← Product Code [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF) · K961717 # NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS (K961717) _Naltiac Medical, Inc. · DWF · Jul 18, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K961717 ## Device Facts - **Applicant:** Naltiac Medical, Inc. - **Product Code:** [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF.md) - **Decision Date:** Jul 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4210 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for Use The NMI Retrograde Cardioplegia Cannulae-RCCS are intended for use in perfusing blood or Cardioplegia solutions via the coronary sinus during cardiopulmonary surgery. ## Device Story Cannula for retrograde cardioplegia delivery during cardiopulmonary surgery. Device features PVC body, polyurethane balloon cuff, polycarbonate/polyethylene stopcocks, polypropylene clamps, PVC luer connectors, and stainless steel guidewire. Placed in coronary sinus by surgeon; self-inflating cuff secures position. Pressure monitoring port allows real-time monitoring of infusion pressure. Enables retrograde delivery of cardioplegic solution to myocardium to induce cardiac arrest and metabolic preservation. Bench testing confirms performance metrics comparable to predicate. ## Clinical Evidence Bench testing only. Evaluated pressure drop across flow rates (100-500 ml/min) in saline and bovine blood at 4°C and 40°C, pressure monitoring port accuracy, balloon burst pressure, guide collapse, leak testing, tubing bond strength, and luer connection compliance. Package integrity and shipping simulation testing performed per ASTM standards. ## Technological Characteristics Materials: PVC body, polyurethane balloon, polycarbonate/polyethylene stopcocks, polypropylene clamps, stainless steel guidewire. 14 French size. Features: self-inflating cuff, pressure monitoring port, suture ring. Luer fittings meet ANSI/HIMA MD70.1-1983. Packaging tested per ASTM F1140-88. Sterilization: Ethylene Oxide (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 - Research Medical, Inc. Retrograde Cardioplegia Cannula ([K880103](/device/K880103.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} K961717 JUL 18 1996 # Summary of Safety and Effectiveness NMI RETROGRADE CARDIOPLEGIA CANNULA - RCCS ## I. General Information A. Generic Name: Retrograde Cardioplegia Cannula B. Trade Name of Device: NMI Retrograde Cardioplegia Cannula-RCCS C. Applicant's Name and Address: Naltiac Medical, Inc. 17194 Preston Rd, Suite 123-206 Dallas, TX 75248 D. Pre-market Notification Number: Not yet assigned ## II. Indications For Use The NMI Retrograde Cardioplegia Cannulae-RCCS are intended for use in perfusing blood or Cardioplegia solutions via the coronary sinus during cardiopulmonary surgery. ## III. Device Description The NMI Retrograde Cardioplegia Cannulae are fabricated with polyvinyl chloride bodies (PVC) and polyurethane balloon cuffs, polycarbonate/polyethylene stopcocks, polypropylene clamps, PVC female luer connectors, and stainless steel guidewires. The features of the device include: self-inflating cuff, pressure monitoring port with 3-way stopcock on lumen extension, suture ring, and 14 French size. The cannulae are placed in the coronary sinus in order to infuse cardioplegia in a retrograde fashion to the myocardium. This practice both arrests the heart and preserves metabolic function during surgery. ## IV. Device Classification: Class II ## V. Safety and Effectiveness Substantial Equivalence: This device has been shown to be substantially equivalent to the Research Medical, Inc. Retrograde Cardioplegia Cannula # K880103 ## VI. Other Safety and Effectiveness Data: Materials: Fluid contact materials of construction comply with Tripartite Biocompatibility Guidance for external devices, blood path direct, short term use Sterilization: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶ Pyrogenicity: Non-Pyrogenic per USP Pyrogen test (LAL) ## Functional Testing Pressure Drop / Saline NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 11 to 76 mmHg at 4°C RMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 7 to 97 mmHg at 4°C {1} Pressure Drop / Saline NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 6 to 60 mmHg at 40°C RMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 6 to 97 mmHg at 40°C Pressure Drop / Bovine Blood (@25% Hematocrit) NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 22 to 121 mmHg at 4°C RMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 14 to 127 mmHg at 4°C NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 11 to 77 mmHg at 40°C RMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 12 to 91 mmHg at 40°C Pressure Monitoring Port: NMI cannulae 0.5 to 0.9 mmHg for downstream pressures of 10 to 80 mmHg RMI cannulae 0.6 to 0.9 mmHg for downstream pressures of 10 to 80 mmHg Balloon Burst: Greater than 130 mmHg Guide Collapse: Less than predicate device Balloon Device: Greater than predicate device Leak Test Requirements: No leaks at 10 psi air on NMI Device @ 4°C and 40°C Tubing Bond Strength: Exceeds 0.4 lb tensile strength @ 4°C and 40°C Luer Connections: Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Taper Fittings Package Integrity: Tyvek/Mylar passed burst test in accordance with ASTM F1140-88 Shipping & Distribution Testing: Passed Distribution Simulation Test per ASTM 40169 Standard Accelerated Aging One year - No affects on performance --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K961717](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K961717) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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