The Gish CAPVRF44 Hardshell Venous Reservoirs are indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six hours (6.0) hours. The Gish CAPVRF44 Hardshell Venous Reservoirs are also indicated for the collection and autotransfusion of the same patient's postoperative shed blood with the addition of the Postoperative Conversion Pack with water seal/manometer.

Device Description

The Gish CAPVRF44 Hardshell Venous Reservoirs with hyaluronan based coating (HA Coating) are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The Gish CAPVRF44 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the ½" venous inlet where it is directed to the bottom of the device and passes through a 160 micron screen filter. Intrathoracic suctioned blood enters the top section of the defoamer/filter cartridge and passes through a defoamer sponge and 20 micron depth filter. The maximum venous flow rate is 8 lpm. The maximum cardiotomy flow rate is 4 lpm.

AI/ML Overview

This document describes a 510(k) submission for the Gish CAPVRF44 Hardshell Venous Reservoir with HA Coating, a medical device used during cardiopulmonary bypass surgery. It is a traditional 510(k) submission, indicating that the device demonstrates substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in a dedicated table format with corresponding performance metrics. Instead, it relies on the concept of "functional requirements and performance specifications" and "applicable industry and safety standards," along with comparison to predicate devices, to establish safety and effectiveness.

However, based on the description, we can infer some performance aspects:

Acceptance Criteria (Inferred from description and intended use)	Reported Device Performance
Functional Requirements/Performance Specifications:
Blood Collection & Storage	Designed for collection, storage, and filtration of blood during cardiopulmonary bypass.
Filtration of intrathoracic suctioned blood	Passes through a defoamer sponge and 20 micron depth filter.
Defoaming of intrathoracic suctioned blood	Passes through a defoamer sponge.
Maximum venous flow rate capability	8 lpm (liters per minute)
Maximum cardiotomy flow rate capability	4 lpm (liters per minute)
Duration of use during cardiopulmonary bypass	Up to six hours (6.0) hours
Compatibility with Postoperative Conversion Pack	Indicated for use with the addition of the Postoperative Conversion Pack for autotransfusion.
Safety Tests:
Biocompatibility (implied HA coating)	Extensive safety, performance, and validations performed. No contra-indications noted for HA coated reservoirs.
Sterility	Sterile
Non-pyrogenic	Non-pyrogenic
Compliance with industry and safety standards	Complies with applicable industry and safety standards.
Substantial Equivalence to Predicate Devices:
Same intended use	Yes
Similar technological characteristics	Yes

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly states that "extensive safety, performance, and validations" were conducted.

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

This type of information is not applicable to this device. This is a medical device (a blood reservoir), not a diagnostic or AI-powered device that requires expert interpretation to establish ground truth for a test set. The validation would have involved engineering tests, material compatibility tests, and performance demonstrations against specifications.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a human-in-the-loop diagnostic or interpretive component requiring adjudication.

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. The device is a physical blood reservoir, and an MRMC study related to AI assistance for human readers is not relevant to its evaluation.

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

This information is not applicable. The device does not involve an algorithm or AI component.

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

The concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. The "ground truth" for this device would be established by:

Engineering specifications and test methods: Verifying that the device meets defined physical dimensions, material properties, flow rates, filtration efficiency, and other operational parameters.
Biocompatibility testing: Demonstrating that the materials are safe for contact with blood, often using established standards and lab tests.
Sterility and pyrogenicity testing: Ensuring the device is sterile and non-pyrogenic according to recognized standards.
Comparison to predicate devices: Demonstrating that the new device performs equivalently or better than previously cleared devices for its intended use.

8. The sample size for the training set

This information is not applicable. The device does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable. The device does not involve a "training set" or corresponding ground truth establishment in the context of machine learning or AI.

Summary

{0}------------------------------------------------

FEB - 4 2009

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

Summary

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

Company making the submission:

Name:	Gish BioMedical, Inc.
Address:	22942 Arroyo VistaRancho Santa Margarita, CA 92688-2600
Telephone:	949-635-6200 voice949-635-6299 faxmartins@gishbiomedical.com
Contact:	Martin SellersSr. Director of Operations and RA

2. Device:

Proprietary Name:	Gish CAPVRF44 Hardshell Venous Reservoir withHA Coating
Common Name:	Cardiopulmonary Blood Reservoir
Classification Name:	Extracorporeal circuit blood defoamerCardiopulmonary bypass blood reservoir

3. Predicate Devices:

Gish CAPVRF45 Hardshell Venous Reservoir, K964973 and Gish CAPVRF44 Hardshell Venous Reservoir with GBS™ Coating, K030726. Both manufactured by Gish Biomedical, Inc.

4. Classifications Names & Citations:

21 CFR 870.4230, 21 CFR 870.4400, Extracorporeal circuit blood defoamer, Cardiopulmonary bypass blood reservoir, Cardiopulmonary Bypass, Class II, DTN, Cardiovascular.

5. Description:

{1}------------------------------------------------

sponge and 20 micron depth filter. The maximum venous flow rate is 8 lom. The maximum cardiotomy flow rate is 4 lpm.

6. Indications for use:

7. Contra-indications:

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

8. Comparison:

The Gish CAPVRF44 Hardshell Venous Reservoirs with HA Coating has the same device characteristics as the predicate devices.

9. Test Data:

The Gish CAPVRF44 Hardshell Venous Reservoir 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 Gish CAPVRF44 Hardshell Venous Reservoirs with HA Coating.

11. Conclusions:

Based upon the testing and comparison to the predict device the Gish Biomedical, Inc., CAPVRF44 Hardshell Venous Reservoir with HA Coating has the same intended use, with similar technological characteristics. Gish Biomedical, Inc., therefore posits that its device is equivalent to predicate devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB ~ 4 2009

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

Re: K081947

Gish CAPVRF44 Hardshell Venous Reservoirs with HA Coating Regulation Number: 21 CFR 870,4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II Product Code: DTN 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.

{3}------------------------------------------------

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 yours,

Duna R. Vochner

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

Enclosure

{4}------------------------------------------------

510(k) Number K (1947

Device Name: Gish CAPVRF44 Hardshell Venous Reservoirs with HA Coating

Indications for use:

The Gish CAPVRF44 Hardshell Venous Reservoirs are indicated for use during cardiopyimonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six hours (6.0) hours. The Gish CAPVRF44 Hardshell Venous Reservoirs are also indicated for the collection and autotransfusion of the same patients are also including and allood with the addition of the Postoperative Conversion Pack with water seal/manometer.

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)

Munna D. Vachme
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number K081947

OS Indications for Use do Delphi Consulting Group Houston, TX 7707

Regulation Number and Section

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.