← Product Code [FDF](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF) · K052930 # NAVIGATOR ENDOSCOPY SYSTEM (K052930) _Neoguide Systems, Inc. · FDF · Jan 31, 2006 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K052930 ## Device Facts - **Applicant:** Neoguide Systems, Inc. - **Product Code:** [FDF](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF.md) - **Decision Date:** Jan 31, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The NeoGuide Endoscopy 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 endossopy and endoscopic surgery. ## Device Story Colonoscope system featuring fifteen active electro-mechanically controlled segments; allows insertion tube to conform to path defined by physician during manual steering. Inputs: manual steering inputs (up/down, left/right knobs), articulation angle transducers, insertion depth sensors. Transformation: software interprets sensor data to control active segments, replicating steerable tip mechanics along insertion tube length. Output: visual feed from distal CCD camera; mechanical shape-conforming insertion tube. Used in clinical settings by physicians for endoscopy/endoscopic surgery. Benefits: improved navigation through colon lumen by reducing loop formation via active shape control. ## Clinical Evidence Evidence includes in vitro bench testing, in vivo animal studies, and clinical study data. No specific performance metrics (e.g., sensitivity, specificity) provided in summary. ## Technological Characteristics Colonoscope with 15 active electro-mechanically controlled segments. Features CCD camera, fiber optic illumination, and standard tool channel. Uses transducers for articulation angle and insertion depth measurement. Software-controlled active segments utilize four control cables per segment for articulation. Class II device. ## 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 - Olympus Optical Co, Ltd. EVIS EXERA Colonovideoscope ([K001241](/device/K001241.md)) - Pentax Precision Instrument Corporation EC3840TL, Video Colonoscope ([K961563](/device/K961563.md)) - Sightline, Colonosight, Video Colonoscope ([K032688](/device/K032688.md)) - USGI Shape Locking Endoscopic Overtube ([K033954](/device/K033954.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}------------------------------------------------ # 1. 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 ### 510(k) Number: K052930 ### Applicant Information: | Date Prepared: | January 20, 2006 | |-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Name:
Address: | NeoGuide Systems, Inc.
104 Cooper Court
Los Gatos, CA 95032
Phone: 408-399-9999
Fax: 408-399-3386 | | Contact Person:
Phone Number:
Facsimile Number: | Michael A. Daniel
Office: 925-254-5228 / Cell 415-407-0223
(925) 254-5187 | #### Device Information: | Classification: | Class II | |----------------------|---------------------------------------| | Trade Name: | NeoGuide Endoscopy System | | Common Name: | Colonoscope | | Classification Name: | Colonoscope, 78 FDF / 21 CFR 876.1500 | #### Predicate Devices: The NeoGuide Endoscopy System is substantially equivalent in intended use and method of operation to a combination of the following predicate devices: K001241 - Olympus Optical Co, Ltd. EVIS EXERA Colonovideoscope K961563 - Pentax Precision Instrument Corporation EC3840TL, Video Colonoscope K032688 - Sightline, Colonosight, Video Colonoscope K033954 - USGI Shape Locking Endoscopic Overtube ### Device Description: The NeoGuide Endoscopy System has many features in common with currently marketed colonoscopes. The colonoscope is manually inserted and withdrawn by the physicial, who manually steers and controls it using up/down and left/right steering control knobs on a handle. The colonoscope distal tip is equipped with a CCD camera and fiber optic illumination bundles for procedural illumination. A standard tool channel is incorporated {1}------------------------------------------------ for therapeutic procedures, as well as valves to control insuflation air, water irrigation, and suction. The NeoGuide Colonoscope differs from currently marketed colonoscopes in that it incorporates fifteen active electro-mechanically controlled segments designed to allow the shape of the insertion tube to conform to the path defined by the physician as the colonoscope tip is manually steered through the colon lumen. The active segments are similar to conventional colonoscope steerable tips, as they each employ four control cables to articulate in the up/down and left/right directions. In order to determine the path selected by the physician during a procedure, the NeoGuide endoscopy system incorporates transducers that measure the angle of articulation of the steerable tip and the depth of insertion of the colonoscope into the patient. Software is required to create an anatomical map and interpret, monitor, and control the insertion tube segments. #### Intended Use: The NeoGuide Endoscopy 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 endossopy and endoscopic surgery. ### Comparison to Predicate Device(s): The NeoGuide Colonoscope is very similar to the predicates listed, including indications for use, patient contacting materials, and physician interface. It features a mechanically actuated tip using a conventional pull wire system which is used to steer the device with a handle essentially identical to the Olympus and Pentax predicates. The NeoCuide Endoscopy System is designed for use in the same manner as existing colonoscopes. However, the steerable distal tip section is replicated multiple times down the length of the insertion tube allowing mechanical control of the insertion tube shape and reproduction of the directional path established by the physician #### Summary: Based upon the intended use, descriptive information, and performance evaluation provided in this pre-market notification, including in vitro bench, in vivo animal and clinical study, the NeoGuide Endoscopy System has been shown to be subsanially equivalent to currently marketed predicate devices. {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 3 1 2006 Mr. Michael A. Daniel Regulatory and Clinical Affairs NeoGuide Systems, Inc. 104 Cooper Court LOS GATOS CA 95032 RE: K052930 Trade/Device Name: NeoGuide Navigator Endoscopy System and Accessories Regulation Number: 21 CFR § 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: December 22, 2005 Received: December 23, 2005 Dear Mr. Daniel: 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. 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. Hogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): _K052930 Device Name: NeoGuide Endoscopy System and Accessories Indications for Use: The NeoGuide Endoscopy 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. Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy C. Brogdon Sign-Off n of Reproductive, Abdominal, a Prological Devices 0(k) Number Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K052930](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K052930) **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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