COBE OXYGENATOR PRODUCTS by COBE CARDIOVASCULAR, INC.

COBE® HARD SHELL VENOUS RESERVOIRS. UNFILTERED AND FILTERED are intended for storage (and filtration, if filtered) of blood during surgical procedures on adults requiring extracorporeal circulation for periods up to six hours.

COBE® VENOUS RESERVOIR BAGS are intended for use as a blood reservoir during extracorporeal blood circulation.

COBE® FLAT SHEET MEMBRANE OXYGENATORS are intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to six hours (one model is a variable prime oxygenator intended to be used during cardiac surgical procedures on neonates, infants, pediatrics, and small adults requiring cardiopulmonary bypass).

COBE® HOLLOW FIBER MEMBRANE OXYGENATORS are intended to be used in adult surgical procedures requiring extracorporeal gas exchange suppport and blood temperature control for periods of up to six hours.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for various COBE® cardiovascular products, indicating that they have been found substantially equivalent to legally marketed predicate devices.

The document discusses:

The FDA's review of COBE Cardiovascular, Inc.'s 510(k) notification.
The determination of substantial equivalence for the listed devices (COBE® Hard Shell Venous Reservoirs, COBE® Venous Reservoir Bags, COBE® Flat Sheet Membrane Oxygenators, COBE® Hollow Fiber Membrane Oxygenators).
The regulatory classification (Class III).
General controls provisions and other regulations applicable to the device.
Instructions for marketing the device and contact information for further regulatory advice.
The intended indications for use for each device, which describe how the device is meant to be used (e.g., for storage of blood during surgical procedures up to six hours, for extracorporeal gas exchange support and blood temperature control up to six hours).

However, it does not include:

Specific quantitative acceptance criteria (e.g., performance metrics, thresholds).
Details of a study proving the device meets acceptance criteria, such as:
- A table of acceptance criteria vs. reported device performance.
- Sample sizes or data provenance for a test set.
- Information on experts or adjudication methods for ground truth.
- Results of any multi-reader multi-case studies or standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Training set sample size or ground truth establishment for a training set.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance based on the provided text.

Summary

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Public Health Service

JAN 27 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lynne Leonard Manager, Regulatory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004-3599

Re: K974085 COBE® Oxygenator Products Regulatory Class: III (Three) Product Code: 74 DTZ October 24, 1997 Dated: October 29, 1997 Received:

Dear Ms. Leonard:

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: 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 regulations.

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Page 2 - Ms. Lynne Leonard

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.qov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, . and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (If known):

Device Names: Cobe® Hard Shell Venous Reservoirs, Unfiltered and Filtered Cobe® Venous Reservoir Bags Cobe® Flat Sheet Membrane Oxygenators Cobe® Hollow Fiber Membrane Oxygenators

Indications For Use:

COBE® VENOUS RESERVOIR BAGS are intended for use as a blood reservoir during extracorporeal blood circulation.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 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.”