(67 days)
The BridgePoint Medical Stingray™ Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Stingray™ Guidewires are not to be used in cerebral blood vessels.
The Stingray™ Guidewire is a conventionally constructed 0.014" diameter, single use, disposable guidewire that consists of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the shaft is taper ground to provide distal flexibility. The distal portion also includes a coaxially positioned coil constructed of platinum/tungsten material for visibility under fluoroscopy. The coil is fixed to the stainless steel core wire via silver alloy solder and is coated with hydrophilic coating. The distal tip of the guidewire is supplied with an angled geometry which transitions to a conventional rounded tip. A short extension with an approximate diameter of 0.0035" (which is a monolithic extension of the core wire) extends approximately 0.007" distal of the rounded tip.
The provided text is a 510(k) summary for the BridgePoint Medical Stingray™ Guidewire. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically seen in performance studies for AI/medical imaging devices.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) through comparison of intended use, technological characteristics, and material properties. This is a common pathway for medical device clearance, especially for devices that are structurally similar to already approved products.
Therefore, I cannot populate the table or provide information for most of the requested points, as the provided text does not describe a performance study with acceptance criteria and results in the way you've outlined for AI or diagnostic devices.
Here's how I would address your request based only on the provided text, indicating where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. The document focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance criteria in a quantitative study. | Not applicable. Performance metrics with specific thresholds are not reported. The device is stated to have "similar physical attributes (flexibility, radiopacity, lubricity, extension wire compatibility, etc.)" to predicate devices, and its distal tip is "radiopaque and can be seen with fluoroscopy" and is "highly lubricious." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. This type of information is not relevant for a substantial equivalence claim based on device design and material comparison.
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 provided. Ground truth determination by experts is not described, as there isn't a diagnostic performance study in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. Adjudication methods are not applicable here.
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. An MRMC comparative effectiveness study was not performed, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. A standalone performance study was not performed, as this is not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The concept of "ground truth" for a diagnostic outcome is not relevant in this 510(k) submission, which describes a guidewire.
8. The sample size for the training set
- Not applicable. The device is a physical guidewire, not an AI model, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
§ 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.