NMI VEIN GRAFT PERFUSION SET

K961181 · Naltiac Medical, Inc. · DTL · Jun 21, 1996 · Cardiovascular

Device Facts

• Record ID: K961181
• Device Name: NMI VEIN GRAFT PERFUSION SET
• Applicant: Naltiac Medical, Inc.
• Product Code: DTL · Cardiovascular
• Decision Date: Jun 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

The NMI Vein Graft Perfusion Set is intended to be used during a cardiopulmonary bypass procedure to connect multiple coronary cannulae to a single infusion line.

Device Story

Device connects multiple coronary cannulae to single infusion line during cardiopulmonary bypass; facilitates fluid delivery to multiple graft sites. Comprised of PVC alloy tubing, PVC quad fitting, polypropylene pinch clamp, PVC female luer, and ABS male luer connectors. Used in clinical OR settings by perfusionists or surgeons. Provides fluid path for perfusion; allows individual flow control via pinch clamps. Benefits patient by enabling efficient, simultaneous perfusion of multiple coronary grafts during bypass surgery.

Clinical Evidence

Bench testing only. Evaluated pressure drop at 4°C and 40°C (100-500 ml/min flow rates), leak testing at 10 psi, luer connection compliance (ANSI/HIMA MD70.1-1983), tubing bond strength (>0.4 lb), package integrity (ASTM F1140-88), and shipping simulation (ASTM 40169). Biocompatibility per Tripartite Guidance; non-pyrogenic per USP LAL test. Accelerated aging validated for one year.

Technological Characteristics

Materials: PVC alloy, polypropylene, ABS. Dimensions: .090 I.D., 3/16 O.D. tubing. Connectivity: Luer lock connectors per ANSI/HIMA MD70.1-1983. 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 procedures requiring connection of multiple coronary cannulae to a single infusion line.

Regulatory Classification

Identification

A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• DLP Multiple Perfusion Set (K791498)

Submission Summary (Full Text)

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JUN 21 1998
K961181

# Summary of Safety and Effectiveness
## NMI VEIN GRAFT PERFUSION SET

## I. General Information

A. Generic Name: Vein Graft Perfusion Set
B. Trade Name of Device: NMI Vein Graft Perfusion Set
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 Vein Graft Perfusion Set is intended to be used during a cardiopulmonary bypass procedure to connect multiple coronary cannulae to a single infusion line.

## III. Device Description

The NMI Vein Graft Perfusion Set is fabricated with PVC alloy tubing, PVC Quad fitting, polypropylene pinch clamp, PVC female luer connector, and ABS male luer connector. The features of the device include: one 3 1/4 inlet leg with female luer port and white pinch clamp, three 9 3/4 in. outlet legs with red pinch clamps terminating in male luer lock connectors, one 3 1/4 in. outlet leg with blue pinch clamp terminating in a male luer lock, and soft flexible tubing on legs, .090 I.D., and 3/16 O.D.

## IV. Device Classification: Class II

## V. Safety and Effectiveness

Substantial Equivalence: The device has been shown to be substantially equivalent to the DLP Multiple Perfusion Set (K791498).

## VI. Other Safety and Effectiveness Data

Materials: Fluid contact of 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 to 500 ml/min = 18 to 125 mmHg @ 4°C

DLP Cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 15 to 180 mmHg @ 4°C.

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Pressure Drop/Saline Continued

NMI Cannuale average pressure drops range at flow rates between 100 and 500 ml/min = 6 to 109 mmHg @ 40°C

DLP Cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 10 to 140 mmHg @ 40°C

Leak Test Requirements:

No leaks at 10 psi on NMI device at 4°C and at 40°C

Luer Connections:

Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Tape Fittings

Tubing Bond Strength:

Exceeds 0.4 lb tensile strength at 4°C and at 40°C

Package Integrity:

Tyvek/Polymylar passed burst test per ASTM F1140-88

Shipping & Distribution Testing:

Passed Distribution Simulation Test per ASTM 40169 Standard

Accelerated Aging:

One (1) year with no affects on performance characteristics