Who is the manufacturer of COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES?

Comeg Endoscopy submitted the Traditional clearance for COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES (K970764).

What is the FDA product code for COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES?

OCX. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES?

510(k) clearance (submission type: Traditional).

What are the predicate devices for COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES?

Karl Storz resectoscope accessories; Circon ACMI Sheaths.

COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES

K970764 · Comeg Endoscopy · OCX · Apr 22, 1997 · Gastroenterology, Urology

Device Facts

Record ID	K970764
Device Name	COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES
Applicant	Comeg Endoscopy
Product Code	OCX · Gastroenterology, Urology
Decision Date	Apr 22, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

Continuous-Flow Inner and Outer Sheaths 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. 2 Fixed Stopcock and 2-Way-Tap Outer Sheaths 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. Obturators: 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. Cystoscope Diagnostic Adapters The intended use for the cystoscope 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. Dilator, Urethral Meatus: 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. Urological Syringe and Evacuator with Adapter 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 and irrigation of the bladder. The evacuator is used to remove loose debris (tissue) from the bladder. It is also connected directly to the sheath. Single Action scissors The intended use for the single action scissors is in urological and gastroenterological procedures to endoscopically cut tissue and/or sutures. Luer Lock Connectors 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.

Device Story

COMEG Endoscopy resectoscope accessories include sheaths, obturators, diagnostic adapters, urethral dilators, syringes, evacuators, scissors, and luer lock connectors. Devices facilitate endoscopic access to urethra and bladder; provide suction/irrigation; protect tissue during insertion; bridge cystoscopes to sheaths; dilate urethral meatus; remove bladder debris; and cut tissue/sutures. Used in urological and gastroenterological procedures by physicians. Manual operation; devices connect to standard endoscopic equipment. Reusable; requires cleaning and sterilization.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: ASTM type 304 stainless steel (ASTM F899-84), brass (chrome plated), PVC, Tecapeek, PTFE, aluminum oxide, silicone. Mechanical design; manual operation. Reusable; requires cleaning and sterilization. No software or energy source.

Indications for Use

Indicated for patients undergoing urological or gastroenterological endoscopic procedures requiring examination, access, tissue/suture cutting, urethral dilation, or bladder irrigation/suction.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Karl Storz resectoscope accessories
Circon ACMI Sheaths

Related Devices

K011496 — CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 · Richard Wolf Medical Instruments Corp. · Aug 10, 2001
K033191 — SOHNIKS · Sohniks Endoscopy, Inc. · Mar 9, 2004
K230535 — KARL STORZ Urological Laser Accessories · Karl Storz SE & CO. KG · Sep 8, 2023
K950719 — OES UROLOGY · Olympus America, Inc. · Dec 11, 1996
K191357 — Flexible HD Cysto-Urethroscope System · KARL STORZ Endoscopy-America, Inc. · Sep 18, 2019

Submission Summary (Full Text)

{0} COMEG Endoscopy K 970764 P192 APR 22 1997 # SUMMARY OF SAFETY AND EFFECTIVENESS FOR RESECTOSCOPE ACCESSORIES §807.92 (a)(1) Contact Person: Peter Duffy Vice President Date of Summary Preparation: February 26, 1997 §807.92 (a)(2) Trade Name: COMEG Endoscopy Resectoscope Accessories Common Name: Endoscope and accessories Classification Name: Endoscope and accessories (21 CFR §876.1500) Urethral dilator (21 CFR §876.5520) 13790 E. RICE PLACE AURORA, CO 80015 PHONE (303) 617-7901 FAX (303) 617-7929 (800) 647-6883 §807.92 (a)(3) Legally Marketed Substantially Equivalent Device: Karl Storz resectoscope accessories and Circon ACMI Sheaths §807.92 (a)(4) Description of Device: The COMEG Endoscopy 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 is biocompatible with human tissue. These devices can be reused and instructions for cleaning and sterilization will be provided. §807.92 (a)(5) 1 {1} COMEG Endoscopy K970764 P292 Intended Use: **Continuous-Flow Inner and Outer Sheaths** 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. **2 Fixed Stopcock and 2-Way-Tap Outer Sheaths** 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. **Obturators:** 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. **Cystoscope Diagnostic Adapters** The intended use for the cystoscope 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. **Dilator, Urethral Meatus:** 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. **Urological Syringe and Evacuator with Adapter** 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 and irrigation of the bladder. The evacuator is used to remove loose debris (tissue) from the bladder. It is also connected directly to the sheath. **Single Action scissors** The intended use for the single action scissors is in urological and gastroenterological procedures to endoscopically cut tissue and/or sutures. **Luer Lock Connectors** 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. §807.92 (a)(6) Comparison of Technical Characteristics: The subject devices are similar to devices marketed by Karl Storz and Circon ACMI. The predicate device for the "Quick-Connection" feature is the Circon ACMI inner and outer sheaths. The intended uses are the same for the subject devices and the competitors' products. 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.