Search Results

This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.

The CROSSLEAD Penetration Peripheral Guide Wire (hereafter "CROSSLEAD Penetration") is steerable guide wire with a maximum diameter of 0.014" (0.36 mm) and 0.018" (0.46 mm) and available in 200 cm, 235 cm and 300 cm length. The guide wire is constructed from a stainless steel core wire with a Pt-Ni-Au alloy coil. The coil is soldered to the core wire with Au-Sn solder. The coil has radio - detectability to achieve visibility and can be made to bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion. The basic structure, construction, and coating of the CROSSLEAD Penetration are similar to that previously described in the predicate ASAHI Peripheral Guide Wire ASAHI Astato XS 40 (K153443) (hereafter "ASAHI Astato XS 40") and reference CROSSLEAD Peripheral Guide Wire (K213315) (hereafter "CROSSLEAD").and ASAHI Peripheral Guide Wire ASAHI Halberd (K150445) (hereafter "ASAHI Halberd")..

The provided document describes the FDA's 510(k) clearance for the CROSSLEAD Penetration Peripheral Guide Wire. This is a medical device, not an AI/ML powered device, so many of the requested fields are not applicable. However, I can extract information related to its non-clinical testing and acceptance criteria as provided.

1. A table of acceptance criteria and the reported device performance

The document states that the CROSSLEAD Penetration met all acceptance criteria in its bench testing. Specific acceptance criteria are not detailed in the summary, but the categories of tests performed are listed. The reported performance is generally stated as "performed similarly to the predicate devices" and "functions as intended."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical bench testing and biocompatibility testing. It generally refers to "bench testing" and "in vitro bench tests." There is no mention of a "test set" in the context of patient data, as this is a device clearance for a physical medical guide wire, not a diagnostic or prognostic algorithm. Therefore, information on sample size for a test set or data provenance (country of origin, retrospective/prospective) is not applicable or provided in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical medical device. "Ground truth" in the context of expert consensus on data is not relevant here. The "ground truth" for the performance of the device is established by meeting specified physical and biological performance criteria during bench and biological compatibility testing, per established international standards (e.g., ISO 10993).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring adjudication of a test set based on expert opinion.

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. This is a physical medical device, not an AI/ML device, and therefore no MRMC study or AI assistance assessment was conducted.

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 AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this medical device is established through compliance with recognized performance standards and validated test methods for physical characteristics and biocompatibility. This includes:

• Compliance with FDA guidance document: "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 15JUN2018."
• Compliance with ISO 10993 series for biocompatibility: This involves specific laboratory tests with predefined acceptance criteria. For example, for cytotoxicity, the ground truth is established by observing no signs of cellular reactivity (Grade 0) for controls. For sensitization, no evidence of delayed dermal contact sensitization in guinea pigs. For pyrogenicity, no increase in rectal temperature by more than 0.5 degrees Celsius.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not an AI/ML algorithm.

Ask a specific question about this device