← Product Code [OCZ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ) · K971202 # COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS (K971202) _Comeg Endoskopie GmbH · OCZ · May 27, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K971202 ## Device Facts - **Applicant:** Comeg Endoskopie GmbH - **Product Code:** [OCZ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ.md) - **Decision Date:** May 27, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use 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. ## Device Story COMEG Endoscopy devices include optical biopsy forceps, urological visual obturators, and optical stone crushing forceps. Devices are used in urological procedures by physicians to perform endoscopic tissue removal, visualization, and stone management. Visual obturators allow cystoscope insertion for real-time visualization during sheath entry into the urethra and bladder. Stone crushing forceps enable mechanical manipulation and fragmentation of calculi. Devices are reusable, stainless steel instruments. Clinical benefit includes minimally invasive access and intervention for urological conditions. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Fabricated from ASTM type 304 stainless steel (meeting ASTM F899-84). Reusable instruments. Mechanical actuation for biopsy and stone crushing. Visual obturators feature a central channel for cystoscope integration. Sterilization instructions provided for reuse. ## Regulatory 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 Short Jaw Biopsy Forceps - Karl Storz Visual Obturators for Cystoscopes - Urethroscopes - Karl Storz Kidney Stone Crusher ## Reference Devices - COMEG Resectoscope accessories ([K970764](/device/K970764.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} COMEG Endoscopy K971202 p192 # SUMMARY OF SAFETY AND EFFECTIVENESS FOR COMEG OPTICAL BIOPSY FORCEPS, UROLOGICAL VISUAL OBTURATORS, OPTICAL STONE CRUSHING FORCEPS ## §807.92 (a)(1) Contact Person: Peter Duffy Vice President Date of Summary Preparation: March 28, 1997 ## §807.92 (a)(2) Trade Name: COMEG Optical Biopsy Forceps COMEG Urological Visual Obturators COMEG Optical Stone Crushing Forceps Common Name: Endoscopes and accessories Classification Name: Endoscope and accessories (21 CFR §876.1500) ## §807.92 (a)(3) Legally Marketed Substantially Equivalent Device: Karl Storz Short Jaw Biopsy Forceps, Visual Obturators for Cystoscopes - Urethroscopes, Kidney Stone Crusher ## §807.92 (a)(4) Description of Device: Endoscopes and accessories are described in 21 CFR §876.1500. 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. ## §807.92 (a)(5) -13- {1} COMEG Endoscopy K 971202 p < q2 Intended Use: 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. §807.92 (a)(6) Comparison of Technical Characteristics: The subject devices are similar to devices marketed by Karl Storz. The "Quick-Connection" feature is also used in COMEG Resectoscope accessories (K970764). 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. -14- {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # MAY 27 1997 Mr. Peter Duffy Vice President COMEG Endoscopy 13790 East Rice Place Aurora, Colorado 80015 Re: K971202 COMEG Optional Stone Crushing Forceps, Visual Obturators, and Optical Biopsy Forceps Dated: March 28, 1997 Received: April 1, 1997 Regulatory Class: II 21 CFR 876.1500/Procode: 78 KOG Dear Mr. Duffy: 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 enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3} COMEG Endoscopy # Indications for Use 510(k) Number (if known) K971202 Device Name: COMEG Optical Biopsy Forceps, Urological Visual Obturators, Optical Stone Crushing Forceps Indications for Use: 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. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ☑ (Per 21 CFR 801.109) OR Over-the-Counter Use ☐ Robert R. Nattley (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K971202 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K971202](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K971202) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com