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Resectoscope and Laser Resectoscope Working Elements are intended to be used in urological procedures to endoscopically remove, cut, coagulate, and/or transect tissue in the bladder, prostate, and/or urethra. The surgeon performs the examination through the urethra. The working elements are devices that house and control the various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The doctor controls the back and forth movement of the electrode using finger controls. The working elements also house a cystoscope for visualization. The high frequency cable transmits electrical current.

Albarran deflectors are intended for use in urological procedures to control the flexible instrumentation that is passed through the COMEG cystoscope sheaths.

Urethrotomes are intended to be used in urological procedures to endoscopically cut and or transect tissue(strictures) in the urethra. The surgeon performs this function through the urethra and will visually (cystoscope) find the location of the stricture in the urethra. Once the stricture is located a urethrotome knife will be extended an the entire urethrotome will be extracted cutting the affected area.

Electrodes are intended to be used endoscopically im conjunction with COMEG resectoscopes, urethrotomes, or cystoscope sheaths. The purpose of the electrodes is for cutting, tissue removal, tissue vaporization, coagulation, and/or transection of tissue. Electrodes are connected to either a resectoscope working element or a high frequency cable. The electrodes are reusable.

The COMEG devices that we intend to market include the following endoscopic electrosurgical instruments and accessories: resectoscope and laser-resectoscope working elements; Albarran deflectors; urethrotomes (urethrotome bridges, obturators, and knives); high frequency cable; and, electrodes. A "Quick-Connection" feature is used to attach the device to the sheath or working element.

Endoscopic electrosurgical instruments and accessories are described in endoscope and accessories 21 CFR 8876.1500, urethrotomes are described in 21 CFR §876.4770, and endoscope ESU unit and accessories are described in 21 CFR §876.4300.

The Resectoscope and Laser Resectoscope Working Elements are intended to be used in urological procedures to endoscopically remove, cut, coagulate, and/or transect tissue in the bladder, prostate, and/or urethra. The surgeon performs the examination through the urethra. The working elements are devices that house and control the various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The doctor controls the back and forth movement of the electrode using finger controls. The working elements also house a cystoscope for visualization. The high frequency cable transmits electrical current.

These devices are composed of stainless steel chrome plated, plastic, and brass chrome plated. The high frequency cable is composed of silicone.

Albarran deflectors are intended for use in urological procedures to control the flexible instrumentation that is passed through the COMEG cystoscope sheaths.

These devices are composed of stainless steel chrome plated and brass chrome plated.

The intended use for the urethrotomes is in urological procedures to endoscopically cut and/or transect tissue (strictures) in the urethra. The surgeon performs this function through the urethra and will visually (cystoscope) find the location of the stricture in the urethra. Once the stricture is located a urethrotome will be extracted, cutting the affected area.

These devices are composed of stainless steel chrome plated, plastic, and brass chrome plated. The complete working unit is comprised of each of the models below plus a cystoscope.

The electrodes are intended to be used endoscopically in conjunction with COMEG resectoscopes, urethrotomes, or cystoscope sheaths. The purpose of the electrodes is for cutting, tissue removal, tissue vaporization, coagulation, and/or transection of tissue. Electrodes are connected to either a resectoscope working element or a high frequency cable. The electrodes are reusable.

These electrodes are composed of stainless steel, teflon, silicone, ultem (black plastic), tungsten, and silver.

The provided document is a 510(k) summary for COMEG Endoscopy Resectoscope and Laser-Resectoscope Working Elements, Albarran Deflectors, Urethrotomes, and Electrodes. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving device performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Instead, the document primarily focuses on:

• Device Description: What the devices are and their components.
• Intended Use: The medical procedures and purposes for which the devices are designed.
• Comparison of Technical Characteristics: A statement that the subject devices are similar to predicate devices (Karl Storz and Circon ACMI) in terms of intended uses, materials, operational principles, and mode of action.

The FDA's review and approval letter (K971881) confirms that the device is "substantially equivalent" to predicate devices, which is the standard for 510(k) clearance. This process typically relies on demonstrating that the new device has the same intended use and similar technological characteristics as a predicate device, or that any differences do not raise new questions of safety and effectiveness. It does not usually require new clinical studies with detailed safety and effectiveness acceptance criteria if substantial equivalence can be demonstrated through other means (e.g., comparison to existing devices, bench testing, non-clinical performance data).

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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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The intended use for the foreign body grasping forceps is in urological procedures to endoscopically remove, manipulate or grasp calculi (i.e. stones) and other foreign objects.

The COMEG Endoscopy devices that we intend to market are foreign body Grasping Forceps. These forceps are composed of stainless steel. They have diameters of 7 and 9 French and lengths of 40 cm. Each model has an alligator jaw with a standard double action mechanism.

The provided text is a summary of safety and effectiveness for grasping forceps (K970489) and does not contain information about acceptance criteria for a device, a study proving it meets such criteria, or any details about AI/algorithm performance. It primarily focuses on the regulatory submission details for a medical device (grasping forceps) in 1997, comparing it to a legally marketed substantially equivalent device.

Therefore, I cannot extract the requested information based on the provided input. The document describes a medical device and its intended use, rather than a study evaluating device performance against acceptance criteria using expert-reviewed data.

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