(207 days)
The ASAHI Corsair Armet is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another.
The ASAHI Corsair Armet is also intended to assist in the delivery of contrast media into the peripheral vasculature.
This device should not be used in coronary vasculature or neuro vasculature.
The ASAHI Corsair Armet consists of a distal tip, a shaft tube that is inserted into vasculature, a protector, and a connector for catheter control and infusion of contrast media. The device has a hydrophilic coating on the outer surface of distal tip and the shaft tube to provide a smooth transition in blood vessels. The distal tip of the Corsair Armet has a tapered shape. PTFE is applied to the inner lumen of the catheter for the purposes of a smooth transition and exchange of guidewires.
This document is a 510(k) summary for the ASAHI Corsair Armet. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific clinical acceptance criteria in a human study. Therefore, much of the requested information (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable or provided in this type of regulatory submission.
However, I can extract the acceptance criteria and the summary of non-clinical performance data provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical Bench Tests) | Reported Device Performance |
|---|---|
| Appearance/Dimensions | Met all acceptance criteria |
| Corrosion Resistance | Met all acceptance criteria |
| Force at Break | Met all acceptance criteria |
| Liquid Leakage under Pressure | Met all acceptance criteria |
| Air Leakage | Met all acceptance criteria |
| Leak and Damage under High Static Pressure | Met all acceptance criteria |
| Radio-Detectability | Met all acceptance criteria |
| Torque Transmission | Met all acceptance criteria |
| Slide Durability | Met all acceptance criteria |
| Kink Resistance | Met all acceptance criteria |
| Torque Durability | Met all acceptance criteria |
Study Proving Device Meets Acceptance Criteria:
A series of non-clinical laboratory bench tests were performed on the ASAHI Corsair Armet. These tests were designed to evaluate the physical and mechanical properties of the device against predefined acceptance criteria for each test parameter.
Missing Information (Not provided in this 510(k) Summary):
- Sample size used for the test set and the data provenance: This document does not detail the specific sample size (number of devices tested) for each bench test, nor does it refer to human "test sets" or data provenance in terms of country of origin or retrospective/prospective nature, as this is pre-market non-clinical testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context is based on engineering specifications and performance standards for medical devices, not expert human interpretation of clinical data.
- Adjudication method for the test set: Not applicable. The results are objective measurements from bench tests against defined specifications.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a percutaneous catheter, not an AI-powered diagnostic or assistive technology for human interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used: For the non-clinical tests, the "ground truth" or reference was established by pre-defined engineering and performance specifications and standards relevant to percutaneous catheters.
- The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
Summary from the Document:
The ASAHI Corsair Armet underwent non-clinical laboratory testing, which included evaluating its appearance/dimensions, corrosion resistance, force at break, liquid leakage under pressure, air leakage, leak and damage under high static pressure, radio-detectability, torque transmission, slide durability, kink resistance, and torque durability.
The document states: "The in vitro bench tests demonstrated that the ASAHI Corsair Armet met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate devices."
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).