(207 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 cerebral blood vessels.
The ASAHI SION blue PTCA Guide Wire is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm lengths. The guide wire is constructed from a stainless steel core wire with platinum-nickel and stainless steel coils. The coil assembly consists of an inner coil and an outer coil, and there is a safety wire for which is soldered to the inner and outer coils and the core wire. The distal end of the guide wire has a radiopaque to achieve visibility. The distal end of the coil part is available straight and is made soft to easily bend with the vessel curve, or available as a pre shaped "J ". Silicone and hydrophilic coatings are applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE. The extension wire is connected to the end of the guide wire outside the body for 180 cm wire.
The provided text describes a medical device, the ASAHI SION blue PTCA Guide Wire, and its 510(k) summary for FDA clearance. It outlines the performance data used to demonstrate substantial equivalence to predicate devices, but does not describe an AI medical device or a study involving AI. Therefore, I will extract information related to the device's acceptance criteria and the study proving it meets those criteria, as much as possible for a non-AI medical device.
Key Missing Information for AI Devices:
The document is for a physical medical device (guide wire) and therefore does not contain information about:
- Sample size used for the test set and the data provenance for an AI model.
- Number of experts used to establish ground truth for an AI model's test set.
- Adjudication method for an AI model's test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study for AI.
- Standalone (algorithm only) performance for AI.
- Sample size and ground truth establishment for a training set in AI.
Here's the information extracted from the provided text, focusing on the acceptance criteria and the study performed for the ASAHI SION blue PTCA Guide Wire:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test/Evaluation | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Tests | ||
| Tensile Strength | Met predetermined performance criteria (details not specified) | Performance data "demonstrates that the ASAHI SION blue PTCA Guide Wire meets all predetermined performance criteria and performs as intended." (Specific numerical results not provided in this summary) |
| Turns to Failure (Torque Strength) | Met predetermined performance criteria (details not specified) | Performance data "demonstrates that the ASAHI SION blue PTCA Guide Wire meets all predetermined performance criteria and performs as intended." (Specific numerical results not provided in this summary) |
| Torqueability (Torque Response) | Met predetermined performance criteria (details not specified) | Performance data "demonstrates that the ASAHI SION blue PTCA Guide Wire meets all predetermined performance criteria and performs as intended." (Specific numerical results not provided in this summary) |
| Tip Flexibility | Met predetermined performance criteria (details not specified) | Performance data "demonstrates that the ASAHI SION blue PTCA Guide Wire meets all predetermined performance criteria and performs as intended." (Specific numerical results not provided in this summary) |
| Coating Adhesion | Met predetermined performance criteria (details not specified) | Performance data "demonstrates that the ASAHI SION blue PTCA Guide Wire meets all predetermined performance criteria and performs as intended." (Specific numerical results not provided in this summary) |
| Slipping Ability of Guide Wire with PTCA Balloon Catheter | Met predetermined performance criteria (details not specified) | Performance data "demonstrates that the ASAHI SION blue PTCA Guide Wire meets all predetermined performance criteria and performs as intended." (Specific numerical results not provided in this summary) |
| Particulate Evaluation | Demonstrated acceptable levels of particulates. (Specific criteria not detailed, but states "conducted with a combination assessment with the subject device itself and data leveraged from the predicate devices with identical product material and manufacturing process.") | Demonstrated acceptable particulate levels, leveraged from subject device assessment and identical predicate device data. (Conclusions of meeting criteria are implicit in the "summary/conclusion" of substantial equivalence) |
| Biocompatibility Tests | Acceptable biocompatibility for use in the vasculature (details from predicate devices not specified in this summary). The materials have a "long history of use in medical devices and are proven to be biocompatible for use in the vasculature." The biocompatibility tests listed below were leveraged from predicate devices with identical materials and manufacturing processes, implying the predicate devices met these criteria. | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." (i.e., met criteria by leveraging predicate device data). |
| Systemic Toxicity Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| In Vitro Hemolysis Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| Intracutaneous Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| Cytotoxicity Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| Sensitization Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| Pyrogen Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| Plasma Recalcification Time | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| Coagulation Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| In Vivo Thromboresistance Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| C3a Complement Activation Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| SC5b-9 Complement Activation Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in this summary. The text mentions "in vitro bench testing" and "particulate evaluation was conducted with a combination assessment with the subject device itself and data leveraged from the predicate devices." For biocompatibility, testing was "leveraged from the predicate devices."
- Data Provenance: The company, Asahi Intecc Co., Ltd., is based in Japan. The testing described (in vitro bench testing) would likely have been conducted by the manufacturer or a contract lab. The data related to predicate devices are from previously cleared 510(k) devices by Asahi Intecc. This would be considered retrospective for the predicate data and likely prospective for the specific bench tests conducted on the ASAHI SION blue device. The country of origin of the data is not specified beyond the company's location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This summary describes a physical medical device and its performance in bench testing, not an AI model requiring expert ground truth or interpretation of images/data. The "truth" in this context is based on engineering specifications and established test methodologies.
4. Adjudication Method for the Test Set
- Not applicable. This is a physical device tested against engineering and biocompatibility standards, not an AI model where human adjudication of results is typical.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No such study was done or described. This is a premarket notification for a physical medical device, not an AI-assisted diagnostic or therapeutic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- For mechanical/physical tests: The ground truth is the established engineering specifications and performance standards for guide wires, and comparison to the performance of equivalent predicate devices.
- For biocompatibility: The ground truth is established biocompatibility standards for medical devices and successful use of identical materials and manufacturing processes in previously cleared predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This summary is for a physical medical device, not an AI model that uses a training set. The term "training set" is not relevant here.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no "training set" in the context of this device.
§ 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.