(77 days)
The MINI Laparoscopes provide visualization inside the patient via natural or surgical generated access.
For examination, diagnostics, and/or therapy for use by surgeons who are trained and qualified in the use of endoscopically used accessories from various medical specialties, such as surgery, urology, gynecology, and ENT.
The PANOVIEW PLUS telescopes are part of the MICRO and MINI instrument set for laparoscopic microsurgery. They are particularly suitable for diagnostics, smaller interventions, and outpatient and pediatric laparoscopy.
The endoscopes design and biocompatability of materials is comparable to earlier Richard Wolf devices. The outer diameter of the submitted devices are smaller and provide minimally invasive laparoscopy. The smaller diameter of the lens results in a smaller endoscopic puncture.
The provided document, K973359 for the PANOVIEW PLUS telescopes 3.5 mm (MINI Laparoscopes), states that no performance data or clinical tests were performed as part of this 510(k) submission.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets those criteria because it is explicitly stated that such studies were not conducted for this submission.
The document indicates:
- 5.0 Performance Data: "No know FDA performance standards exist."
- 6.0 Clinical Tests: "No clinical tests performed."
The conclusion drawn by the manufacturer is: "The devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual." This statement is a general assertion rather than a report of specific performance data or a study demonstrating adherence to acceptance criteria.
The 510(k) clearance was based on substantial equivalence to existing predicate devices, not on a new performance study demonstrating the device meets specific 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.