It is indicated for patients with insulin dependent Diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professional experienced in insulin pump therapy.

Device Description

The Disetronic D-TRONplus Insulin Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, shock resistant and fulfills the requirements for IP X7 to maximize patient convenience. The pump housing is made of impact resistant plastic. The total system consists of the pump, adapter, cartridge and the optional PC software that allows convenient programming of the pump or monitoring of the therapy. Furthermore the pump's data memory can be read out and displayed by using third party diabetes management software. The D-TRONplus Insulin Infusion Pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors.

Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a stepper motor driving a rubber stopper forward into the cartridge. The frequency of the motor revolution is controlled by the microprocessor according to the information programmed by the user or their care provider. The rate of the hourly basal infusion for twenty-four hours, subsequent boluses and any temporary increase or reduction in the basal rate can be simply entered using the four buttons on the pump. Additionally, the user controls infusion start, infusion stop and has access to information important to proper monitoring of the pump and the therapy directly on the pump.

The D-TRONblus pump is equipped with an infrared interface that allows data transmission between the pump and a personal computer. Disetronic provides the DiaLog PC software as an accessory to the D-TRONplus pump that facilitates the programming and monitoring of the device.

AI/ML Overview

The provided document is a 510(k) summary for the Disetronic D-TRONplus Insulin Infusion Pump. It focuses on establishing substantial equivalence to a predicate device based on design equivalency and performance/safety testing.

This document does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the way typically expected for an AI/CADe device. Instead, it states that the device was "designed and tested in accordance with IEC 60601-2-24" for safety and that its "electronic and mechanical design is not unique and therefore the specifications fully address pump performance."

Therefore, most of the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies (which are relevant for AI/CADe devices) is not applicable to this submission type.

Here’s a breakdown of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Compliance with International Electrotechnical Commission (IEC) standards for infusion pumps and controllers.	The D-TRONplus Insulin Infusion Pump has been designed and tested in accordance with IEC 60601-2-24 (Particular requirements for safety of infusion pumps and controllers), which incorporates IEC 60601-1 (general safety requirements) and IEC 60601-1-2 (Electromagnetic compatibility - requirements and tests). The electronic and mechanical design "fully address pump performance."
Substantial Equivalence to Predicate Device (D-TRON Insulin Infusion Pump K994186 / K021725)	Based on "design equivalency and performance and safety testing," the device is determined to be substantially equivalent to currently marketed devices.
Technological Characteristics (no adverse effect due to modifications)	"The modifications made to the currently marketed D-TRON Insulin Infusion Pump have not affected the technological characteristics. Therefore, the D-TRONplus Insulin Infusion Pump has the same technological characteristics."

2. Sample size used for the test set and the data provenance:

Not applicable. This document describes a medical device (insulin pump) submission, not an AI/CADe algorithm. The "testing" refers to meeting engineering and safety standards for the physical device, not a performance evaluation against a diagnostic dataset.

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

Not applicable. No ground truth establishment by experts for a diagnostic test set is mentioned.

4. Adjudication method for the test set:

Not applicable. No test set requiring expert adjudication is described.

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:

Not applicable. This relates to an AI/CADe device, not this insulin pump.

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

Not applicable. This is an insulin pump, not a diagnostic algorithm.

7. The type of ground truth used:

Not applicable. For an insulin pump, "ground truth" would be related to its engineering specifications and accurate delivery of insulin according to internal controls and calibration, not a diagnostic reference standard. The document implies compliance with engineering standards (IEC).

8. The sample size for the training set:

Not applicable. No machine learning or AI training set is mentioned.

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

Not applicable. No machine learning or AI training set is mentioned.

Summary

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SEP 1 1 2002

510(k) Summary

D-TRONplus Insulin Infusion Pump

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K
Decision Date
Submitter:	Disetronic Medical Systems AGKirchbergstrasse 190, PostfachCH-3401 Burgdorf, Switzerland
Contact:	Sandra Soniec, Phone +41 34 424 4111
Trade/Proprietary Name:	Disetronic D-TRONplus Insulin Infusion Pump
Common/Usual Name:	Insulin Infusion Pump and Accessories
Classification Name:	Infusion Pump

Substantial Equivalence

The D-TRONplus Insulin Infusion Pump is substantially equivalent to the currently marketed D-TRON Insulin Infusion Pump K994186 / K021725.

Device Description

Indications for Use

The Disetronic D-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician.

It is indicated for patients with insulin dependent diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump

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510(k) Summary D-TRONplus Insulin Infusion Pump

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therapy must be highly motivated to perform self glucose monitoring on a frequent and reqular basis. They must be adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training. support, and follow-up of health care professional experienced in insulin pump therapy.

Technological Characteristics

The modifications made to the currently marketed D-TRON Insulin Infusion Pump have not affected the technological characteristics. Therefore, the D-TRONplus Insulin Infusion Pump has the same technological characteristics.

Performance Data

The Disetronic D-TRONplus Insulin Infusion Pump has been designed and tested in accordance with IEC 60601-2-24 of the International Electrotechnical Commission: Particular requirements for safety of infusion pumps and controllers. IEC 60601-2-24 incorporates the requirements of IEC 60601-1 for all general safety requirements and IEC 60601-1-2 for Electromagnetic compatibility - requirements and tests. The electronic and mechanical design is not unique and therefore the specifications fully address pump performance.

Conclusion

Based on the design equivalency and performance and safety testing. Disetronic Medical Systems has determined that the D-TRONplus Insulin Infusion Pump is substantially equivalent to the devices currently marketed in the United States.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 2002

Ms. Sandra Soniec Manager, Regulatory Affairs Disetronic Medical Systems AG Kirchbergstrasse 190, Postfach, CH-3401 Burgdorf, SWITZERLAND

Re: K022831

Trade/Device Name: Disetronic D-TRONplus Insulin Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: August 21, 2002 Received: August 26, 2002

Dear Ms. Soniec:

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. Soniec

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,

Timothy A. Ulatowski

TimothyA. 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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INDICATIONS FOR USE STATEMENT

510(k) File Number:

Disetronic D-TRONplus Insulin Infusion Pump Device Name:

Indications For Use:

The Disetronic D-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician.

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)
OR
Over-Th

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Division of Anesthesiology, General Hos Infection Control Dental D

510(k) Number: K022831

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).