NEUROLOGICAL ENDOSCOPE

{0} 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: 847.913.1113 Fax: 847.913.1488 K970162 OCT 29 1997 RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION 510(k) Summary of Safety and Effectiveness | Submitter: | | | Date of Preparation: October 8, 1997 | | | --- | --- | --- | --- | --- | | Company / Institution name: RICHARD WOLF MEDICAL INSTRUMENTS CORP. | | | FDA establishment registration number: 14 184 79 | | | Division name (if applicable): N.A. | | | Phone number (include area code): (847) 913-1113 | | | Street address: 353 Corporate Woods Parkway | | | FAX number (include area code): (847) 913-0924 | | | City: Vernon Hills | State/Province: Illinois | Country: USA | | ZIP / Postal Code: 60061 | | Contact name: Mr. Robert L. Casarsa | | | | | | Contact title: Quality Assurance Manager | | | | | | Product Information: | | | | | | Trade name: Neurological Endoscope | | Model number: 8765.001, 15016.299, 15016.300, 15016.301, 8989.401/.431, 8765.611, 8765.701 | | | | Common name: Neuro Endoscope Set | | Classification name: Neurological Endoscope | | | | Information on devices to which substantial equivalence is claimed: | | | | | | 510(k) Number | Trade or proprietary or model name | | Manufacturer | | | 1 | 1 Gaab Neuroendoscope system Sheath, 83-1521 | | 1 Codman | | | 2 | 2 Auero Neuroendoscope system Sheath 28160D | | 2 Storz | | | 3 | 3 Sheath Insert W/ Inflow Stopcock Connection 28160 J | | 3 Storz | | | 4 | 4 Bougie Guide Obturator | | 4 Storz | | | 5 | 5 Telescope Gaab 83-1523 | | 5 Codman | | | 6 | 6 Auero system Telescope 27020 A | | 6 Storz | | | 7 | 7 Auero Monoplar coagulating Electrode 27160B | | 7 Storz | | | 8 | 8 Injection Needle 83-1534 | | 8 Codman | | | 9 | 9 Suction Catheter 10468 A | | 9 Storz | | | 10 | 10 Neuroendoscope (Ventriculoscope) K941239 | | 10 Asculap | | 1.0 Description The set consists of a sheath, obturators, telescope, forceps, scissors, electrodes, suction needle, and adapters. {1} RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION ## 2.0 Intended Use The device is intended for use for direct visualization, diagnosis and therapeutic application during intracranial procedures, such as - cyst fenestration - shunt placement - intraventricular coagulation - ventriculostomy of the 3rd ventricle when the aqueduct is obstructed - coagulation of small intraventricular lesions - biopsy of lesions which lead to the stricture of a ventricle The instrument simultaneously permits visual control and utilization of a working, an irrigation, and an aspiration channel. The Neuro-Endoscope can be used with or without a stereotactic frame. A special adapter is available to affix the endoscope. ## 3.0 Technological Characteristics - Procedure can be performed through one single burr hole. - Uses a small flexible endoscope able to pass through the working channel and the possibility of using different rigid telescopes with various viewing angles. - Rigid telescopes can be advanced in a second stage beyond the tip of the sheath to penetrate small openings or channels and to “look around the corner”. ## 4.0 Substantial Equivalence The Richard Wolf Neuroendoscopy Set is substantially equivalent to the following devices: - Codman and Shurtleff, Inc.’s Gaab Neuroendoscope System - Karl Storz Auero Neuro-Endoscope System - Aesculap, Inc. Neuroendoscope All devices have the same intended use. ## 5.0 Performance Data - To ensure that the user is electrically isolated from the device, the instruments and connection cables are designed so that the connection instrument/cable overlaps. - Abrasion/Flaking testing was performed to assure the integrity and bonding of the insulation material to the instruments. - Testing was performed to verify thermal safety. Thermal damage is unlikely to occur using the Richard Wolf Neuroendoscopy Set. ## 6.0 Clinical Tests Clinical tests were performed by Eric Weber, MD, PhD, at the University of South Alabama under protocol # 92-105. {2} RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION 7.0 Conclusions Drawn These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual. By: Robert L. Casarsa Quality Assurance Manager Date: Oct 7, 97 {3} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 OCT 29 1997 Re: K970162 Trade Name: Neurological Endoscope Regulatory Class: II Product Code: GWG Dated: October 8, 1997 Received: October 9, 1997 Dear Mr. Casarsa: 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 current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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. {4} Page 2 - Mr. Robert L. Casarsa 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) 594-4595. 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,  Enclosure {5} Page ___ of ___ 510(k) Number (if known): K970162 Device Name: *Neuro logical Endoscope* Indications For Use: The device is intended for use for direct visualization, diagnosis and therapeutic application during intracranial procedures, such as - cyst fenestration - shunt placement - intraventricular coagulation - ventriculostomy of the 3rd ventricle when the aqueduct is obstructed - coagulation of small intraventricular lesions - biopsy of lesions which lead to the stricture of a ventricle The instrument simultaneously permits visual control and utilization of a working, an irrigation, and an aspiration channel. The Neuro-Endoscope can be used with or without a stereotactic frame. A special adapter is available to affix the endoscope. (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)