(87 days)
Not Found
No
The device description and performance studies focus on the physical components and functional performance of a simple tubing set, with no mention of AI/ML or data processing.
Yes
The device's intended use is to connect multiple coronary cannulae to a single infusion line during a cardiopulmonary bypass procedure, which directly contributes to the treatment of a patient during surgery.
No
The device, a Vein Graft Perfusion Set, is described as connecting multiple coronary cannulae to a single infusion line during a cardiopulmonary bypass procedure. Its function involves fluid delivery and connection, not the diagnosis of a medical condition.
No
The device description explicitly lists physical components made of PVC, polypropylene, and ABS, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be used during a cardiopulmonary bypass procedure to connect multiple coronary cannulae to a single infusion line." This describes a device used in vivo (within the body) to facilitate a surgical procedure.
- Device Description: The description details tubing, connectors, and clamps, all components of a medical device used for fluid delivery during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body to provide diagnostic information. This device's function is purely mechanical and related to fluid management during a surgical procedure.
N/A
Intended Use / 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.
Product codes
Not Found
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 luck, and soft flexible tubing on legs, .090 1.D., and 3/16 O.D.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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 to 500 mVmin = 18 to 125 mmHg @ 4℃, DLP Cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 15 to 180 mmHg @ 4°C, 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
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.(b)
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.
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Summary of Safety and Effectiveness NMI VEIN GRAFT PERFUSION SET
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: | 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 |
11. 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.
111. 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 luck, and soft flexible tubing on legs, .090 1.D., and 3/16 O.D.
IV. Device Classification: Class II
Safety and Effectiveness V.
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. Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10° Sterilization: Non-Pyrogenic per USP Pyrogen test (LAL) Pyrogenicity:
Functional Testing
Pressure Drop/Saline
NMI Cannulae average pressure drops range at flow rates between 100 to 500 mVmin = 18 to 125 mmHg @ 4℃
DLP Cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 15 to 180 mmHg @ 4°C.
1
| 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 |
. . . . . . .
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