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510(k) Data Aggregation
(85 days)
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
This guide wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.
The ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) consists of a core wire and a coil assembly. The coil assembly consists of a stainless steel distal safety wire and an outer coil, soldered to the core wire. The outer coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010). The coil and taper core wire of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) are coated with polyurethane and coated with a hydrophilic polymer upon the polyurethane coat. The distal portion of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) is soft in order to easily bend in accordance with the vessel curve. Accessories such as a Torque device. Shaping device and Inserter are included in the packaging of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010).
The provided text describes the 510(k) premarket notification for the ASAHI Neurovascular Guide Wire (ASAHI CHIKAI X 010). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets a set of performance criteria through a study with human readers or AI algorithms. As such, the information typically requested for AI/human reader studies (e.g., sample size for test/training sets, expert qualification, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not applicable to this document. This submission relies on non-clinical bench testing to demonstrate performance and similarity to predicate devices.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes non-clinical laboratory testing performed to demonstrate substantial equivalence. The "acceptance criteria" are generally based on meeting established specifications derived from predicate device performance and the manufacturer's own standards.
| Test | Test Method Summary | Acceptance Criteria / Reported Device Performance |
|---|---|---|
| Tensile Strength | Determine maximum allowable tensile load between connections by pulling until failure. | Acceptance Criteria: Determined by evaluation of predicate devices and ASAHI's established tensile strength specifications. |
| Performance: All test articles met established tensile strength acceptance criteria. | ||
| Torque Strength | Distal end inserted & advanced through simulated model. Distal tip held stationary while proximal end rotated until failure. | Acceptance Criteria: Determined by evaluation of predicate devices and ASAHI's established torque strength specifications. |
| Performance: All test articles met the acceptance criteria. | ||
| Torqueability | Guide wire inserted through catheter & into Rotational Response model. Proximal end rotated from 0° to 720°. Torque response at distal end measured at each 90° angle. | Acceptance Criteria: Met by test articles. |
| Performance: Torque response is similar or better than predicate. | ||
| Tip Flexibility | Force to deflect the guide wire 45° and 90° at 5, 10, and 20 mm from distal tip measured by a force analyzer. | Acceptance Criteria: Established by evaluation of predicate devices and ASAHI's established Tip Flexibility specifications. |
| Performance: All test articles met established Tip Flexibility acceptance criteria. | ||
| Coating Adherence | Integrity of coated outer coil & core wire determined before, and after, pretreatment and manipulation in excess of that expected in clinical use. | Acceptance Criteria (Implied): Coating integrity maintained. |
| Performance: Test results confirmed that the integrity of the coating was maintained during simulated clinical use in all test articles. | ||
| Coating Integrity / Particulate Characterization | Total quantity and size of the particulates generated during the simulated use of the device is measured. | Acceptance Criteria (Implied): Similar to predicate. |
| Performance: Test results are similar to the predicate. | ||
| Catheter Compatibility | Evaluated by measuring the force to withdraw the guide wire after insertion through a test catheter. | Acceptance Criteria: Met by test articles. |
| Performance: Resistance to catheter withdrawal is similar or better than predicate. | ||
| Bench Testing (Simulated) | Guide wire inserted through guide catheter placed in simulated model and advanced to target area. Interventional catheter inserted over guide wire & advanced to target cerebral artery multiple times. | Acceptance Criteria (Implied): Device functions as intended, similar to predicate. |
| Performance: The in vitro bench tests demonstrated that the device met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for each test. It consistently states "All test articles met..." or "The total quantity and size of the particulates generated...". This implies that for each test, a sufficient number of device samples were tested to provide statistical confidence, though the exact 'n' is not detailed.
- Data Provenance: The testing appears to be laboratory-based, non-clinical bench testing conducted by the manufacturer, ASAHI INTECC CO., LTD., which is based in Japan. This is not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This submission is for a medical device (guide wire) and relies on engineering and material performance specifications through bench testing, not on interpretation of images or clinical outcomes that would require expert consensus for ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. As this is non-clinical bench testing, there are no human readers or expert adjudications involved in establishing ground truth. The "ground truth" or "reference standard" for these tests is the quantitative measurement or observation against predetermined engineering specifications.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Not Applicable. An MRMC study involves human readers interpreting cases, often with and without AI assistance, to assess diagnostic performance. This document concerns a physical device, not an imaging AI or a diagnostic tool that relies on human interpretation in that manner.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) Performance
- Not Applicable. There is no algorithm or AI component to this device. Its performance is based purely on its physical and mechanical properties.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical tests is established by engineering specifications, physical measurements, and performance characteristics benchmarked against predicate devices. For example, tensile strength is measured against a specified load, and coating adherence is visually and physically assessed against a standard.
8. The Sample Size for the Training Set
- Not Applicable. The device does not involve machine learning or AI, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there's no training set, there's no ground truth for it. The "acceptance criteria" here are established engineering and performance benchmarks, often derived from industry standards, historical data on predicate devices, and internal quality control specifications.
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