(942 days)
The SAFE MINI hollow fibre oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.
The SAFE MINI venous/cardiotomy reservoir is intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and filter and defoam intra-thoracic suction blood prior to returning it to the extracorporeal circuit.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Polystan AS for their SAFE MINI Membrane Oxygenator with Integrated Heat Exchanger. It states that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing. However, the document does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a study proving the device meets acceptance criteria.
The letter explicitly states the Indications For Use for the device:
- SAFE MINI hollow fibre oxygenator: intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.
- SAFE MINI venous/cardiotomy reservoir: intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and filter and defoam intra-thoracic suction blood prior to returning it to the extracorporeal circuit.
To answer the request, information from a separate study report or regulatory submission, which is not part of this document, would be required.
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Public Health Service
OCT 1 3 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1
Thomas Andersen R & D Engineer Polystan AS 8 Walgerholm DK-3500 Vaelose Denmark
K980974 · Re: SAFE MINI Regulatory Class: III (three) Product Code: DTZ Dated: September 27, 1999 Received: September 29, 1999
Dear Mr. Andersen:
We have reviewed your Section 510(k) notification of intent to market we have reviewed above and we have determined the device in the device fereiched above a che indications for use stated in the Substantially Cqualiti marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the interstate commence prior co the ao, 20, 2017 -Medical Bevice Amendance, of the Federal Food, Drug, and In accordance with the promy, therefore, market the device, subject to The general controls the general controls provisions of the Act. che general Controls provisations of the 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 It your device ID orablemarket Approval), it may be subject to such controls. Or ciable. Existing major regulations affecting your device additional concreter. - En of Federal Regulations, Title 21, Parts 800 can be round in choically equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: 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 consoming jour premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act one gavices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Thomas Andersen
This letter will allow you to begin marketing your device as described
and the substantial williation - The FDP finding of substantial This letter will allow you to begin marketing your substantial
in your 510(k) premarket notification. The finding of substantial in your 510(k) prematice to a legally marketed predicate device equivalence of your device to a regarly markoved in
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 If you desire specific advice for your as the 809.10 for in vitro regulation (21 CFR Part our and and the office of Compliance at diagnostic devices), please concessions on the promotion and (301) 594-4648. Additionally, for questions of the office of Compliance at
advertising of your device, please contact the regulation entitled, Also, please note the regulation entitled, (301) 594-4639. (301) 594-4639. Also, premarket notification"(21 CFR 807.97).
"Misbranding by reference to premarket notification"(21 CFR 807.97) "Misbranding by reference to premarket noter the Act may
Other general information on your responsibilities under the active other general information of Small Manufacturers Assistance at its
be obtained from the Division of Small Manufacturers Assistance at its
and on the and one on 2011 an (30) 1 be obtained from the bivibion of (301) 443-6597, or at its internet address or at its fitting addross addross and main. html".
Sincerely yours,
C./ Jure E. Semperele
Celia M. Witten, Ph.D., M.D. Acting 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
K980974 510(k) Number (if known):
Device Name: SAFE MINI Membrane Oxygenator with Integrated Heat Exchanger
Indications For Use:
The SAFE MINI hollow fibre oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.
The SAFE MINI venous/cardiotomy reservoir is intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and filter and defoam intra-thoracic suction blood prior to returning it to the extracorporeal circuit.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bace E. Cooper be
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices K980974 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
3
§ 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.”