CHASE TWO STAGE VENOUS RETURN CATHETER

K964195 · Chase Medical, Inc. · DWF · Mar 19, 1997 · Cardiovascular

Device Facts

• Record ID: K964195
• Device Name: CHASE TWO STAGE VENOUS RETURN CATHETER
• Applicant: Chase Medical, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Mar 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CHASE Two Stage Venous Return Catheter is indicated for single tube venous drainage from the right atrium and vena cava during extracorporeal circulation for open heart surgery.

Device Story

Two-stage venous return catheter; facilitates venous drainage during extracorporeal circulation for open heart surgery. Device consists of 27.9 cm 51 French flexible tubing, molded rigid reducer with six openings for atrial drainage, and 7.6 cm 36 French flexible tubing with rigid tip containing six openings for vena cava drainage. Includes obturator to minimize blood loss during insertion. Used by surgeons in clinical settings. Provides drainage path for blood during cardiopulmonary bypass.

Clinical Evidence

Bench testing only. Testing included leak testing (no leaks at 10 psi at 4°C and 40°C), tubing bond strength (>10 lb tensile strength at 4°C and 40°C), package integrity (ASTM F1140-88), shipping/distribution testing (National Safe Transit Association standards), and accelerated aging (two-year shelf life).

Technological Characteristics

Flexible plastic tubing (51 French and 36 French); rigid plastic reducer and tip. Materials identical to predicate. Sterilization: 100% Ethylene Oxide (Overkill Method, SAL 10^-6). Packaging: Tyvek/Polymylar.

Indications for Use

Indicated for patients undergoing open heart surgery requiring extracorporeal circulation; facilitates single tube venous drainage from the right atrium and vena cava.

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

• Sarns two stage venous return catheter (K770431)

Submission Summary (Full Text)

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K964195
MAR 19 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

## CHASE TWO STAGE VENOUS RETURN CATHETER

### I. General Information

A. Generic Name: Two Stage Venous Return Catheter
B. Trade Name of Device: CHASE TWO STAGE VENOUS RETURN CATHETER
C. Applicant’s Name and Address: CHASE MEDICAL INC., Richardson, TX
D. Pre-market Notification Number: Not assigned

### II. Indication for Use:

The CHASE Two Stage Venous Return Catheter is indicated for single tube venous drainage from the right atrium and vena cava during extracorporeal circulation for open heart surgery.

### III. Device Description

The CHASE Two Stage Venous Return Catheter consists of a 27.9 cm (11”) length of 51 French flexible plastic tubing attached to a molded, rigid plastic reducer. The reducer has six openings which permit drainage from the right atrium. The reducer is attached to a 7.6 cm (3”) length of 36 French flexible plastic tubing, which has a rigid plastic tip. The tip has six openings which allow drainage from the vena cava. The tubing is marked approximately 3 cm and 4.5 cm from the base of the reducer as a reference for determining tip and side hole location during catheter insertion. An obturator is installed in the catheter to minimize blood loss from the reducer during the insertion of the catheter into the right atrium and vena cava.

### IV. Device Classification:

Class II device

### V. Safety and Effectiveness:

Substantial Equivalence: This device is substantially equivalent to the Sarns two stage venous return catheter K770431.

### 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 Two Stage Venous Return Catheter 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 |
| 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 |