SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING by GISH BIOMEDICAL, INC.

The Gish Soft Venous Reservoirs with GBS™ 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 six (6.0) liters per minute for periods up to six (6.0) hours.

Device Description

The Gish Soft Venous Reservoirs with GBS™ 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 12" 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 nonpyrogenic.

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

The Gish the Soft Venous Reservoirs with GBS™ 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 submission for a medical device, the "Gish Soft Venous Reservoirs SVR with GBS™ Coating," claiming substantial equivalence to a predicate device. However, it does not include specific acceptance criteria, detailed study designs, or reported device performance metrics in a way that allows for the creation of the requested table or the detailed answers to all the questions. The submission focuses on describing the device, its indications for use, and a claim of equivalence based on general "safety, performance, and validations prior to release."

Here's an attempt to answer the questions based only on the provided text, highlighting what information is missing:

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

Acceptance Criteria	Reported Device Performance
Not Specified	Not Specified
(No specific quantitative or qualitative criteria for performance are mentioned in the document.)	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, the results of these tests and the specific specifications they met are not provided.

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. (The document mentions "extensive safety, performance, and validations prior to release," but provides no details on where or how these were conducted, or whether they were retrospective or prospective).

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)

Not applicable/Not specified. This device is a physical medical device (blood reservoir), not an AI/diagnostic software. The concept of "ground truth" as typically applied to diagnostic studies or AI algorithms does not directly apply here in the same way. The evaluation would be based on engineering specifications, biocompatibility tests, and functional performance, not expert-adjudicated diagnostic labels.

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

Not applicable/Not specified. (See explanation for question 3).

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 device is a blood reservoir, not an AI or diagnostic tool that would involve human readers or an MRMC study.

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

Not applicable. This device is a physical blood reservoir, not an algorithm.

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

Not applicable/Not specified. For a physical device like this, "ground truth" would relate to meeting engineering specifications, biocompatibility standards (e.g., ISO 10993), and functional performance parameters (e.g., flow rates, air removal efficiency, blood damage). The document states "extensive safety, performance, and validations" were done but does not detail the nature of these tests or how their "ground truth" (i.e., acceptable performance) was established beyond stating they meet "functional requirements and performance specifications."

8. The sample size for the training set

Not applicable. This device is a physical blood reservoir, not a machine learning model.

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

Not applicable. This device is a physical blood reservoir, not a machine learning model.

Summary of Findings:

The provided 510(k) summary is for a physical medical device (a blood reservoir) and focuses on demonstrating substantial equivalence to a predicate device. It references general "safety, performance, and validations" but does not provide the detailed scientific study data, specific acceptance criteria, or performance metrics that would be necessary to answer most of the questions, particularly those related to diagnostic performance or AI algorithms. The questions posed seem to be more tailored for a submission involving AI software or diagnostic tools, rather than a hardware device like the one described.

Summary

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

Summary

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

MAR 0 5 2003

1. Company making the submission:

	Company	Correspondent (contract):
Name:	Gish BioMedical, Inc.	Delphi Consulting Group
Address:	22942 Arroyo Vista	11874 South Evelyn Circle
	Rancho Santa Margarita	Houston, TX 77071-3404
	CA 92688-2600
Telephone:	949-635-6240 voice	832-285-9423 voice
	949-635-6294 fax	775-429-9524 fax
Contact:	Edward F. Waddell	harvey@delphiconsulting.com
	Director RA/QA	J. Harvey Knauss
		Consultant

2. Device:

Proprietary Name:	Soft Venous Reservoir SVR with GBS™ Coating
Common Name:	Soft Venous Reservoir
Classification Name:	Reservoir, Blood, Cardiopulmonary Bypass

1. Predicate Devices:
  Gish Soft Venous Reservoir, Gish Biomedical, Inc., K955046.
1. Classifications Names & Citations:
  21 CFR 870.4400, Reservoir, Blood, Cardiopulmonary Bypass, Class II, DTN, Cardiovascular.
1. Description:
  The Gish Soft Venous Reservoirs with GBS™ 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 12" 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 nonpyrogenic.

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

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

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

1. Indications for use:
  The Gish Soft Venous Reservoirs with GBS™ 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 six (6.0) liters per minute for periods up to six (6.0) hours.
1. Contraindications:
  For heparin coated devices, heparin has been reported, on rare occasions, to induce thrombocytopenia. Since patients undergoing cardiopulmonary bypass are routinely svstemically 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.
1. Comparison:
  The Soft Venous Reservoirs with GBS™ Coating have the same device characteristics as the predicate devices.
1. Test Data:
  The Gish Soft Venous Reservoirs with GBS™ 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.
1. 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 Soft Venous Reservoirs with GBS™ Coating.
1. Conclusions:
  The conclusion drawn from these tests is that Gish Soft Venous Reservoirs with GBS™ Coating is equivalent in safety and efficacy to its predicate device.

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

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 eagle with three stripes extending from its back, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 5 2003

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

Re: K024065

Gish Soft Venous Reservoirs SVR with GBSTM Coating. Regulation Number: 21 CFR 870.4400 Regulation Name: Reservoir, Blood, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTN Dated: February 6, 2003 Received: February 10, 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. Iisting 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 – 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 (OS) 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 yours,

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

Enclosure

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

024065 510(k) Number K_______________________________________________________________________________________________________________________________________________________________

Device Name: Gish Soft Venous Reservoirs SVR with GBS™ Coating

Indications for use:

Prescription Device: Yes

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	____________________
------------------	----------------------

Over-The-Counter Use	____________________
----------------------	----------------------

(Per 21 CFR 801.109)

(Division Sign-Off)

Division of Cardiovas510(k) Number K061265

(Optional Format 1-2-96)

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.