(139 days)
The Affinity™ Hollow Fiber Membrane Oxygenator Systems are intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
Not Found
This document is an FDA 510(k) clearance letter for a medical device (Affinity™ Hollow Fiber Oxygenator with Trillium™ Biopassive Surface, K973760). It signifies that the device is substantially equivalent to a legally marketed predicate device.
Unfortunately, this document does NOT contain information regarding acceptance criteria or a study proving the device meets those criteria. Medical device clearance documents like this typically do not include detailed performance study results or acceptance criteria.
These details would be found in the manufacturer's 510(k) submission to the FDA, which is a much more extensive document that typically includes:
- Detailed descriptions of the device and its intended use.
- Performance data from various tests (e.g., in vitro, animal, and sometimes human clinical studies) to demonstrate substantial equivalence. This data would be compared against the performance of a predicate device or against pre-defined acceptance criteria.
- Risk analysis.
- Labeling information.
Therefore, I cannot provide the requested information based solely on the provided FDA clearance letter. To answer your questions, one would need access to the full 510(k) submission or the underlying studies conducted by AVECOR Cardiovascular, Inc. for the Affinity™ Hollow Fiber Oxygenator.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dennis E. Steger Director Regulatory Affairs/ Quality Assurance AVECOR Cardiovascular, Inc. 7611 Northland Drive Minneapolis, MN 55428
FEB 1 8 1998
Re: K973760 Affinity™ Hollow Fiber Oxygenator with Trillium™ Biopassive Surface Regulatory Class: III (Three) Product Code: DTZ Dated: December 19, 1997 Received: December -29, 1997 ------------------------------------------------
Dear Mr. Steger:
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 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 Regulation (QS) for Medical Devices and on the for General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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. Dennis E. Steger
This letter will allow you to begin marketing your device as described in your 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 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/dsmamain.html."
Sincerely yours,
Thomas J. Callshan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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870.4350 - DTZ III CPB Oxygenator
510(k) Number (if known): K 973760
Device Name: Avecco llióv Indications For Use:
The Affinity™ Hollow Fiber Membrane Oxygenator Systems are intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Bia R. Lumperl
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”