COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR

K963518 · Cobe Cardiovascular, Inc. · DTZ · Dec 8, 1997 · Cardiovascular

Device Facts

• Record ID: K963518
• Device Name: COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: DTZ · Cardiovascular
• Decision Date: Dec 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Optima XP™ is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

Device Story

The Optima XP is a hollow fiber membrane oxygenator with an integral heat exchanger used during cardiopulmonary bypass. It functions by facilitating gas exchange and regulating blood temperature for adult patients. The device is operated by clinical staff in a surgical setting. It receives blood flow from the patient, processes it through a membrane oxygenator to exchange gases, and passes it through a heat exchanger to control temperature before returning the blood to the patient. The device is a modification of the predicate Optima oxygenator, featuring increased membrane surface area achieved by decreasing fiber diameter and increasing fiber count. This design change results in improved oxygen transfer rates compared to the predicate. The device is sterilized via ethylene oxide and features nonpyrogenic fluid pathways.

Clinical Evidence

No clinical testing was performed. Safety and efficacy were established through in vitro bench testing comparing the Optima XP to the predicate Optima device. Results demonstrated increased oxygen transfer rates for the Optima XP, with other performance parameters (CO2 transfer, blood trauma, pressure drops) showing no statistically significant differences.

Technological Characteristics

Hollow fiber membrane oxygenator with integral heat exchanger. Materials are nonpyrogenic. Sterilized by ethylene oxide. Features increased membrane surface area compared to predicate via decreased fiber diameter and increased fiber count. Operates as a passive gas exchange and heat transfer device.

Indications for Use

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

Predicate Devices

• COBE® Optima™ Hollow Fiber Membrane Oxygenator (K963518)

Submission Summary (Full Text)

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510(k) Pre-Market Notification: Optima XP
K963518
page 8

9. 510(k) Summary

| SUBMITTER: | COBE Cardiovascular, Inc.®
14401 W. 65th Way
Arvada, CO 80004 |
| --- | --- |
| CONTACT PERSON: | Mary L. Armstrong
Phone: [phone]
Fax: [phone] |
| DATE PREPARED: | August 27, 1996 |
| DEVICE TRADE NAME: | COBE® Optima XP™ Hollow Fiber Membrane Oxygenator |
| COMMON NAME: | Hollow Fiber Membrane Oxygenator with Heat Exchanger |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator and Cardiopulmonary Bypass Heat Exchanger |
| PREDICATE DEVICE: | COBE® Optima™ Hollow Fiber Membrane Oxygenator |

DEVICE DESCRIPTION:

The Optima XP™ is a hollow fiber membrane oxygenator with integral heat exchanger. Used in conjunction with other ancillary equipment and disposable products, this device will satisfy an adult patient's gas exchange and body temperature regulation requirements during surgical procedures.

The product is sterilized by ethylene oxide gas and has nonpyrogenic fluid pathways.

INDICATIONS FOR USE:

The Optima XP™ is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

TECHNOLOGICAL CHARACTERISTICS:

The Optima XP™ is a new device created by modifying the existing Optima oxygenator by decreasing the fiber diameter and increasing the number of fibers. The result is an increase in membrane surface area in the Optima XP compared to the Optima.

The is no change in the intended use of the device.

There is no change to the heat exchanger. There are no significant changes to the processes or materials used to manufacture or sterilize the device.

Optima XP™ and Optima™ are trademarks of COBE Laboratories, Inc.

COBE® and COBE Cardiovascular® are registered trademarks of COBE Laboratories, Inc.

DEC - 8 1997
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510(k) Pre-Market Notification: Optima XP
page 9

## NONCLINICAL TEST RESULTS:

The oxygen transfer rate of the Optima XP is increased compared to the Optima. The new device also has a higher operating volume and gas side pressure drop. Carbon dioxide transfer rate, blood pathway pressure drop, unrecoverable volume, and blood trauma characteristics are not significantly different compared to the Optima.

The heat exchanger in both devices is identical in design, manufacture and installation, and therefore has not been evaluated for this 510(k).

## CLINICAL TEST RESULTS:

No clinical testing was performed. Safety and efficacy were determined by *in vitro* testing.

## CONCLUSIONS:

1. The increased membrane surface area of the Optima XP increases the oxygen transfer when compared to the Optima as intended.
2. Corresponding increases in priming volume and gas side pressure drop are acceptable.
3. No statistically significant differences were detected in other performance aspects of the Optima XP when compared to the Optima.
4. *In vitro* testing demonstrates the Optima XP is as safe and effective and performs as well as or better than the Optima.

Optima XP™ and Optima™ are trademarks of COBE Laboratories, Inc.

COBE® and COBE Cardiovascular® are registered trademarks of COBE Laboratories, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Rockville MD 20857

J. Dennis Bruner, Ph.D.
Director of Quality
COBE Cardiovascular, Inc.
14401 W. 65th Way
Arvada, Colorado 80004

DEC - 8 1997

Re: K963518
COBE® Optima XP™ Hollow Fiber Membrane Oxygenator
Regulatory Class: III (Three)
Product Code: DTZ
Dated: November 21, 1997
Received: November 25, 1997

Dear Dr. Bruner:

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 Regulations, 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 - J. Dennis Bruner, Ph.D.

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. Callahan

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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510(k) Pre-Market Notification: Optima XP
page 1

1. Indications For Use

510(k) Number (If known): K 963518

Device Name: COBE® Optima XP™ Hollow Fiber Membrane Oxygenator

Indications For Use:

The Optima XP™ is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Alta & Rampere
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K 963518

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

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