← Product Code [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF) · K964199 # CHASE CORONARY SINUS PERFUSION CANNULA (K964199) _Chase Medical, Inc. · DWF · Mar 19, 1997 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K964199 ## Device Facts - **Applicant:** Chase Medical, Inc. - **Product Code:** [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF.md) - **Decision Date:** Mar 19, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4210 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for Use The CHASE coronary sinus perfusion cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction. ## Device Story Triple-lumen cannula for retrograde cardioplegia delivery; transatrial placement. Main lumen delivers cardioplegia/blood; second lumen monitors pressure; third lumen inflates/deflates distal balloon. Includes stylet for placement and syringe for balloon control. Used in OR by cardiac surgeons. Wire-reinforced silicone body. Output: cardioplegia delivery and pressure monitoring. Benefits: enables myocardial protection during cardiac procedures. ## Clinical Evidence Bench testing only. Testing included leak testing (10 psi at 4°C/40°C), tubing bond strength (>10 lb tensile), Luer connection compliance (ANSI/HIMA MD70.1-1983), package integrity (ASTM F1140-88), shipping/distribution vibration/drop tests, and accelerated aging (2-year shelf life). ## Technological Characteristics Triple-lumen cannula; wire-reinforced silicone body. Luer connections per ANSI/HIMA MD70.1-1983. Packaging: Tyvek/Polymylar per ASTM F1140-88. Sterilization: Ethylene Oxide (Overkill Method, SAL 10⁻⁶). ## Regulatory 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 - Quest Coronary Sinus Perfusion Cannula ([K941166](/device/K941166.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K964199 MAR 19 1997 # SUMMARY OF SAFETY AND EFFECTIVENESS ## CHASE MEDICAL CORONARY SINUS PERFUSION CANNULA ### I. General Information A. Generic Name: Coronary Sinus Perfusion Cannula B. Trade Name of Device: Chase Coronary Sinus Perfusion Cannula C. Applicant's Name and Address: Chase Medical Inc. 1876 Firman Drive. Richardson, Texas 75081 D. Pre-market Notification Number: Not yet assigned ### II. Indications for Use The CHASE coronary sinus perfusion cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction. ### III. Device Description The CHASE coronary sinus perfusion cannula is a triple lumen cannula. The main lumen is the delivery conduit for blood or cardioplegia solution. A second lumen is a pressure monitoring line and begins at the tip of the cannula and terminates with a connector for coupling to a pressure monitoring device. A third lumen is used as a means to inject or withdraw air or fluid for the inflation and deflation of a balloon located near the tip of the cannula. The cannula's silicone body is reinforced with wire wound axially along the length of the cannula. A stylet is included to facilitate transatrial placement of the cannula into the coronary sinus. A syringe is included for balloon inflation and deflation. ### IV. Device Classification: Class II ### V. Safety and Effectiveness Substantial Equivalence: The device is substantially equivalent to the Quest Coronary Sinus Perfusion Cannula K941166. ### 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 coronary sinus perfusion cannula 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 Luer Connections: Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Tape Fittings 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K964199](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K964199) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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