(144 days)
The NMI Coaxial Microintroducer Set is used for the percutaneous introduction of a guidewire into the vascular system.
NMI Coaxial Microintroducer Sets are offered with a 21 gauge needle (4 CM or 7 CM length with or without Echogenic tip), different guidewire configurations (0.018" stainless steel wire body or a Nitinol wire body and with or without Radiopaque tip), and a sheath and dilator assembly (4F X 10 CM regular or stiff, 5F X 10 CM regular or stiff, and 5F X 15 CM stiff), enable users to gain vascular access.
This 510(k) summary reports on a medical device (NMI Coaxial Microintroducer Set) which is not an AI/ML device. Therefore, acceptance criteria and study data related to AI/ML device performance are not applicable. The provided document details the substantial equivalence of the NMI Coaxial Microintroducer Set to a predicate device based on non-clinical performance and technological characteristics.
However, based on the provided text, I can extract the following information about the device's testing and substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the testing performed to demonstrate substantial equivalence, rather than a specific set of acceptance criteria with numerical targets. The "acceptance criteria" are implied by the standards used and the conclusion of substantial equivalence.
| Performance Attribute | Acceptance Criteria/Standard (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | ISO 11070: Sterile, Single-Use Intravascular Catheter Introducers:1999 (Tensile strength requirements for introducers) | Tested in accordance with ISO 11070. Assumed to meet requirements to claim substantial equivalence. |
| Leak Integrity | ISO 11070: Sterile, Single-Use Intravascular Catheter Introducers:1999 (Leakage requirements) | Tested in accordance with ISO 11070. Assumed to meet requirements to claim substantial equivalence. |
| Radiopacity | ISO 11070: Sterile, Single-Use Intravascular Catheter Introducers:1999 (Visualizability under fluoroscopy) | Tested in accordance with ISO 11070. Assumed to meet requirements to claim substantial equivalence. |
| Dimensional Accuracy | Industry standards for medical device dimensions, likely referenced by ISO 11070 | Dimensional verification performed. Assumed to meet requirements for proper function and substantial equivalence. |
| Biocompatibility | ISO 10993-1 (Biological evaluation for medical devices) | Biocompatibility testing performed per ISO 10993-1. Assumed to meet requirements. |
| Luer Performance | ISO 594-2: Conical Fittings 6% (Luer) Taper for Syringes, Needles, Certain Medical Equipment - Part 2 (1998) | Luer performance testing performed per ISO 594-2. Assumed to meet requirements. |
| Compatibility | Compatibility with other components in the intended use | Compatibility testing performed. Assumed to be compatible with intended accessories/uses. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the exact sample sizes used for each non-clinical test (e.g., tensile testing, leak testing). It only states that tests were performed "in accordance with" the specified ISO standards. These standards typically outline appropriate sample size requirements for the tests.
- Data Provenance: The data is from non-clinical tests performed by the manufacturer (Navilyst Medical, Inc.). This is not patient data, so concepts like country of origin or retrospective/prospective are not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This device is evaluated based on non-clinical performance data (material properties, mechanical integrity, etc.) against established engineering standards (ISO). There is no "ground truth" in the clinical sense established by human experts for these types of tests.
4. Adjudication Method for the Test Set:
- Not Applicable. As the evaluation is based on objective non-clinical tests against engineering standards, there is no need for an adjudication method involving human experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not an AI/ML or image-based diagnostic device. An MRMC study is not relevant or performed for this type of medical device.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
- Not Applicable. This is a physical medical device, not an algorithm. Standalone performance for an algorithm is not relevant. The "performance" here refers to the physical device's characteristics.
7. Type of Ground Truth Used:
- Benchmark Standards and Engineering Specifications: The "ground truth" for this device's performance is derived from established international standards (ISO 11070, ISO 594-2, ISO 10993-1) and the manufacturer's own design specifications, which are compared to those of the predicate device. The goal is to demonstrate that the device performs equivalently to the predicate and meets safety and performance standards.
8. Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device, so there is no training set in the sense of machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).