The Gish Soft Venous Reservoir with HA Coating is indicated for use collecting systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six (6.0) hours.

Device Description

The Gish Soft Venous Reservoirs with HA Coating consist of a bag with three fluid ports and two aspiration ports and are intended to prevent venous air from entering the extracorporeal circuit. The design of the Soft Venous Reservoir reduces blood stagnation and will collapse if emptied; a built in safety mechanism that minimizes accidental air delivery to the oxygenator. Each Soft Venous Reservoir contains one ½" venous inlet (blue) with integral temperature port and luer port, one 3/8" cardiotomy inlet (white), one 3/8" arterial outlet (red) and two 1/8" aspiration ports with attached 3-way stopcocks. The components of this system which have contact with the fluid path are sterile and non-pyrogenic. All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating. The Gish the Soft Venous Reservoirs with HA Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Gish Soft Venous Reservoir (SVR) with HA Coating, based on the provided 510(k) summary:

The provided document is a 510(k) summary for a medical device (Gish Soft Venous Reservoir with HA Coating). These types of submissions primarily demonstrate substantial equivalence to a legally marketed predicate device rather than presenting detailed "acceptance criteria" and "study results" in the way one might expect for a novel AI/software product or a clinical trial. Instead, the "acceptance criteria" are implied by the performance of the predicate devices and the "study" is a series of engineering and performance tests to ensure the new device functions similarly and safely.

Therefore, I will interpret your request within the context of a 510(k) submission for a physical medical device.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Requirements: - Capable of collecting systemic venous and cardiotomy return blood. - Designed to operate at flow rates of 1.0 to 8.0 liters per minute. - Designed to operate for periods up to 6.0 hours. - Prevents venous air from entering the extracorporeal circuit. - Reduces blood stagnation. - Collapses if emptied (safety mechanism).	Device is indicated for collecting systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. Designed to operate at flow rates of 1.0 to 8.0 liters per minute. Designed to operate for periods up to 6.0 hours. Intended to prevent venous air from entering the extracorporeal circuit. Design reduces blood stagnation. Will collapse if emptied; a built-in safety mechanism that minimizes accidental air delivery to the oxygenator.
Material Biocompatibility: - All materials contacting fluid path must be biocompatible.	All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating.
Sterility & Non-pyrogenicity: - Components in fluid path must be sterile and non-pyrogenic.	The components of this system which have contact with the fluid path are sterile and non-pyrogenic.
Safety and Effectiveness: - Equivalent in safety and effectiveness to predicate devices.	The device has been subjected to extensive safety, performance, and validations. Concluded to have the same intended use and similar technological characteristics as predicate devices, thus equivalent in safety and effectiveness.

Study Information

Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a "test set" in the context of clinical data or patient outcomes. The "test set" here refers to the actual physical devices (Gish SVR with HA Coating) that underwent "various performance tests" and "validations". The number of devices tested is not explicitly stated.
- Data Provenance: The testing was conducted by Gish Biomedical, Inc. This is internal company testing, likely done in a laboratory or simulated environment, rather than involving human clinical data from a specific country or being retrospective/prospective in a clinical study sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable in this 510(k) submission. "Ground truth" established by experts is typically relevant for diagnostic devices or AI algorithms where interpretation is involved. For a physical blood reservoir, engineering specifications and established test methodologies serve as the "ground truth" or benchmarks. Product specifications and performance standards are typically set by internal R&D, engineering, and regulatory teams, often informed by industry standards and regulatory guidance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical trials or studies to resolve discrepancies in expert interpretation, particularly in diagnostic contexts. For physical device performance testing, results are typically objective measurements against predefined specifications; there is no "adjudication" between expert opinions on the performance data itself.
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 is a physical medical device (blood reservoir) and not an AI or imaging diagnostic device. Therefore, an MRMC study is completely irrelevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical blood reservoir, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth," while not referred to as such, is based on engineering specifications, performance standards, and comparison to the predicate devices' established safety and effectiveness. The device's ability to meet its functional requirements (flow rates, volume, air prevention, etc.) and demonstrate biocompatibility and sterility are the "truths" being validated.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set."
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

Summary

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

FEB - 4 2009 Summary

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:

Name:	Gish Biomedical, Inc.
Address:	22942 Arroyo VistaRancho Santa Margarita, CA92688-2600	FDA CDRH DMCJUL 2 3 2008Received
Telephone:	949-635-6200 voice949-635-6291 faxmartins@gishbiomedical.com
Contact:	Martin SellersDirector of Regulatory Affairs

2. Device:

Proprietary Name:	Soft Venous Reservoir (SVRXX) with HA Coating
Common Name:	Soft Venous Reservoir
Classification Name:	Reservoir, Blood, Cardiopulmonary Bypass

3. Predicate Devices:

Gish Soft Venous Reservoir, K955046 and Gish SVR Soft Venous Reservoir with GBS™ Coating, K024065. Both manufactured by Gish Biomedical, Inc.

4. Classifications Names & Citations:

21 CFR 870.4400, Reservoir, Blood, Cardiopulmonary Bypass, Class II, DTN, Cardiovascular.

5. Description:

The components of this system which have contact with the fluid path are sterile and non-pyrogenic.

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All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating.

The Gish the Soft Venous Reservoirs with HA Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

6. Indications for use:

The Gish Soft Venous Reservoirs with HA Coating are indicated to collect systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six (6.0) hours.

7. Contra-indications:

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

8. Comparison:

The Gish SVR Soft Venous Reservoir with HA Coating has the same device characteristics as the predicate devices.

9. Test Data:

The Gish SVR Soft Venous Reservoirs with HA Coating have 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.

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 SVR Soft Venous Reservoirs with HA Coating.

11. Conclusions:

Based upon the testing and comparison to the predict device the Gish Biomedical, Inc., Soft Venous Reservoir 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

FEB-- 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K082082

Gish Soft Venous Reservoir (SVR) 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.

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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 yours,

Dana R. Buchner

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 (){ 20} 2

Device Name: Gish Soft Venous Reservoir (SVR) 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

R. La Ines

Division Sign-Off) (Division Sign-on)
Division of Cardiovascular Devices

510(k) Number K082082

ndications forUse K082082.doc alphi Consulting Group Houston, TX 77071

Section 4 510(k) Submission Page

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.