COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR

K013480 · Cobe Cardiovascular, Inc. · DTZ · Nov 16, 2001 · Cardiovascular

Device Facts

• Record ID: K013480
• Device Name: COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: DTZ · Cardiovascular
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The COBE® SMARxT® Optimin™ is indicated for use in surgical procedures requiring extracorporeal gas exchange support and blood procedure control. It is intended to be used in procedures requiring a tomporature comrow rate of 5 liters/min and lasting up to six hours.

Device Story

The COBE SMARxT Optimin is a sterile, single-use hollow fiber membrane oxygenator with an integral heat exchanger. It functions during cardiopulmonary bypass to provide gas exchange and blood temperature regulation. The device is designed for smaller adult and pediatric patients. It is operated by clinical staff in surgical settings. The primary modification from the predicate is the addition of a surface-modifying additive to improve blood compatibility. The device is not to be resterilized.

Clinical Evidence

Bench testing only; in-vitro tests were performed to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Hollow fiber membrane oxygenator with integral heat exchanger; includes surface-modifying additive for improved blood compatibility; sterile, non-pyrogenic, single-use; maximum blood flow rate 5 L/min; duration up to 6 hours.

Indications for Use

Indicated for patients undergoing surgical procedures requiring extracorporeal gas exchange support and blood temperature control, specifically smaller adult and pediatric patients, with a maximum blood flow rate of 5 liters/minute and duration 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 Optimin Hollow Fiber Membrane Oxygenator (K991452)

Submission Summary (Full Text)

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Special 510(k)-Device Modification: COBE SMARxT Optimin

19

### 510(k) Summary

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

NOV 1 6 2001

KD13480

Shawn Riedel CONTACT PERSON: Phone: [phone] Fax: [phone]

October 18, 2001 DATE PREPARED:

COBE SMARxT Optimin Surface Modified Hollow Fiber DEVICE TRADE NAME: Membrane Oxygenator

Hollow Fiber Membrane Blood Oxygenator with Integral COMMON/USUAL NAME: Heat Exchanger

Cardiopulmonary Bypass Oxygenator CLASSIFICATION NAME: Cardiopulmonary Bypass Heat Exchanger

COBE Optimin Hollow Fiber Membrane Oxygenator, #K991452 PREDICATE DEVICE:

DEVICE DESCRIPTION/INDICATIONS FOR USE

The COBE SMARxT Optimin is a sterile device with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. The device is a blood oxygenator with integral heat exchanger, intended to be used in surgical procedures requiring extracorporeal gas exchange support and blood temperature control, requiring a maximum blood flow rate of 5 liters/minute and lasting up to six hours. The size and specifications of the device make it particularly suited for smaller adult and pediatric patients.

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The COBE SMARxT Optimin Hollow Fiber Oxygenator is identical to the COBE Optimin Hollow Fiber Oxygenator in design, intended use, method of operation, components, packaging, and fundamental scientific technology. The primary difference between the two devices is that the COBE SMARxT Optimin Hollow Fiber Oxygenator contains a surface-modifying additive that improves the blood compatibility of the device.

TESTING TO DETERMINE SUBSTANTIAL EQUIVALENCE

In-vitro tests were performed to demonstrate that the COBE SMARXT Optimin Hollow Fiber Oxygenator described in this submission is substantially equivalent to the COBE Optimin Hollow Fiber Oxygenator (K991452).

Image /page/0/Picture/17 description: The image shows the word "CONFIDENTIAL" in large, bold, black letters. The word is slightly tilted upwards from left to right. The font appears to be a sans-serif typeface, and the letters are closely spaced together.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 6 2001

Mr. Shawn Riedel COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004

Re: K013480

COBE SMARxT Optimin Surface Modified Holow Fiber Membrane Oxygenator Regulation Number: 804.4350, 870.4240 Regulation Name: Cardiopulmonary Bypass Oxygenator Cardiopulmonary Bypass Heat Exchanger Regulatory Class: II (Two) Product Code: DTZ, DTR Dated: October 18, 2001 Received: October 19, 2001

#### Dear Mr. Riedel:

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 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

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## Page 2 - Mr. Shawn Riedel

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.

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" (21CFR 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,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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NOV 1 6 2001

## Indications For Use

510(k) Number (If known):

KD13480

Device Name: COBE® SMARxT® Optimin™ Hollow Fiber Membrane Oxygenator

Indications For Use:

The COBE® SMARxT® Optimin™ is indicated for use in surgical procedures requiring extracorporeal gas exchange support and blood procedure control. It is intended to be used in procedures requiring a tomporature comrow rate of 5 liters/min and lasting up to six hours.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K063480

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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