(263 days)
The Streamer Polymer guide wires are intended for use in the coronary and peripheral vasculature to facilitate the selective placement of interventional catheters with compatible guidewire lumen and Biotronik coronary venous leads.
The Biotronik Streamer polymer guide wire is a disposable medical device designed for single use only. It consists of a PTFE coated 195cm 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over a 38cm segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and is varied to produce 3 unique levels of support, standard support, extra support (ES) and extra distal support (XT). There are a total of 8 versions of the guidewire, 2 standard support versions (straight & J), 4 extra support versions (straight and ), Bulach and Berlin) and 2 extra distal support versions (straight & J}. The distal part of the reduced section is covered with a platinum tungsten spring coil of equivalent diameter to the main core body. This provides greater visibility on x-ray equipment. A 30cm length of blue heat shrink polymer tubing is applied over the tapered distal end of the wire and ground to form a constant outer diameter, OD. The polymer jacket over distal coils provides for smoother lead-guidewire interaction.
The provided text describes a 510(k) premarket notification for the "Streamer Polymer Guidewire" and focuses on demonstrating its substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and performance against them.
Therefore, the requested information for acceptance criteria and specific study details (like sample sizes for test/training, ground truth methods, expert qualifications, MRMC studies, or standalone performance) is not present in the provided document. The document describes a "Summary of Testing" but does not provide granular details on acceptance criteria or the specific methodologies for each test.
Based on the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the successful tests "demonstrated the Streamer Polymer Guidewires consistently performed within their design parameters, are safe and effective and perform as well as the predicate devices." However, specific quantitative acceptance criteria or detailed performance metrics are not provided.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not provided.
- Data Provenance: The testing was conducted by Brivant Limited, an Irish company. No information on the country of origin of the data or whether it was retrospective or prospective is given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of information is typically relevant for studies involving human interpretation (e.g., imaging diagnostics), not for hardware performance testing of a guidewire. The ground truth for guidewire performance is typically based on engineering specifications and physical measurements.
4. Adjudication method for the test set:
- Not applicable/Not provided. This is not relevant for the type of bench testing described for a guidewire.
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:
- No. This is not applicable as the device is a medical guidewire, not an AI-powered diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance assessment was done in the sense that the guidewire's physical characteristics were tested independently. However, the details of "algorithm only" performance are not applicable since it's a physical device, not a software algorithm. The "Summary of Testing" lists various physical and mechanical tests:
- Tensile strength
- Torque strength
- Torque response
- Coating performance
- Radiopacity
- Tip flexibility
- Catheter compatibility testing
- Accelerated aging
- Transportation testing
- Sterilisation validation adoption
- Biocompatibility testing (in compliance with ISO 10993-1 and ISO 10993-4)
7. The type of ground truth used:
- For the physical tests, the "ground truth" would be the established engineering specifications, material standards, and benchmark performance of predicate devices. The document states that the successful tests "demonstrated the Streamer Polymer Guidewires consistently performed within their design parameters" and "perform as well as the predicate devices."
8. The sample size for the training set:
- Not provided. This is generally not applicable for non-AI medical devices undergoing physical performance testing.
9. How the ground truth for the training set was established:
- Not applicable/Not provided as there is no specific "training set" in the context of physical product testing for a guidewire in the way it is understood for AI/ML models.
§ 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.