CHASE LEFT VENT SAFETY VALVE

K964391 · Chase Medical, Inc. · DWF · May 13, 1997 · Cardiovascular

Device Facts

• Record ID: K964391
• Device Name: CHASE LEFT VENT SAFETY VALVE
• Applicant: Chase Medical, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: May 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Indications for Use

Indicated for use during open heart surgery to manage vent line flow, pressure, and vacuum.

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

• C.R. Bard overpressure safety valve (K820297)

Submission Summary (Full Text)

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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