Who is the manufacturer of CHASE CURVED LEFT HEART VENT CATHETER?

Chase Medical, Inc. filed the 510(k) submission for CHASE CURVED LEFT HEART VENT CATHETER (K964194).

What is the FDA product code for CHASE CURVED LEFT HEART VENT CATHETER?

DWF. It is classified under 21 CFR 870.4210 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CHASE CURVED LEFT HEART VENT CATHETER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CHASE CURVED LEFT HEART VENT CATHETER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CHASE CURVED LEFT HEART VENT CATHETER

Q: What are the predicate devices for CHASE CURVED LEFT HEART VENT CATHETER?

Sarns Curved Left Heart Vent Catheter (K770430).

K964194 · Chase Medical, Inc. · DWF · Apr 16, 1997 · Cardiovascular

Device Facts

Record ID	K964194
Device Name	CHASE CURVED LEFT HEART VENT CATHETER
Applicant	Chase Medical, Inc.
Product Code	DWF · Cardiovascular
Decision Date	Apr 16, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4210
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The CHASE Curved Left Heart Vent Catheter is indicated for use in venting the left heart during cardiopulmonary bypass with entrance made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve.

Device Story

Device is a 20 French preformed, flexible plastic vent catheter; features perforated section and tapered rigid tip for insertion; includes rigid connector for 6.4mm I.D. tubing; depth marking rings provided. Used by surgeons during cardiopulmonary bypass procedures to vent the left heart. Device facilitates drainage of blood from the left atrium/ventricle to maintain a bloodless field and prevent distension. Operation involves manual insertion through the right superior pulmonary vein and mitral valve. Benefits include effective decompression of the left heart during 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 (Tyvek/Polymylar burst test per ASTM F1140-88), shipping/distribution vibration/drop tests, and accelerated aging (two-year shelf life).

Technological Characteristics

20 French preformed flexible plastic tube; rigid plastic tapered tip; rigid plastic tube connector for 6.4mm I.D. tubing; depth marking rings. Sterilization: 100% Ethylene Oxide (Overkill Method, SAL 10⁻⁶). Packaging: Tyvek/Polymylar per ASTM F1140-88.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass requiring left heart venting via the right superior pulmonary vein and mitral valve.

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 Curved Left Heart Vent Catheter (K770430)

Related Devices

K170488 — Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr · Surge Cardiovascular · Aug 10, 2017
K022022 — JOSTRA VENT CATHETERS, MODELS LV & HKV · Jostra AG · Sep 11, 2002
K981601 — CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER · Sorin Group Italia S.R.L. · Jul 28, 1998
K012143 — 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 · Medtronic Cardiac Surgical Products · Oct 24, 2001
K113411 — EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA · Edwards Lifesciences, LLC · Jun 11, 2012

Submission Summary (Full Text)

{0} KR24194 APR 16 1997 # SUMMARY OF SAFETY AND EFFECTIVENESS ## CHASE CURVED LEFT HEART VENT CATHETER ### I. General Information A. Generic Name: Curved Left Heart Vent Catheter B. Trade Name of Device: CHASE CURVED LEFT HEART VENT 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 Curved Left Heart Vent Catheter is indicated for use in venting the left heart during cardiopulmonary bypass with entrance made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve. ### III. Device Description The vent catheter consists of a preformed, flexible plastic tube, (20 French), with a perforated section. A small tapered tip of rigid plastic is attached to the perforated section to aid in the insertion of the catheter. A rigid plastic tube connector for 6.4mm (1/4”) I.D. tubing is permanently attached to the other end of the catheter tube. Marking rings on the tube serve as an indication of insertion depth. ### IV. Device Classification: Class II device ### V. Safety and Effectiveness: Substantial Equivalence: This device is substantially equivalent to the Sarns Curved Left Heart Vent Catheter K770430. ### 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 Curved Left Heart Vent Catheter are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition. {1} # 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 |