MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES

{0}------------------------------------------------ # F: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS # 510(k) SUMMARY | 1) | Submitter: | Dexide, Inc.<br>7509 Flagstone Drive<br>Fort Worth, TX 76118-6995<br>Phone No.: (817) 589-1454 | |----|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Contact Person: | Lynette Caldwell<br>Director of Quality Assurance | | | Date Prepared: | Friday, May 29, 1998 | | 2) | Name of Device: | MultApump™ System | | | Common Name: | Irrigation Pump | | 3) | Predicate Device: | Davol (Bard) -K961492 | | 4) | Description of Device: | The “candidate device” consists of a Disposable Pump<br>Head, pump motor, clamp & bracket, power supply and<br>power cord(s) for use in laparoscopy. The Disposable<br>Pump Head is a sterile, single-use device, composed of<br>Stainless Steel, glass filled Polypropylene, Medical Grade<br>EPDM, ABS plastic, plastic and flexible PVC tubing. It has<br>an interface dock for attachments of the reusable pump<br>motor. The pump motor, clamp, power supply and power<br>cord are reusable components. | | 5) | Intended Use: | The “candidate device” is designed to be used in<br>conjunction with a laparoscopic irrigation/suction device to<br>provide controlled powered irrigation during laparoscopic<br>surgical procedures. | - Technological characteristics the candidate device is comparable to the predicate device 6) in that both devices provide controlled powered irrigation during laparoscopic surgical procedures. {1}------------------------------------------------ ## SECTION G: ### MANUFACTURER'S STATEMENT OF SUBSTANTIAL EQUIVALENCE (To be provided with 510(k) notification for tier 2 devices) STATEMENT OF INDICATIONS FOR USE: The "candidate device" is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage. CLAIMS: The pump motor, clamp, bracket, power supply and power cord are reusable components. The Disposable Pump is supplied as a sterile, single-use product. This notification contains all of the information required by 21 CFR 807.87. A completed copy of the "DRAERD Premarket Notification 510(k) Reviewer's Screening Checklist" is attached. The candidate device conforms to the following voluntary and mandatory standards: There are no existing mandatory performance standards that Dexide, Inc is aware. The candidate device has the same technological characteristics as a legally marketed predicate device. Specifically, the features, specifications, materials, and mode of action are equivalent. If the candidate device is a kit, all of the contents of the kit are either pre-Amendment devices or have been cleared for marketing through previous 510(k)'s. The kit contains no drug or biologic products. The above statements are accurate representations of this 510(k) Premarket Notification and of the device this firm intends to market. All data and information submitted in this Premarket Notification is truthful and accurate and no material fact has been omitted (21 CFR 807.87(J)). | MANUFACTURER: | Dexide, Inc. | | |-------------------------|-------------------------------|----------------| | OFFICIAL CORRESPONDENT: | Lynette Caldwell | (signature) | | | Lynette Caldwell | (printed name) | | TITLE: | Director of Quality Assurance | | | DATE: | August 4, 1998 | | {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three figures in profile, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 5 1998 Ms. Lynette Caldwell Director of Quality Assurance Dexide, Inc. 7509 Flagstone Drive Fort Worth, TX 76118-6995 K981940 Re: Trade Name: MultApump Disposable Pump Head and Accessories Regulatory Class: II Product Code: GCJ Dated: August 10, 1998 Received: August 21, 1998 Dear Ms. Caldwell: 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 The general controls provisions of the Act 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. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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. {3}------------------------------------------------ #### Page 2 - Ms. Lynette Caldwell 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.qov/cdrh/dsmamain.html". Sincerely yours, 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 {4}------------------------------------------------ | Page | 1 | |------|---| | of | 1 | | 510(k) Number (if known): | K981940 | |---------------------------|-------------------| | Device Name: | MultApump™ System | : Intended Use: . . . . . . The MultApump™ System is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures. (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 General Restorative Devices | K981940 | | 510(k) Number | | | Prescription Use | OR | Over-The-Counter Use | |------------------|----|----------------------| |------------------|----|----------------------| (Optional Format 1-2-96) __ OR Prescription Use (Per 21 CFR 801.109)