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510(k) Data Aggregation
(265 days)
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
The ASAHI® PTCA Guide Wire ASAHI SION black consists of a core wire and a coil assembly. The coil assembly consists of an inner coil, safety wire, 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 the ASAHI® PTCA Guide Wire ASAHI SION black. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE. The ASAHI® PTCA Guide Wire ASAHI SION black is available in various lengths and tip shapes. The shorter length device is designed for use with a commercially available ASAHI INTECC extension wire.
This document describes the premarket notification for the ASAHI® PTCA Guide Wire ASAHI SION black. It does not contain information about an AI/ML powered device, therefore no information regarding acceptance criteria or a study that proves the device meets acceptance criteria related to AI/ML device performance can be extracted.
The document discusses non-clinical laboratory testing performed on the guide wire to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not a software or AI-based one. The types of tests conducted are standard for guide wires (e.g., tensile strength, torqueability, tip flexibility, etc.) and the conclusion is that the device met all acceptance criteria and performed similarly to predicate devices.
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(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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(238 days)
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
As a basic structure, the Fielder XT-A, Fielder XT-R, consists of a taper core wire and 2 types coils (a tapered outer coil and an inner rope coil). The taper core wire and the coils are soldered together. The coil is radiopaque so as to easily confirm its position under radioscopy.
The coil and distal part of tapered core wire of the products are coated with polyurethane and then covered with hydrophilic polymer. The proximal end of the tapered core wire is coated with PTFE.
The nominal outer diameter of both the Fielder XT-A and Fielder XT-R is 0.36mm. with a distal diameter of 0.26mm. Both the Fielder XT-A and Fielder XT-R are available in 190cm and 300cm, total length. The tip shape is straight.
The provided document does not contain an acceptance criteria table with reported device performance for a medical device. Instead, it is an FDA 510(k) summary for the ASAHI Fielder XT-A and ASAHI Fielder XT-R guide wires, demonstrating substantial equivalence to predicate devices. The document outlines general testing performed but does not provide specific quantitative acceptance criteria or detailed results.
However, based on the information provided, here's a breakdown of what is available regarding testing and equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "The in vitro bench tests demonstrated that the ASAHI Fielder XT-A and ASAHI Fielder XT-R met acceptance criteria and performed similarly to the predicate devices."
It does not provide a table with specific quantitative acceptance criteria or the numerical results of the device's performance against those criteria. It only lists the types of tests performed.
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Device functions as intended | Met acceptance criteria and performed similarly to predicate devices. |
| Safety profile similar to predicate devices | Verified to be the same as those of the predicates. |
| Effectiveness profile similar to predicate devices | Verified to be the same as those of the predicates. |
| Specific detailed criteria (e.g., tensile strength in Newtons) | Not provided in the document. |
| Specific numerical performance (e.g., actual tensile strength) | Not provided in the document. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the exact sample size for each bench test performed (Dimensional Verification, Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adhesion, Catheter Compatibility, Coating Integrity / Particulate testing).
- Data Provenance: The tests were "Non clinical laboratory testing" performed by "ASAHI INTECC CO.,LTD" (applicant). The company is based in Nagoya, Aichi, Japan, with research facilities and factories in Osaka, Seto, Thailand, and Hanoi, suggesting the testing likely occurred in one of these locations. The data is retrospective for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and therefore not provided. The testing described is bench testing of physical device characteristics, not clinical studies requiring expert interpretation of patient data to establish ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable as the testing involves objective physical measurements and comparisons to predicate devices, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was done. The device is a PTCA guide wire, and its performance is evaluated through bench testing and comparison to existing predicate devices, not through a comparative clinical effectiveness study with human readers interpreting imaging.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
This question is not applicable. The device is a physical medical device (guide wire), not an algorithm or AI system. Its performance is inherent to the device itself.
7. Type of Ground Truth Used:
The "ground truth" for the bench tests was based on predetermined acceptance criteria for physical and mechanical properties, likely derived from engineering specifications and performance characteristics of functionally equivalent predicate devices. For example, a certain tensile strength or torqueability range would be considered acceptable based on established standards for guide wires.
8. Sample Size for the Training Set:
This information is not applicable. There is no training set mentioned or implied as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set.
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