← Product Code [OCV](/productcode/OCV) · K992006 # NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 (K992006) _Integra Neurocare, LLC · OCV · Aug 17, 1999 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K992006 ## Device Facts - **Applicant:** Integra Neurocare, LLC - **Product Code:** [OCV](/productcode/OCV.md) - **Decision Date:** Aug 17, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use Neuroview® Instrument Holder (Model 300-33) is intended for use in holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures. ## Device Story Neuroview Instrument Holder (Model 300-33) is a reusable, stainless steel mechanical accessory designed for use in operating rooms. It consists of a rail clamp, adjustable stainless steel rods, toggle clamps, and an instrument clamp. The device is table-mounted and allows surgeons to position and lock a Neuro Navigational Endoscope over a patient. It does not contact the patient, blood, or bodily fluids. The device is sold non-sterile and is autoclavable. By maintaining a stable, fixed position for the endoscope, it facilitates accurate endoscope manipulation and instrument passage during procedures, reducing the need for manual holding. ## Clinical Evidence Bench testing only. No clinical data provided. Performance is based on mechanical stability and the ability to maintain a locked position. ## Technological Characteristics Materials: Stainless steel. Mounting: Table-mounted. Adjustability: Manual toggle clamps and rods. Sterilization: Autoclavable. Connectivity: None. Software: None. ## 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. In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period. ## Predicate Devices - KSEA Endoscope Holder ([K990334](/device/K990334.md)) - Codman Rigid and Steerable Endoscope Holders ([K945572](/device/K945572.md)) - Leonard Arm-Support Arm-Endoscope Accessory ([K951854](/device/K951854.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}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter. The eagle design is composed of three parallel lines that create a sense of movement and depth. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Integra NeuroCare LLC Ms. Nancy A. Mathewson, Esq. Manager, Regulatory Affairs 5955 Pacific Center Boulevard San Diego, CA. 92121 JUL 2 7 2015 Re: K992006 Trade/Device Name: Neuroview® Instrument Holder (Model 300-33) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCV, GCJ Dated (Date on orig SE ltr): June 14, 1999 Received (Date on orig SE ltr): June 15, 1999 Dear Ms. Mathewson, This letter corrects our substantially equivalent letter of August 17, 1999. 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 {1}------------------------------------------------ Page 2 - 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); 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 contact 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. 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 {2}------------------------------------------------ -t- - . . - - - #### INDICATIONS FOR USE Indications 510(k) Number: K 992006 Device Name: Neuroview® Instrument Holder (Model: 300-33) #### Indications for Use: Neuroview® Instrument Holder (Model: 300-33) is intended for use in holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures. ## (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 _ Optional Format 1-2-96) Thunell S. Reymore for J20 (Division Sign-Off) Division of General 510(k) Number . 11 {3}------------------------------------------------ AUG 17 1999 # TEGRA NEUROCARE 5955 Pacific Center Boulerard . San Dicgo. CA 92121-4309 . (858) 455-1115 . Fax: (850) 455-8290 Summary of Safety and Effectiveness Page 1 of 2 K 99200\$ ## "NEUROVIEW® INSTRUMENT HOLDER (MODEL 300-33)" #### SUMMARY OF SAFETY AND EFFECTIVENESS Submitter's name and address: Integra NeuroCarc LLC 5955 Pacific Center Blvd. San Diego, CA 92121-4309 Contact person and telephone number: Nancy A. Mathewson Manager Regulatory Affairs (858) 455-1115 X 185 Manufacturing Facility: Integra NeuroCare LLC 5955 Pacific Center Blvd. San Diego, CA 92121-4309 Establishment Registration Number: 2023988 Date Summary was prepared: June 11, 1999 Name of the device: Neuroview@ Instrument Holder (Model 300-33) Proprietary Name: Endoscope Holder Common Name: Neurological Endoscope (21 CFR 882.1480) Classification Name: Substantial Equivalence: The Neuroview@ Instrument Holder (Model 300-33) is substantially equivalent to the following currently marketed instruments or endoscope holders: - KSEA Endoscope Holder (K990334) ● - Codman Rigid and Steerable Endoscope Holders (K945572) 0 - Leonard Arm-Support Arm-Endoscope Accessory (K951854) . {4}------------------------------------------------ Device Description: The Neuroview Instrument Holder, Model 300-33, is a reusable, stainless steel accessory used to hold currently marketed Neuro Navigational Endoscopes. The holder consists of a rail clamp, adjustable stainless steel rods, toggle clamps, and an instrument clamp. This Instrument Holder, as well as the predicate devices, includes a one-piece design that is completely stable when used to position an instrument. The arms contain adjustable stainless steel clamps and holders that will adapt to any operating room table and hold any Neuro Navigational Endoscope. The holder can be positioned over the patient and locked into place to facilitate accurate Endoscope manipulation and instrument passage. The Instrument Holder, as well as the predicates accessory devices, is sold non-sterile and autoclavable for rapid operating room preparation. This Instrument Holder is intended to hold the Neuroview Endoscope in place. It has no direct contact with the patient. The only important performance aspect of the Instrument Holder is that it maintains its position once it has been positioned and tightened in place. Statement of intended use: The Neuroview® Instrument Holder (Model 300-33) is intended for use in holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures. Comparison of technological characteristics to predicate devices: A feature comparison chart between Neuroview Instrument Holder (Model 300-33) and the currently marketed predicates KSEA Endoscope Holder, Codman® Rigid and Steerable Endoscope Holders and Leonard Arm-Support Arm-Endoscope Accessory is presented in Table 1. Safety None of the Neuroview Instrument Holder (Model 300-33) components have patient, blood, and/or fluid contact. The Instrument Holder is composed of stainless steel materials that are widely used in other instrument and scope holders. | Parameter | Neuroview Instrument Holder (300-33) | KSEA Endoscope Holder | Codman Rigid and Steerable Endoscope Holders | Leonard Arm-Support Arm-Endoscopic Accessory | |-----------------------|--------------------------------------|---------------------------------------|----------------------------------------------|----------------------------------------------| | Manufacturer | Integra NeuroCare LLC | Karl Storz Endoscopey-America, Inc., | Johnson & Johnson Professionals, Inc | Leonard Medical, Inc | | Intended Use | Rigidly Affix Endoscopes | Rigidly Affix Endoscopes | Rigidly Affix Endoscopes | Rigidly Affix Endoscopes | | Materials | Stainless Steel | Stainless Steel and Anodized Aluminum | Stainless Steel and Silicone Rubber | Stainless Steel | | Means of Mounting | Table Mounted | Table Mounted | Table Mounted | Table Mounted | | Adjustable | Yes | Yes | Yes | Yes | | Possible to sterilize | Yes | Yes | Yes | Yes | Table 1: Substantial Equivalence Comparison Chart --- **Source:** [https://fda-staging.innolitics.com/device/K992006](https://fda-staging.innolitics.com/device/K992006) **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