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 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.

AI/ML Overview

This document, K062323, is a 510(k) summary for the Deltec Cozmo® Insulin Infusion Pump Model 1800 with CoZmonitor® Blood Glucose Module. It focuses on demonstrating substantial equivalence to pre-existing devices rather than presenting detailed acceptance criteria and a study to prove meeting those criteria for a novel device.

The provided text does not include acceptance criteria or a study designed to explicitly prove the device meets pre-defined acceptance criteria in the manner typically expected for a new or significantly modified medical device requiring such rigorous assessment.

Instead, the submission relies on the concept of "substantial equivalence" to predicate devices. Here's what we can extract and what's missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Software Functional Performance	Established specifications for proper pump operation (implied from "Verification and validation of software controlled programming functions related to proper pump operation").	"Results of this testing showed the Deltec Cozmo® Insulin Pump Model 1800 met and performed to established specifications."
Clinical Effectiveness	Not explicitly defined as acceptance criteria for this 510(k) given its reliance on substantial equivalence.	"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." (This indicates no clinical performance data was generated or reported for acceptance against specific criteria).
Safety	Not explicitly defined as acceptance criteria for this 510(k).	No specific safety performance metrics or data reported in this summary, relying on the safety profile of predicate devices.
Equivalence to Predicate Devices	Substantially equivalent to currently distributed Deltec Cozmo® Insulin Pump Model 1700 and Animas IR 1250.	"The Deltec Cozmo® Insulin Pump Model 1800 is substantially equivalent to other currently commercially available insulin infusion pumps on the market today."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable / Not reported. The document states "Verification and validation of software controlled programming functions related to proper pump operation were conducted," but it does not specify the sample size (e.g., number of test cases, number of devices tested) for this functional testing.
Data Provenance: Not reported. The testing was internal to the manufacturer (Smiths Medical MD, Inc.) as part of their verification and validation process, but no details on the origin of data (e.g., country, retrospective/prospective) are provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable / Not reported. The "ground truth" for functional software testing would typically be the expected output or behavior according to the design specifications. This doesn't involve external or clinical experts establishing ground truth in the way a diagnostic AI device would.

4. Adjudication Method for the Test Set

Not applicable / Not reported. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation or clinical outcomes where discrepancies need resolution. This document describes functional and software verification, which generally follows pre-defined test protocols with expected pass/fail outcomes, not expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. A MRMC comparative effectiveness study was not done. The document explicitly states: "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." Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, implicitly for the software functionality. The "functional testing" described for "software controlled programming functions related to proper pump operation" would be a standalone evaluation of the algorithm's performance against specifications. However, specific performance metrics (e.g., accuracy, precision) for these algorithms (like insulin-on-board calculations, Hypo Manager recommendations) are not reported in this summary. The summary only states it "met and performed to established specifications."

7. The Type of Ground Truth Used

For the reported "Functional Testing": The ground truth would be the engineering specifications and design requirements for the software and device functions. This is derived from product design documents, not external clinical data, pathology, or outcomes in this context.

8. The Sample Size for the Training Set

Not applicable / Not reported. This device is an insulin pump, not an AI/ML-based diagnostic or prognostic algorithm that typically requires a distinct "training set" in the machine learning sense. The software functions were likely developed through traditional software engineering processes, not trained on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable / Not reported. As this is not an AI/ML device in the modern sense requiring a training set, the concept of establishing ground truth for a training set does not apply.

Summary of Missing Information in the Context of Your Request for an Acceptance Criteria Study:

The provided 510(k) summary is for an insulin pump, which is a physical medical device with software, not a diagnostic AI algorithm. Consequently, many of the requested details such as sample sizes for test/training sets, data provenance, expert qualifications for ground truth, and MRMC studies, are either not applicable, not reported, or addressed through traditional device verification and validation (V&V) processes rather than a "study proving acceptance criteria" in the way one would for a novel AI diagnostic.

The key takeaway is that the device gained clearance based on substantial equivalence to predicate devices and internal functional testing demonstrating performance to established specifications, with no explicit clinical studies or external ground truth validation reported in this summary.

Summary

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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.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 Model 1800with CoZmonitor® Blood Glucose Module
Equivalence Device Comparison:	Deltec Cozmo® Insulin Infusion Pump and AnimasIR 1250

II. DEVICE DESCRIPTION

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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 (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

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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

Prescription Use (Per 21 CFR 801.109) Over-The Counter Use X

Indications for Use:

Deltec Cozmo® Insulin Pump with CoZmonitor™ Glucose Monitor

Prescription Use X (Per 21 CFR 801.109)

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

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).