TRUMP-IT II AND MAGNUM 250

{0}------------------------------------------------ ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS VIII. Submitter's Name A. - 1. Address Valley West, Inc. P. O. Box 678 Highway 6 North Meridian, TX 76665 - 2. Phone Number (254) 435-2306 - 3. Contact Person C. Kenneth French, President 4. Summary Preparation Date January 13, 1998 ### B. Device Name - 1. Trade/Proprietary Name Trump-It II™ and Magnum 250 - 2. Common/Usual Name Trumpet Valve Suction-Irrigation Handpiece - 3. Classification Name(s) General and Plastic Surgery Laparoscope and Accessories 1973814 {1}------------------------------------------------ Food and Drug Admin. Center for Devices & Radiological Health (HFZ-401) 01/13/98 Amendment A #### C. Predicate Device(s) : In terms of safety, effectiveness, and intended use, the Candidate Device is substantially-equivalent to the following legally-marketed device ("Predicate Device"): | Device Name: | Nezhat-Dorsey Hydro-Dissection<br>System & Accessories | |-------------------------------|--------------------------------------------------------| | Manufacturer: | American Hydro-Surgical Instruments,<br>Inc. | | 510(k) Number: | K951086 | | Substantial Equivalence Date: | 3/16/95 | #### D. Device Description ## 1. Function When used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, and legally-marketed suction source, the Candidate Device provides suction and irrigation to the surgical site during general laparoscopic procedures. ## 2. Scientific Basis Provides pinpoint suction and irrigation to the surgical site during laparoscopic procedures by combining a hand-held trumpet valve suctionirrigator and laparoscopic probe. # 3. Significant Physical/Performance Characteristics - a) Design Sterile, disposable. For single use only. {2}------------------------------------------------ Food and Drug Admin. Center for Devices & Radiological Health (HFZ-401) 01/13/98 Amendment A - Materials b) The materials from which this device is constructed are proprietary. - Physical Properties c) Not Applicable. #### Intended Use Statement E. # 1. Disease/Conditions The Candidate Device is intended for use in the treatment of disease conditions via general laparoscopic surgical procedures. # 2. Patient Population The Candidate Device is indicated for use in patient populations eligible for treatment via general laparoscopic surgical procedures. #### Technological Characteristics Summary F. The Candidate Device consists of a hand-held trumpet valve suction-irrigator designed to provide pinpoint suction and irrigation to the surgical site during general laparoscopic procedures. This device is designed for use with legally-marketed irrigation pumps, irrigant bags and bottles, and legallymarketed suction sources. ^&quot; Trademark of American Surgical Specialties Company {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image is a simple, minimalist composition consisting of a series of small, dark dots or dashes arranged in a horizontal line across a white background. The dots are spaced irregularly, with varying distances between them. The overall impression is one of sparseness and simplicity, with the dots appearing almost like a faint trail or a series of isolated marks. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 . IAN 3 0 1998 Ms. Julie H. Byerly Regulatory Affairs Consultant Valley West, Incorporated C/O Accureg, Incorporated 300 NW 82nd Avenue, Suite 402 Plantation, Florida 33324 Re: K973814 > Trade Name: Trump-It II and Magnum 250 Regulatory Class: II Product Code: GCJ Dated: January 13, 1998 Received: January 15, 1998 Dear Ms. Byerly: 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 (OS) 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 {4}------------------------------------------------ Page 2 - Ms. Byerly 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) 594-4595. 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-freenumber (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, J. Collez Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices ... . -Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### IX. INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K973814 Device Name: Trump-It II™ or Magnum 250 Indications for Use: The device is indicated for use in patients eligible for treatment via general laparoscopic surgical procedures. ""Trademark of American Surgical Specialties Company (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | | (Division Sign-Off) | |-----------------------------------------|---------------------| | Division of General Restorative Devices | | | 510(k) Number | K973814 | |---------------|---------| |---------------|---------| | Prescription Use | XX | |----------------------|----| | (Per 21 CFR 801.109) | | OR | Over-The-Counter Use | | |----------------------|--| |----------------------|--| (Optional Format 1-2-96)