The provided documentation does not contain information about acceptance criteria and a study proving the device meets those criteria, as it is a 510(k) submission for a non-AI/ML medical device (a vessel cannula). The device's safety and effectiveness are established through substantial equivalence to a predicate device, not through performance metrics or clinical trials in the way an AI/ML device would be.

Therefore, most of the requested fields are not applicable to this submission.

Here's a breakdown of the available information:

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

Acceptance Criteria	Reported Device Performance
Substantial Equivalence	Substantially equivalent to the Cobe Labs Vessel Cannula (K760624)
Materials	All materials identical to the predicate device.
Sterilization	Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶
Functional Testing	Non-differentiable from the predicate device due to exact same fit, form, and material composition.
Package Integrity	Tyvek/Polymylar passed burst test per ASTM F1140-88
Shipping & Distribution	Passed National Safe Transit Ass. vibration and drop tests
Accelerated Aging	Two-year shelf life

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable as this is a physical medical device, not an AI/ML system. There is no "test set" in the context of data for an algorithm.

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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device's safety and effectiveness relies on its physical and functional equivalence to a legally marketed predicate device, and the results of standard engineering and materials testing (e.g., sterilization validation, burst tests).

8. The sample size for the training set:
Not applicable.

9. How the ground truth for the training set was established:
Not applicable.

Summary

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K971019

SUMMARY OF SAFETY AND EFFECTIVENESS

CHASE VESSEL CANNULA

JUL 21 1997

l. General Information

A. Generic Name:	Vessel Cannula
B. Trade Name of Device:	Chase Vessel Cannula
C. Applicant's Name and Address:	CHASE MEDICAL, INC., Richardson, TX
D. Pre-market Notification Number:	Not assigned

Indication for Use: II.

The Vessel Cannula is indicated for use during open-heart surgery to perfuse fluid into vein grafts.

III. Device Description:
The Vessel Cannula has stepped barbs at its tip and female luer fitting.
Class I device IV. Device Classification:
V. Safety and Effectiveness:

Substantial Equivalence: This device is substantially equivalent to the Cobe Labs Vessel Cannula (K760624).

VI. Other Safety and Effectiveness Data:
All material are identical to the predicate device. Materials: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10° Sterilization:

Functional Testing

All functional characteristics of the Chase Vessel Cannula are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.

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SUMMARY OF SAFETY AND EFFECTIVENESS

Package Integrity:

Tyvek/Polymylar passed burst test per ASTM FI 140-88

Per National Safe Transit Ass. vibration and

Shipping & Distribution Testing:

. .

Accelerated Aging:

Two year shelf life

drop tests

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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 its wings spread, symbolizing protection and care. 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 20856

Mr. Bert Davis President Chase Medical, Inc. 1876 Firman Drive Richardson, Texas 75081 - -

JUL 2 | 1997

K971019 Re : Chase Vessel Cannula Requlatory Class: II (Two) Product Code: 74 DWF Dated: June 30, 1997 Received: June 30, 1997

Dear Mr. Davis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Requiation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Bert Davis

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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870. 4210 - DWF II - CPB Vascular Catheter, Cannula,		or Tubing
------------------------------------------------------	--	-----------

510 (k) Number (if known) :	K971019
Page	of
Device Name:
Indications For Use:

CHASE MEDICAL, INC.

VESSEL CANNULA

Intended Use:

The Vessel Cannula is indicated for use during open-heart surgery to perfuse fluid into vein grafts.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bess R. Lamperle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_ 8971019

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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).