukegan Road - MPWM<br>McGaw Park, IL 60085 | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Sharon Nichols<br>Manager, Regulatory Affairs | | Telephone: | (847) 785-3311 | | Date Prepared: | July, 2003 | | Product Trade Name: | Bone Cement Radio-Opacifier | | Common Name: | Barium Sulfate, USP | | Classification: | Class II per 21 CFR §8825300 | | Predicate Device: | Parallax Tracer Radiopaque Particles | | Intended Use: | This device is used as an additive to Codman Cranioplastic<br>(Type 1-slow set) to provide radiopacity for imaging<br>purposes. | | Substantial Equivalence: | The Bone Cement Radio-Opacifier is substantially equivalent<br>to the Parallax Tracer Radiopaque Particles in that:<br>- Intended use is the same<br>- Performance attributes are the same | | Description: | The Bone Cement Radio-Opacifier is an additive to be used<br>with Codman Cranioplastic (K873689) to provide radiopacity<br>to the resin and assist in placement and visualization of<br>material. | | Summary of testing: | Based on the product performance information provided in<br>this notification, the subject device has been shown to be<br>substantially equivalent to the currently marketed predicate<br>device. | | Non-clinical Test Results: | Performance testing demonstrated that the end product<br>Cranioplastic and Bone Cement Radio-Opacifier is<br>substantially equivalent to currently marketed Cranioplastic<br>with Radio-Opacifier from Parallax with regard to functional<br>characteristics. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 3 1 2003 Ms. Sharon Nichols Regulatory Affairs Manager Cardinal Health 1500 Waukegan Road McGraw Park, Illinois 60085-6787 Re: K032388 Trade Name: Bone Cement Radio-Opacifier Regulation Number: 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: MYU Dated: July 31, 2003 Received: August 4, 2003 Dear Ms. Nichols: 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 (QS) regulation (21 CFR Part 820); and if {2}------------------------------------------------ Page 2 - Ms. Sharon Nichols 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 (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, Sincerely yours, R. Mark A. Milker 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 {3}------------------------------------------------ Cardinal Health 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461 Image /page/3/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of three curved lines above the company name. The lines are arranged in a way that they are close together on the left and spread out on the right. The company name is written in a bold, sans-serif font. Page 1 of 1 510(k) Number (if known): Device Name: Indications For Use: K032388 Bone Cement Radio-Opacifier This device is used as an additive to Codman Cranioplastic (Type 1-slow set) to provide radiopacity for imaging purposes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use Mark A Milkerso (Division Sign-Off) Division -General, Restornities and Neurological Devices 5106