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510(k) Data Aggregation
(96 days)
The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the alimentary tract. This device is not indicated for neuro or cardiac use.
The Guidewire is constructed of a stainless steel core wire and a stainless steel or platinum coil welded/brazed in place over the core wire. The coll may cover the entire core wire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum iridium marker bands may be placed under the coil to aid in visualization. Exit markers may be printed on the proximal section of the guidewire to aid the physician in determining the depth of insertion.
This 510(k) summary describes a medical device called the TechDevice Guidewire. The device is intended to facilitate the placement and exchange of catheters and other instruments in the alimentary tract, but not for neuro or cardiac use. The submission states that substantial equivalence was based on a comparison of labeling, physical and performance design characteristics to predicate devices, as well as the results of comparative bench testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Tensile Strength A | Comparative bench testing performed |
| Torque Strength B | Comparative bench testing performed |
| Torqueability C | Comparative bench testing performed |
| Tip Flexibility D | Comparative bench testing performed |
| Coating Integrity E | Comparative bench testing performed |
2. Sample Size and Data Provenance
The document does not specify the sample sizes used for the comparative bench testing (test set sizes). It also does not mention the country of origin of the data or whether the data was retrospective or prospective. It only states "comparative bench testing."
3. Number of Experts and Qualifications
This information is not provided in the document. Bench testing typically does not involve human expert review in the same way clinical studies do.
4. Adjudication Method
This information is not provided in the document. Adjudication methods are typically associated with clinical studies involving human interpretation, not bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. The document describes bench testing of physical and performance characteristics, not a clinical study involving human readers or AI.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical guidewire, not an algorithm or software. The performance described is for the physical device itself.
7. Type of Ground Truth Used
The ground truth for the performance tests would be the established engineering standards or specifications for each of the measured characteristics (Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Integrity). The document implies that the "ground truth" was the performance of the predicate devices. The phrase "comparative bench testing" suggests that the TechDevice Guidewire's performance was compared directly against the predicate devices for these characteristics.
8. Sample Size for the Training Set
Not applicable. This device is a physical guidewire, not an AI or software device that uses a training set. The "training" in the context of device development would refer to the design and engineering process, not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device. The design and manufacturing process would be guided by engineering principles and comparison to predicate devices, rather than a data-driven ground truth.
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