(160 days)
The Cardiopulmonary Bypass Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.
Cardiopulmonary Bypass Pump Tubing
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, results of a study, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for a Cardiopulmonary Bypass Pump Tubing, detailing its classification, regulatory compliance, and indications for use. It does not include the specifics of performance testing or clinical studies.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2002
Terumo Medical Corporation c/o Mr. Gary A. Courtney 125 Blue Ball Road Elkton, MD 21921
Re: K993189
Cardiopulmonary Bypass Pump Tubing Regulation Number: 21 CFR 870.4390 Regulation Name: Cardiopulmonary Bypass Pump Tubing Regulatory Class: Class II (two) Product Code: DWE Dated: January 17, 2000 Received: January 19, 2000
Dear Mr. Courtney:
This letter corrects our substantially equivalent letter of March 1, 2000 regarding the incorrect Indications for Use.
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). 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 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.
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Page 2 - Mr. Gary A. Courtney
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.
This letter will allow you to continue 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 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsma/dsmamain.html.
Sincercly yours,
Datel
Bram D. Zuckerman, M.D.
Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K993189
Device Name: Cardiopulmonary Bypass Pump Tubing
Indications For Use:
The Cardiopulmonary Bypass Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures.
The tubing is intended for use in procedures lasting up to 6-hours in duration.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respilatory Devices
510(k) Number
K993189
OR
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
: 20
§ 870.4390 Cardiopulmonary bypass pump tubing.
(a)
Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).