(18 days)
The ASAHI Astato 30 Peripheral Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
The Asahi peripheral guide wire is a steerable guide wire with a diameter of 0.018" and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body for 180 cm wire. The wire is constructed from a stainless steel core wire with spring. The core wire and coil are soldered together. The distal end of the guide wire has a radiopaque tip that is straight and is made soft to easily bend with the vessel curve. The hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE.
The provided text describes a 510(k) summary for the ASAHI Astato 30 Peripheral Guide Wire. This document is for a medical device and therefore the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to demonstrating substantial equivalence to predicate devices through performance data.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence: Device materials are the same as predicate devices. | The ASAHI Astato 30 Peripheral Guide Wire is of the same materials as the predicate devices. |
| Dimensional/Design Equivalence: Dimensional specifications and design ensure compatibility for intended use. | The dimensional specifications and design of the device ensures compatibility for the intended use. |
| Performance as Intended: Mechanical and functional bench testing demonstrates the device performs as intended. | This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Astato 30 Peripheral Guide Wire performs as intended. Summary/Conclusion: Bench testing demonstrates that the device functions as intended. |
| Substantial Equivalence: Characteristics are substantially equivalent to specified predicate devices and other currently marketed devices for the same indication for use. | The ASAHI Astato 30 Peripheral Guide Wire characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "This 510(k) notice includes mechanical and functional bench testing." It does not specify:
- The exact sample size for the test set of the bench testing.
- The country of origin of the data.
- Whether the data was retrospective or prospective (bench testing is typically considered prospective in its execution for the submission, but the source of components might be retrospectively sourced).
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 section is not applicable as the study described is a bench test of a physical device, not an AI/software device that requires expert ground truth for interpretation of medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the study described is a bench test, not a study involving human interpretation with adjudication.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for a physical medical device (guide wire), not an AI or software device that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is a physical guide wire, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" would be the engineering specifications and performance standards for guide wires, as well as the performance of the predicate devices. The device was tested to ensure it met those specifications and performed comparably to legally marketed predicate devices.
8. The sample size for the training set
This section is not applicable as the document describes bench testing for a physical guide wire, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable as the document describes bench testing for a physical guide wire, not a machine learning model.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.