(158 days)
The Betatrans Intraoperative Autotransfusion System is designed for the collection and reinfusion of intraoperative drainage blood collected intraoperatively. The system is intended to reduce or eliminate the need for transfusion of homologous blood, which can carry a variety of infectious agent including Hepatitis or HIV.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Betatrans Intraoperative Autotransfusion System. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
Therefore, I cannot provide the requested information based on the given text. The letter only confirms that the device has been found substantially equivalent to a predicate device and can be marketed.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 30 1998
Mr. Robert M. Engler Director of Operations Duxbury Scientific, Inc. 80 Seabury Point Road Duxbury, MA 02332
K982241 Re : Betatrans Intraoperative I and II Autotransfusion Systems Regulatory Class: II (Two) Product Code: CAC September 19, 1998 Dated: Received: September 24, 1998
Dear Mr. Engler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Robert M. Engler
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding acberibed in your ivalence 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE OPTIONAL FORMAT
510(k) Number (if known): __ K 982241
Device Name: BETATRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM
Indications For Use:
The Betatrans Intraoperative Autotransfusion System is designed for the collection and reinfusion of intraoperative drainage blood collected intraoperatively. The system is intended to reduce or eliminate the need for transfusion of homologous blood, which can carry a variety of infectious agent including Hepatitis or HIV.
Bete L. Lamperle
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_K 98 224 /
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use (Per 21 CFR 801.109)
Over The Counter Use_________________
(Optional Format 1-2-96 Reproduced)
§ 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).