(153 days)
The GeniCon Laparoscope is available in 3.5mm, 5mm and 10mm diameters with working lengths of 28cm to 44cm. This device has applications in gynecologic, general, thoracic and urology Endoscopic procedures to establish visualization for viewing an interior cavity of the body.
The GeniCon Platinum Series Laparoscope is a reusable device with a glass rod lens assembly that connects an eyepiece to a viewing lens on the distal end of the scope encompassed within a stainless steel shaft. Surrounding the glass rod assembly and contained with the stainless steel shaft is a series of light fibers that transfer light energy to illumination into the body cavity being viewed.
The provided text is a 510(k) Summary for the GeniCon Platinum Series Laparoscope. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria and specific performance metrics for the GeniCon device itself.
Therefore, the document does not contain the information requested in the prompt, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, training sets, or data provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- How ground truth was established for training sets.
The relevant sections of the document explicitly state:
- "Performance: The FDA has not adopted performance standards for this product." (Page 0)
- "Conclusion: Based on the indications for use and technological characteristics, the GeniCon Platinum Series Laparoscope has been shown to be effective for its intended use and substantially equivalent to the predicate device." (Page 0)
This indicates that the submission relies on substantiating similarity to an already approved device rather than providing new performance data against a set of acceptance criteria.
§ 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.