(87 days)
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 aora. The cannulae may also be use to aspirate air from the ascending aorta.
The NMI Antegrade Cannulae are manufactured in vented and non-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.
This document describes the NMI Antegrade Cardioplegia Cannulae, a medical device intended to deliver cardioplegia solutions to the heart or vent them away, and to aspirate air from the ascending aorta. The provided text primarily establishes substantial equivalence to a predicate device and presents performance data from functional testing.
Based on the information provided, here's an analysis of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as pass/fail thresholds. Instead, it provides performance ranges for the NMI Cannulae and compares them directly to the predicate DLP Cannulae. The implicit acceptance criterion appears to be that the NMI device performs comparably or better than the predicate device across various functional tests.
| Acceptance Criteria (Implicit: Comparable/Better than Predicate) | Reported Device Performance (NMI Cannulae) | Predicate Device Performance (DLP Cannulae) |
|---|---|---|
| Pressure Drop/Saline @ 4°C (100-500 ml/min Flow) | 8 to 45 mmHg | 6 to 63 mmHg |
| Pressure Drop/Saline @ 37°C (100-500 ml/min Flow) | 3 to 40 mmHg | 6 to 62 mmHg |
| Pressure Drop/Bovine Blood (25% Hematocrit) @ 4°C (100-500 ml/min Flow) | 10 to 66 mmHg | 9 to 93 mmHg |
| Pressure Drop/Bovine Blood (25% Hematocrit) @ 37°C (100-500 ml/min Flow) | 5 to 46 mmHg | 9 to 69 mmHg |
| Leak Test Requirements: No leaks at 10 psi air | No leaks at 10 psi air on NMI device at 4°C and 40°C | (Not explicitly stated for predicate, but implied pass) |
| Tubing Bond Strength: Exceeds 0.4 lb tensile strength | Exceeds 0.4 lb tensile strength @ 4°C and 40°C | (Not explicitly stated for predicate, but implied pass) |
| Luer Connections: Meets ANSI/HIMA MD70.1-1983 | Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Tape Fittings | (Not explicitly stated for predicate, but implied pass) |
| Package Integrity: Passed burst test per ASTM F1140-88 | Tyvek/Polymylar passed burst test per ASTM F1140-88 | (Not explicitly stated for predicate, but implied pass) |
| Shipping & Distribution Testing: Passed Distribution Simulation Test per ASTM 40169 Standard | Passed Distribution Simulation Test per ASTM 40169 Standard | (Not explicitly stated for predicate, but implied pass) |
| Accelerated Aging: No affects on performance characteristics after 1 year | One (1) year with no affects on performance characteristics | (Not explicitly stated for predicate, but implied pass) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the functional testing of the NMI Cannulae or the predicate device. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The testing appears to be laboratory-based functional testing rather than clinical study data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to the provided document. The data presented is from functional engineering tests, not a study requiring expert-established ground truth for a test set (like image analysis or clinical diagnosis).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable to the provided document, as the testing involves objective measurements of physical properties rather than subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable to the provided document. The device is a physical medical instrument (cardioplegia cannula), not an AI diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical medical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the functional tests is based on objective, quantifiable physical properties and established engineering standards. For example, pressure drop measurements are objective readings, and compliance with standards like ANSI/HIMA MD70.1-1983 and ASTM F1140-88 serves as the "ground truth" for those specific tests. There is no biological or diagnostic ground truth (like pathology or expert consensus) involved in these functional tests.
8. The sample size for the training set
This section is not applicable. The document describes a physical medical device and its functional testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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SUMMARY OF SAFETY AND EFFECTIVENESS
NMI ANTEGRADE CARDIOPLEGIA CANNULAE
1. General Information
الموالي الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع المو
| 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 123-206Dallas, Texas |
| D. Pre-market Notification Number: | Not yet assigned |
11. 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 aora. The cannulae may also be use to aspirate air from the ascending aorta.
III. Device Description
The NMI Antegrade Cannulae are manufactured in vented and non-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
Safety and Effectiveness V.
| 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 BiocompatibilityGuidance 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℃
DLP Cannulae average pressure drops range at flow rates between 100 and 500 ml/min= 6 to 63 mmHg @ 4ºC
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SUMMARY OF SAFETY AND EFFECTIVENESS
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| 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 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 |
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
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.(b)
Classification. Class II (performance standards).