The COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to six hours.

Device Description

The COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is a flat sheet membrane blood oxygenator with integral heat exchanger. A surface-modifying material is added to the primary blood contact surfaces of the oxygenator and integral heat exchanger to improve the blood competibility of the device. The product is sterlized by ethylene oxide, is for single use only, and has a nonpyrogenic fluid pathway.

AI/ML Overview

The provided text describes a 510(k) Pre-Market Notification for a medical device, the COBE® CML Duo® With SMAR.T™ Surface Modified Membrane Oxygenator. However, the document does not contain the level of detail requested in the prompt regarding specific acceptance criteria, reported device performance metrics, sample sizes for test and training sets, expert qualifications, or ground truth establishment methods in a format that would allow for the direct completion of all requested sections.

The document primarily focuses on establishing "substantial equivalence" to a predicate device (COBE® CML Duo® Membrane Oxygenator) rather than providing detailed performance studies against pre-defined acceptance criteria.

Here's an analysis of what can be extracted and what is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in a quantitative table. The acceptance criteria for substantial equivalence are implied to be that the "new" device performs at least as well as the predicate device in various tests, and does not significantly affect safety and effectiveness due to the surface-modifying material.
Reported Device Performance: No specific quantitative performance metrics (e.g., specific gas transfer rates, pressure drop values, or blood cell damage percentages) are provided in the text. The document only lists the types of tests performed.

What can be inferred or extracted for a conceptual table:

Acceptance Criteria Category (Implied)	Reported Device Performance (Implied)
Biocompatibility	Demonstrated
In-vitro performance (Stability, SEM, Blood pathway volume, Pressure drop, Gas transfer, Integrity, Unrecoverable blood volume, Blood cell damage, Heat exchanger performance, Leaching, Blood compatibility)	Demonstrated substantial equivalence to predicate device
Ex-vivo performance (Perfusion, Animal survivor experiments, Blood compatibility)	Demonstrated substantial equivalence to predicate device
Safety & Effectiveness	No significant impact compared to predicate device

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified. The document mentions "in-vitro testing" and "ex-vivo testing," including "perfusion and animal survivor experiments." However, the number of samples, animals, or runs for these tests is not provided.
Data Provenance: The studies were performed by the manufacturer, COBE Cardiovascular, Inc., presumably in the US (location of contact person). The data is retrospective in the sense that it's reported after the fact for the 510(k) submission, but it represents new testing conducted for this specific device modification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.
- Rationale: This type of device (membrane oxygenator) relies on physical and biological performance characteristics, not expert interpretation of data like images. The "ground truth" would be established through laboratory measurements and animal study outcomes, not expert consensus on qualitative data.

4. Adjudication method for the test set:

Adjudication Method: Not applicable or specified.
- Rationale: As noted above, this device's performance is gauged by quantitative measurements and biological outcomes, not subjective qualitative assessments requiring adjudication among experts.

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:

MRMC Study: No.
Effect Size: Not applicable.
- Rationale: This device is a membrane oxygenator, not an AI software or a device that assists human readers in interpreting data. Therefore, an MRMC study and AI assistance metrics are irrelevant.

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

Standalone Performance: Not applicable.
- Rationale: This device is a physical medical device, not an algorithm.

7. The type of ground truth used:

Type of Ground Truth: The ground truth for evaluating the device's performance relies on:
- In-vitro measurements: Laboratory testing results against established physical and chemical standards for device performance, material properties (e.g., gas transfer rates, pressure drops, blood cell damage, material leaching).
- Ex-vivo animal study outcomes: Physiological measurements and survival rates in animal models to assess biocompatibility and overall function.
- Comparison to the predicate device's known performance as the benchmark for "substantial equivalence."

8. The sample size for the training set:

Sample Size for Training Set: Not applicable/Not specified.
- Rationale: This device is not an AI algorithm that requires a training set. The "training" in manufacturing physical devices refers to process validation and quality control, not data training.

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

How Ground Truth for Training Set was Established: Not applicable.
- Rationale: As above, no training set in the context of machine learning is involved.

Summary of what's present in the document:

The provided 510(k) summary focuses on demonstrating "substantial equivalence" of a modified medical device to a predicate device. It lists the types of tests performed (biocompatibility, in-vitro, ex-vivo) to support this claim, but it does not provide the specific quantitative acceptance criteria, the detailed results from these tests, or the methodological specifics (like sample sizes or expert involvement) that a direct "study" report would contain. The FDA's letter confirms that the device was found substantially equivalent based on these submissions.

Summary

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510(k) Pre-Market Notification: COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator

K974812

. IUN 1 1098

510(k) Summary

SUBMITTER:

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

Lynne Leonard CONTACT PERSON: Phone: (303) 467-6586 (303) 467-6429 Fax:

December 17, 1997 DATE PREPARED:

COBE® CML Duo® With SMAR.T™ DEVICE TRADE NAME: Surface Modified Membrane Oxygenator

Flat Sheet Membrane Oxygenator with Integral Heat Exchanger COMMON/USUAL NAME:

Cardiopulmonary Bypass Oxygenator with Heat Exchanger CLASSIFICATION NAME:

COBE® CML Duo® Membrane Oxygenator PREDICATE DEVICE:

DEVICE DESCRIPTION:

INDICATIONS FOR USE

The COBE® CML Duce With SMAR,T™ Surface Modified Membrane Oxygenator is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to six hours.

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The COBE® CML Duo® With SMAR.T™ Surface Modified Membrane Oxygenator has the same intended use as the COBE® CML Duo® Membrane Oxygenator. The only differences between the Duo with SMAR.T Oxygenator and the currently marketed Duo Oxygenator are 1) the Duo with SMAR, T Oxygenator contains the surface-modifying material and the Duo Oxygenator does not; 2) a surfactant is used in the heat exchanger of the Duo Oxygenator but not in the heat exchanger of the Duo with SMAR, T Oxygenator. Otherwise, all materials, components, and sterilization and manufacturing processes for the two devices are the same.

Biocompatibility testing, in-vitro testing, and ex-vivo testing were performed to demonstrate that the COBE® CML Duo® With SMAR TT* Surface Modified Membrane Oxygenator is substantially equivalent to the currently marketed COBE® CML Duo® Membrane Oxygenator.

106

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510(k) Pre-Market Notification: COBE® CML Duo® With SMAR,T™ Surface Modified Membrane Oxygenator

In-vitro testing consisted of:

Stability testing, surface-modifying material SEM Analysis Blood pathway operating volume Pressure drop Gas pathway pressure drop Gas transfer Gas transfer duration Blood pathway integrity Unrecoverable blood volume Blood cell damage Heat exchanger performance Surface-modifying material leaching Surface-modifying material blood compatibility

Ex-vivo testing consisted of:

Perfusion and animal survivor experiments Surface-modifying material blood compatibility

These data support that the COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is substantially equivalent to the currently marketed COBE® CML Duo® Membrane Oxygenator, and that the addition of the surface-modifying material does not significantly affect safety and effectiveness.

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Public Health Service

JUN 1

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re : K974812 COBE® CML® Duo With SMAR,T™ Requlatory Class: III (Three) Product Code: DTZ Dated: March 24, 1998 : Received: March 25, 1998

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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 Please note: this response to your premarket Federal Register. 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 beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 requlation (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" (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/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 ------Radioloqical Health

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510(k) Pre-Market Notification: COBE® CML Duo® With SMAR,T™ Surface Modified Membrane Oxygenator

Indications For Use

510(k) Number (if known): K974812

Device Name: COBE® CML Duo® With SMAR_T™ Surface Modified 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)

Lou Campbell

(Division-Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K974812

Prescription Use (Per 21 CFR 801.109) OR

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.”