(47 days)
The Autovac TC system is indicated for the continuous collection and infusion of wound drainage from orthopedic procedures such as Total Knee Replacement, Total Hip Replacement and Spinal Fusion. The blood is to be collected via a surgical drain tube placed in the operative site.
Not Found
This document is a 510(k) clearance letter from the FDA for the Autovac Orthopedic Autotransfusion System. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the substantial equivalence determination for marketing the device. Therefore, I cannot extract the requested information from this document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 6 2002
Mr. John Karpowicz Director of Engineering Boehringer Laboratories, Inc. P.O. Box 870 Norristown, PA 19404
K014187 Re:
Trade Name: Autovac Orthopedic Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion apparatus. Regulatory Class: Class II (two) Product Code: CAC Dated: December 20, 2001 Received: December 21, 2001
Dear Mr. Karpowicz:
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 applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. John Karpowicz
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, 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). Other general information on your responsibilities under the Act may be obtained 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,
_
Roy D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular And Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K014187 |
|---|---|
| Device Name: | Autovac Orthopedic Autotransfusion System |
| Indications For Use: |
The Autovac TC system is indicated for the continuous collection and infusion of wound drainage from orthopedic procedures such as Total Knee Replacement, Total Hip Replacement and Spinal Fusion. Total
Knee Replacement, Total Hip Replacement and Spinal Fusion. The blood is to be collected in Total Rip Replacement and Spinal Fusion. The be
is to be collected via a surgical drain tube placed in the operative site.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K01487
1 Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).