The Vision Hollow Fiber Oxygenator with Guardian™ Coating is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to eight (8.0) liters per minute for periods of up to six (6.0) hours.

Device Description

The Gish Vision Hollow Fiber Oxygenator with Guardian™ Coating consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The hollow fiber membrane consists of a polypropylene gas permeable mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a one piece, stainless steel bellows configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the outside convolutions of the stainless steel bellows, and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible and coated with a proprietary coating. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifugal pump connected through the tubing. The Gish Vision Hollow Fiber Oxygenator with Guardian™ Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Vision Hollow Fiber Oxygenator with Guardian™ Coating) seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and detailed performance metrics as might be seen for novel devices requiring PMA approval.

Therefore, the information typically requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance evaluation for software-based diagnostic devices is not applicable and not present in this 510(k) summary for a hardware medical device like an oxygenator.

The document generally states that "The Vision Hollow Fiber Oxygenator with Guardian™ Coating has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards." However, it does not detail these specific tests, their acceptance criteria, or the reported performance in a quantitative manner.

Here's an attempt to answer your questions based on the limited and different nature of information in a 510(k) summary for this type of device:

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

This information is not provided in the 510(k) summary. The document states "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." However, it does not specify what those functional requirements or performance specifications are, nor does it present a table of acceptance criteria versus reported performance. The focus is on demonstrating "substantial equivalence" to a predicate device, implying that its performance is comparable, but not quantifying it.

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

This information is not provided. The summary only mentions "extensive safety, performance, and validations prior to release" and "Final testing". It does not specify sample sizes for any test sets, nor does it detail data provenance. Given the device type (oxygenator), the "testing" would likely involve bench testing, animal studies, or cadaveric studies, rather than human clinical data in the way a diagnostic AI would.

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 information is not applicable and not provided. For a hardware device like an oxygenator, "ground truth" in the context of expert consensus (as used for diagnostic AI) is not relevant. Performance criteria would be based on engineering specifications, physiological measurements (e.g., oxygen transfer rate, CO2 removal), and material biocompatibility, likely evaluated by biomedical engineers, toxicologists, and in-vitro/in-vivo studies.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human readers/experts in diagnostic imaging studies to establish a ground truth. This is not relevant for the testing of a medical hardware device like an oxygenator.

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 information is not applicable and not provided. MRMC studies are used to evaluate the performance of diagnostic AI systems, specifically how AI assistance impacts human reader performance on diagnostic tasks. The device in question is a medical hardware device (an oxygenator) and does not involve human interpretation of outputs assisted by AI.

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

This information is not applicable and not provided. Standalone performance evaluations are conducted for AI algorithms that perform a diagnostic or analytical task without immediate human intervention. The device here is a physical oxygenator, so this concept does not apply.

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

This information is not explicitly stated in a way that aligns with "ground truth" for diagnostic AI. For an oxygenator, "ground truth" for performance would likely be established through:

Engineering Specifications: Meeting predefined oxygenation and CO2 removal rates, blood flow rates, priming volume.
Biocompatibility Testing: According to ISO standards, potentially including in-vitro cytotoxicity, hemolysis, thrombogenicity tests.
Mechanical Integrity Testing: Pressure resistance, leak tests.
Sterility Testing.
Pre-clinical (animal) studies: Demonstrating functional performance in a living system.

The 510(k) summary only generally states that "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."

8. The sample size for the training set

This information is not applicable and not provided. As a physical medical device (oxygenator) and not an AI or machine learning algorithm, there is no "training set."

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

This information is not applicable and not provided. As there is no "training set" for this type of device, the concept of establishing ground truth for it is irrelevant.

Summary

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Summary

MAR 3 1 2003

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR part 807.92.

1. Company making the submission:

	Company	Correspondent (contract):
Name:	Gish BioMedical,	Delphi Consulting Group
Address:	Inc.	11874 South Evelyn Circle
	22942 Arroyo Vista	Houston, TX 77071-3404
	Rancho Santa
Telephone:	Margarita	713-723-4080 voice
	CA 92688-2600	775-429-9524 fax
Contact:	949-635-6200 voice	harvey@delphiconsulting.com
	949-635-6299 fax	J. Harvey Knauss
	Edward F. Waddell	Consultant
	Director RA/QA

2. Device:

Proprietary Name:	Vision Hollow Fiber Oxygenator with Guardian™ Coating
Common Name:	Blood Oxygenator
Classification Name:	Oxygenator, Cardiopulmonary Bypass

3. Predicate Devices:

Vision Hollow Fiber Oxygenator, Gish Biomedical, Inc., K961530.

4. Classifications Names & Citations:

21 CFR 870.4350, Oxygenator, Cardiopulmonary Bypass, Class II, DTZ, Cardiovascular.

5. Description:

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exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible and coated with a proprietary coating.

The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifugal pump connected through the tubing. The Gish Vision Hollow Fiber Oxygenator with Guardian™ Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

6. Indications for use:

The Vision Hollow Fiber Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to eight (8.0) liters per minute for periods of up to six (6.0) hours.

7. Contra-indications:

For heparin coated oxygenators (HFOE), heparin has been reported, on rare occasions, to induce thrombocytopenia. Since patients undergoing cardiopulmonary bypass are routinely systemically heparinized, and although the amount of heparin contributed by this device is very small in comparison to the typical dose given, caution should be exercised when using this device in patients with known or suspected heparin sensitivity.

8. Comparison:

The Vision Hollow Fiber Oxygenator with Guardian ™ Coating has the same device characteristics as the Predicate devices.

9. Test Data:

The Vision Hollow Fiber Oxygenator with Guardian™ Coating has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards.

10. Literature Review:

A review of literature pertaining to the safety and effectiveness has been conducted. Appropriate safequards have been incorporated in the design of the Vision Hollow Fiber Oxygenator with Guardian™ Coating.

11. Conclusions:

The conclusion drawn from these tests is that the Vision Hollow Fiber Oxygenator with Guardian™ Coating is equivalent in safety and efficacy to its predicated devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2003

Gish Biomedical, Inc. c/o Mr. J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071-3404

Re: K023381

Vision Hollow Fiber Oxygenator with Coating Regulation Number: 21 CFR 870.4350 Regulation Name: CPB Oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: January 21, 2003 Received: January 23, 2003

Dear Mr. Knauss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. J. Harvey Knauss

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours.

Ara Hunkur for
Prem D. Zuckerman, M.D.

ram D. Fuckerman. N Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K

Device Name: Vision Hollow Fiber Oxygenator with Guardian™ Coating

Indications for use:

Prescription Device:

Federal Law (US) restricts this device to sale by or on the order of a physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	OR	Over-The-Cour


(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K023381

(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.”