The Deltec Cozmo™ Insulin Infusion Pump (Model 1700) is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes.

The Deltec Cozmo™ 3-ml Cartridge is designed for use with the Deltec Cozmo™ Insulin Infusion Pump for Continuous Subcutaneous Insulin Infusion (CSII).

The Deltec Cozmo™ Treatment Assistant™ PC Communications System is designed for use with Deltec Cozmo™ Insulin Infusion Pump as a tool in optimizing diabetes management. It allows communications between the pump and a computer for accessing data stored in pump memory, and programming the pump.

Device Description

The Deltec Cozmo™ Insulin Infusion Pump is a small, ambulatory, battery-powered, microprocessor controlled, external insulin syringe pump. Key features of the pump include: backlit liquid crystal display (LCD), 4-key keypad, separate audio bolus button, AAA-battery power source, waterproof, audible alarm option, vibratory alarm option, real time clock, belt-clip and interface, various basal and bolus delivery rates, stored memory, PC-downloading and programming capability, IR windows, 3-ml cartridge, cartridge cap and child-proof cartridge cap.

The Deltec Cozmo™ 3-ml Cartridge is a syringe style reservoir and is a proprietary design for use specifically with the Deltec Cozmo™ Insulin Infusion Pump. It is not compatible with other pumps. The 3-ml Cartridge is made of three separate pieces: barrel, plunger and rod. The barrel has an integral luer fitting on one end, volume markings, and a raised ring at the opposite end of the luer fitting that acts as a stop for the plunger. The plunger is conical in shape with a double o-ring seal design. The plunger and rod are detachable with a snap-fit design. The rod is removed from the plunger prior to cartridge insertion into the pump.

The Deltec Cozmo™ Treatment Assistant™ PC Communications System is a software program, which allows communications between a personal computer (PC) and an infusion pump. It allows for downloading of information from the pump to a PC and for programming of the pump via a PC. The "connection" between the pump and the PC is via infra-red (IR) windows on the back of the pump and the computer's IR port. A standard off-the-shelf IR cable connector for the PC may also be used if the user's computer does not have an integral IR port.

AI/ML Overview

The provided text is for a 510(k) premarket notification for the Deltec Cozmo™ Insulin Infusion Pump and Accessories. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing specific acceptance criteria and detailed study performance as would be seen in a clinical trial or a novel device submission. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement is not explicitly detailed in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary focuses on demonstrating functional similarity and safety through various types of testing, but it does not present a table of quantitative acceptance criteria for device performance (e.g., accuracy of insulin delivery within specific tolerances) and then report measured performance against those criteria.

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

Test Set Description: The document refers to "Functional Testing" which included "software validation, verification of software controlled programming functions, and software related to proper pump operation" for the pump and the PC Communications System, along with "In-vitro testing and biocompatibility testing" for the 3-ml Cartridge.
Sample Size: The specific sample sizes for these tests are not disclosed.
Data Provenance: The tests are described as "in-vitro testing" and "functional testing," implying they were conducted in a lab environment. The document does not mention human subject testing or data from specific countries of origin in this context. It's retrospective in the sense that the testing was completed before the submission.

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

This information is not provided. Given the nature of functional and in-vitro testing for an insulin pump, the "ground truth" would typically be established based on engineering specifications, regulatory standards, and established scientific principles for measuring device performance (e.g., fluid delivery accuracy, software functionality, material biocompatibility). These evaluations would be performed by qualified engineers, testers, and scientists, but the number and specific qualifications are not detailed here.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where independent reviewers assess outcomes. For functional and in-vitro testing, the assessment typically involves comparing test results against pre-defined specifications and pass/fail criteria, which is a different process than multi-expert adjudication.

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

MRMC Study: No MRMC comparative effectiveness study was conducted or described.
AI vs. Human Assistance: This device is an insulin infusion pump and associated software, not an AI-powered diagnostic or assistive technology for human 'readers'. Therefore, the concept of human readers improving with AI assistance is not applicable to this submission.

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

Standalone Performance: The core components being tested are the insulin pump's mechanical and software functions, and the PC communication system's software functionality. These are inherently "standalone" in the sense that the device's accuracy and function are tested independently of a human user's direct intervention in that specific test setting (though the ultimate use involves human interaction).
Details: The document states "Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified," and "In-vitro testing and biocompatibility testing was performed on the Deltec Cozmo™ 3-ml Cartridge." These represent standalone evaluations of the device components. However, specific performance metrics from these standalone tests are not provided.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc)

The "ground truth" for the various tests mentioned would be based on:

Engineering Specifications/Standards: For functional testing (e.g., insulin delivery rates, alarm accuracy).
Software Requirements Specifications: For software validation and verification.
Biocompatibility Standards: For the cartridge (e.g., ISO 10993 series).
Material Specifications: For the cartridge components.

The document does not refer to expert consensus from healthcare professionals, pathology, or outcomes data to establish ground truth for these tests. Clinical studies were "not deemed necessary."

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a mechanical/software medical device, not a machine learning or AI algorithm that requires a "training set" in the context of supervised learning to develop its functionality. Its design and operation are based on explicit programming and engineering principles rather than learned patterns from data.

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

This information is not applicable as there is no "training set" in the context of AI/ML for this device. The functionality of the pump and its software is designed and validated against engineering specifications and regulatory requirements.

Summary

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AUG 1 3 2002

KO28655

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Deltec Cozmo™ Insulin Infusion Pump (Model 1700) and Accessories

June 3, 2002

I. GENERAL INFORMATION

Applicant's Name and Address:	Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	Lisa J. StoneManager, Regulatory Affairs
Common/Usual Name:	Insulin Infusion Pump and Accessories
Proprietary Name:	Deltec Cozmo™ Insulin Infusion Pump (Model1700) and Accessories
Equivalence Device Comparison:	MiniMed Model 508 Insulin Pump, MiniMed 3.0 ml Reservoir, Deltec CADD-Diplomat® System,and MiniMed Com-Station™ CommunicationSystem

DEVICE DESCRIPTION II.

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and the PC is via infra-red (IR) windows on the back of the pump and the computer's IR port. A standard off-the-shelf IR cable connector for the PC may also be used if the user's computer does not have an integral IR port.

III. INTENDED USE OF THE DEVICE

The Deltec Cozmo™ Insulin Infusion Pump (Model 1700) is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes.

The Deltec Cozmo™ 3-ml Cartridge is designed for use with the Deltec Cozmo™ Insulin Pump for Continuous Subcutaneous Insulin Infusion (CSII).

The Deltec Cozmo™ Treatment Assistant™ PC Communications System is designed for use with the Deltec Cozmo™ Insulin Infusion Pump as a tool in optimizing diabetes management. It allows communications between the pump and a computer for accessing data stored in pump memory, and programming of the pump.

IV. DEVICE COMPARISON

The Deltec Cozmo™ Insulin Infusion Pump is similar in design, function, and intended use to the MiniMed Model 508 Insulin Pump (K990801). The pumps are small, ambulatory, battery-powered, microprocessor controlled, external insulin syringe pump delivery systems. Each device is indicated for the delivery of insulin and includes the following features: backlit liquid crystal display (LCD), 4-key keypad, audible alarm option, vibratory alarm option, real time clock, belt-clip and interface, various basal and bolus delivery rates, stored memory, PC-downloading capability, IR windows, and 3-ml medication cartridge.

The Deltec Cozmo™ 3-ml Cartridge is similar in design, function, and intended use to the MiniMed 3-ml Reservoir (K991936). Each device is a syringe style reservoir with a capacity of 3 ml. They are made of the same materials and both are provided with a 22-gauge needle. Each device is indicated for use in the infusion of insulin with an external infusion pump.

The Deltec Cozmo™ Treatment Assistant™ PC Communications System is similar in design, function, and intended use to the Deltec CADD-Diplomat® System (K973917). The products allow communications between a personal computer (PC) and an infusion pump. The software programs allow for downloading of information from the pump to a PC and for programming of the pump via a PC. The Deltec Cozmo™ Treatment Assistant™ PC Communications System is also similar to the MiniMed Com-Station™ Communication System (K993012), which uses IR communication.

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510(k) Summary of Safety and Effectiveness Page 3 of 3

V. SUMMARY OF STUDIES

A. Functional Testing

Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified for the Deltec Cozmo™ Insulin Infusion Pump and the Deltec Cozmo™ Treatment Assistant™ Communications System.

In-vitro testing and biocompatibility testing was performed on the Deltec Cozmo™ 3-ml Cartridge.

B. Clinical Studies

Clinical studies were not deemed necessary regarding the use of the Deltec Cozmo™ Insulin Infusion Pump and Accessories.

C. Conclusions Drawn from Studies

Based upon the information provided above, the Deltec Cozmo™ Insulin Infusion Pump and Accessories are substantially equivalent to other commercially available devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three curved lines that resemble a bird or a wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design. The text is in all capital letters and is evenly spaced around the circle.

AUG 1 3 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Stone Managing, Regulatory Affairs Deltec, Incorporated 1265 Grey Fox Road Saint Paul, Minnesota 55112

Re: K020655

Trade/Device Name: Deltec Cozmo™ Insulin Infusion Pump (Model 1700), Deltec Cozmo™ 3-ml Cartridge, and Deltec Cozmo™ Treatment Assistant™ PC Communications System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: June 3, 2002 Received: June 4, 2002

Dear Ms. Stone

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.

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.

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Page 2 - Ms. Stone

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

JAWithdmer for,

Timothy A. Ulatowski 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Deltec Cozmo™ Insulin Infusion Pump (Model 1700), Deltec Cozmo™ 3-ml Cartridge, and Deltec Cozmo™ Treatment Assistant™ PC Communications System

Indications for Use:

"The Deltec Cozmo™ Insulin Infusion Pump (Model 1700) is a syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes."

"The Deltec Cozmo™ 3-ml Cartridge is designed for use with the Deltec Cozmo™ Insulin Infusion Pump for Continuous Subcutaneous Insulin Infusion (CSII).

"The Deltec Cozmo™ Treatment Assistant™ PC Communications System is designed for use with Deltec Cozmo™ Insulin Infusion Pump as a tool in optimizing diabetes management. It allows communications between the pump and a computer for accessing data stored in pump memory, and programming the pump."

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109

Over-The Coun

Over-The Counter Use

ion Sianivision of Anesthesiology General Hosnital Infection Control, Dental

510(k) Number: K020655

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).