The Gish Tubing and Connectors with HA 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) liters per minute for periods up to six (6) hours

Device Description

The Gish Tubing and Connectors with HA Coating are used in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass cırcuit - 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", Luer and reducer types. The components of this system which have contact with the fluid path are sterle and nonpyroqenic. All materials of the Gish Tubing and Connectors are biocompatible and coated with a proprietary coating. The Gish Tubing and Connectors with HA Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

AI/ML Overview

The provided text describes the Gish Tubing and Connectors with HA Coating, a medical device used in cardiopulmonary bypass procedures. However, the text explicitly states that "The Gish Tubing and Connectors 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." It further concludes that "The conclusion drawn from these tests is that Gish Tubing and Connectors with HA Coating is equivalent in safety and efficacy to its predicated devices."

Despite these statements, the document does not provide any specific acceptance criteria or detailed results of the studies conducted to demonstrate that the device meets those criteria. It mentions "extensive safety, performance, and validations" and "various performance tests" but does not enumerate the criteria, the reported device performance against them, or the methodology of these tests.

Therefore, I cannot fully complete the requested table and answer the study-related questions based solely on the provided text.

Here's an attempt to answer based on the available information, with specific notes about what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document	Not specified in the document (The document only states that the device "meets all of its functional requirements and performance specifications" and is "equivalent in safety and efficacy to its predicated devices".)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only generally refers to "extensive safety, performance, and validations prior to release."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The device is a physical tubing and connector system, and "ground truth" would likely refer to objective performance metrics (e.g., burst pressure, flow rate, biocompatibility) rather than expert interpretation of images or data.

4. Adjudication method for the test set

Not applicable/Not specified. Given the nature of the device (physical components), an adjudication method as typically used for expert consensus on diagnostic interpretations is unlikely. Performance tests would likely involve objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is involved. This device is a cardiopulmonary bypass tubing and connector system, not an AI or diagnostic tool.

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

No, this is not applicable for this device. This term is relevant for AI algorithms. The Gish Tubing and Connectors with HA Coating is a physical medical device. The "standalone" performance would refer to the device's inherent physical and functional properties, which the text states were "subjected to extensive safety, performance, and validations."

7. The type of ground truth used

Implicitly, the ground truth would be objective performance specifications and safety standards. For example, tests would likely establish metrics such as:
- Biocompatibility (e.g., according to ISO standards)
- Flow rates (specified as 1 to 6 liters per minute)
- Pressure resistance
- Tensile strength
- Leak integrity
- Sterility
- Non-pyrogenicity
- Durability for up to six hours of operation.
The document states "All materials of the Gish Tubing and Connectors are biocompatible and coated with a proprietary coating." This indicates biocompatibility testing was a factor.

8. The sample size for the training set

Not applicable/Not specified. This device is not an AI algorithm that requires a "training set." The development process would involve iterative design, testing, and validation of physical prototypes, not machine learning training.

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

Not applicable. (See answer to #8).

Summary of what the document does state regarding studies:

"The Gish Tubing and Connectors 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."
"A review of literature pertaining to the safety and effectiveness has been conducted."
"The conclusion drawn from these tests is that Gish Tubing and Connectors with HA Coating is equivalent in safety and efficacy to its predicated devices."

The document focuses on declaring equivalence to predicate devices and adherence to internal specifications rather than detailing the specific acceptance criteria and study results.

Summary

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Kort/881

510(k) (Tradıtıonal) Submıssıon Section 5, 510(k) Summary

JAN 2 3 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,CA 92688-2600
Telephone	949-635-6200 voice949-635-6299 faxedw@gishbiomedical.com
Contact	Edward F WaddellDirector RA/QA

2 Device

Proprietary Name	Gish Tubing and Connectors with HA Coating
Common Name	Cardiopulmonary Bypass Tubing and Connectors
Classification Name	Catheter, Cannula or Tubing, VascularCardiopulmonary BypassAdaptor, Stopcock, Manifold, or Fitting,Cardiopulmonary Bypass

3 Predicate Devices

Gısh Tubıng and Connectors Both manufactured by Gısh Bıomedical, Inc

র্ব Classifications Names & Citations

21 CFR 870 4210, Catheter, Cannula or Tubıng, Vascular Cardiopulmonary Bypass, Class II, DWF, Cardiovascular

21 CFR 870 4290, Adaptor, Stopcock, Manifold, or Fitting, Cardiopulmonary Bypass, Class II, DTL, Cardiovascular

5 Description

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The components of this system which have contact with the fluid path are sterle and nonpyroqenic

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

The Gish Tubing and Connectors 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 Tubing and Connectors with HA Coating are indicated for use in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass cırcuit it is designed to operate at flow rates of one (1 0) to six (6) liters per minute for periods up to six (6) hours

7 Contra-Indications '

For HA coated tubing and connectors, no contra-indications have been noted

8 Comparıson

The Gish Tubing and Connectors with HA Coating have the same device characteristics as the predicate devices

9 Test Data

The Gish Tubing and Connectors with HA Coating has been subjected to extensive safety, performance, and validations prior to release Final testing for the systems ıncludes vanous 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 Tubing and Connectors with HA Coating

11 Conclusions

The conclusion drawn from these tests is that Gish Tubing and Connectors with HA Coating is equivalent in safety and efficacy to its predicated devices

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2009

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

Re K081881

Gish Tubing and Connectors with HA Coating Regulation Number 21 CFR 870 4210 Regulation Name Cardiopulmonary Bypass Cannula or Tubing Regulatory Class Class II Product Code DWF 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 regure 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 etther 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 (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 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.

onna 2. Volmer

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_08) 88 |

Device Name Gish Tubing and Connectors 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
	OR
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)

uma R. Jones
(Driver Sig. OR)

(Division Simn-Off) Division of Cardiovascular Devices

510(k) Number_k08)&&

Indications forUse_K081881 doo Gish Blomadles Rancho Santa Marganta CA 92688

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).