(56 days)
Optical Biopsy Forceps - The intended use is in urological procedures to endoscopically remove tissue for evaluation.
Urological Visual Obturators - The intended use is in urological procedures to endoscopically examine and allow access to the urethra and bladder. The obturator is inserted into the sheath and its blunt end protrudes from the distal end. It protects the tissue when the sheath is entered into the area under examination. The visual obturator has a cystoscope directly inserted in the center of the obturators to allow for visualization while entering the subject.
Optical Stone Crushing Forceps - The intended use for the optical stone crushing forceps is in urological procedures to endoscopically remove, manipulate, crush, or grasp calculi (i.e. stones) and other foreign objects.
Endoscopes and accessories are described in 21 CFR 8876.1500. The COMEG Endoscopy devices that we intend to market include Optical Biopsy Forceps, Urological Visual Obturators, and Optical Stone Crushing Forceps. The stainless steel of which the devices are fabricated is ASTM type 304 which meets the ASTM specification F899-84 Standards for Stainless Steel Billet, Bar and Wire for Surgical Instruments and is biocompatible with human tissue. The devices can be reused and instructions for cleaning and sterilization will be provided.
The provided document is a 510(k) premarket notification for COMEG Endoscopy devices, specifically Optical Biopsy Forceps, Urological Visual Obturators, and Optical Stone Crushing Forceps. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving efficacy or meeting specific acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study design, sample sizes, expert involvement, ground truth establishment, or clinical effectiveness.
The document states:
- "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
- "The subject devices are similar to devices marketed by Karl Storz. ... The intended uses are the same for the subject devices and the competitor's product. The materials used to fabricate both the COMEG and the Karl Storz devices and the operational principles and mode of action are similar as well."
This indicates that the FDA's clearance was based on a comparison to existing devices rather than a de novo study to establish performance against 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.