The COBE® Optimin™ Hollow Fiber Membrane Oxygenator is intended to be used in surgical procedures requiring extracorporeal gas exchange support and blood temperature control. It is intended to be used in procedures requiring a maximum blood flow rate of 5 liters/min and lasting up to six hours.

Device Description

The COBE® Optimin™ Hollow Fiber Membrane Oxygenator 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. Microporous polypropylene, hollow fiber membrane material separates the blood and gas pathways inside the oxygenator, with the blood pathway outside and the gas pathway inside the hollow fiber membrane. Blood is pumped into the blood inlet port. The blood inlet and blood outlet ports are 3/8" and include a locking mechanism which accepts a 1/4" reducing connector if the user desires to utilize 1/4" ID rather than 3/8″ ID circuit tubing. The blood is channeled into the blood pathway of the heat exchanger, where the blood temperature is varied by controlling the water temperature in the water pathway of the heat exchanger. As the blood exits the heat exchanger it passes around a stainless steel temperature probe well, where the temperature of the blood may be monitored as it enters the oxygenator. Blood from the heat exchanger enters the oxygenator through the inlet manifold, and then flows around the outside of the fibers are oriented horizontally in the oxygenator case, with flow entering the top of the fiber bundle and exiting the bottom to facilitate priming and debubbling. Gas exchange takes place as the blood makes its way into the bottom outlet manifold where it is directed out of the oxygenator through the blood outlet port and back to the patient. Sweep gas is introduced into the fibers through the gas inlet cap. The gas flows through the lumen of the hollow fibers. Gas exchange between the blood and gas pathways takes place through the micropores in the hollow fiber wall. Sweep gas flowing through the fibers collects in the outlet cap, where it may be scavenged.

AI/ML Overview

The COBE® Optimin™ Hollow Fiber Membrane Oxygenator demonstrated substantial equivalence to predicate devices (COBE® Optima XP™ and TERUMO® Capiox® SX 10) through in-vitro testing. The submission does not provide explicit acceptance criteria values, but instead states the device performance "supports substantial equivalence" based on various in-vitro tests.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly state specific numerical acceptance criteria for each test. Instead, it indicates that the in-vitro test data "support substantial equivalence" to the predicate devices. This implies that the device's performance fell within an acceptable range compared to the predicate devices, but the exact thresholds are not detailed in this summary.

Test	Acceptance Criteria (Implied)	Reported Device Performance
1. Blood pathway operating volume	Comparable to predicate devices	Data supports substantial equivalence to predicate devices
2. Blood pathway pressure drop	Comparable to predicate devices	Data supports substantial equivalence to predicate devices
3. Gas pathway pressure drop	Comparable to predicate devices	Data supports substantial equivalence to predicate devices
4. Oxygen transfer rate	Comparable to predicate devices	Data supports substantial equivalence to predicate devices
5. Carbon dioxide transfer rate	Comparable to predicate devices	Data supports substantial equivalence to predicate devices
6. Oxygen transfer duration (min/max flow)	Comparable to predicate devices	Data supports substantial equivalence to predicate devices
7. Carbon dioxide transfer duration (min/max flow)	Comparable to predicate devices	Data supports substantial equivalence to predicate devices
8. Blood pathway integrity	Comparable to predicate devices	Data supports substantial equivalence to predicate devices
9. Water pathway integrity	Comparable to predicate devices	Data supports substantial equivalence to predicate devices
10. Unrecoverable blood volume	Comparable to predicate devices	Data supports substantial equivalence to predicate devices
11. Blood trauma (platelet reduction, WBC reduction, plasma free hemoglobin generation)	Comparable to predicate devices (within acceptable limits)	Data supports substantial equivalence to predicate devices
12. Heat exchanger efficiency	Comparable to predicate devices	Data supports substantial equivalence to predicate devices

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the in-vitro testing.
The data provenance is in-vitro testing – meaning testing performed outside a living organism, typically in a lab setting. The country of origin of the data is not specified, but the submission is to the US FDA. The nature of in-vitro testing makes the retrospective/prospective distinction less applicable in the typical clinical study sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to this type of device submission. The "ground truth" for the performance characteristics of an oxygenator in in-vitro testing is typically established by established engineering standards, validated laboratory protocols, and comparison to the performance of predicate devices, rather than expert consensus on medical images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods are typically relevant in studies involving human interpretation or clinical endpoints, which is not the case for these in-vitro mechanical and biological performance tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. This device is a medical device (oxygenator), not an AI diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are irrelevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on established engineering and biological principles for oxygenator function, validated in-vitro testing methods, and direct comparison to the physical and functional characteristics of legally marketed predicate devices. It's not based on expert consensus, pathology reports, or patient outcomes data in the context of this 510(k) submission for substantial equivalence based on in-vitro data.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This section is not applicable as there is no training set for a physical medical device.

Summary

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510(k) Pre-Market Notification: COBE® Optimin™ Hollow Fiber Membrane Oxygenator

Image /page/0/Picture/1 description: The image shows a handwritten string of characters and numbers. The string starts with the letter 'K', followed by the numbers '99145'. The number '5' has a subscript of '15', and the string ends with the number '2'.

OCT 7 1999

510(k) Summarv

SUBMITTER:	COBE Cardiovascular®, Inc.14401 W. 65th WayArvada, CO 80004
CONTACT PERSON:	Lynne LeonardPhone: (303) 467-6586Fax: (303) 467-6429
DATE PREPARED:	April 20, 1999
DEVICE TRADE NAME:	COBE® Optimin™ Hollow Fiber Membrane Oxygenator
COMMON/USUAL NAME:	Hollow Fiber Membrane Blood Oxygenator with Integral Heat Exchanger
CLASSIFICATION NAME:	Cardiopulmonary Bypass Oxygenator with Heat Exchanger
PREDICATE DEVICES:	COBE® Optima XP™ Hollow Fiber Membrane OxygenatorTERUMO® Capiox® SX 10 Hollow Fiber Membrane Oxygenator.

DEVICE DESCRIPTION:

INDICATIONS FOR USE

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STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The COBE® Optimin™ Hollow Fiber Membrane Oxygenator is substantially equivalent to the currently marketed COBE® Optima XP™ Hollow Fiber Membrane Oxygenator (K963518). The COBE® Optimin™ Oxygenator has a lower priming volume and is rated for lower blood and gas flow rates than the COBE® Optima XP™ Oxygenator, thus the COBE® Optimin™ Oxygenator is for smaller adult and pediatric patients, whereas the COBE® Optima XP™ Oxygenator is for adult patients.

The COBE® Optimin™ Oxygenator is substantially equivalent to the currently marketed Terumo® Capiox® SX 10 Hollow Fiber Oxygenator (K960074). Specifications for the two devices are comparable and they are substantially equivalent in features and intended use.

Substantial equivalence was based on in-vitro testing of the COBE® Optimin™ Hollow Fiber Membrane Oxygenator. In-vitro testing consisted of:

1. Blood pathway operating volume
1. Blood pathway pressure drop
1. Gas pathway pressure drop
Oxygen transfer rate 4.
1. Carbon dioxide transfer rate
Oxygen transfer duration, minimum/maximum flow rates 6.
1. Carbon dioxide transfer duration, minimum/maximum flow rates
1. Blood pathway integrity
Water pathway integrity 9.
1. Unrecoverable blood volume
1. Blood trauma (platelet reduction, white blood cell reduction, and plasma free hemoglobin generation)
1. Heat exchanger efficiency

These data support substantial equivalence of the COBE® Optimin™ Hollow Fiber Membrane Oxygenator to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol in the center, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

7 1999 OCT -

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

K991452 Re : COBE® Optimin™ Hollow Fiber Membrane Oxygenator Regulatory Class: III (Three) Product Code: 74 DTZ Auqust 9, 1999 Dated: Received: August 10, 1999

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 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 - Ms. Lynne Leonard

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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) 594-4648. Additionally, for questions on the promotion and 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" (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 (800) 638-2041 or (301) 443-6597 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 Radiological Health

Enclosure

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Indications For Use

510(k) Number (If known): k99452/s'

Device Name: COBE® Optimin™ Hollow Fiber Membrane Oxygenator

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bea B. Lemperle

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular, Respira
Division of Cardiovascular, Devices Division of Caralogical Devices 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.”