FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253

{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 a bird or eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird image. The text is in all capital letters and is evenly spaced around the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Richard Wolf Medical Instruments Corporation Mr. Robert L. Casarsa Quality Assurance Manager 353 Corporate Woods Parkway Vernon Hills, IL 60061 ## JUL 2 7 2015 K991178 Re: Trade/Device Name: Flexible Fiberscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated (Date on orig SE ltr): April 5, 1999 Received (Date on orig SE ltr): April 7, 1999 Dear Mr. Casarsa, This letter corrects our substantially equivalent letter of June 11, 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}------------------------------------------------ \$\rho_{gi} \propto r\$ 9911 78 510(k) Number (if known):_ Device Name: Flexible Fiberscope ## Intended Use: The flexible fiberscopes are used to examine body cavities and hollow organs via natural accesses or surgically created accesses. ## Indications and Field of Application: dications and Field of Application. For examination, diagnosis, and / or therapy in connection with endoscopic accessories and For examination, diagnosis, and / Officialpy in corporal flexible lithoripsy probes, e.g., auxiliary instruments, in particular, for intracorporal of the instrument auxiliary instruments, in particular, for intraces poraring channel of the instrument. The instruments are used in the medical disciplines of urology, surgery, gynecology, and The instruments are used in the medical personnel. Applications to the heart, the heart, the ENT by adequately trained a the circulatory systems are excluded. Important! Product dimensions must correspond to the anatomic requirements, i.e., use the flexible fiberscope appropriate to the medical discipline. (PLEASE DO NOT WRITE EELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number: K991178 Prescription Use Per 21 CRF 801.109 OR 5 - 1 Over-The Counter_ {3}------------------------------------------------ ## Contraindications: K99 "78 ff 206 r Contraindications directly related to the product are currently unknown. Based on the patient's general condition, the attending physician must determine if the application is appropriate. For further information refer to the latest medical literature. ## Combinations: The flexible fiberscopes are used in combination with light sources and flexible light cables, video cameras, or reflex cameras and lenses/objectives, suction irrigation devices, as well as endoscopic accessories (flexible lithotripsy probes, forceps, HF instruments, sheaths laser fibers, etc.). Caution! Ensure devices used in combination are compatible n their intended use and relevant specifications, e.g., working length, diameter, etc. Comply with the device instruction manuals used in combination with the submitted devices. Important! If the fiberscopes are used as uretero-renoscopes or in choledochus revisions, they must be placed via a guide wire. ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) | (Division Sign-Off) | | |--------------------------------------------------------------------|---------| | Division of Reproductive, Abdominal, ENT, and Radiological Devices | | | 510(k) Number | K991178 | | Prescription Use | OR Over-The Counter | |--------------------|------------------------| | Per 21 CRF 801 109 | 5-2 | {4}------------------------------------------------ ■ i 491178 Pg. 1 of r 355 Corporate Woods Parkway Vernon Hills, Illinous 60064 Phone: 847.913.1443 Fax: \$47.913.1488 ## RICHARD WOL MEDICAL INSTRUMENTS CORPORAT ## 510(k) Summary of Safety and Effectiveness | Submitter: | | |------------|--| |------------|--| | Company / Institution name: | Richard Wolf Medical Instruments Corp. | |--------------------------------|----------------------------------------| | Division name (if applicable): | N.A. | | Street address: | 353 Corporate Woods Parkway | | City: | Vernon Hills | | State/Province: | Illinois | | Country: | USA | | ZIP/Postal Code: | 60061 | | Contact name: | Mr. Robert L. Casarsa | | Contact title: | Quality Assurance Manager | | Date of Preparation | April 5, 1999 | |--------------------------------------|----------------| | FDA establishment regulation number: | 14 184 79 | | Phone number (include area code): | (847) 913-1113 | | FAX number (include area code): | (847) 913-0924 | | Product Information: | | |----------------------|--| |----------------------|--| | Trade name: | Flexible Fiberscope | |----------------------|----------------------| | Model number: | 7331.001 | | Common name: | Flexible Fiberscopes | | Classification Name: | Flexible Endoscopes | | Information on devices to which substantial equivalence is claimed: | | |---------------------------------------------------------------------|--| |---------------------------------------------------------------------|--| | 510(k) Number | Trade or proprietary or model name | Manufacturer | |---------------|----------------------------------------------------------------------|----------------| | 1 K980401 | 1 Flexible Fiberscopes | 1 Richard Wolf | | 2 K963855 | 2 Compact Operating Ureteroscopes & Uretero-Renoscopes Devices (URS) | 2 Richard Wolf | | 3 | 3 | 3 | | 4 | 4 | 4 | | 5 | 5 | 5 | | 6 | 6 | 6 | ### 1.0 Description The flexible fiberscopes consist of a flexible insertion part, a control part, a bent eyepiece for direct view or connection of a video camera and straight working channel, especially for the use with lithotripsy probes. ਰੋ {5}------------------------------------------------ 用 K991175 pg.29r ### 2.0 Intended Use The flexible fiberscopes are used to examine body cavities and hollow organs via natural accesses or surgically created accesses. ### 3.0 Technological Characteristics There are no significant technological characteristic changes to the new devices when compared to the existing devices. The tip of the sheath has an active 130° / 160° up/down. The image is transmitted via objective, fiber bendle and eyepiece for direct view or connection of a video camera. The straight working channel is used for procedures such as lithotripsy and biopsy removal while simultaneously providing irrigation. The bent eyepiece funnel can be moved to the right or left. Auxiliary instruments, such as gaping forceps, sone extractors, or HF button electrodes are inserted by a proximal mounted insertion cock with supply and discharge. A leakage test unit or a gas sterilization valve can be connected to an attachment of the fiberscope. ### Substantial Equivalence 4.0 The submitted devices pose the same type of questions about safety and effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing pre-enactment and 510(k) devices sold by Richard Wolf (K980401, K963855). ### 5.0 Performance Data No known FDA performance standard exists. ### 6.0 Clinical Tests No clinical tests performed. ### 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 **Date:** Mac 31 99 Quality Assurance Manager