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The intended use for the continuous-flow inner and outer sheaths is in urological procedures to endoscopically examine and allow access to the urethra and bladder and also provide simultaneous suction and irrigation for the resectoscope. The surgeon performs the procedure through the urethra. The sheaths are devices that allow for a less traumatic passage for cystoscopes, resectoscopes, and various instrumentation. The intended use for these devices is in urological procedures to endoscopically examine and allow access to the urethra and bladder. The surgeon performs the examination through the urethra. The sheaths are devices that allow for a less traumatic passage for cystoscopes and various instruments and also allow for simultaneous suction and irrigation. The intended use for the obturators 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 intended use for the cysotocope diagnostic adapter is in urological procedures to bridge the cystoscope to the cystoscope sheath. In versions with operating channels, it also provides passage for instruments. The intended use for the dilator is in urological procedures. It is inserted into the urethra and is intended to dilate the penis for insertion of a catheter or instrumentation. The intended use for the urological syringe and evacuator with adapter is in urological procedures. The syringe is connected directly to the sheath and is used for manual suction of the bladder. The evacuator is used to remove loose debris (tissue) from the bladder. It is also connected directly to the sheath. The intended use for the single action scissors is in urological and gastroenterological procedures to endoscopically cut tissue and/or sutures. The intended use for the luer lock connectors is in urological procedures. The luer is connected directly to the sheath suction and irrigation port and is used to connect catheters and suction and irrigation tubes to sheaths. They provide an adaption, extension, or stopcock.

The COMEGEndoscopy devices that we intend to market include the following resectoscope accessories (Tier 1 devices): sheaths; obturators; cystoscope diagnostic adapters; dilator, urethral meatus; urological syringe and evacuator with adaptor; cystoscope (single action) scissors; and, luer lock connectors. Resectoscope accessories are described in endoscope and accessories 21 CFR §876.1500 and dilators are described in urethral dilator 21 CFR §876.5520. The materials used to fabricate these devices include stainless steel, brass chrome plated, plastic (polyvinylchoride (PVC) and Tecapeek), PTFE, aluminum oxide, and silicone. The stainless steel of which these 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 isbiocompatible with human tissue. These devices can be reused and instructions for cleaning and sterilization will be provided.

This document describes a 510(k) premarket notification for COMEG Endoscopy Resectoscope Accessories. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices already on the market.

Therefore, I cannot provide the requested information. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
6. Information about a standalone algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document primarily addresses sections of a 510(k) application related to device description, intended use, and comparison to legally marketed predicate devices to establish substantial equivalence.

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