AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE

K973760 · Avecor Cardiovascular, Inc. · DTZ · Feb 18, 1998 · Cardiovascular

Device Facts

• Record ID: K973760
• Device Name: AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE
• Applicant: Avecor Cardiovascular, Inc.
• Product Code: DTZ · Cardiovascular
• Decision Date: Feb 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Affinity Hollow Fiber Membrane Oxygenator System functions within extracorporeal perfusion circuits; provides gas exchange (oxygenation/CO2 removal) and thermal regulation (heating/cooling) for blood during cardiopulmonary bypass. Device features Trillium Biopassive Surface to improve hemocompatibility. Operated by perfusionists or clinicians in surgical settings (OR). Blood flows through hollow fiber membrane; gas exchange occurs across membrane interface; heat exchange occurs via integrated heat exchanger. Output is oxygenated, temperature-controlled blood returned to patient. Benefits include maintenance of physiological gas levels and temperature during procedures lasting up to 6 hours.

Technological Characteristics

Hollow fiber membrane oxygenator; integrated heat exchanger; Trillium Biopassive Surface coating for hemocompatibility. Class III device (Product Code: DTZ).

Indications for Use

Indicated for patients undergoing routine cardiopulmonary bypass procedures requiring extracorporeal circulation for oxygenation, carbon dioxide removal, and blood temperature regulation (cooling/warming) for durations up to 6 hours.

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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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 [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.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)