(84 days)
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Not Found
No
The summary describes standard features of an insulin pump and blood glucose monitor, such as programming, data logging, alerts, and reporting. There is no mention of AI or ML algorithms being used for tasks like predictive glucose monitoring, automated insulin dosing adjustments based on complex patterns, or personalized therapy optimization beyond user-defined settings. The "Hypo Manager" is a rule-based alert and recommendation system, not indicative of AI/ML.
Yes
The device, an insulin pump, is designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes, which is a therapeutic intervention.
Yes
The "Deltec CoZmonitor™ Blood Glucose Monitor" component is explicitly described as providing a "quantitative measurement of glucose (or sugar) in whole blood," which is used to monitor diabetes management. This function is a diagnostic measurement.
No
The device description clearly details hardware components like the insulin pump itself and the blood glucose monitor module, which are physical devices, not just software. While there is associated software (CoZmanager® 2.0), the primary medical device is a hardware system.
Based on the provided text, the Deltec CoZmonitor™ Blood Glucose Monitor is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The text explicitly states: "All testing is performed outside of the body (in other words, in-vitro diagnostic use only with FreeStyle™ Test Strip and FreeStyle™ Control Solution..." and "All testing is performed outside of the body (in other words, in-vitro diagnostic use only)."
- Intended Use: Its intended use is to provide a "quantitative measurement of glucose (or sugar) in whole blood," which is a diagnostic measurement performed on a biological sample (blood) outside of the body.
- Components: It is used with "FreeStyle™ Test Strip and FreeStyle™ Control Solution," which are typical components of an in vitro diagnostic system for blood glucose monitoring.
The Deltec Cozmo® Insulin Pump itself is not an IVD. It is a therapeutic device designed for delivering insulin. While it works in conjunction with the CoZmonitor, its primary function is not diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LZG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Subcutaneous (for insulin infusion), finger, forearm, upper arm, thigh, calf or hand (for blood glucose sampling)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).
0
Ka323
NOV - 1 2006
510(k) SUMMARY
Deltec Cozmo™ Insulin Infusion Pump
I. GENERAL INFORMATION
| Applicant's Name and Address: | Smiths Medical MD, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
|--------------------------------|-----------------------------------------------------------------------------------------|
| Contact Person: | David H. Short
Director Regulatory and Clinical Affairs |
| Common/Usual Name: | Insulin Infusion Pump and Glucose Monitor |
| Proprietary Name: | Deltec Cozmo® Insulin Infusion Pump Model 1800
with CoZmonitor® Blood Glucose Module |
| Equivalence Device Comparison: | Deltec Cozmo® Insulin Infusion Pump and Animas
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.
1
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.
2
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.
3
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 (240) 276-0115. 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/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
4
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
上462323