COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR

K974812 · Cobe Cardiovascular, Inc. · DTZ · Jun 1, 1998 · Cardiovascular

Device Facts

• Record ID: K974812
• Device Name: COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: DTZ · Cardiovascular
• Decision Date: Jun 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to six hours.

Device Story

Flat sheet membrane oxygenator with integral heat exchanger; provides extracorporeal gas exchange and blood temperature control during adult surgical procedures. Device incorporates surface-modifying material on primary blood contact surfaces to improve blood compatibility. Single-use; ethylene oxide sterilized; nonpyrogenic fluid pathway. Operated by perfusionists or surgical staff during cardiopulmonary bypass. Output consists of oxygenated, temperature-regulated blood returned to patient. Benefits include improved biocompatibility compared to non-modified versions, reducing potential adverse blood-surface interactions during bypass support.

Clinical Evidence

No clinical data. Evidence consists of bench testing (stability, SEM analysis, gas transfer, pressure drop, blood cell damage, heat exchanger performance, leaching, and blood compatibility) and ex-vivo testing (perfusion and animal survivor experiments).

Technological Characteristics

Flat sheet membrane oxygenator with integral heat exchanger. Surface-modifying material applied to blood contact surfaces. Sterilized via ethylene oxide. Single-use. Nonpyrogenic fluid pathway.

Indications for Use

Indicated for adult patients undergoing surgical procedures requiring extracorporeal gas exchange support and blood temperature control for up to six 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.”

Predicate Devices

• COBE® CML Duo® Membrane Oxygenator (K974812)

Submission Summary (Full Text)

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510(k) Pre-Market Notification: COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator

K974812

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. IUN 1 1098

# 510(k) Summary

SUBMITTER:

COBE Cardiovascular, Inc. ® 14401 W. 65th Way Arvada, CO 80004

Lynne Leonard CONTACT PERSON: Phone: [phone] [phone] Fax:

December 17, 1997 DATE PREPARED:

COBE® CML Duo® With SMAR.T™ DEVICE TRADE NAME: Surface Modified Membrane Oxygenator

Flat Sheet Membrane Oxygenator with Integral Heat Exchanger COMMON/USUAL NAME:

Cardiopulmonary Bypass Oxygenator with Heat Exchanger CLASSIFICATION NAME:

#### COBE® CML Duo® Membrane Oxygenator PREDICATE DEVICE:

## DEVICE DESCRIPTION:

The COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is a flat sheet membrane blood oxygenator with integral heat exchanger. A surface-modifying material is added to the primary blood contact surfaces of the oxygenator and integral heat exchanger to improve the blood competibility of the device. The product is sterlized by ethylene oxide, is for single use only, and has a nonpyrogenic fluid pathway.

#### INDICATIONS FOR USE

The COBE® CML Duce With SMAR,T™ Surface Modified Membrane Oxygenator is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to six hours.

## STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The COBE® CML Duo® With SMAR.T™ Surface Modified Membrane Oxygenator has the same intended use as the COBE® CML Duo® Membrane Oxygenator. The only differences between the Duo with SMAR.T Oxygenator and the currently marketed Duo Oxygenator are 1) the Duo with SMAR, T Oxygenator contains the surface-modifying material and the Duo Oxygenator does not; 2) a surfactant is used in the heat exchanger of the Duo Oxygenator but not in the heat exchanger of the Duo with SMAR, T Oxygenator. Otherwise, all materials, components, and sterilization and manufacturing processes for the two devices are the same.

Biocompatibility testing, in-vitro testing, and ex-vivo testing were performed to demonstrate that the COBE® CML Duo® With SMAR TT* Surface Modified Membrane Oxygenator is substantially equivalent to the currently marketed COBE® CML Duo® Membrane Oxygenator.

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#### 510(k) Pre-Market Notification: COBE® CML Duo® With SMAR,T™ Surface Modified Membrane Oxygenator

In-vitro testing consisted of:

Stability testing, surface-modifying material SEM Analysis Blood pathway operating volume Pressure drop Gas pathway pressure drop Gas transfer Gas transfer duration Blood pathway integrity Unrecoverable blood volume Blood cell damage Heat exchanger performance Surface-modifying material leaching Surface-modifying material blood compatibility

Ex-vivo testing consisted of:

Perfusion and animal survivor experiments Surface-modifying material blood compatibility

These data support that the COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is substantially equivalent to the currently marketed COBE® CML Duo® Membrane Oxygenator, and that the addition of the surface-modifying material does not significantly affect safety and effectiveness.

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Public Health Service

JUN 1

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re : K974812 COBE® CML® Duo With SMAR,T™ Requlatory Class: III (Three) Product Code: DTZ Dated: March 24, 1998 : Received: March 25, 1998

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 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 (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 A substantially equivalent determination assumes compliance with 895. 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 Please note: this response to your premarket Federal Register. 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 beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 requlation (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/dsma/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

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

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510(k) Pre-Market Notification: COBE® CML Duo® With SMAR,T™ Surface Modified Membrane Oxygenator

# Indications For Use

510(k) Number (if known): K974812

Device Name: COBE® CML Duo® With SMAR_T™ Surface Modified Membrane Oxygenator

Indications For Use:

The COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to six hours.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lou Campbell

(Division-Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K974812

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________