NMI ANTEGRAD CARDIOPLEGIA CANNULA
K961180 · Naltiac Medical, Inc. · DWF · Jun 21, 1996 · Cardiovascular
Device Facts
| Record ID | K961180 |
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| Device Name | NMI ANTEGRAD CARDIOPLEGIA CANNULA |
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| Applicant | Naltiac Medical, Inc. |
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| Product Code | DWF · Cardiovascular |
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| Decision Date | Jun 21, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 870.4210 |
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| Device Class | Class 2 |
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| Attributes | Therapeutic |
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Intended Use
The NMI Antegrade Cardioplegia Cannulae are intended to be used to deliver cardioplegia solutions to the heart or venting cardioplegia away from the heart via the ascending aorta. The cannulae may also be used to aspirate air from the ascending aorta.
Device Story
NMI Antegrade Cardioplegia Cannula; used during cardiac surgery to deliver cardioplegia solutions to heart or vent cardioplegia/air from ascending aorta. Device consists of PVC catheter body, radiopaque flexible PVC tip, stainless steel needle stylet, vent line adapter, polypropylene pinch clamp, PVC suture ring, and PVC female luer lock connector. Operated by surgeons/clinicians in OR. Provides fluid pathway for cardioplegia delivery or aspiration. Benefits patient by facilitating myocardial protection during surgery.
Clinical Evidence
Bench testing only. Performance validated via pressure drop testing (saline and bovine blood at 4°C and 37°C), leak testing at 10 psi, tensile bond strength testing, luer connection compliance (ANSI/HIMA MD70.1-1983), package integrity (ASTM F1140-88), and distribution simulation (ASTM 40169). Biocompatibility confirmed per Tripartite Guidance. Sterilization validated via Ethylene Oxide (SAL 10⁻⁶).
Technological Characteristics
Materials: PVC catheter body/tip/suture ring/luer, stainless steel needle stylet, polypropylene clamp. Complies with Tripartite Biocompatibility Guidance. Dimensions: 12 and 14 gauge. Energy: None (passive). Sterilization: Ethylene Oxide (Overkill Method). Connectivity: None. Standards: ANSI/HIMA MD70.1-1983 (luer), ASTM F1140-88 (package), ASTM 40169 (distribution).
Indications for Use
Indicated for patients undergoing cardiac surgery requiring delivery of cardioplegia solutions or venting of the ascending aorta.
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
- DLP, Inc. Aortic Root Cannulae (K790565A)
Related Devices
- K964198 — CAHSE AORTIC ROOT CANNULA · Chase Medical, Inc. · Mar 19, 1997
- K240193 — R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) · Sorin Group Italia S.R.L. · Feb 22, 2024
- K162500 — Ostial Sprit Cannulae · Spyder Medical · Jan 12, 2017
- K020515 — JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA · Jostra AG · Apr 24, 2002
- K140569 — ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) · Maquet Cardiopulmonary, AG · Nov 19, 2014
Submission Summary (Full Text)
{0}
JUN 21 1986
K961180
# SUMMARY OF SAFETY AND EFFECTIVENESS
## NMI ANTEGRADE CARDIOPLEGIA CANNULAE
### I. General Information
A. Generic Name: Aortic Root Cannula
B. Trade Name of Device: NMI Antegrade Cardioplegia Cannula
C. Applicant's Name and Address: Naltiac Medical, Inc.
17194 Preston Rd, Suite 123-206
Dallas, Texas
D. Pre-market Notification Number: Not yet assigned
### II. Indications for Use
The NMI Antegrade Cardioplegia Cannulae are intended to be used to deliver cardioplegia solutions to the heart or venting cardioplegia away from the heart via the ascending aorta. The cannulae may also be used to aspirate air from the ascending aorta.
### III. Device Description
The NMI Antegrade Cardioplegia Cannulae are manufactured in vented and non-vented 12 and 14 gauge. The devices consist of a PVC catheter body with optional vent line, radiopaque flexible PVC tip, stainless steel needle stylet, vent line adapter, polypropylene pinch clamp, PVC suture ring and PVC female luer lock connector.
### IV. Device Classification: Class II
### V. Safety and Effectiveness
Substantial Equivalence: The device has been shown to be substantially equivalent to the DLP, Inc. Aortic Root Cannulae #K790565A.
### 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 = 8 to 45 mmHg @ 4°C
DLP Cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 6 to 63 mmHg @ 4°C
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# SUMMARY OF SAFETY AND EFFECTIVENESS
Pressure Drop/Saline Continued
NMI Cannulae average pressure drops range at flow rates between 100 and 500 ml/min= 3 to 40 mmHg @ 37°C
DLP Cannulae average pressure drops range at flow rates between 100 and 500 ml/min= 6 to 62 mmHg @ 37°C
Pressure Drop/Bovine Blood (@ 25% Hematocrit) to
NMI Cannulae average pressure drops range at flow rates between 100 and 500 ml/min= 10 to 66 mmHg @ 4°C
DLP Cannulae average pressure drops range at flow rates between 100 and 500 ml/min= 9 to 93 mmHg @ 4°C
NMI Cannulae average pressure drops range at flow rates between 100 and 500 ml/min= 5 to 46 mmHg @ 37°C
DLP Cannulae average pressure drops range at flow rates between 100 and 500 ml/min= 9 to 69 mmHg @ 37°C
Leak Test Requirements:
No leaks at 10 psi air on NMI device at 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 Tape Fittings
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
