← Product Code [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF) · K964200

# CHASE MULTIPLE PERFUSION SET (K964200)

_Chase Medical, Inc. · DWF · Apr 16, 1997 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K964200

## Device Facts

- **Applicant:** Chase Medical, Inc.
- **Product Code:** [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF.md)
- **Decision Date:** Apr 16, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4210
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **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).

## Regulatory 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](/device/K791498.md))

## 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  |

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K964200](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K964200)

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