The Chase Blood Vessel Shunt is intended to be used to internally shunt blood vessels during anastomosis. The shunt bulbs allow a dry field to be maintained during a vessel anastomosis procedure. The shunt also allows blood to be delivered distally past the anastomosis during vessel repair. The blood vessel shunt is easily removed prior to the final sutures being tied. Select the blood vessel shunt which is appropriate for the internal diameter of the blood vessel.

Device Description

The Chase Blood Vessel Shunt is a stcrile, single use, disposable shunt composed of two silicone bulbs on the distal ends of a flexible silicone tubular shaft. A tab on a tether is attached to the mid-point of the flexible shaft forming a "T" configuration. The shunt is radiopaque.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Chase Blood Vessel Shunt:

Based on the provided documents, the Chase Blood Vessel Shunt was cleared via a 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive de novo clinical studies with predefined acceptance criteria. Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes, and ground truth establishment in a traditional clinical study context is not explicitly available or described in these documents.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Substantial Equivalence	Equivalence to a predicate device.	"Substantially equivalent to the Research Medical Inc. Intravascular Shunt."
Biocompatibility	Meet ISO standards for biocompatibility.	"All materials have successfully passed ISO standards for biocompatibility."
Sterilization	Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10^-6.	"Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10^-6."
Functional Characteristics	Non-differentiable functional characteristics compared to predicate.	"All functional characteristics of the Chase Blood Vessel Shunt are non-differentiable as compared with the predicate."
Package Integrity	Pass burst test per ASTM F1140-88.	"Tyvek/Polymylar passed burst test per ASTM F1140-88."
Shipping & Distribution	Pass National Safe Transit Ass. vibration and drop tests.	"Per National Safe Transit Ass. vibration and drop tests."
Shelf Life	Two-year shelf life.	"Two year shelf life."
Radiopacity	Not explicitly stated as a criterion, but mentioned as a device feature.	"The shunt is radiopaque."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. The "study" described is a declaration of substantial equivalence, material testing, and functional comparison to a predicate, not a clinical trial with a defined test set of patients or cases.
Data Provenance: Not applicable in the context of a clinical test set. The data presented relates to engineering tests (biocompatibility, sterilization, packaging, shipping) and a qualitative comparison to a predicate device. Data provenance for these tests would typically be from in-house labs or certified testing facilities.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. There is no mention of a clinical test set requiring expert-established ground truth. The "ground truth" for functional equivalence was based on direct comparison to the predicate device and established engineering standards.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence and non-clinical performance data.

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

Standalone Performance Study: Not applicable. This device is a physical medical instrument, not a software algorithm, so the concept of "standalone performance" in that context is not relevant. The closest equivalent is the "functional testing" which states all characteristics are "non-differentiable" from the predicate.

7. The Type of Ground Truth Used

Ground Truth Type: For this 510(k) submission, the "ground truth" is established through:
- Predicate Device Equivalence: The existence and performance of the legally marketed Research Medical Inc. Intravascular Shunt.
- Industry Standards: ISO standards for biocompatibility and ASTM standards for package integrity.
- Validated Methods: Ethylene Oxide sterilization validation and national shipping test protocols.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/algorithm device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Training Set Ground Truth Establishment: Not applicable.

Summary

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Kg72665

SUMMARY OF SAFETY AND EFFECTIVENESS

CHASE BLOOD VESSEL SHUNT

General Information I.

AUG 22 1997

. .

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

Indication for Use: 【 .

Device Description 【】【.

Class II device Device Classification: IV.
V. Safety and Effectiveness:

Substantial Equivalence: This device is substantially equivalent to the Research Medical Inc. Intravascular Shunt.

Other Safety and Effectiveness Data: VI.

Materials:	All materials have successfully passed ISO standards forbiocompatibiliy.
Sterilization:	Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL$10^{-6}$

Functional Testing

All functional characteristics of the Chase Blood Vessel Shunt are non-differentiable as compared with the predicate.

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SUMMARY OF SAFETY AND EFFECTIVENESS

Package Integrity:

Shipping & Distribution Testing:

Accelerated Aging:

Tyvek/Polymylar passed burst test per ASTM F1140-88

Per National Safe Transit Ass. vibration and drop tests

Two year shelf life

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

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

AUG 22 2 1997

K972665 Re: Blood Vessel Shunt Regulatory Class: II (two) Product Code: 74 DWF Dated: July 14, 1997 Received: July 16, 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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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. Callahan

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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510(k) Number (if known): × 97 2665

Device Name: CHASE MEDICAL INC. BLOOD VESSEL SHUNT

Indications For Use:

The Chase Blood Vessel Shunt is intended to be used to internally shunt blood vessels The Chase Blood Vesser Shunt is intended to be maintained during a vessel
during anastomosis. The shunt bulbs allow a dry field to days ready past the anastomosis procedure. The shunt also allows blood to be delivered distally past the anastomosis during vessel repair. The blood vessel shunt is easily removed prior to the anastomosis during vessel repair. The blood vessel shunt which is appropriate for the internal diameter of the blood vessel.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bera L. Lopes Co.

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

510(k) Number K972665

Prescription Use (Per 21 CFR 801.109) OR

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).