NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS

K961717 · Naltiac Medical, Inc. · DWF · Jul 18, 1996 · Cardiovascular

Device Facts

• Record ID: K961717
• Device Name: NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS
• Applicant: Naltiac Medical, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Jul 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Indications for Use

Indicated for patients undergoing cardiopulmonary surgery requiring retrograde infusion of cardioplegia solutions or blood into the coronary sinus to arrest the heart and preserve myocardial metabolic function.

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

• Research Medical, Inc. Retrograde Cardioplegia Cannula (K880103)

Submission Summary (Full Text)

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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

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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