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510(k) Data Aggregation
(89 days)
The Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included to facilitate directional manipulation of the guidewires.
The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The 300cm length allows exchange of therapeutic devices without the use of other exchange devices, i.e. extension wires. The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire have a nominal diameter of 0.014".
All device materials, manufacturing processes and product dimensions are identical to the Boston Scientific Scimed ChoICE™ ES 300cm exchange guidewire and the ChoICE™ 300cm Floppy exchange guidewire.
The provided document describes the safety and effectiveness of the Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire, primarily through a comparison to predicate devices and in vitro performance testing. It does not detail an AI-driven device, a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone algorithm-only performance study. Therefore, sections pertaining to these aspects, ground truth, and expert evaluation are not applicable based on the provided text.
Here's an analysis of the available information:
Acceptance Criteria and Device Performance
The acceptance criteria for the Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire are implicitly defined by their "substantial equivalence" to predicate devices and successful in vitro and biocompatibility testing, indicating that the devices perform according to their intended use and are safe. The document directly compares features and explicitly states the outcomes of testing.
| Acceptance Criteria / Feature | Reported Device Performance (Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire) |
|---|---|
| Functionality | Substantially equivalent to predicate devices. |
| Intended Use | Substantially equivalent to predicate devices (general intravascular use, neuro and peripheral vasculature, not for coronary arteries). |
| Design | Substantially equivalent to predicate devices. |
| Materials | Substantially equivalent to predicate devices (predominately stainless steel, platinum, PTFE, polyurethane, lubricious coating). |
| Method of Operation | Substantially equivalent to predicate devices. |
| Size (Diameter) | 0.014" minimum; substantially equivalent to predicate devices. |
| Length | 300cm; substantially equivalent to predicate devices (specifically ChoICE™). |
| Sterilization Methods | Substantially equivalent to predicate devices. |
| Packaging | Substantially equivalent to predicate devices. |
| Biocompatibility | Confirmed according to ISO-10993; substantially equivalent to predicate devices. |
| Labeling | Substantially equivalent to predicate devices. |
| Particle Analysis | Testing included; results indicate proper performance and safety. |
| Friction Testing | Testing included; results indicate proper performance and safety. |
| Angular Rotation | Testing included; results indicate proper performance and safety. |
| Tip Buckling | Testing included; results indicate proper performance and safety. |
| Tip Stiffness | Testing included; results indicate proper performance and safety. |
Study Details
2. Sample size used for the test set and the data provenance
The document explicitly states "In vitro performance testing" for the guidewires, including particle analysis, friction testing, angular rotation, tip buckling, and tip stiffness. However, no specific sample sizes for these tests are provided in the document. The data provenance is implied to be laboratory-based (in vitro) testing conducted by Boston Scientific Target. There is no mention of human subject data, retrospective or prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The studies described are in vitro performance and biocompatibility tests for medical devices, not diagnostic or AI-based assessments requiring expert ground truth for interpretation of images or patient data.
4. Adjudication method for the test set
This information is not applicable, as the tests described are objective, physical, and chemical performance evaluations rather than subjective interpretations requiring adjudication.
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
This information is not applicable as the document describes a guidewire device, not an AI-assisted diagnostic tool or system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document describes a physical medical device (guidewire) and its in vitro performance, not an algorithm or AI system.
7. The type of ground truth used
For the in vitro performance tests (particle analysis, friction, angular rotation, tip buckling, tip stiffness), the "ground truth" would be established by objective, predetermined engineering and material science specifications or industry standards for guidewire performance.
For biocompatibility testing, the ground truth was established by adherence to ISO-10993, which provides a framework for biological evaluation of medical devices.
8. The sample size for the training set
This information is not applicable as the document describes a guidewire device, not an AI or machine learning model that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
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