(83 days)
The Anchorage™ Access Kit facilitates percutaneous access in order to establish a guide through which surgical instruments or devices can be intubated.
The Anchorage Access Kit is a system of components used to gain percutaneous access and provide a conduit for the Anchorage Closure Device (K073096) or other surgical instruments.
The provided text is a 510(k) summary for the Epitek Anchorage™ Access Kit. This type of document is used for regulatory submission and typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the manner requested for AI/ML devices.
Therefore, the information required to populate the acceptance criteria and study details is not available in the provided text. The document states:
"Results of the in-vitro testing, biocompatibility testing, and conformance to consensus and voluntary standards conducted prior to introduction into commerce demonstrate that the Anchorage Access Kit is substantially equivalent to the specified predicate device."
This statement confirms that testing was done, but it does not provide details on:
- Specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
- Reported device performance against such criteria.
- Sample sizes for test sets or training sets.
- Data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC studies or effect sizes.
- Standalone performance.
- Type of ground truth used.
- How ground truth was established for training or testing.
This information is typically found in clinical study reports or detailed performance verification documents, which are not part of this 510(k) summary.
§ 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.