(117 days)
The injeTak™ Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile and single use only.
The injeTAK'" Adjustable Tip Needle consists of a metal needle cannula and an outer movable sheath with an attached adjusting mechanism. The needle sheath diameter is 6Fr with 35-50cm in length, The stainless steel needle is 25gauge Needle tip length adjusting mechanism is used to adjust & set the relative distance between the distal needle point to the distal end tip of needle sheath in a range of 0-5 millimeter (mm). Numbers (0, 2, 3, 5) printed on handle of the adjusting mechanism are used to indicate the individual needle tip (penetration) lengths in millimeter (mm) unit.
The provided text is a 510(k) summary for the injeTAK™ Adjustable Tip Needles. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, performance studies, or details relevant to artificial intelligence (AI) or machine learning (ML) models. Such information is typically found in sections detailing validation studies, clinical trials, or software performance reports, which are absent in this document.
Therefore, I cannot provide the requested information based on the input text. The questions posed are related to the evaluation and validation of AI/ML-driven medical devices, which this document does not cover.
To answer your questions, I would need a document that describes:
- Specific performance metrics and thresholds (acceptance criteria).
- Details of a study (clinical or analytical) conducted to evaluate the device's performance against those criteria.
- Information on the dataset used (sample size, provenance, ground truth establishment, expert qualifications, adjudication).
- If applicable, details of MRMC studies or standalone algorithm performance.
§ 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.