COBE OXYGENATOR PRODUCTS

K974085 · Cobe Cardiovascular, Inc. · DTZ · Jan 27, 1998 · Cardiovascular

Device Facts

• Record ID: K974085
• Device Name: COBE OXYGENATOR PRODUCTS
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: DTZ · Cardiovascular
• Decision Date: Jan 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

COBE® oxygenators and venous reservoirs facilitate extracorporeal circulation during surgical procedures. Devices manage blood storage, filtration, gas exchange, and temperature control. Operated by perfusionists or surgeons in clinical/OR settings during cardiopulmonary bypass. Oxygenators utilize flat sheet or hollow fiber membrane technology to perform gas exchange; reservoirs collect and store blood. Output is the maintenance of physiological gas levels and temperature during bypass. Benefits include support of vital functions during cardiac or other surgeries requiring extracorporeal circulation.

Clinical Evidence

No clinical data provided; bench testing assumed per regulatory requirements for this class of cardiovascular device.

Technological Characteristics

Devices include hard shell venous reservoirs (filtered/unfiltered), venous reservoir bags, and membrane oxygenators (flat sheet and hollow fiber). Designed for extracorporeal circulation and blood temperature control. Materials and specific ASTM standards not detailed in provided text. Systems are mechanical/fluidic in nature; no software or electronic sensing/actuation described.

Indications for Use

Indicated for adult patients undergoing surgical procedures requiring extracorporeal circulation, gas exchange, and blood temperature control for up to six hours. One specific flat sheet membrane oxygenator model is indicated for neonates, infants, pediatrics, and small adults requiring cardiopulmonary bypass.

Regulatory Classification

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.

Special Controls

*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.”

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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® 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.

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)

OR

Over-The-Counter Use