(77 days)
No
The device description and performance studies focus on the physical properties and functional performance of a medical cannula, with no mention of AI or ML.
Yes
The device is described as cannulae intended for use in perfusing blood or cardioplegia solutions during cardiopulmonary surgery to arrest the heart and preserve metabolic function, which are therapeutic interventions.
No
The device description and intended use clearly state that it is used for perfusing solutions to the coronary sinus during surgery, not for diagnostic purposes.
No
The device description explicitly lists physical components made of materials like PVC, polyurethane, polycarbonate, polyethylene, polypropylene, and stainless steel. This indicates it is a hardware 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 "perfuse blood or Cardioplegia solutions via the coronary sinus during cardiopulmonary surgery." This describes a device used in vivo (within the body) for a surgical procedure.
- Device Description: The description details a physical cannula designed for insertion into the coronary sinus. This is a surgical instrument.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples. It is used to deliver substances into the body.
Therefore, the NMI Retrograde Cardioplegia Cannulae-RCCS is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NMI Retrograde Cardioplegia Cannulae-RCCS are intended for use in perfusing blood or Cardioplegia solutions via the coronary sinus during cardiopulmonary surgery.
Product codes
Not Found
Device Description
The NMI Retrograde Cardioplegia Cannulae are fabricated with polyvinyl chloride bodies (PVC) and polyurethane balloon cuffs, polycarbonate/polyethylene stopcocks, polypropylene clamps, PVC female luer connectors, and stainless steel guidewires. The features of the device include: self-inflating cuff, pressure monitoring port with 3-way stopcock on jumen extension, suture ing. and 14 French size. The cannulae are placed in the coronary sinus in order to infuse cardioplegia in a retrograde fashion to the myocardium. This practice both arrests the heart and preserves metabolic function during surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus
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 and 500 ml/min = 11 to 76 mmHg at 4°C; RMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 7 to 97 mmHq at 4°C. NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 6 to 60 mmHg at 40°C; RMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 6 to 97 mmHg at 40°C.
Pressure Drop / Bovine Blood (@25% Hematocrit): NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 22 to 121 mmHg at 4°C; RMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 14 to 127 mmHg at 4°C. NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 11 to 77 mmHg at 40°C; RMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 12 to 91 mmHg at 40°C.
Pressure Monitoring Port: NMI cannulae 0.5 to 0.9 mmHg for downstream pressures of 10 to 80 mmHg; RMI cannulae 0.6 to 0.9 mmHg for downstream pressures of 10 to 80 mmHg.
Balloon Burst: Greater than 130 mmHg.
Guide Collapse: Less than predicate device.
Balloon Device: Greater than predicate device.
Leak Test Requirements: No leaks at 10 psi air on NMI Device @ 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 Taper Fittings.
Package Integrity: Tyvek/Mylar passed burst test in accordance with ASTM F1140-88.
Shipping & Distribution Testing: Passed Distribution Simulation Test per ASTM 40169 Standard.
Accelerated Aging: One year - No affects on performance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
JUL 1 8 1996
Summary of Safety and Effectiveness NMI RETROGRADE CARDIOPLEGIA CANNULA - RCCS
1. General Information
| A. Generic Name: | Retrograde Cardioplegia Cannula |
|---|---|
| B. Trade Name of Device: | NMI Retrograde Cardioplegia Cannula-RCCS |
| 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 Retrograde Cardioplegia Cannulae-RCCS are intended for use in perfusing blood or Cardioplegia solutions via the coronary sinus during cardiopulmonary surgery.
111. Device Description
The NMI Retrograde Cardioplegia Cannulae are fabricated with polyvinyl chloride bodies (PVC) and polyurethane balloon cuffs, polycarbonate/polyethylene stopcocks, polypropylene clamps, PVC female luer connectors, and stainless steel guidewires. The features of the device include: self-inflating cuff, pressure monitoring port with 3-way stopcock on jumen extension, suture ing. and 14 French size. The cannulae are placed in the coronary sinus in order to infuse cardioplegia in a retrograde fashion to the myocardium. This practice both arrests the heart and preserves metabolic function during surgery.
IV. Device Classification: Class II
V. Safety and Effectiveness
Substantial Equivalence: This device has been shown to be substantially equivalent to the Research Medical, Inc. Retrograde Cardioplegia Cannula # K880103
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° 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 = 11 to 76 mmHg at 4°C
RMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 7 to 97 mmHq at 4°C
1
| Pressure Drop / Saline | NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 6 to 60 mmHg at 40°C |
|---|---|
| RMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 6 to 97 mmHg at 40°C | |
| Pressure Drop / Bovine Blood (@25% Hematocrit) | NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 22 to 121 mmHg at 4°C |
| RMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 14 to 127 mmHg at 4°C | |
| NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 11 to 77 mmHg at 40°C | |
| RMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 12 to 91 mmHg at 40°C | |
| Pressure Monitoring Port: | NMI cannulae 0.5 to 0.9 mmHg for downstream pressures of 10 to 80 mmHg |
| RMI cannulae 0.6 to 0.9 mmHg for downstream pressures of 10 to 80 mmHg | |
| Balloon Burst: | Greater than 130 mmHg |
| Guide Collapse: | Less than predicate device |
| Balloon Device: | Greater than predicate device |
| Leak Test Requirements: | No leaks at 10 psi air on NMI Device @ 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 Taper Fittings |
| Package Integrity: | Tyvek/Mylar passed burst test in accordance with ASTM F1140-88 |
| Shipping & Distribution Testing: | Passed Distribution Simulation Test per ASTM 40169 Standard |
| Accelerated Aging | One year - No affects on performance |
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