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510(k) Data Aggregation
(171 days)
Asahi PTCA Guide Wire Asahi SION Series
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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