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510(k) Data Aggregation
(120 days)
ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in coronary arteries, lower limb blood vessels, neurovasculature and carotid arteries.
The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 consists of a core wire and a coil assembly. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16. The coil and taper core wire of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 are coated with polyurethane and coated with a hydrophilic polymer upon the polyurethane coat. The distal portion of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is soft in order to easily bend in accordance with the vessel curve. The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is available in various lengths and tip shapes. Accessories such as a Torque device, Shaping device and Inserter are included in the packaging of the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16.
This document is a 510(k) Summary for the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16, submitted by ASAHI INTECC CO., LTD. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a dedicated study for a new clinical indication.
Therefore, many of the requested categories regarding acceptance criteria and study design for a new device or algorithm are not directly applicable or available in this document. This document describes the testing performed to show the new device is as safe and effective as a previously cleared device.
Here's the information extracted and organized as requested, with notes where information is not applicable or present in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that non-clinical laboratory testing was performed and that the device "met all acceptance criteria." However, it does not explicitly list the specific quantitative acceptance criteria for each test. Instead, it generally states that the device "performed similarly to the predicate devices" and "functions as intended."
| Test Performed | Acceptance Criteria (Not explicitly stated as quantitative thresholds in the document) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Performed similarly to predicate devices | Met all acceptance criteria / Performed similarly to predicate devices |
| Torque Strength | Performed similarly to predicate devices | Met all acceptance criteria / Performed similarly to predicate devices |
| Torqueability | Performed similarly to predicate devices | Met all acceptance criteria / Performed similarly to predicate devices |
| Tip Flexibility | Performed similarly to predicate devices | Met all acceptance criteria / Performed similarly to predicate devices |
| Coating Adhesion/Integrity | Performed similarly to predicate devices | Met all acceptance criteria / Performed similarly to predicate devices |
| Catheter Compatibility | Performed similarly to predicate devices | Met all acceptance criteria / Performed similarly to predicate devices |
| Biocompatibility | Similar to predicate/reference devices (for all endpoints except complement activation) | Met all acceptance criteria / Leveraged from predicate/reference devices |
2. Sample size used for the test set and the data provenance
The document mentions "non clinical laboratory testing" and "in vitro bench tests." These are likely physical tests on device samples. The sample size for these tests is not specified in the provided text. The data provenance is laboratory testing (bench tests). There is no mention of patient data (country of origin, retrospective/prospective) as this is a physical device equivalence submission, not a clinical study of an AI/software device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device submission. Ground truth for physical device performance is typically established through standardized testing methods, not expert human assessment in the way it's used for AI diagnostic tools.
4. Adjudication method for the test set
This information is not applicable as there are no expert readers or interpretations for physical bench testing outcomes.
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 document describes a physical medical device (guide wire), not an AI algorithm, and therefore, an MRMC study or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used
For the non-clinical testing, the "ground truth" would be established by objective measurements and predefined pass/fail criteria based on engineering specifications and comparison to the predicate device's established performance, rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not applicable as this document does not describe an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this document does not describe an AI/ML algorithm that requires a training set.
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(29 days)
The Asahi Regalia XS 1.0 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 Regalia XS 1.0 Peripheral Guide Wire is steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is made flexible to bend easily at the vessel curve. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire. The proximal section of this guide wire is coated with PTFE.
This document is a 510(k) summary for the Asahi Regalia XS 1.0 Peripheral Guide Wire. It asserts substantial equivalence to predicate devices, and therefore, does not contain information about acceptance criteria or a study proving the device meets new acceptance criteria.
The submission states: "This submission represents a change to the existing product labeling. Additional performance testing is not applicable." This indicates that no new performance studies were conducted for this specific 510(k) submission.
Therefore, the requested information cannot be filled from the provided text.
Here's how I would answer based only on the provided text, indicating what information is not available:
Acceptance Criteria and Device Performance Study for Asahi Regalia XS 1.0 Peripheral Guide Wire
Based on the provided 510(k) summary, the sponsor (Asahi Intecc Co., Ltd.) states that additional performance testing is not applicable for this submission, as it represents a change to existing product labeling. The device's substantial equivalence is asserted based on similarities in materials and dimensional specifications to already cleared predicate devices. Therefore, there are no specific, new acceptance criteria or a study described within this document that proves the device meets such criteria.
The document emphasizes substantial equivalence rather than presenting new performance data.
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Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not specified as no new performance testing was conducted.
- Reported Device Performance: Not reported as no new performance testing was conducted beyond asserting equivalence to predicate devices based on material and dimensional characteristics.
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Sample size used for the test set and the data provenance: Not applicable. No new test set and data provenance for performance evaluation are described.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment for a test set is described.
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Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and 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 guide wire, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (guide wire), not an algorithm.
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The type of ground truth used: Not applicable. No new ground truth for performance evaluation is described. The basis for clearance is substantial equivalence to legally marketed predicate devices.
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The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable. No training set is described.
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