CHASE VESSEL OCCLUDER

K964390 · Chase Medical, Inc. · MJN · Jan 31, 1997 · Cardiovascular

Device Facts

• Record ID: K964390
• Device Name: CHASE VESSEL OCCLUDER
• Applicant: Chase Medical, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Jan 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vessel Occluder is intended to be used to internally occlude blood vessels during anastomosis.

Device Story

Device consists of two silicone rubber bulbs on distal ends of flexible shaft; tab on tether attached to shaft midpoint forms 'T' configuration. Used in coronary artery bypass procedures; inserted proximally and distally through vessel opening to occlude blood flow. Enables dry field maintenance during graft anastomosis. Operated by surgeons in OR. Benefits patient by facilitating precise surgical anastomosis through bloodless field.

Clinical Evidence

Bench testing only. Includes bond strength testing (>0.4 lb tensile strength at 4°C and 40°C), package integrity (ASTM F1140-88 burst test), shipping/distribution vibration and drop tests, and accelerated aging (5-year shelf life).

Technological Characteristics

Materials: Silicone rubber. Dimensions: Flexible shaft with dual distal bulbs. Sterilization: Ethylene Oxide (Overkill Method, SAL 10⁻⁶). Packaging: Tyvek/Polymylar.

Indications for Use

Indicated for internal occlusion of blood vessels during coronary artery bypass procedures to create a bloodless field at the anastomosis site.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Bio-Vascular 'Flo-Rester' vessel occluder (K883696)

Submission Summary (Full Text)

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JAN 31 1997
K964390

# SUMMARY OF SAFETY AND EFFECTIVENESS

## CHASE VESSEL OCCLUDER

### I. General Information

A. Generic Name: Vessel Occluder
B. Trade Name of Device: CHASE VESSEL OCCLUDER
C. Applicant’s Name and Address: CHASE MEDICAL INC., Richardson, TX
D. Pre-market Notification Number: Not assigned

### II. Indication for Use:

The Vessel Occluder is intended to be used to internally occlude blood vessels during anastomosis.

### III. Device Description

The Vessel Occluder is composed of two silicone rubber bulbs on the distal ends of a flexible shaft. A tab on a tether is attached to the midpoint of the flexible shaft forming a “T” configuration. Vessel Occluders are useful in coronary artery bypass procedures to create a bloodless field at the anastomosis. The occluder bulbs are inserted proximally and distally through the vessel opening. The occluder bulbs allow a dry field to be maintained during the anastomosis of bypass graft.

### IV. Device Classification: Class II device

### V. Safety and Effectiveness:

Substantial Equivalence: This device has been shown to be substantially equivalent to the Bio-Vascular “Flo-Rester” vessel occluder (K883696).

### 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 Vessel Occluder are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.

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FROM Chase Medical 2142353446
01-30-97 11:12AM TO 13014804204
=16 P.2/2

# SUMMARY OF SAFETY AND EFFECTIVENESS

Bond Strength: Exceeds 0.4 lb tensile strength @ 4°C and 40°C

Package Integrity: Tyvek/Polymylar passed burst test per ASTM F1140-88

Shipping & Distribution Testing: Per National Safe Transit Assoc. Vibration and drop tests

Accelerated Aging: Five year shelf life