← Product Code [FDF](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF) · K121582 # INVENDO C25 COLONOSCOPY SYSTEM (K121582) _Invendo Medical Gbmh · FDF · Dec 20, 2012 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K121582 ## Device Facts - **Applicant:** Invendo Medical Gbmh - **Product Code:** [FDF](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF.md) - **Decision Date:** Dec 20, 2012 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The invendo C25 Colonoscopy System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. The colonoscope component of the invendo C25 Colonoscopy System, the SC20 colonoscope, is a single-use disposable device. The SC20 colonoscope cannot be reprocessed. ## Device Story System provides visualization and access to adult lower GI tract for endoscopy/surgery. Components: invendo C25 base system (supply/processing unit, drive, handheld control) and SC20 single-use disposable colonoscope. Operator uses handheld unit to control distal tip deflection, insufflation, irrigation, and suction. CMOS camera and LEDs at distal tip provide visual input; user views output to guide navigation and perform biopsies/polypectomies via working channel. System includes check valves, decompression line, and level sensors. Used in clinical settings by physicians. Benefits include disposable colonoscope eliminating reprocessing needs for the scope and modified base unit regimen. ## Clinical Evidence No clinical data. Bench testing only. Validated via IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, ISO 10993-5, and ISO 10993-10. Additional testing included check valve performance under worst-case conditions, decompression line evaluation, backflow assessment, and reprocessing performance verification. ## Technological Characteristics System comprises base unit and single-use SC20 colonoscope. Features CMOS camera, LED illumination, working channel, insufflation, irrigation, and suction. Connectivity includes handheld control unit. Standards: IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, ISO 10993-5, ISO 10993-10. Includes GUI for adjusting rinse, deflection speed, and insufflation gas. Integrated level sensors and check valves. ## 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 - invendo C20 colonoscopy system ([K100624](/device/K100624.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}------------------------------------------------ 1421582 Special 510(k) premarket Notification Invendo C25 Colonoscopy System # Section 7 endo medical THE FUTURE OF ENDOSCOPY DEC 2 0 2012 #### Special 510k Summary 7 ## Applicant Information invendo medical GmbH Name: - Address: Peterhofstr. 3b 86438 Kissing Germany - Contact: Oliver v. Ruepprecht Manager QA/RA Phone : +49 ~ 8233 - 744 98 16 Fax : +49-8233-744 98 15 Mail : oliver.ruepprecht@invendo-medical.de ## Device Information - Device Name: invendo C25 Colonoscopy System Components: invendoscope SC20 (SC20 colonoscope) invendo C25 Base System (base unit, drive, cleaner, handheld) Common Name: Colonoscope Class II, FDF 876.1500 Classification: Predicate invendo C20 colonoscopy system (K100624) device Intended use The invendo C25 Colonoscopy System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. > The colonoscope component of the invendo C25 Colonoscopy System, the SC20 colonoscope, is a single-use disposable device. The SC20 colonoscope cannot be reprocessed. {1}------------------------------------------------ Description The invendo C25 Colonoscopy System is a modified version of the invendo C20 Colonoscopy System. Like the predicate device, the invendo C25 Colonoscopy System is steered and controlled by the operator. The distal tip of the colonoscope is deflectable and includes a CMOS camera and LEDs for illumination. A working channel is incorporated to enable biopsies and polypectomies. The invendo C25 Colonoscopy System includes insufflation, irrigation and suction functions. The invendo C25 Colonoscopy System consists of two components: (1) the invendo C25 base system; and (2) a single-use, disposable colonoscope, the SC20 colonoscope. The invendo C25 base system provides the SC20 colonoscope with the above mentioned functions and transfers user commands to the colonoscope. To control the colonoscope, the operator uses a handheld control unit. All colonoscope functions are solely activated by the user. The invendo C25 base system consists of the Supply and Processing Unit (SPU or base unit), the handheld control and the drive unit. Description of the differences The main differences between the C25 Colonoscopy System and the predicate are check valves integrated into the single use colonoscope, an additional decompression line for the rinse tube and the reprocessing regimen for the base unit that eliminates the need to clean and high-level disinfect after each patient. In addition, the C25 colonoscopy system includes minor technology, material, accessory (lubricant), and cosmetic changes compared to the predicate. These minor changes include, for example, an increased deflecting length of the colonoscope; changes to the internal power supply system; additional settings in the graphical user interface that allow the user to change the settings for rinsing function, deflection speed and insufflation gas during, and not only prior to, an examination; a reduction of the safety current of the light source; and the integration of an additional level sensor in the lubrication chambers of the system. Performance and safety Tests The following non-clinical testing was performed to validate the design and to assure conformity with design standards: - IEC 60601-1 "Medical electrical equipment part 1 General requirements for safety" incl. national deviations - IEC 60601-2-18 "Medical electrical equipment part 2 Particular requirements for the basic safety and essential performance of endoscopic equipment" 7-2 {2}------------------------------------------------ K121582 Page 3 of 3 - IEC 60601-1-2 "Medical electrical equipment part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility -Requirements and tests" - ISO 10993-5 "Biological evaluation of medical devices -- Part 5: -Tests for in vitro cytotoxicity" - ISO 10993-10 "Biological evaluation of medical devices -- Part -10: Tests for irritation and skin sensitization" - -Test of the check valve under worst case conditions - Evaluation of the decompression line and the corresponding system tests - -Evaluation of the backflow into the system without any check valves - -Evaluation of the reprocessing performance - Evaluation of the performance compared to the predicate device In all instances, the SC20 colonoscope and the C25 base system functioned as intended, performed as well as or better than the predicate, and met individual test specifications. ## Substantial equivalence The invendo C25 Colonoscopy System has the same intended use, indications for use, functions, operational principles and components as the predicate device. As a result, the C25 is substantially equivalent to its predicate. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 20, 2012 invendo medical GmbH % Mr. Oliver v. Ruepprecht Manager OA/RA Peterhofstr. 3b 86438 KISSING GERMANY Re: K121582 Trade/Device Name: invendo C25 Colonoscopy System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: November 21, 2012 Received: November 26, 2012 ### Dear Mr. Ruepprecht: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ ## Page 2 - Mr. Oliver v. Ruepprecht Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and 1 sting (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Benjamin R. Fisher -S Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ **nvendo medical** THE FUTURE OF ENDOSCOPY # 13 Indications for Use Statement 510(k) Number (if known): _ KI ZI 5 82 Device Name: invendo C25Colonoscopy System Indications for Use: The invendo C25 Colonoscopy System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. The colonoscope component of the invendo C25 Colonoscopy System, the SC20 Colonoscope, is a single use disposable device. The SC20 colonoscope cannot be reprocessed. Prescription Use × (Part 21 CFR 801 Subpart D) AND Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) # Benjamin R. Hisher -S 2012.12.20 1/3:11:03 - (Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number K121582 confidential 13-1 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K121582](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K121582) **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. 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