The COBE Optima™ and CML Duo™ are 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 Description

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

The CML Duo™ is a flat sheet membrane oxygenator with integral heat exchanger. Used in conjunction with other ancillary equipment and disposable products, this device will satisfy the patient's gas exchange and body temperature regulation requirements.

The products are sterilized by ethylene oxide gas and have nonpyrogenic fluid pathways.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and the study proving the device meets them, presented in the requested format:

Acceptance Criteria and Device Performance Study for COBE® Optima™ and CML Duo™ Membrane Oxygenators with Seal Modifications

This 510(k) submission (K964043) covers modifications to the COBE Optima™ end cap-to-core joint and the COBE Optima™ and CML Duo™ heat exchanger seals. The core assertion is that these modifications do not significantly change the specifications or performance of the devices. Therefore, the acceptance criteria are based on demonstrating that the modified devices perform equivalently to the predicate devices in critical areas.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Performance	Blood pathway pressure drop for the modified COBE Optima oxygenator should not significantly change from the predicate device.	"Blood pathway pressure drop... for the COBE Optima oxygenator with modified seals were tested and did not significantly change from the predicate device."
	Blood pathway integrity for the modified COBE Optima oxygenator should not significantly change from the predicate device.	"Blood pathway integrity for the COBE Optima oxygenator with modified seals were tested and did not significantly change from the predicate device."
	Blood pathway pressure drop for the modified CML Duo oxygenator should not significantly change from the predicate device.	"Blood pathway pressure drop... for the CML Duo oxygenator with modified seals were tested and did not significantly change from the predicate device."
	Blood pathway integrity for the modified CML Duo oxygenator should not significantly change from the predicate device.	"Blood pathway integrity for the CML Duo oxygenator with modified seals were tested and did not significantly change from the predicate device."
Biocompatibility	Raw materials used for the modifications must be safe for use in the COBE Optima and COBE CML Duo.	"Biocompatibility tests of the raw materials used for these modifications indicate that they are safe for use in the COBE Optima and the COBE CML Duo."
Manufacturing/Sterilization	Modifications should not lead to significant changes in manufacturing processes or sterilization methods. (Implied acceptance by the FDA's "no significant changes" statement)	"There are no significant changes being made to the processes used to manufacture or sterilize the devices." (This statement is a declaration by the manufacturer, implicitly accepted by the FDA's clearance).
Labeling	Modifications should not result in any labeling changes. (Implied acceptance by the FDA's "no labeling changes" statement)	"These modifications will not result in any labeling changes for the devices..." (This statement is a declaration by the manufacturer, implicitly accepted by the FDA's clearance, as the FDA explicitly mentions "for the indications for use stated in the enclosure" without requiring new labeling for performance changes).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document mentions "Blood pathway pressure drop and blood pathway integrity... were tested" but does not provide specific numbers of devices tested or the number of measurements taken.
Data Provenance: The testing was "in vitro." This implies laboratory testing, likely conducted by the manufacturer (COBE Cardiovascular, Inc.) to compare the modified devices to the predicate devices. The country of origin of the data is not specified, but given the manufacturer's location (Arvada, CO, USA), it's highly probable the testing occurred in the USA. The testing is prospective in the sense that it was conducted on the modified devices before market clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission is for a medical device modification and relies on in vitro engineering and materials testing, not a clinical study involving human patients or expert interpretation of diagnostic images/data to establish ground truth. The "ground truth" for these tests is based on established engineering principles and measurements.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this was in vitro testing. There was no need for human adjudication of results in the way it would be applied in a clinical trial or diagnostic performance study. The evaluation likely involved direct measurement and comparison to predefined engineering specifications or performance ranges derived from the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images). The current submission pertains to the physical and functional performance of a blood-oxygenating device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is not an algorithm or AI system. It is a physical medical device. The in vitro testing can be considered "standalone" in the sense that it evaluates the device's intrinsic performance characteristics without human involvement beyond operating the testing equipment.

7. The Type of Ground Truth Used

The ground truth for this in vitro testing was based on:

Functional Performance Metrics: Direct measurements of physical attributes like blood pathway pressure drop and blood pathway integrity, compared to the established performance of the legally marketed predicate devices.
Biocompatibility Standards: Results of biocompatibility tests on raw materials, likely conforming to ISO or other recognized standards for medical device materials, demonstrating safety for patient contact.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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K964043
Sept. 29, 1997

510(k) Summary

SUBMITTER:

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

Mary L. Armstrong CONTACT PERSON: Phone: (303) 467-6521 Fax: (303) 467-6525
October 7, 1996 DATE PREPARED:
COBE® Optima™ Hollow Fiber Membrane Oxygenator DEVICE TRADE NAMES: COBE® CML Duo™ Flat Sheet Membrane Oxygenator
Hollow Fiber Membrane Oxygenator with Heat Exchanger COMMON NAMES: Flat Sheet Membrane Oxygenator with Heat Exchanger
Cardiopulmonary Bypass Oxygenator and Cardiopulmonary Bypass CLASSIFICATION NAME: Heat Exchanger
COBE® Optima™ Hollow Fiber Membrane Oxygenator PREDICATE DEVICES: COBE® CML Duo™ Flat Sheet Membrane Oxygenator

DEVICE DESCRIPTION:

The products are sterilized by ethylene oxide gas and have nonpyrogenic fluid pathways.

INDICATIONS FOR USE:

The COBE Optima™ and CML Duo™ are 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:

This 510(k) covers a modification to the COBE Optima™ end cap to core joint and a modification to the COBE Optima and CML Duo heat exchanger seals. These modifications will not result in any labeling changes for the devices and are not intended to change the specifications or performance of these

()ntima™ and (ML Duo™ are trademarks of COBE Laboratories, Inc.

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

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devices. There are no significant changes being made to the processes used to manufacture or sterilize the devices. The modifications to the COBE Optima and CML Duo seals are being made to improve the manufacturability of these devices.

NONCLINICAL TEST RESULTS:

Blood pathway pressure drop and blood pathway integrity for the COBE Optima oxygenator with modified seals were tested and did not significantly change from the predicate device. Blood pathway pressure drop and blood pathway integrity for the CML Duo oxygenator with modified seals were tested and did not significantly change from the predicate device.

Biocompatibility tests of the raw materials used for these modifications indicate that they are safe for use in the COBE Optima and the COBE CML Duo.

CLINICAL TEST RESULTS:

No clinical testing was performed. Safety and efficacy can be determined by in vitro testing.

CONCLUSION:

In vitro testing and biocompatibility testing show that the modified devices are safe and not significantly different from the predicate devices.

Optima™ and CML Duo™ are trademarks of COBE Laboratories, Inc.

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

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

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

SEP 2 9 1997

K964043 Re : COBE® Optima™ and COBE® CML Duo™ Membrane Oxygenators with Seal Modifications Regulatory Class: III (Three) Product Code: 74 DTZ Dated: September 15, 1997 Received: September 16, 1997

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory 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 (301) Additionally, for questions on the promotion and 594-4648. advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

Thomas J. Čallahan, 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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510(k) Pre-Market Notification: COBE Optima and CML Duo Seal Modifications DTZ III - 870.4350 - CPB Oxygenator

Indications For Use

510(k) Number (if known): X 9624045'

Device Names: COBE Optima™ Hollow Fiber Membrane Oxygenator COBE® CML Duo™ Flat Sheet Membrane Oxygenator

Indications For Use:

The Optima™ and CML Duo™ are 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)

Berr B. Bumper Co.

Division of Cardiovascular. Respiratory, and Neurological Devices

×964043 510(k) Number _

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

Regulation Number and Section

§ 870.4350 Cardiopulmonary bypass oxygenator.

(a)
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.(b)
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.”