(270 days)
This Product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.
The CROSSLEAD Peripheral Guide Wire (hereafter "CROSSLEAD") is a steerable guide wire with a maximum diameter of 0.035 inches (0.89mm) and available in 200cm and 300cm length. The guide wire is constructed from a Ni-Ti alloy core wire with a stainless steel coil. The coil is soldered to the core wire with Ag-Sn solder. The coil has radiopacity to achieve visibility and can be made to bend easily 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 are unchanged from that previously described in the predicate Radifocus Glidewire Advantage (K063372) and reference ASAHI Silverway (K183062) and ASAHI Regalia XS 1.0 (K083146)
The provided text describes the regulatory submission for a medical device called "CROSSLEAD Peripheral Guide Wire". This document does not contain information about an AI/ML powered device, and therefore the acceptance criteria and study details related to AI/ML device performance are not present.
The document discusses the substantial equivalence of the CROSSLEAD device to previously cleared predicate devices through non-clinical testing and biocompatibility assessments.
Here's a breakdown of the information that is provided, as it relates to the non-AI device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the CROSSLEAD met "all acceptance criteria" but does not provide specific quantitative acceptance criteria or the numerical performance results for each test. Instead, it offers a list of tests performed.
| Test Category | Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|---|
| Non-Clinical Performance Tests | Met all acceptance criteria (specifics not provided) | Performed similarly to the predicate devices. Functions as intended. |
| Biocompatibility (Cytotoxicity) | No signs of cellular reactivity (Grade 0) for controls | Non-cytotoxic |
| Biocompatibility (Sensitization) | No evidence of causing delayed dermal contact sensitization | Non-sensitizing |
| Biocompatibility (Irritation) | Test extract and negative control exhibit similar edema and erythema scores | Non-irritant |
| Biocompatibility (Systemic Tox.) | Test article not show significantly greater biological activity than control | No Systemic Toxicity |
| Biocompatibility (Pyrogen Test) | Not increase rectal temperature by more than 0.5 degrees Celsius | Non-pyrogenic |
| Biocompatibility (Hemolysis) | Non-hemolytic | Non-hemolytic |
| Biocompatibility (Thromboplastin) | UPTT of plasma not significantly decreased compared to controls | Not an activator |
| Biocompatibility (Complement) | No significant increase in SC5b-9 compared to controls | Not an Activator |
| Biocompatibility (Thrombogenicity) | Comparable to predicate control for thrombogenic response | Comparable thromboresistance with control |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified for the non-clinical or biocompatibility tests.
- Data Provenance: Not specified. The tests were performed in a lab setting ("bench testing") and are likely internal to the manufacturer or conducted by contract research organizations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This concept is not applicable to the non-clinical and biocompatibility testing described. These tests involve laboratory measurements against established standards, not expert interpretation of data.
4. Adjudication Method for the Test Set:
Not applicable, as this refers to expert review in clinical or diagnostic assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. This type of study is not relevant for the evaluation of a physical guide wire.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
No. This device is not an algorithm.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" would be the established engineering specifications and performance benchmarks derived from relevant FDA guidance documents (e.g., "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 15JUN2018"). For biocompatibility, the ground truth is defined by the ISO 10993 standards and the expected biological responses.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 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.