(84 days)
The PT2TM Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. The PT2TM Guide Wires are not intended for use in the cerebral vasculature.
The AddWireTM Extension Wire creates an extended guide wire that can be used to exchange out a therapeutic device without removing the original guide wire from the anatomy. When the exchange is complete, the Extension Wire can be detached and the original guide wire can be used in a conventional manner.
Guide Wire: The PT2TM Guide Wires with ICE® hydrophilic coating are steerable, polymer-tipped guide wires. The PT2TM is available in a nominal diameter of 0.014 inches, two rail support models, Light Support and Moderate Support, and nominal lengths of 185 and 300 centimeters with Brachial and Femoral marks at 90cm and 100cm respectively. The distal two centimeters of all models are radiopaque and available in either a straight shapeable or a pre-formed J-Tip. The 185-centimeter version of the PT2TM is designed with a proximal extension section. This proximal extension section allows connection to the AddWireTM Extension Wire or the similarly designed TrooperTM/PatriotTM Extension Wire. The PT2TM corewire consists of a PTFE coated SS corewire segment coupled to a tapered Nitinol corewire segment. The PT2TM coupler is a stainless steel material. The distal most end of the PT2TM corewire is a SS ribbon. The distal tapered Nitinol corewire segment of the PT2TM is coated with an adhesive pre-coat. The pre-coated corewire is then jacketed with a Tungsten loaded polyurethane sleeve. The entire polymer sleeve of the PT2TM Guide Wire is coated with ICE® Hydrophilic coating.
Extension Wire: The AddWireTM Extension Wire is a PTFE coated SS wire with a connector at the distal end that connects to the proximal end of BSC extendable guide wires. The nominal length is 145 cm and the nominal diameter is 0.014 inches. The AddWireTM Extension Wire is similar in design and materials to the LRM Extension Wire that is currently marketed by BSC as the TrooperTM/PatriotTM Extension Wire.
The Boston Scientific Corporation (BSC) PT2™ Guide Wire and AddWire™ Extension Wire, covered by K030617, received 510(k) clearance based on substantial equivalence to existing predicate devices.
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly list acceptance criteria in a quantitative table format. Instead, it states that "Test results verified that the PT2TM Guide Wires met all of the minimum requirements and are adequate for their intended use" and similarly for the AddWire™ Extension Wire. The performance is summarized qualitatively by confirming that both devices met their respective minimum requirements and are adequate for their intended use.
However, based on the non-clinical tests conducted, the implicit acceptance criteria would have been successful completion of these tests without failure, demonstrating performance comparable to the predicate devices.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance (Summary) |
|---|---|
| PT2™ Guide Wire: | |
| Tensile Strength | Met minimum requirements, adequate for intended use. |
| Combined Load | Met minimum requirements, adequate for intended use. |
| Coupler Fatigue | Met minimum requirements, adequate for intended use. |
| Torque Response | Met minimum requirements, adequate for intended use. |
| Tip Prolapse | Met minimum requirements, adequate for intended use. |
| Coating Adherence | Met minimum requirements, adequate for intended use. |
| Visual Inspection | Met minimum requirements, adequate for intended use. |
| Polymer Peel | Met minimum requirements, adequate for intended use. |
| PTCA Catheter Compatibility | Met minimum requirements, adequate for intended use. |
| Biocompatibility | Met minimum requirements, adequate for intended use. |
| AddWire™ Extension Wire: | |
| Tensile Strength | Met minimum requirements, adequate for intended use. |
| Coating Adherence | Met minimum requirements, adequate for intended use. |
| Visual Inspection | Met minimum requirements, adequate for intended use. |
| PTCA Catheter Compatibility | Met minimum requirements, adequate for intended use. |
| Exchange System Connectability | Met minimum requirements, adequate for intended use. |
| Biocompatibility | Met minimum requirements, adequate for intended use. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the non-clinical tests (tensile, fatigue, etc.) for either the PT2™ Guide Wire or the AddWire™ Extension Wire. The data provenance is not explicitly stated but is implicitly from in-vitro laboratory testing conducted by Boston Scientific Corporation. This would be considered prospective testing as it was performed specifically for this submission.
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)
This submission relies on non-clinical (bench) testing and comparison to predicate devices, not on clinical data involving human subjects or expert ground truth determination from images/patient data. Therefore, the concept of "experts establishing ground truth" as typically seen in AI/diagnostic studies is not applicable here. The "experts" would be the engineers and scientists at Boston Scientific Corporation who designed and performed the tests, verifying the device's physical and functional properties. Their qualifications are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
As this is a non-clinical, bench testing submission, there was no adjudication method as typically applied to clinical data or subjective assessments by multiple experts. The tests performed are objective, measurable physical and mechanical tests.
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 MRMC comparative effectiveness study was performed or is relevant for this type of medical device (guide wire and extension wire). This is a submission for a physical, interventional device, not an AI or diagnostic imaging device that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is a physical medical instrument, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for non-clinical testing is established by objective engineering specifications, material standards, and benchmark performance of predicate devices. Biocompatibility testing relies on established and accepted biological and chemical assays. The performance is compared against these predetermined specifications and the known performance characteristics of the predicate devices.
8. The sample size for the training set
Not applicable. This submission is for a physical medical device and does not involve a "training set" in the context of an AI or machine learning model.
9. How the ground truth for the training set was established
Not applicable. As stated above, 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.