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 Description

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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device modification, specifically the COBE SMARxT Optimin Surface Modified Hollow Fiber Membrane Oxygenator. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a de novo study with acceptance criteria and performance metrics for a new device.

Therefore, the requested information elements (acceptance criteria table, sample sizes, expert qualifications, MRMC studies, standalone performance, ground truth types, and training set information) are not applicable in the context of this 510(k) summary.

Here's why and what information can be extracted:

Why the requested information is not applicable:

Substantial Equivalence: The primary goal of a 510(k) submission, especially for a modification, is to show that the new device is as safe and effective as a legally marketed predicate device. This is achieved by demonstrating that it has the same intended use and fundamentally similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
No New Acceptance Criteria: The device is not being evaluated against a new set of functional or clinical acceptance criteria as if it were a novel device. Instead, its performance is compared to the predicate's established performance to ensure no degradation or new risks.
No De Novo Clinical Study: The "STUDY" described in this document is a series of "in-vitro tests" designed to show equivalency, not a large-scale clinical trial to establish new performance metrics or compare against human readers.

What information can be extracted/inferred from the document regarding the "study":

Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implied): That the COBE SMARxT Optimin's in-vitro performance (e.g., gas exchange, heat exchange, blood compatibility) must be comparable to or better than the predicate device (COBE Optimin Hollow Fiber Membrane Oxygenator, K991452) and meet the established safety and performance profile for such devices. The document explicitly states the modification "improves the blood compatibility of the device," implying this was a key parameter assessed.
- Reported Device Performance: The document states: "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)." It does not provide specific numerical performance results from these in-vitro tests in this summary, but rather a concluding statement of substantial equivalence.
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the summary document. In-vitro tests typically involve multiple units but the exact number isn't provided.
- Data Provenance: The tests were "In-vitro tests" conducted by the manufacturer, COBE Cardiovascular, Inc. (location: Arvada, CO). These would be prospective laboratory tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As this was an in-vitro engineering and performance comparison, expert review in the sense of clinical ground truth (e.g., radiologist consensus) is not relevant. The "ground truth" would be established by validated laboratory measurement techniques against predetermined, engineering specifications or performance ranges of the predicate device.
Adjudication method for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically for clinical interpretation (e.g., image reading). For in-vitro performance testing, the results are objectively measured and compared to specifications or predicate performance.
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:
- No. This device is a blood oxygenator, not an AI-powered diagnostic tool. Therefore, MRMC studies and "improvement with AI vs without AI assistance" are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware medical device with a surface modification, not an algorithm.
The type of ground truth used:
- For the in-vitro tests, the "ground truth" would be objective laboratory measurements of various performance parameters (e.g., gas exchange efficiency, heat exchange capacity, thrombogenicity/blood compatibility metrics) taken from the device itself, compared to the established performance characteristics and specifications of the predicate device.
The sample size for the training set:
- Not Applicable. There is no "training set" in the context of an in-vitro comparison between two physical devices. The device is not based on a machine learning algorithm.
How the ground truth for the training set was established:
- Not Applicable. (See point 8).

Summary

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

510(k) Summary

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

NOV 1 6 2001

KD13480

Shawn Riedel CONTACT PERSON: Phone: (303) 467-6521 Fax: (303) 467-6429

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

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 (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,

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:

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

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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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.”