The Gish Tubing and Connectors with GBS™ Coating are indicated for use in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit. 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) hours.

Device Description

The Gish Tubing and Connectors with GBS™ Coating are used in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit. Specifically they are used in connecting oxygenators, reservoirs, filters, heat exchangers and other devices used in surgical procedures. The tubing is polyvinyl chloride (PVC). The connectors are polycarbonate of various configurations such as straight, "Y", Leur and reducer types.

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

All materials of the Gish Tubing and Connectors are biocompatible and coated with a proprietary coating.

The Gish Tubing and Connectors with GBS™ Coating may be purchased separately or preconnected with tubing and other components of an extracorporeal circuit

AI/ML Overview

This looks like a 510(k) submission for a medical device called "Gish Tubing and Connectors with GBS™ Coating." The document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a dedicated study to prove direct performance against those criteria.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set) are not applicable or cannot be extracted from the provided text.

Here is an attempt to answer the questions based only on the provided text, noting where information is not available:

A table of acceptance criteria and the reported device performance

The document does not provide a table of explicit, quantitative performance acceptance criteria (e.g., specific thresholds for tensile strength, flow rate consistency, or biocompatibility metrics) nor does it report detailed quantitative performance against such criteria. The "performance" described is in the context of general safety and functional requirements.

Acceptance Criteria Description (Implicit)	Reported Device Performance (Summary)
Safety and Effectiveness	Subjected to extensive safety, performance, and validations.
Functional Requirements	Meets all its functional requirements.
Performance Specifications	Meets performance specifications.
Biocompatibility	All materials are biocompatible and coated with a proprietary coating.
Sterility & Non-pyrogenic	Components in contact with fluid path are sterile and nonpyrogenic.
Flow Rate Capability	Designed to operate at flow rates of 1.0 to 6.0 liters/minute.
Duration of Use	Designed for periods up to six (6) hours.
Equivalence to Predicate Device	Equivalent in safety and efficacy to its predicate devices.

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

Not explicitly stated. The document mentions "various performance tests" and "final testing for the systems" but does not give specific sample sizes or details about data provenance.
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. This device is a cardiopulmonary bypass component, not an interpretive diagnostic device that would typically rely on expert-established ground truth in this manner for a 510(k) submission. Performance is assessed through engineering, biocompatibility, and functional testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept typically relates to consensus building among human readers for diagnostic studies, which is not the methodology described for this hardware device.
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 study focuses on a medical device (tubing and connectors) for extracorporeal blood flow, not an AI or diagnostic imaging system that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device. The device's performance is inherently "standalone" in its primary function as a physical conduit. The "performance" refers to its physical and material properties and its function in the bypass circuit.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly detailed, but based on the nature of the device (cardiopulmonary bypass tubing), the "ground truth" for performance would be established through a combination of:
- Engineering specifications and standards: Adherence to defined physical and mechanical properties (e.g., burst pressure, flow resistance, tensile strength).
- Biocompatibility testing: In vitro and in vivo studies to ensure material safety and compatibility with blood and tissues.
- Functional testing: Simulation of intended use conditions (e.g., flow rate, duration).
- Sterility and pyrogenicity testing: Adherence to standards for sterile medical devices.
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. This is not a machine learning or AI device that requires a training set.

Summary

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Summary

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

Company making the submission: 1.

MAR 1 4 2003

	Company	Correspondent (contract):
Name:	Gish BioMedical, Inc.	Delphi Consulting Group
Address:	22942 Arroyo Vista	11874 South Evelyn Circle
	Rancho Santa MargaritaCA 92688-2600	Houston, TX 77071-3404
Telephone:	949-635-6240 voice949-635-6294 fax	713-723-4080 voice775-429-9524 fax
Contact:	Edward F. WaddellDirector RA/QA	harvey@delphiconsulting.comJ. Harvey KnaussConsultant

2. Device:

Proprietary Name:	Gish Tubing and Connectors with GBS™ Coating
Common Name:	Cardiopulmonary Bypass Tubing and Connectors
Classification Name:	Catheter, Cannula or Tubing, Vascular CardiopulmonaryBypassAdaptor, Stopcock, Manifold, or Fitting, CardiopulmonaryBypass

Predicate Devices: 3.
Gish Tubing and Connectors, Gish Biomedical, Inc.
Classifications Names & Citations: ধ:
21 CFR 870.4210, Catheter, Cannula or Tubing, Vascular Cardiopulmonary Bypass, Class II, DWF, Cardiovascular.

21 CFR 870.4290, Adaptor, Stopcock, Manifold, or Fitting, Cardiopulmonary Bypass, Class II, DTL, Cardiovascular.

1. Description:
  The Gish Tubing and Connectors with GBS™ Coating are used in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit. Specifically they are used in connecting oxygenators, reservoirs, filters, heat exchangers and other devices used in surgical procedures. The tubing is polyvinyl chloride (PVC). The connectors are polycarbonate of various configurations such as straight, "Y", Leur and reducer types.

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

All materials of the Gish Tubing and Connectors are biocompatible and coated with a proprietary coating.

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The Gish Tubing and Connectors with GBS™ Coating may be purchased separately or preconnected with tubing and other components of an extracorporeal circuit

1. Indications for use:
  The Gish Tubing and Connectors with GBS™ Coating are indicated for use in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit. 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) hours.
1. Contraindications:
  For heparin coated devices, 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.
1. Comparison:
  The Gish Tubing and Connectors with GBS™ Coating have the same device characteristics as the predicate devices.
ഗ് Test Data:
The Gish Tubing and Connectors 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 Tubing and Connectors with GBS™ Coating.
1. Conclusions:
  The conclusion drawn from these tests is that Gish Tubing and Connectors with GBS™ Coating is equivalent in safety and efficacy to its predicated devices.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2003

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

Re: K030077

Tubing and Connectors with GBS Coating. Regulation Number: 21 CFR 870.4290, 870.4210 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Cardiopulmonary Bypass Vascular Catheter, Cannula and Tubing Regulatory Class: Class II (two) Product Code: DTL, DWF Dated: January 6, 2003 Received: January 8, 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/cdrb/dsma/dsmamain.html

Sincerely yours,

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

Enclosure

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510(k) Number K030077

Device Name: Gish Tubing and Connectors with GBS™ Coating.

Indications for use:

The Gish Tubing and Connectors with GBS™ Coating are indicated for use in Surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit. 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) hours.

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

Over-The-Counter Use

(Division Sign-Off
Division or Caldruve

510(k) Number. K030072

(Per 21 CFR 801.109)

Section 4 Page 2

Regulation Number and Section

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.