← Product Code [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF) · K964391

# CHASE LEFT VENT SAFETY VALVE (K964391)

_Chase Medical, Inc. · DWF · May 13, 1997 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K964391

## Device Facts

- **Applicant:** Chase Medical, Inc.
- **Product Code:** [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF.md)
- **Decision Date:** May 13, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4210
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Therapeutic

## Indications for Use

The Chase Left Vent Safety Valve is intended to be used during open heart surgery and placed in a vent line to permit flow only away from the heart, prevent buildup of line pressure, and limit line vacuum.

## Device Story

Three-function assembly for open heart surgery vent lines; includes check valve for unidirectional flow away from heart; downstream vent valve prevents drain line pressure buildup; inwardly directed umbrella valve limits vacuum intensity. Used in clinical setting by surgical staff. Device ensures safety by regulating pressure/vacuum during cardiac procedures.

## Clinical Evidence

Bench testing only. Leak testing performed at 10 psi air at 4°C and 40°C. Package integrity verified via burst test (ASTM F1140-88). Shipping and distribution testing conducted per National Safe Transit Association standards. Accelerated aging supports two-year shelf life.

## Technological Characteristics

Three-function assembly: check valve, vent valve, and umbrella valve. Materials identical to predicate. Sterilization: Ethylene Oxide (Overkill Method, SAL 10⁻⁶). Packaging: Tyvek/Polymylar.

## 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

- C.R. Bard overpressure safety valve ([K820297](/device/K820297.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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K964391
MAY 13 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

## CHASE LEFT VENT SAFETY VALVE

### I. General Information

A. Generic Name: Left Vent Safety Valve

B. Trade Name of Device: CHASE LEFT VENT SAFETY VALVE

C. Applicant’s Name and Address: CHASE MEDICAL INC., Richardson, TX

D. Pre-market Notification Number: Not assigned

### II. Indication for Use:

The Chase Left Vent Safety Valve is intended to be used during open heart surgery and placed in a vent line to permit flow only away from the heart, prevent buildup of line pressure, and limit line vacuum.

### III. Device Description

The Left Vent Safety Valve is a three function assembly that is positioned in the vent line and includes a check valve which permits flow only away from the heart. A second vent valve is located downstream of the check valve to prevent buildup of drain line pressure. A third inwardly directed umbrella valve limits line vacuum intensity.

### IV. Device Classification:

Class II device

### V. Safety and Effectiveness:

Substantial Equivalence: This device is substantially equivalent to the C.R. Bard overpressure safety valve, (K820297).

### 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 Left Vent Safety Valve 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

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/K964391](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K964391)

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