BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771

{0}------------------------------------------------ 4/16/99 1 ■ 353 Corporate Woods Vernon I lills, Illinois 6006 I Phone: 847.913.4143 Fax: \$47.943.4488 RICHARD W MEDICAL INSTRUMENTS CORPORA Image /page/0/Picture/9 description: The image shows a black square with a white drawing inside. The drawing appears to be a stylized representation of an animal, possibly a dog or wolf, standing on its hind legs. The animal has a long neck and a pointed head, and it is wearing some sort of garment or harness around its body. # 510(k) Summary of Safety and Effectiveness | Submitter: | Date of Preparation: | | | |----------------------------------------|-------------------------------------------------------|----------|--------------------| | Company / Institution name: | January 13, 1999 | | | | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FDA establishment registration number: | | | | Division name (if applicable): | 1418479 | | | | N.A. | Phone number (include area code): | | | | | (847) 913-1113 | | | | Street address: | FAX number (include area code): | | | | 353 Corporate Woods Parkway | (847) 913-0924 | | | | City: | State/Province: | Country: | ZIP / Postal Code: | | Vernon Hills | Illinois | USA | 60061 | | Contact name: | | | | | Mr. Robert L. Casarsa | | | | | Contact title: | | | | | Quality Assurance Manager | | | | | Product Information: | | | | | Trade name: | Model number: | | | | Bipolar forcep set (modular) | 8393.741, 8393.771, 8394.741, 8394.771 | | | | Common name: | Classification name: | | | | Modular Bipolar forceps | Coagulator-Cutter, Endoscopic,<br>Bipolar Accessories | | | Information on devices to which substantial equivalence is claimed: | 510(k) Number | Trade or proprietary or model name | Manufacturer | |---------------|-----------------------------------------------|------------------------------------| | 1 pre-enact. | 1 Kleppinger bipolar forceps 8383.21, 8384.21 | 1 Richard Wolf GmbH | | 2 K981321 | 2 Modular Bipolar Forcep Sets 8390/91/93/94 | 2 Richard Wolf Medical Instruments | ### 1.0 Description The modular bipolar forcep set provides precise grasping and axial holding placement of the jaws, performs thorough hygiene, and site irrigation can be achieved without using additional instruments. {1}------------------------------------------------ Image /page/1/Picture/3 description: The image contains a single Chinese character, '得', in a bold, sans-serif font. The character is black against a white background. The character appears to be centered in the image. #### 2.0 Intended Use The coagulation of tubes, tissue coagulation and vascular coagulation, and to stop bleedings under endoscopic vision, including coagulation of the fallopian tube and the mesoalpinx for female sterilization. #### 3.0 Technological Characteristics There are no significant technological characteristic changes to the new devices compared to the pre-enactment devices. The insulation of the electrodes is changed to a more durable coated material. A cleaning port is added. The instruments are identical to those cleared by K981321. #### 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 pre-enactment devices sold by Richard Wolf. In addition, the submitted devices are substantially equivalent to devices sold by various competitors. #### 5.0 Performance Data No known FDA performance standard exists. The bipolar forceps were tested to meet the appropriate sections of the ANSV AAMI standard on high frequency devices HF18 and IEC601-2-2, Device materials tests were performed to assure biocompatibility of the new material. The tests indicated that no irrigation would occur. #### 6.0 Clinical Tests No special clinical tests performed. #### 7.0 Conclusions Drawn These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual. By: Robert L. Pearson Date: Apr 16, 99 Robert L. Casarsa Quality Assurance Manager {2}------------------------------------------------ Image /page/2/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 eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 16 1999 Mr. Robert L. Casarsa Quality Assurance Manager RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 Corporate Woods Parkway Vernon Hills, IL 60061 Re: K990147 Modular Bipolar Forcep Set, Kleppinger Principle Dated: January 13, 1999 Received: January 19, 1999 Regulatory Class: III 21 CFR 884.4150/Procode: 85 HIN 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 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. 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 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/dsma/dsmamain.html". Sincerely yours. CAPT 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}------------------------------------------------ ## * (*) : 10) : 510(k) Number (if known): Modular Bipolar Forcep Set. Kleppinger Principle Device Name:__________________________________________________________________________________________________________________________________________________________________ ### Intended Use: The coagulation of tubes, tissue coagulation and vasculation, and to stop bleedings under endoscopic vision, including coagulation of the fallopian tube and the mesoalpinx for female sterilization. (IT EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOXITIER PAGE IF NEEDED) Prescription Use Per 21 CFR 801.109 --- **(Division Sign-Off)** and Radiological Devices 510(k) Number_ Division of Reproductive, Abdominal, ENT, ()R Over-The Counter_ 5 - 1