(119 days)
PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA). The PCI Guide Wires are not to be used in the neurovasculature.
SION blue PLUS is steerable guide wire with a maximum diameter of 0.36mm (0.014 inches) and available in 190cm and 300cm lengths. The guide 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 guide wire has a 3cm radiopaque tip to achieve visibility and is available in a straight, Pre-shape and J-shape to bend with the vessel curve. A silicone and hydrophilic coatings are applied to the distal portion of SION blue PLUS. The proximal sections of the SION blue PLUS are coated with PTFE. The extension wire is connected to the end of the guide wire outside of the body for 190cm model.
This FDA 510(k) clearance letter pertains to a conventional medical device (a guide wire), not an AI/ML-enabled device. Therefore, the information requested about acceptance criteria, study data, ground truth establishment, expert adjudication, and MRMC studies, which are typical for AI/ML device clearances, is not present in this document.
The document details non-clinical bench testing for the SION blue PLUS guide wire to demonstrate its substantial equivalence to a predicate device.
Here's a breakdown of the available information based on your request, highlighting what is included and what is not applicable to this type of device submission:
1. A table of acceptance criteria and the reported device performance
The document states that "The in vitro bench tests demonstrated the SION blue PLUS met all acceptance criteria and performed similarly to the predicate/reference devices." However, it does not provide a specific table of acceptance criteria with corresponding performance data. It lists the types of tests performed:
- Dimensional Verification
- Visual Inspection
- Simulated Use/Human body Phantom
- Tensile Strength (including Tip Pull test)
- Torque Strength
- Torqueability
- Coating Integrity
- Particulate Evaluation
- Lubricity/Catheter Compatibility
- Corrosion Resistance
- Kink Resistance
- Tip Flexibility
- Radiopacity
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Sizes: Not specified. For physical device bench testing, sample sizes are typically determined by engineering standards and statistical power analysis for the specific tests (e.g., n=3, n=5, n=10 per test) but are not typically detailed in 510(k) summaries as they are for clinical or AI/ML studies.
- Data Provenance: Not applicable in the sense of clinical study data provenance (country, retrospective/prospective). The data comes from in vitro bench testing conducted by the manufacturer, ASAHI INTECC CO., LTD. (Global Headquarters and R&D Center in Seto, Aichi, Japan).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information is relevant for AI/ML device evaluations where human experts establish ground truth for image interpretation or diagnosis. For a physical device like a guide wire, performance is measured against engineering specifications and industry standards, not against "expert ground truth" in a clinical diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used in clinical or AI/ML studies where multiple human readers might disagree on a diagnosis or interpretation, requiring a consensus mechanism. This is not relevant for bench testing of a physical medical device.
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
- Not applicable. An MRMC study is a type of clinical study used to evaluate the diagnostic performance of a device (often AI-enabled) by comparing multiple readers' interpretations across multiple cases, sometimes with and without AI assistance. This device is a physical catheter guide wire, not a diagnostic or AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to the evaluation of an AI algorithm's performance independent of human interaction. Since SION blue PLUS is a physical guide wire, this concept does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the clinical sense. For this device, "ground truth" equates to the pre-defined engineering specifications, performance standards, and material properties that the device must meet during bench testing. For example, a tensile strength test would have an acceptance criterion (e.g., withstand X Newtons of force), and the device's measured performance against this criterion is the "truth."
8. The sample size for the training set
- Not applicable. This concept pertains to AI/ML devices where a "training set" is used to develop the algorithm. This device is a physical instrument, not an AI.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary, the provided 510(k) clearance letter is for a physical medical device. The types of detailed information requested regarding AI/ML study design, ground truth, expert adjudication, and sample sizes for training/test sets are not relevant to this specific device submission and therefore are not present in the document. The document focuses on demonstrating substantial equivalence through non-clinical bench testing of the device's physical and material properties.
§ 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.