(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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.