(87 days)
K790565A
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No
The device description and performance studies focus on the physical characteristics and functional performance of a mechanical cannula, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
Therapeutic devices are those that treat a disease or condition. This device is used to deliver solutions to the heart or vent solutions away from the heart, which is a supportive function during a medical procedure, not a treatment in itself.
No
The device is described as cannulae used to deliver cardioplegia solutions or aspirate air, and its performance studies focus on functional aspects like pressure drop, leaks, and bond strength, not on detecting or diagnosing medical conditions.
No
The device description clearly lists physical components such as a PVC catheter body, stainless steel needle stylet, and other hardware, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver or vent cardioplegia solutions to/from the heart via the ascending aorta, and to aspirate air. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a cannula (a tube inserted into the body), not a reagent, instrument, or system used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnosing diseases, or providing information about a patient's health status based on laboratory tests.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used for a therapeutic/surgical procedure.
N/A
Intended Use / 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Heart, ascending aorta
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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
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):
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
Key Metrics
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Predicate Device(s)
K790565A
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '961180'. The numbers are written in a simple, clear style, making them easily readable.
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 123-206 | |
| Dallas, 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 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℃
DLP Cannulae average pressure drops range at flow rates between 100 and 500 ml/min= 6 to 63 mmHg @ 4ºC
1
SUMMARY OF SAFETY AND EFFECTIVENESS
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-心
| 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 |