STERILE AMBULATORY RESERVOIR 60ML/100ML

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Bruce Craney Director Product Development Building Medical Device Company 8777 East Via De Ventura, Suite 315 Scottsdale, Arizona 85258 JUL 18 1997 Re: K962159 Trade Name: Sterile Ambulatory Reservoir 60mL/100mL Regulatory Class: II Product Code: MRZ Dated: June 26, 1997 Received: June 27, 1997 Dear Mr. Craney: 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 {1} Page 2 - Mr. Craney 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 {2} Page 1 of 1 510(k) Number (if known): K962159 Device Name: S.P.A.R.™ Sterile Ambulatory Reservoir Cat. No. 900621 - 60 mL and 900915 - 100 mL ## Indications For Use: The S.P.A.R.™ Sterile Ambulatory Reservoir is intended for use with the Pharmacia Deltec CADD® Model 5800 Ambulatory Infusion Pump, manufactured and distributed by Sims Deltec Inc. St. Paul, Minnesota. The S.P.A.R.™ Medication Reservoir is intended for use as an accessory to the Pharmacia Deltic CADD® infusion pump by replacing the Deltic Medication Cassette™, Model 2050 - 50 mL and 2100 - 100 mL with the S.P.A.R. Reservoir. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDHR, Office of Device Evaluation (ODE) (Division Sign-Off) *Plebsia Cricenta* Division of Dental, Infection Control, and General Hospital Devices 510(k) Number *K962159* Prescription Use ☑ OR Over-The-Counter Use ☐ (Per 21 CRF 801.109) (Optional Format 1-2-96) 485 ON 8552 665 105 + 07 371030 7H1111111111111111111111111111111111111111111111111111111111