(20 days)
The Tegress™ Implant Needles are accessories for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.
The Tegress™ Implant Needle is an accessory for currently marketed endoscopes and is used for tissue during an endoscopic procedure. The Tegress™ Implant Needle is a Transurethral Flexible Needle with Stabilizing Cannula that consists of a stainless steel non-coring needle at the tip. A full-length needle guard protects the species of a semi-rigid catheter/tubing and The Transurethral Needle and Stabilizing Cannula with Working Working Channel Seal. Working Channel Geal. - The "Transarenial and are compatible with DMSO.
The provided text is a 510(k) summary for the Tegress™ Implant Needle, a medical device. This document describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding performance evaluation.
The "Performance Data Summary" section explicitly states: "The Tegress™ Implant Needle referenced in this submission is held to the same design, The Tegress™ Informance specifications as those needles currently manufactured by manufacture, and performance specification and validation activities for the modifications to the Tegress™ Implant Needle were conducted." This indicates that the claim of safety and effectiveness relies on its similarity to existing, already-approved devices, rather than a new standalone performance study with detailed acceptance criteria.
Therefore, I cannot provide the requested information from this document. The sections of your request that cannot be answered from the provided text are:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or specific performance metrics are reported.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is detailed.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable; this device is an implant needle, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this device is an implant needle, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.