DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817

K062323 · Smiths Medical MD, Inc. · LZG · Nov 1, 2006 · General Hospital

Device Facts

• Record ID: K062323
• Device Name: DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817
• Applicant: Smiths Medical MD, Inc.
• Product Code: LZG · General Hospital
• Decision Date: Nov 1, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Deltec 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 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 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™ Control Solution, as other products can give inaccurate results.

Device Story

Deltec Cozmo® Insulin Pump is a syringe-based infusion pump for CSII; used for diabetes management. Features include quick-start programming, food database, user-defined BG targets/alerts, insulin-on-board tracking, pump disconnect tracking, and 'Hypo Manager' (recommends carbohydrate intake for low BG). CoZmonitor® module attaches to pump for in-vitro blood glucose measurement using FreeStyle™ test strips. CoZmanager® 2.0 PC software allows data download and pump programming via IR connection. Device assists patients in basal pattern scheduling and therapy reporting. Healthcare providers use generated reports to adjust management programs. Benefits include improved glycemic control and simplified insulin delivery/monitoring.

Clinical Evidence

No clinical data. Effectiveness established via functional verification and validation of software-controlled programming functions, demonstrating performance to specifications, and by comparison to legally marketed predicate devices.

Technological Characteristics

Syringe infusion pump; IR connectivity for PC communication; software-controlled programming; includes blood glucose monitoring module. Materials and specific standards not detailed. Software-based feature set includes food database, insulin-on-board calculation, and hypo-management logic.

Indications for Use

Indicated for patients with diabetes requiring Continuous Subcutaneous Insulin Infusion (CSII) and blood glucose monitoring. Used for diabetes management and monitoring by patients and healthcare providers.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Deltec Cozmo® Insulin Pump Model 1700
• Animas IR 1250

Submission Summary (Full Text)

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Ka323
NOV - 1 2006

# 510(k) SUMMARY

# Deltec Cozmo™ Insulin Infusion Pump

#### 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 Model 1800<br>with CoZmonitor® Blood Glucose Module |
| Equivalence Device Comparison: | Deltec Cozmo® Insulin Infusion Pump and Animas<br>IR 1250 |

### II. DEVICE DESCRIPTION

The Deltec Cozmo® Insulin Infusion Pump with CoZmonitor® Blood Glucose Module is lightweight and easy to use. The Deltec Cozmo® Insulin Pump incorporates a number of features to assist users in the management of their diabetes. Some of these features include a quick start program to allow users easy pump set-up and programming, enhancements to existing features, the addition of a food data base, user established blood glucose targets and alerts, insulin-on-board to alert the user of remaining active insulin following bolus administration, pump disconnect feature that allows the user to disconnect from the pump and allowing the pump to then keep track of insulin that would have been delivered during the disconnect period, Hypo Manager that alerts the patient of low BG levels and recommends carbohydrate units to ingest to elevate BG to patient specific specified levels, Therapy Summary Report to assist with diabetes management, weekly schedule to allow the user to set basal patterns to match activities of daily living. The Deltec Cozmo® Insulin Pump is used with the CoZmonitor® Blood Glucose Module

The CoZmanager® 2.0 is a PC based program that allows the user to download information from the pump and to program the pump via an IR connection between the pump and the PC. CoZmanager® 2.0 allows the user to customize names of features as well as establish meal selections based on individual needs. A number of reports are available from the program.

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### III. INTENDED USE OF THE DEVICE

The Deltec Cozmo® Insulin Pump is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes.

### IV. DEVICE COMPARISON

The Deltec Cozmo® Insulin Pump Model 1800 is similar to the currently distributed Deltec Cozmo® Insulin Pump Model 1700 pump, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump.

The Deltec Cozmo® Insulin Pump Model 1800 is substantially equivalent to other commercially available insulin pumps such as the Animas IR 1250.

### V. SUMMARY OF STUDIES

#### A. Functional Testing

Verification and validation of software controlled programming functions related to proper pump operation were conducted and results of this testing showed the Deltec Cozmo® Insulin Pump Model 1800 met and performed to established specifications.

#### B. Clinical Studies

Clinical studies were not deemed necessary to establish effectiveness of the Deltec Cozmo® Insulin Pump Model 1800 as the pump is similar to other currently commercially available insulin pumps on the market today.

### C. Conclusion Drawn from the Studies

Based on the information provided above, the Deltec Cozmo® Insulin Pump Model 1800 is substantially equivalent to other currently commercially available insulin infusion pumps on the market today.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 2006

Mr. David H. Short Director Regulatory Affairs and Design Assurance Smiths Medical MD, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

Re: K062323

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: October 9, 2006 Received: October 10, 2006

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 (Special 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.

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# 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Suitti Y. Michin Omd
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

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# Indications for Use

# 510(k) Number (if known): K062323

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.

Over-The Counter Use Prescription Use OR X (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 with FreeStyle™ Test Strip and FreeStyle™ Control Solution, as other products can give inaccurate results.

Prescription Use (Per 21 CFR 801.109) 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)

OR

OR

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)

Cim

Anesthesiology, General Hospital
Lion Center, Dental Devices

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