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.
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.
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.

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.

AI/ML Overview

The provided document is a 510(k) Summary for the Deltec Cozmo™ Insulin Infusion Pump with CoZmonitor™ Glucose Monitor. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics for the entire system based on strict statistical endpoints.

Based on the document, here's a breakdown of the requested information, focusing on what is explicitly stated and noting what is not applicable or not provided in this regulatory submission format:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present formal acceptance criteria (e.g., precision, accuracy ranges) or a detailed statistical performance table for the entire integrated system (Deltec Cozmo® Insulin Pump with CoZmonitor™ Glucose Monitor) in terms of glucose measurement accuracy as one might expect from a de novo IVD submission. Instead, it relies on the predicate device's established performance and focuses on the usability and functional aspects of the integration.

The usability study provides direct performance observations related to the successful completion of tasks:

Acceptance Criteria (Task Success)	Reported Device Performance (Number/% of Participants)
Successfully obtain blood glucose reading within two attempts	57 of 57 (100%)
Successfully obtain blood glucose reading with first attempt	55 of 57 (96.5%)
Obtain correct blood glucose readings using low, middle, and high control samples	52 of 57 (91.2%)
Monitor easy to attach to pump	55 of 57 (96.5%)
Monitor easy to use	55 of 57 (96.5%)
Easy to understand messages on pump screen	55 of 57 (96.5%)
Easy to select appropriate pump menu options	56 of 57 (98.2%)
Successfully used the CoZmonitor™ Glucose Monitor	56 of 57 (98.2%)

Note on Glucose Measurement Accuracy: The document states, "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." This implies that the glucose measurement accuracy itself relies on the established performance of the FreeStyle™ system, which is the "predicate" for the glucose monitoring component, and not newly established in this submission. The "correct blood glucose readings" in the usability study likely refer to whether the device correctly displayed the expected values for the control solutions, indicating proper function, rather than an independent validation of its analytical accuracy against a gold standard in a clinical setting.

2. Sample Size used for the test set and the data provenance

Test Set Sample Size: 57 participants (23 females, 32 males, 2 did not provide age).
Data Provenance: The study appears to be prospective, as participants were "asked to obtain their blood glucose reading" and "provided three control samples." The study was conducted at the location of the manufacturer or a contracted research facility, as it involved "Deltec Cozmo Insulin Pump users" as participants. The country of origin is implicitly the US, given the FDA 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Glucose Monitor Performance Ground Truth: For the "obtain correct blood glucose readings using the low, middle, and high control samples," the ground truth was the known nominal values of the control solutions. This does not involve human experts establishing ground truth in the usual sense for clinical diagnoses.
Usability Ground Truth: "Correct" performance for usability tasks (e.g., successfully obtaining a reading, attaching the monitor) was likely determined by study protocol observers. The document does not specify the number or qualifications of these observers.

4. Adjudication method for the test set

For "correct blood glucose readings" with control samples: Adjudication was against the known, expected values of the control solutions. Any reading outside of the expected range would be considered incorrect.
For usability tasks: The document describes direct observation of task completion. No formal adjudication method (like 2+1 or 3+1 consensus) among multiple expert reviewers is mentioned for the usability study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was conducted. This device is an insulin pump with an integrated glucose monitor, not an AI-powered diagnostic imaging device that would typically involve human readers interpreting cases. Therefore, this section is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in spirit. The performance of the glucose monitoring component relies on the validated FreeStyle™ technology, which functions in a standalone manner to measure glucose. The integration piece (transferring data to the pump, displaying messages, guiding users to bolus options) is software-driven. The "functional testing" and "software validation" mentioned would cover the standalone performance of these digital components. The usability study itself assesses the user's interaction with the integrated system.

7. The type of ground truth used

Usability: Direct observation of task completion by trained personnel and participant self-reporting of ease-of-use.
Glucose Readings (for control samples): Manufacturer-stated known values for low, middle, and high glucose control solutions.

8. The sample size for the training set

Not applicable / Not provided. This 510(k) submission is for a medical device (insulin pump with an integrated glucose monitor) and does not describe the development or training of an AI algorithm in the contemporary sense. The "software validation" refers to traditional software engineering verification and validation, not machine learning model training. The glucose monitoring technology ("powered by FreeStyle™") would have undergone its own extensive development and validation prior to this integration.

9. How the ground truth for the training set was established

Not applicable. As no AI training set is described, there's no ground truth establishment for a training set in this context.

Summary

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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.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	David H. ShortDirector 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

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.

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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

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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.

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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.

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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 (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

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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)

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:_KG31738

Regulation Number and Section

§ 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).