SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER

{0}------------------------------------------------ MAY 27 2004 K031738 ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ## Deltec Cozmo™ Insulin Infusion Pump with CoZmonitor™ Glucose Monitor ### April 9, 2004 #### I. GENERAL INFORMATION | Applicant's Name and Address: | Smiths Medical MD, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 | |--------------------------------|--------------------------------------------------------------------------------------------------| | Contact Person: | David H. Short<br>Director Regulatory and Clinical Affairs | | Common/Usual Name: | Insulin Infusion Pump and Glucose Monitor | | Proprietary Name: | Deltec Cozmo® Insulin Infusion Pump with CoZmonitor™ Glucose Monitor | | Equivalence Device Comparison: | Deltec Cozmo® Insulin Infusion Pump and TheraSense FreeStyle Tracker™ Diabetes Management System | #### II. DEVICE DESCRIPTION A CoZmonitor™ Glucose Monitor is a modified FreeStyle Tracker™ meter module designed to be coupled with the Deltec Cozmo® Insulin Pump. The Deltec Cozmo® Insulin Infusion Pump with CoZmonitor™ Glucose Monitor is lightweight and easy to use. Users follow their usual practice of blood sampling. The FreeStyle™ test strip is inserted into the CoZmonitor™ Glucose Monitor, which is attached to the Deltec Cozmo® Insulin Pump. The CoZmonitor™ Glucose Monitor will automatically transfer the blood glucose information to the Deltec Cozmo® Pump through an infrared port. If the user's blood glucose level is higher than normal, he or she can go directly to the bolus menu of the pump to correct it without having to manually re-enter the blood glucose value, ensuring more consistent insulin delivery. In addition, blood glucose results are combined with insulin delivery data and stored in the Deltec Cozmo® Pump's history log to provide a complete picture of the user's diabetes management, allowing them to be more proactive in their insulin decisions. The system's central data storage capabilities also allow users to go through fewer steps and therapy calculations – reducing the risk of data or transcription errors. {1}------------------------------------------------ ### III. INTENDED USE OF THE DEVICE The Deltcc Cozmo® Insulin Pump is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes. The Deltec CoZmonitor™ Blood Glucose Monitor is available as an accessory to be used solely with the Deltec Cozmo® Insulin Pump. Because the monitor is powered by FreeStyle™, blood sampling will be performed using the finger, forearm, upper arm, thigh, calf or hand. All testing is performed outside of the body (in other words, in-vitro diagnostic use only with FreeStyle™ Test Strip and FreeStyle™ Control Solution, as other products can give inaccurate results. The Deltec CoZmonitor™ Blood Glucose Monitoring System is designed to be used only with the Deltec Cozmo® Insulin Pump to help you and your healthcare provider monitor your diabetes management program. When used properly, the monitor provides a quantitative measurement of glucose (or.sugar) in whole blood. Because the monitor is powered by FreeStyle™, blood sampling can be performed using the finger, forearm, upper arm, thigh, calf or hand. All testing is performed outside of the body (in other words, in-vitro diagnostic use only). Use only with FreeStyle™ Test Strip and FreeStyle™Cry (100 Control Solution, as other products can give inaccurate results. #### DEVICE COMPARISON IV. The Deltec Cozmo® Insulin Pump is very similar to the currently distributed pump, with the exception of updated software to allow for its use with the CoZmonitor™ Glucosc Monitor. The CoZmonitor™ Glucose Monitor is a modified FreeStyle Tracker™ meter module designed to be coupled with the Deltec Cozmo® Insulin Pump. The FreeStyle Tracker™ meter modified to include the mechanical connections to allow for the connection to a Deltec Cozmo® Insulin Pump along with designing the module to fit on the back of the pump, updated software to allow for use with the pump, infrared ports to allow for commis cations with the pump, and the use of a CR2032 battery ### V. SUMMARY OF STUDIES #### A. Functional Testing Software validation, verification of software controlled programming functions, and software related to proper pump operation were completed for the Deltec Cozmo® Insulin Pump with CoZmonitor™ Glucose Monitor. #### B. Clinical Studies Clinical studies were not deemed necessary regarding the Deltec Cozmo® Insulin Pump with CoZmonitor™ Glucose Monitor due to their similarity in design and function to the current Deltec Cozmo™ Insulin Pump and TheraSense FreeStyle Tracker™ monitor. Usability studies of the Deltec CoZmonitor™ Blood Glucose Monitoring System were conducted with 57 participants (23 females and 32 males) ranging in age from 9 years to 76 years. Two participants did not provide their age. All participants were Deltec Cozmo® Insulin Pump users {2}------------------------------------------------ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Deltec Cozmo™ Insulin Infusion Pump with CoZmonitor™ Grucose Monitor April 9, 2004 and ranged from 1 month to >12 months. Five participants did not provide the length of time they had used the Deltec Cozmo® Insulin Pump. Participants were asked to obtain their blood glucose reading and 57 of 57 participants were able to successfully obtain their blood glucose reading within two attempts, 55 of 57 partics partics parts successfully obtain blood glucose readings with their first attempt. Participants were also provided three control samples with low, middle, and high glucose concentrations and were asked to obtain glucose readings from each sample and 52 of 57 participants were able to obtain correct blood glucose readings using the low, middle and high control samples. Of the 5 participants that did not obtain correct glucose readings, I participant obtained an out of range reading for the high control on test and retest; one participant abtained an out of range reading for a middle control, but did not retest; two participants did not sample 1 of the 3 control samples, but were able to obtain correct readings for the other two control samples, Participants were asked to attach the CoZmonitor™ Glucose Monitor to the Deltec Cozmo® Insulin Pump and 55 of 57 participants indicated the CoZmonitor™ Glucose Monitor was easy to attach to the Deltec Cozmo® Insulin Pump. 55 of 57 participants indicated the CoZmonitori was Casy Glucose Monitor was easy to use. 55 of 57 participants indicated the CoZmonitor™ Glucose Monitor System was easy for them to know what to do based on the messages displayed on the Deltec Cozmo® Insulin Pump screen. 56 of 57 participants indicated that it was easy for them to select the appropriate choice from Deltec Cozmo® Insulin Pump menu options to bring their blood glucose reading back on target. 56 of 57 participants indicated that they successfully used the CoZmonitor™ Glucose Monitor. #### C. Conclusion Drawn from the Studies Based upon the information provided above, the Deltec Cozmo® Insulin Pump with CoZmonitor™ Glucose Monitor is substantially equivalent to other commercially available devices. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Public Health Service ## MAY 2 7 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. David H. Short Director Regulatory and Clinical Affairs Smiths Medical MD, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112 Re: K031738 Trade/Device Name: Deltec Cozmo® Insulin Pump with CoZmonitor™ Glucose Monitor Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: March 16, 2004 Received: March 17, 2004 Dear Mr. Short: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (Spccial Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ Page 2 -Mr. Short Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 vours. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use ### 510(k) Number (if known): K031738 Deltec Cozmo® Insulin Pump with CoZmonitor™ Glucose Monitor Device Name: ### Indications for Use: ## Deltec Cozmo® Insulin Pump The Deltec Cozmo® Insulin Pump is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes. | Prescription Use X | OR | Over-The Counter Use | |----------------------|----|----------------------| | (Per 21 CFR 801.109) | | | ### Indications for Use: ### CoZmonitor™ Glucose Monitor The Deltec CoZmonitor™ Blood Glucose Monitor is available as an accessory to be used solely with the Deltec Cozmo® Insulin Pump. Because the monitor is powered by FreeStyle™, blood sampling can be performed using the finger, forearm, upper arm, thigh, calf or hand. All testing is performed outside of the body (in other words, in-vitro diagnostic use only). Use only with FreeStyle™ Test Strip and FreeStyle™ Control Solution, as other products can give inaccurate results. Prescription Use (Per 21 CFR 801.109) ાર Over-The Counter Use X ### Indications for Use: ### Deltec Cozmo® Insulin Pump with CoZmonitor™ Glucose Monitor The Deltec CoZmonitor™ Blood Glucose Monitoring System is designed to be used only with the Deltec Cozmo® Insulin Pump to help you and your healthcare provider monitor your diabetes management program. When used properly, the monitor provides a quantitative measurement of glucose (or sugar) in whole blood. Because the monitor is powered by FreeStyle™, blood sampling can be performed using the finger, forearm, upper arm, thigh, calf or hand. All testing is performed outside of the body (in other words, in-vitro diagnostic use only). Use only with FreeStyle™ Test Strip and FreeStyle™ Control Solution, as other products can give inaccurate results. Prescription Use X (Per 21 CFR 801.109) ()R Over-The Counter Use ---------- PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) . Concurrence of CDRH, Office of Device Evaluation (ODE) 29. May (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number:_KG31738