(28 days)
The NMI Coaxial Microintroducer Set is used for the percutaneous introduction of a guidewire into the vascular system.
The 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.
Here's a breakdown of the acceptance criteria and study information for the NM1 Coaxial Microintroducer Set, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile Strength | Tested in accordance with ISO 11070 |
| Dimensional Accuracy | Verified in accordance with ISO 11070 |
Note: The document states the device was tested to ISO 11070, indicating that the device met the requirements of this standard for tensile strength and dimensional accuracy. Specific numerical values for criteria or performance were not provided in the 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "non-clinical test performed."
- Data Provenance: Not explicitly stated. The document indicates "non-clinical testing," which typically means laboratory or bench testing, not human-patient data from a specific country. This would be considered retrospective in the sense that no new patient data was collected.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the evaluation involved non-clinical, bench testing (Tensile Testing and Dimensional Verification) against an ISO standard, not expert review of clinical data.
4. Adjudication Method for the Test Set:
This information is not applicable as the evaluation involved non-clinical, bench testing against an ISO standard, which would not involve an adjudication method in the traditional sense. The standard itself would define the pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for imaging or diagnostic devices where human readers interpret results, and the document describes a physical medical device (introducer set) evaluated through non-clinical bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
Yes, a standalone performance evaluation was done. The performance data presented (tensile testing and dimensional verification) assesses the device's physical and mechanical characteristics in a standalone manner, without human interaction being a variable in the performance assessment itself. The "human-in-the-loop" concept is not directly applicable to this type of device and testing.
7. The Type of Ground Truth Used:
The ground truth used was compliance with an industry standard: ISO 11070: "Sterile, Single-Use Intravascular Catheter Introducers." This standard defines the acceptable performance characteristics for devices of this type.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical medical instrument, not an AI or algorithm-based system that requires a "training set" for machine learning. The "training set" concept does not apply here.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 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).