CHASE MULTIPLE PERFUSION SET

K964200 · Chase Medical, Inc. · DWF · Apr 16, 1997 · Cardiovascular

Device Facts

• Record ID: K964200
• Device Name: CHASE MULTIPLE PERFUSION SET
• Applicant: Chase Medical, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Apr 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Chase Medical multiple perfusion sets are intended for use in conjunction with cardiopulmonary bypass surgery for simultaneous perfusion of the aortic root and 3 or 4 vein grafts.

Device Story

Device used during open-heart surgery; facilitates simultaneous delivery of cardioplegia solution to aortic root and 3 or 4 vein grafts. Surgeon connects set to perfusion equipment; cardioplegia solution infused to stop and preserve heart. Device ensures bloodless, still surgical field. Benefits patient by enabling precise, simultaneous myocardial protection during bypass.

Clinical Evidence

Bench testing only. Testing included leak testing at 10 psi (4°C and 40°C), tubing bond strength (>10 lb tensile), luer connection compliance (ANSI/HIMA MD70.1-1983), package integrity (ASTM F1140-88), and shipping/vibration/drop testing. Two-year shelf life validated via accelerated aging.

Technological Characteristics

Materials identical to predicate. Luer connections compliant with ANSI/HIMA MD70.1-1983. Packaging tested per ASTM F1140-88. Sterilization via 100% Ethylene Oxide (Overkill Method, SAL 10⁻⁶).

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring simultaneous cardioplegia delivery to the aortic root and 3 or 4 vein grafts.

Regulatory Classification

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.

Predicate Devices

• DLP, Inc. Multiple Perfusion Set (K791498)

Submission Summary (Full Text)

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K964000
APR 16 1997
510K Summary

# Chase Medical Multiple Perfusion Set

## I. General Information

A. Generic Name: Multiple Perfusion Set
B. Trade Name of Device: Chase Multiple Perfusion Set
C. Applicant's Name and Address: Chase Medical Inc. 1876 Firman Drive. Richardson, Texas 75081
D. Pre-market Notification Number: Not yet assigned

## II. Indications for Use

Chase Medical multiple perfusion sets are intended for use in conjunction with cardiopulmonary bypass surgery for simultaneous perfusion of the aortic root and 3 or 4 vein grafts.

## III. Device Description

During open-heart surgery, the patient’s heart is temporarily stopped to allow the surgeon a bloodless, still surface in order to complete the surgical repair. The process of stopping the heart is often achieved by infusing into the heart a solution containing various drugs which act to stop and preserve the heart. This cardioplegia solution is delivered into the heart by way of the aorta and/or into vein grafts. The multiple perfusion set allows the simultaneous perfusion of cardioplegia into the aortic root and vein grafts.

## IV. Device Classification: Class II

## V. Safety and Effectiveness

Substantial Equivalence: The device is substantially equivalent to the DLP, Inc. Multiple Perfusion Set # K791498.

## VI. Other Safety and Effectiveness Data

Materials: All material are identical to the predicate device.
Sterilization: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶

## Functional Testing

All functional characteristics of the Chase Medical multiple perfusion set 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

| Leak Test Requirements: | No leaks at 10 psi air on Chase device at 4°C and 40°C |
| --- | --- |
| Tubing Bond Strength: | Exceeds 10 lb. tensile strength @ 4°C and 40°C |
| Luer Connections: | Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Tape Fittings |
| Package Integrity: | Tyvek/Polymylar passed burst test per ASTM F1140-88 |
| Shipping & Distribution Testing: | Per National Safe Transit Ass. vibration and drop tests |
| Accelerated Aging: | Two year shelf life |