PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX

{0}------------------------------------------------ 3/5/99 g 1 of 2 553 Corporate Woods Vernon I lills, Illinois 6006 i Phone: 847.913.4443 Fax: \$47.943.1488 510(k) Summary of Safety and Effectiveness RICHARD WOLF | Date of Preparation | December 23, 1998 | |---------------------|-------------------| |---------------------|-------------------| | Submitter: | | |----------------------------------------|----------------------------------------| | 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: | Endoscopes with Panoview Plus Optics | |----------------------|--------------------------------------| | Model number: | 8672.xxx and 8686.xxx | | Common name: | Endoscopes | | Classification name: | Endoscopes | Information on devices to which substantial equivalence is claimed: | | 510(k) Number | Trade or proprietary or model name | Manufacturer | |---|---------------|------------------------------------------------------|--------------| | 1 | pre-enactment | Cysto-Urethrosocpe for children, Model 8670 and 8680 | Richard Wolf | | 2 | | 2 | 2 | #### 1.0 Description An endoscope with 1.9 mm and 2.7 mm diameter, typically used in endoscopy in infants and babies. ### 2.0 Intended Use The endoscopes serve to visualize the inside of the patient via natural or surgically generated access. {1}------------------------------------------------ K 984607 - pg r of r #### Technological Characteristics 3.0 - · increased image size and greater brightness - sharp, brilliant quality over the entire image . - autoclavable 134°C / 273°C . ### 4.0 Substantial Equivalence The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing devices sold by Richard Wolf. #### 5.0 Performance Data No performance standards are known. The devices conform to the relevant provisions of European Device Directive 93/42/EEC. #### 6.0 Clinical Tests Clinical tests performed were not performed. ### 7.0 Conclusions Drawn These devices are designed and tested to assure their safety and effectiveness when used according to the instructions manual. By: Robert L. Casares Robert L. Casarsa Quality Assurance Manager Date: Dec 23 98 {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 5 1999 Mr. Robert L. Casarsa Quality Assurance Manager RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, IL 60061 Re: K984607 Thin Endoscopes with Panoview Plus Optics Dated: December 23, 1998 Received: December 28, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 FBP & GCM 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 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). 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 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 Requlations. 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. 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) 594-4613. 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 requlation 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/dsma/dsmamain.html". Sincerely yours, APT Daniel G. Schultz. M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ **Indications for Use** 510(k) Number (if known): __ K 98 46 07 Device Name: Thin Endoscopes with Panoview Plus Optics # Intended Use: The endoscopes serve to visualize the inside of the patient via natural or surgically generated access. ### Indications and Fields of Application: For examination, diagnosis and/or therapy by personnel trained in the use of endoscopic instrumentation used in various medical disciplines, such as surgery, urology, gynecology, and ENT. ### Contraindications: There are no known contradindications directly related to the product. The attending physician must determine the appropriateness of the application while considering the general condition of the patient. ## Combinations: The endoscopes are used in connection with light sources and flexible light cables, video cameras or reflex cameras and objective lenses, as well as accessories for endoscopic use, e.g. trocar sleeves, forceps, electrodes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number Prescription Use Per 21 CFR 801.109 5 - 1 Over-The Counter