(29 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 neurovasculature.
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. The primary change in this Special 510(k) involves a minor change in the shape of the distal tip.
The provided document is a 510(k) Summary for the ASAHI Corsair Armet. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or safety through large-scale clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, and expert involvement for diagnostic algorithm performance is not present in this document.
The document describes non-clinical (bench) testing performed to confirm the device's performance against pre-defined acceptance criteria, primarily related to its physical characteristics and functionality.
Here's a breakdown of the available information based on your request, with an emphasis on what is not provided due to the nature of this regulatory submission:
1. A table of acceptance criteria and the reported device performance
The document lists the types of non-clinical tests performed, but does not provide a specific table detailing the quantitative acceptance criteria for each test or the exact numerical performance values. It generally states that the device "met all acceptance criteria" and "performed similarly to the predicate devices."
| Test Category | Acceptance Criteria (Not explicitly quantified in document) | Reported Device Performance (Summary statement) |
|---|---|---|
| Appearance/Dimensions | Implied conformance to specifications | Met all acceptance criteria |
| Corrosion Resistance | Implied resistance to corrosion | Met all acceptance criteria |
| Force at Break | Implied strength/durability | Met all acceptance criteria |
| Liquid Leakage under Pressure | Implied absence of leakage | Met all acceptance criteria |
| Air Leakage | Implied absence of leakage | Met all acceptance criteria |
| Leak and Damage under High Static Pressure | Implied resistance to damage/leakage | Met all acceptance criteria |
| Radio-Detectability | Implied sufficient visibility under imaging | Met all acceptance criteria |
| Torque Transmission | Implied efficient torque transfer | Met all acceptance criteria |
| Slide Durability | Implied resistance to wear during sliding | Met all acceptance criteria |
| Kink Resistance | Implied resistance to kinking | Met all acceptance criteria |
| Torque Durability | Implied maintained torque performance over time | Met all acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the non-clinical tests. These are typically bench tests conducted on a sufficient number of units to demonstrate consistency, but not usually reported with statistical sample sizes in a 510(k) summary.
- Data Provenance: The tests were "non clinical laboratory testing." No country of origin for the data is specified, but the applicant is Asahi Intecc Co., Ltd. from Japan, and the testing likely occurred internally or at a contracted lab.
- Retrospective or Prospective: These were bench tests, so the concept of retrospective or prospective (which applies to clinical data) is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this type of non-clinical device testing. "Ground truth" established by human experts (like radiologists) pertains to diagnostic algorithms, not to the physical performance of a catheter. The ground truth for these tests is based on engineering specifications and measurement standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as it relates to expert consensus on clinical or diagnostic data. For bench testing, results are typically analyzed against predefined, objective, and measurable acceptance criteria.
5. 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
This information is not applicable. This device is a percutaneous catheter, not an AI-powered diagnostic tool. Therefore, MRMC studies and the effect of AI assistance on human readers are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is hardware (a catheter), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For non-clinical testing, the "ground truth" implicitly refers to the engineering specifications and performance standards. For example, for "Force at Break," the ground truth would be a defined minimum force the device must withstand, determined by engineering principles and safety margins. For "Dimensions," the ground truth is the specified dimensional tolerances.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of medical device submission.
§ 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).