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510(k) Data Aggregation
(171 days)
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal anqioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
ASAHI PTCA Guide Wire ASAHI SION (hereafter "ASAHI SION"), ASAHI PTCA Guide Wire ASAHI SION blue (hereafter "ASAHI SION blue") and ASAHI PTCA Guide Wire ASAHI SION J (hereafter "ASAHI SION J") are steerable guidewires with a maximum diameter of 0.014 inches (0.36mm) and available in 180cm. 190cm and 300cm lengths. The quide wire is constructed from stainless-steel core wire with platinum-nickel and stainless-steel coils. The coils assembly consists of an inner coil and an outer coil, as well as a safety wire which is soldered to the inner and outer coils and the core wire. The distal end of the quide wire has a radiopaque tip to achieve visibility and is available in a straight (ASAHI SION) and shaped "J" (ASAHI SION blue, ASAHI SION J) and Pre-Shape (ASAHI SION and ASAHI SION blue) to easily bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire (ASAHI SION and ASAHI SION J). A silicone and hydrophilic coating are applied to the distal portion of the guide wire for (ASHI SION blue). The proximal sections of the ASAHI SION Series are coated with PTFE.
The provided document is a 510(k) Pre-market Notification from the FDA for the Asahi PTCA Guide Wire Asahi SION Series. It describes non-clinical testing performed to establish substantial equivalence to predicate devices. However, it does not include information about any studies that would involve AI or human readers.
Here's the breakdown of the information provided for the device's acceptance criteria and studies, as requested, focusing on what is available in the document:
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, the specific quantitative acceptance criteria values for each test are not explicitly detailed. The performance is reported as meeting these (unstated) criteria and being similar to predicate devices.
| Test Performed | Reported Device Performance |
|---|---|
| Tensile Strength | Met all acceptance criteria and performed similarly to predicate devices. |
| Torque Strength | Met all acceptance criteria and performed similarly to predicate devices. |
| Coat Adhesion | Met all acceptance criteria and performed similarly to predicate devices. |
| Particulate | Met all acceptance criteria and performed similarly to predicate devices. |
| Biocompatibility | Passed various ISO 10993 tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility). |
2. Sample Size for the Test Set and Data Provenance:
The document mentions "non-clinical laboratory testing" and "in vitro bench tests." It does not specify the sample sizes used for these tests. The data provenance is described as non-clinical laboratory testing, implying controlled lab environments, not patient data from specific countries. It is retrospective, as it's testing a finished product against established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is a non-clinical device performance study, not involving human interpretation of data where expert ground truth would be established. The acceptance criteria are based on engineering and material science standards.
4. Adjudication Method for the Test Set:
Not applicable. This is a non-clinical device performance study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not conducted or described in this document. This filing is for a physical medical device (guidewire), not a software or AI-based diagnostic tool that would typically involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not conducted or described. The device is a physical guidewire, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests is established by industrial standards and pre-defined specifications for medical devices (e.g., ISO 10993 for biocompatibility, and unspecified internal criteria for mechanical properties like tensile strength, torque strength, coat adhesion, and particulate matter).
8. The Sample Size for the Training Set:
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set mentioned, there is no corresponding ground truth establishment process for it.
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(114 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 Gladius Mongo consists of a one-piece core wire and a distal 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 the ASAHI® PTCA Guide Wire ASAHI Mongo. 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 only. The ASAHI® PTCA Guide Wire ASAHI Mongo is available in various lengths. The shorter length device is designed for use with a commercially available ASAHI INTECC extension, wire.
The provided text describes the 510(k) premarket notification for the "ASAHI® PTCA Guide Wire ASAHI Gladius Mongo 14 and ASAHI Gladius Mongo 14 ES." This document pertains to a medical device (a guide wire), not an AI algorithm or a diagnostic tool. Therefore, the questions regarding acceptance criteria and studies for an AI/ML powered device, specifically those requiring information on human readers, ground truth establishment for AI training/test sets, and expert adjudication, are not applicable to this document.
The document focuses on demonstrating substantial equivalence of the new guide wire to a legally marketed predicate device (ASAHI® Fielder XT-A). It primarily relies on non-clinical testing/performance data to show that the new device functions as intended and has a similar safety and effectiveness profile.
Here's a breakdown of the relevant information provided, responding to the spirit of the request where applicable to a traditional medical device:
1. A table of acceptance criteria and the reported device performance:
The document lists the following non-clinical tests performed, implying that internal acceptance criteria were met. However, the specific quantitative acceptance criteria and the exact reported performance results (e.g., specific tensile strength values or torque strength ranges) are not detailed within this public summary. The statement is qualitative: "met all acceptance criteria and performed similarly to the predicate device."
| Test Performed | Implied Acceptance Criteria (Qualitative) | Reported Device Performance (Qualitative) |
|---|---|---|
| Tensile Strength | Met predefined strength requirements | Performed similarly to predicate |
| Torque Strength | Met predefined torque requirements | Performed similarly to predicate |
| Torqueability | Met predefined torqueability standards | Performed similarly to predicate |
| Tip Flexibility | Met predefined flexibility standards | Performed similarly to predicate |
| Coating Adhesion | Met predefined adhesion standards | Performed similarly to predicate |
| Catheter Compatibility | Compatible with standard catheters | Performed similarly to predicate |
| Particulate Testing/ Coating Integrity | Met predefined particulate limits and coating integrity standards | Performed similarly to predicate |
| Lubricity Testing | Met predefined lubricity standards | Performed similarly to predicate |
| Biocompatibility | Materials are biocompatible (similar to predicate/reference devices) | Verified to be the same as predicate/reference devices based on material similarity |
Regarding the other questions, they are not directly applicable to this type of device submission:
- 2. Sample sized used for the test set and the data provenance: This refers to data for an AI model. For this physical device, "sample size" would refer to the number of devices tested for each non-clinical test. This specific number is not provided in the summary. Data provenance is not relevant for a physical device's bench testing.
- 3. Number of experts used to establish the ground truth... and qualifications: This is for AI performance evaluation. Not applicable.
- 4. Adjudication method... for the test set: This is for AI performance evaluation. Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: This is for AI performance evaluation. Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is for AI algorithm performance. Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This is for AI ground truth. For this device, "ground truth" would be established by validated test methods and engineering specifications.
- 8. The sample size for the training set: This is for AI model training. Not applicable.
- 9. How the ground truth for the training set was established: This is for AI model training. Not applicable.
In summary, the provided document is a 510(k) summary for a physical medical device (a guide wire), and the questions posed are primarily designed for the evaluation of AI/ML-powered medical devices. Therefore, most of the specific details requested regarding AI acceptance criteria, ground truth, and study design are not found within this document. The core of this submission is demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical bench testing.
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(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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