ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE

{0} 510(k) Premarket Notification Syringe•Mate System K971168 510(k) SUMMARY Syringe•Mate System JUL 15 1997 ## Submitted by: Patricia S. Barsanti Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073 ## Date Prepared: March 29, 1997 ## Proposed Device: Syringe•Mate System ## Predicate Devices: Uni•Dose Infusion Pump Baxter Multiday Infusor ## Proposed Device Description: The new device consists of a line of Syringe•Mate System infusion pumps which will be manufactured with three different fixed, flow rates: *One Day Syringe•Mate System (4.2 mL/hr) *Five Day Syringe•Mate System (0.8 mL/hr) *Seven Day Syringe•Mate System (0.6 mL/hr) ## Summary of Technological Characteristics of New Device to Predicate Devices The Syringe•Mate System differs in material composition but is the same in overall design and intended use as the predicate devices. MAR 28 1997 s:\510k\zpump\A1-6 Baxter Confidential 31 {1} 510(k) Premarket Notification Syringe•Mate System # Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests The biological and chemical reactivity of the new materials have been assessed using biological methods specified in ISO 10993-1 and USP Physicochemical tests. The materials were found to be acceptable for their intended use. Data regarding the functional performance of the Syringe•Mate System have also been generated. Testing was conducted to evaluate flow rate, residual volume and pressure relief valve performance. Performance testing results indicate that the Syringe•Mate System meets or exceeds the functional requirements and supports its suitability for use. MAR 2 8 1997 s:\510k\zpump\A1-6 Baxter Confidential 32 {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 15 1997 Ms. Patricia S. Barsanti, RAC Regulatory Affairs Manager Baxter Healthcare Corporation P.O. Box 490 Route 120 and Wilson Road Round Lake, Illinois 60073 Re: K971168 Trade Name: One-Day/Five-Day/Seven-Day Syringe Mate Regulatory Class: Unclassified Product Code: MEB Dated: June 19, 1997 Received: June 24, 1997 Dear Ms. Barsanti: 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 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 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 {3} Page 2 - Ms. Barsanti 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) 594-4618. 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/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4} 510(k) Premarket Notification Syringe•Mate System 510(k) Number: ~~Not Available-~~ K971168 Device Name: Syringe•Mate System (Models 2C1141, 2C1142, 2C1143) Indications for Use: The Syringe•Mate System is indicated for patients requiring slow, continuous intravenous, epidural, or subcutaneous administration of medications. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) *Patricia Cucente* Division of Dental, Infection Control, and General Hospital Devices 510(k) Number *K971168* Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96)