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510(k) Data Aggregation
(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.
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