← Product Code [FDF](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF) · K001241 # EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I (K001241) _The Olympus Optical Co. · FDF · May 9, 2000 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K001241 ## Device Facts - **Applicant:** The Olympus Optical Co. - **Product Code:** [FDF](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF.md) - **Decision Date:** May 9, 2000 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The CF-Q160 AL/I and the PCF-160 AL/I are intended for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). ## Device Story EVIS EXERA Colonovideoscopes (CF-Q160 AL/I and PCF-160 AL/I) are flexible endoscopes used for visualization and surgery in the lower digestive tract. The device integrates with an Olympus video system center, light source, and documentation equipment. A key modification is the addition of a control mechanism allowing the physician to vary the stiffness of the insertion tube to facilitate navigation through the colon. The device is operated by physicians in clinical settings. Output is provided via a video monitor for real-time visualization, aiding in diagnostic and therapeutic procedures. The stiffness control mechanism assists in insertion, potentially improving procedural efficiency and patient comfort. ## Clinical Evidence No clinical data provided; substantial equivalence is based on design and intended use comparisons. ## Technological Characteristics Flexible colonovideoscopes with integrated stiffness control mechanism for the insertion tube. Designed for use with Olympus video system centers, light sources, and endo-therapy accessories. Class II device (21 CFR 876.1500). ## 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. ## 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}------------------------------------------------ ## AY - 9 71 Koo1241 pg 1 of 2 ## 510(k) Summary EVIS EXERA Colonovideoscopes CF-Q160 AL/I and PCF-160 AL/I A. Submitter's Name, Address, Phone and Fax Numbers ## 1. Manufacturer of subject device Name & Address of manufacturer: Registration number: Address, Phone and Fax numbers of R&D department, Endoscope division: Olympus Optical Co., Ltd. 2-3-1 Shinjyuku Monolis Nishishinjyuku Shinjuku-ku, Tokyo, Japan 8010047 2951 Ishikawa-Cho Hachioji-shi, Tokyo 192-8507 telephone (426) 42-5101 Facsimile (426) 46-2786 B. Name of Contact Person Name: Address, Phone and Fax numbers: Laura Storms-Tyler Olympus America Inc. Director, Regulatory Affairs Two Corporate Center Drive Melville, NY 11747-3157 Telephone (516) 844-5688 Facsimile (516) 844-5416 C. Device Name, Common Name, Classification Name and Predicate Devices | Device Name: | Olympus EVIS EXERA Colonovideoscopes CF-Q160 AL/I and PCF-160 AL/I | |----------------------|--------------------------------------------------------------------| | Common Name: | Endoscopic Video Information System | | Classification Name: | Endoscope and accessories
21 CFR 876.1500, Class II | Summary Preparation Date: April 17, 2000 D. Device Description: The EVIS EXERA Colonovideoscopes CF-Q160 AL/1 and PCF-160 AL/1 have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories such as biopsy forceps and ancillary equipment. The modifications to these devices is to provide a control mechanism to the endoscopes which allows the user the ability to vary the stiffness of the insertion tube, as a means of aiding the physician in inserting the colonoscope into the human colon. {1}------------------------------------------------ Koo1241 pg 2 of 2 - E. Statement of Intended Use The CF-Q160 AL/I and the PCF-160 AL/I are intended for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). - F. Summary including Conclusions drawn from Non-Clinical Tests When compared to similar devices, the EVIS EXERA Colonovideoscopes CF-Q160 AL/I and PCF-160 AL/I do not incorporate any significant changes in intended use, material or design that could affect safety or efficacy. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 **MAY - 9 2000** Olympus Optical Co., LTD c/o Ms. Laura Storms-Tyler Director, Regulatory Affairs and Quality Assurance Olympus America Inc. Two Corporate Center Drive Melville, NY 11747 Re: K001241 EVIS EXERA Colonovideoendoscopes Dated: April 17, 2000 Received: April 18, 2000 Requiatory Class: II. 21 CFR §876.1500/ Procode: 78 FDF Dear Ms. Storms-Tyler: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have detemned the device is substantially equivalent (for the including for use stated in the enclosure) to legally marketed predicate devices marketed in Interstate commerce pror 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 Cosmelic 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 proctice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class III (Prematiet Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Oode of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Reculation (QS) for Medical Devices: General requiration (21 CFR Part 820) and that, It rough periodic QS inspections, the Food and Drug Admisistation (FDA) will verify such assumptions. Fallure 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 Radiation Control provisions, or other Federal laws or requiations. 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 diagnosic devices), please contact the Office of Compliance at (301) 594-4591. 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" (21CFR 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) 636-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html", Sincerely yours. Daniel C. Schultz, M.D. Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(s) {3}------------------------------------------------ | 510(k) Number (If known): | K001241 | |---------------------------|-----------------------------------| | Device Name: | EVIS EXERA Colonovideo endoscopes | Indications for Use: The EVIS EXERA Colonovideoscopes CF-Q160 AL/I and the PCF-160 AL/I are intended for THE LYN LABO Popic surgery within the lower digestive tract (including the anus, sigmoid colon, colon and ileocecal valve). ## (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 **__** (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K001241 (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K001241](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K001241) **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