Who is the manufacturer of CHASE AORTIC PERFUSION CANNULA?

Chase Medical, Inc. filed the 510(k) submission for CHASE AORTIC PERFUSION CANNULA (K970914).

What is the FDA product code for CHASE AORTIC PERFUSION CANNULA?

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 AORTIC PERFUSION CANNULA?

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

Who can help prepare an FDA 510(k) submission like CHASE AORTIC PERFUSION CANNULA?

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 AORTIC PERFUSION CANNULA

Q: What are the predicate devices for CHASE AORTIC PERFUSION CANNULA?

Sarns Aortic Arch Cannula (K770429); DLP Aortic Root Cannula (K790565).

K970914 · Chase Medical, Inc. · DWF · May 13, 1997 · Cardiovascular

Device Facts

Record ID	K970914
Device Name	CHASE AORTIC PERFUSION CANNULA
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 Aortic Perfusion Cannula is indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass. Additionally, the Aortic Perfusion Cannula can be used to occlude the ascending aorta as well as deliver cardioplegia solution to and aspirate air from the aorta.

Device Story

Three-lumen cannula; primary lumen returns oxygenated blood from extracorporeal circuit to ascending aorta; second lumen inflates distal balloon for aortic occlusion; third lumen delivers cardioplegia solution via proximal orifices; used by surgeons during cardiopulmonary bypass; facilitates perfusion, occlusion, and cardioplegia delivery in single device.

Clinical Evidence

Bench testing only; functional characteristics compared to predicates.

Technological Characteristics

Three-lumen cannula; distal balloon; cardioplegia delivery orifices; materials identical to predicate devices; sterilization via 100% Ethylene Oxide (Overkill Method) to SAL 10⁻⁶.

Indications for Use

Indicated for patients undergoing surgical procedures requiring cardiopulmonary bypass; used for ascending aorta perfusion, aortic occlusion, cardioplegia delivery, and air aspiration.

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 Aortic Arch Cannula (K770429)
DLP Aortic Root Cannula (K790565)

Related Devices

K964199 — CHASE CORONARY SINUS PERFUSION CANNULA · Chase Medical, Inc. · Mar 19, 1997
K112694 — EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER · Edwards Lifesciences, LLC · Oct 14, 2011
K113182 — EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER · Edwards Lifesciences, LLC · Dec 7, 2011
K990573 — ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA · Estech, Inc. · Mar 11, 1999
K032632 — REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH · Estech, Inc. · Oct 22, 2003

Submission Summary (Full Text)

{0} K970914 MAY 13 1997 # SUMMARY OF SAFETY AND EFFECTIVENESS ## CHASE AORTIC PERFUSION CANNULA ### I. General Information A. Generic Name: Aortic Perfusion Cannula B. Trade Name of Device: CHASE AORTIC PERFUSION CANNULA C. Applicant’s Name and Address: CHASE MEDICAL INC., Richardson, TX D. Pre-market Notification Number: Not assigned ### II. Indication for Use: The Aortic Perfusion Cannula is indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass. Additionally, the Aortic Perfusion Cannula can be used to occlude the ascending aorta as well as deliver cardioplegia solution to and aspirate air from the aorta. ### III. Device Description The CHASE Aortic Perfusion Cannula is a three lumen cannula. The primary lumen is the conduit that returns oxygenated blood from the extracorporeal circuit to the ascending aorta. A second lumen allows a balloon to be inflated at the distal tip of the cannula. A third lumen delivers cardioplegia solution through orifices proximal to the balloon. ### IV. Device Classification: Class II device ### V. Safety and Effectiveness: Substantial Equivalence: This device is substantially equivalent to the combination of Sarns Aortic Arch Cannula (K770429), DLP Aortic Root Cannula (K790565), and an aortic cross clamp. ### VI. Other Safety and Effectiveness Data: Materials: All materials are identical to materials used in similar devices that have similar intended uses. Sterilization: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶ ## Functional Testing All functional characteristics of the Chase Medical Aortic Perfusion Cannula are non-differentiable as compared with the predicates.