The Vision Hollow Fiber Oxygenator with HA 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 hyaluronan based coating (HA), 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 confiqured 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 HA Coating may be purchased separately or preconnected with tubing and other components of an extracorporeal circuit.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study details:

This document describes a medical device submission (510(k)) for a blood oxygenator. It does not describe an AI/ML-based medical device. Therefore, many of the questions regarding AI/ML-specific study design (like ground truth establishment, training sets, multi-reader studies, effect sizes) are not applicable to this document.

However, I can extract the information relevant to a traditional medical device submission for the Vision Hollow Fiber Oxygenator with HA Coating.

Acceptance Criteria and Device Performance for Vision Hollow Fiber Oxygenator with HA Coating

Evaluation Summary:
The provided document is a 510(k) summary for a traditional medical device, the Gish Vision Hollow Fiber Oxygenator with HA Coating. It outlines the device's characteristics, intended use, and a generic statement about safety, performance, and validation testing. It does not provide specific numerical acceptance criteria or detailed results of tests performed to demonstrate compliance. Instead, it relies on demonstrating substantial equivalence to predicate devices (Vision Hollow Fiber Oxygenator, K961530, and Vision Hollow Fiber Oxygenator with Guardian Coat, K023381).

In the context of the provided document, the "acceptance criteria" are implied to be that the new device performs equivalently to the predicate devices and meets its functional requirements and performance specifications, without introducing new safety concerns.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implied)	Reported Device Performance
Functional Requirements/Performance Specifications:
Oxygenation of and Carbon Dioxide Removal from human blood	Device "meets all of its functional requirements and performance specifications."
Blood flow rate of 1.0 to 8.0 liters per minute (Indications for Use)	Tested and validated to operate within this range.
Duration of use up to 6.0 hours (Indications for Use)	Tested and validated for use up to 6.0 hours.
Air trapping and removal capability	Device "allows for trapping and removal of air."
Heat exchange capability	Heat exchanger functions as the "primary element to effect heat exchange."
Safety Requirements:
Biocompatibility of materials	All materials are "biocompatible and coated with a proprietary coating."
Compliance with industry and safety standards	"Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."
Equivalence to Predicate Devices (K961530 & K023381)	"The Vision Hollow Fiber Oxygenator with HA Coating has the same device characteristics as the Predicate devices." and "is equivalent in safety and effectiveness to predicate devices."

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

Sample Size for Test Set: Not explicitly stated. The document refers to "extensive safety, performance, and validations" and "various performance tests." However, specific sample sizes for these tests (e.g., number of devices tested, number of in-vitro runs, number of animal studies if applicable) are not provided.
Data Provenance: Not specified. The document states "Final testing for the systems includes various performance tests." It does not mention clinical data, country of origin, or whether the data was retrospective or prospective. Given the device type and 510(k) pathway, it's highly likely that the "testing" refers to bench testing, in-vitro studies, and potentially pre-clinical animal studies, rather than human clinical trials for a blood oxygenator, especially if substantial equivalence is claimed to existing predicate devices.

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

Not Applicable. This is a traditional medical device submission, not an AI/ML device requiring human expert annotation for ground truth. The "ground truth" for this type of device is established through objective engineering and biological performance metrics (e.g., oxygen transfer efficiency, pressure drop, hemolysis rates) and comparison to established predicate device performance.

4. Adjudication Method for the Test Set

Not Applicable. As there are no human experts establishing ground truth via consensus, there is no adjudication method in the sense of AI/ML evaluation. Device performance is determined by objective measurements against specifications.

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

Not Applicable. This is not an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

Objective Performance Metrics and Comparison to Predicate Devices. The "ground truth" for this device's performance and safety is based on:
- Engineering Specifications: Meeting predefined performance characteristics (e.g., blood flow rates, oxygen transfer efficiency, pressure drop).
- Biocompatibility Standards: Adherence to established standards for material safety.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is the established safety and effectiveness profile of the legally marketed predicate devices, against which the new device is compared. This comparison implies the new device must perform at least as well as, and not worse than, the predicate devices without raising new questions of safety or effectiveness.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device, so there is no "training set."

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

Not Applicable. This is not an AI/ML device.

Summary

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510(k) (Traditional) Submission Section 5, 510(k) Summary

Summarv

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

1. Company making the submission:

FEB - 2 2009

Name:	Gish BioMedical, Inc.
Address:	22942 Arroyo VistaRancho Santa Margarita,CA 92688-2600
Telephone:	949-635-6200 voice949-635-6299 faxedw@gishbiomedical.com
Contact:	Edward F. WaddellDirector RA/QA

2. Device:

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

3. Predicate Devices:

Vision Hollow Fiber Oxygenator, K961530 and Vision Hollow Fiber Oxygenator with Guardian Coat, K023381. Both manufactured by Gish Biomedical, Inc.

4. Classifications Names & Citations:

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

5. Description:

K080708 Summary.doc
Delphi Consulting Group
Houston, TX 77071

Section 5 510(k) Submission Page #

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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 HA Coating may be purchased separately or preconnected 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) liters per minute for periods of up to six (6.0) hours.

7. Contra-indications:

For HA coated oxygenators, no contra-indications have been noted.

8. Comparison:

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

9. Test Data:

The Vision Hollow Fiber Oxygenator with HA 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 safeguards have been incorporated in the design of the Vision Hollow Fiber Oxygenator with HA Coating.

11. Conclusions:

Based upon the testing and comparison to the predict device the Gish Biomedical, Inc., Vision Hollow Fiber Oxygenator with HA Coating has the same intended use, with similar technological characteristics. Gish Biomedical, Inc., therefore posits that its device is equivalent in safety and effectiveness to predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with three swooping lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 2009

Gish Biomedical, Inc. c/o Ms. Janet Peets Regulatory & Clinical Affairs Specialist 22942 Arroyo Vista Rancho Santa Margarita, CA 92688

Re: · K080708

Vision Hollow Fiber Oxygenator with HA Coating Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: January 8, 2009 Received: January 12, 2009

Dear Ms. Peets:

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 -- Ms. Janet Peets

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Duna R. Lochner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K_080709

Device Name: Vision Hollow Fiber Oxygenator with HA Coating

Indications for use:

Prescription Device:

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

Prescription Use : Yes

Over-The-Counter Use: No

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Anna R. Kline

(Division Sign-Off) Consion of Cardiovascular Devices

S (U(K) Number K080708

KOBOZOR Indications forlise do Delphi Consulting Group Houston, TX 77071

Section 4 510(k) Submission Page

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.”