The DAHEDI 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 therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis, as well as adhere to a proper diet and exercise regiment. 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 DAHED! Insulin Infusion Pump is a very small, ambulatory, battery operated portable pump that is designed for the treatment of Insulin Dependent Diabetes Mellitus. The DAHEDI Insulin Infusion Pump infuses small amounts of insulin through a catheter into the patient via subcutaneous administration twenty-four hours a day. It is compact, watertight and shock resistant to maximize patient convenience. The pump uses a commercially available insulin reservoir that holds reqular insulin into which the pump drives a piston rod that displaces precise amounts of insulin at exact times throughout the day. Insulin is delivered from the insulin reservoir of the pump to the body through a thin, plastic tube called an "infusion set." The infusion set has a small needle or flexible catheter that the user inserts under the skin (most commonly in the subcutaneous tissue of the abdomen). Insulin passes through the infusion set into a needle or a soft Teflon cannula into the body. The pump is compatible with all commercially available subcutaneous insulin infusion sets with female luer lock connectors. The insulin reservoirs and catheters are sterile and single use (disposable). The pump itself is not sterile as it does not come in contact with the insulin. Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a motor driving a piston forward into the cartridge. The frequency of the motor revolution is controlled by the pump according to the information entered into the pump by the user or his care provider. The rate of the basal infusion, initiation of boluses, any dosage limitations or modifications can be simply entered using the buttons on the pump. Additionally, the user controls infusion start, infusion stop and has access to information important to the proper monitoring of the pump and the therapy. An optional IR adapter allows the user to send 42 days of history into a standard IBM compatible Personal computer.

AI/ML Overview

The provided text describes a 510(k) submission for the DAHEDI Insulin Infusion Pump, asserting its substantial equivalence to a predicate device based on functional comparison and performance and safety testing. However, it does not contain the specific details required to populate a table of acceptance criteria and reported device performance in the way typically expected for a detailed study.

Here's an attempt to answer your request based on the available information, with important caveats highlighting what is not present in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All test results demonstrate that the system specifications and functional requirements were met." and "The DAHEDI Insulin Infusion Pump has been designed and tested in accordance with IEC 601-2-24...". However, it does not provide a specific table of quantitative acceptance criteria or the numerical results of the performance tests.

Performance Metric/Acceptance Criteria	Reported Device Performance
Functional Requirements	Met
System Specifications	Met
Safety Requirements (IEC 601-2-24)	Met
Electromagnetic Interference (EMI)	Met (per IEC 601-1-2)
Precision of Insulin Delivery	Not explicitly quantified, but implied to be "precise amounts" and "controlled delivery" and comparable to predicate.
Accuracy of Insulin Delivery	Not explicitly quantified.
Reliability/Durability	Not explicitly quantified.
Battery Life	Not explicitly quantified.
Watertightness	Confirmed as "watertight".
Shock Resistance	Confirmed as "shock resistant".

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

The document does not specify the sample size (number of pumps or test runs) used for the performance and safety testing. It also does not explicitly state the provenance of any data (e.g., country of origin, retrospective or prospective). The testing appears to be part of the product development and regulatory submission process, implying prospective testing specific to the device.

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

This section is not applicable as the document describes performance and safety testing against engineering standards (IEC 601-2-24) and functional specifications, not a clinical study involving ground truth established by medical experts for diagnostic purposes.

4. Adjudication method for the test set

Not applicable, as ground truth establishment by experts for a test set is not described. The testing involves engineering and regulatory compliance, likely with internal quality control and verification procedures.

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 is not an AI/diagnostic device. It is an insulin infusion pump.

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

This question is framed for AI algorithms. For a device like an insulin pump, standalone performance refers to the device's ability to operate according to its specifications independently. The document implies that the device's functional and safety performance was tested in a standalone manner to ensure it met "system specifications and functional requirements."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the performance and safety testing, the "ground truth" would be the established engineering standards and specifications (e.g., IEC 601-2-24) to which the device was designed and tested. Compliance with these quantitative and qualitative standards serves as the benchmark.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set" in the conventional sense. The "proprietary digital control chip" has "hardwired" operations rather than being "trained."

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

Not applicable, as no training set for a machine learning model is mentioned or implied. The device's control parameters are "hardwired" and based on engineering design.

Summary

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JUN 1 5 1999

510(K) SUMMARY

9.0 Summary of Safety and Effectiveness

K991376

9.1 Trade/Proprietary Name: DAHEDI Insulin Infusion Pump
Insulin Infusion Pump and Accessories 9.2 Common/Usual Name:
Infusion Pump 9.3 Classification Name:
9.4 Substantial Equivalence: The DAHEDI Insulin Infusion Pumps are substantially equivalent to the Disetronic H-Tron Plus V 100 Insulin Infusion Pumps (K973044).

9.5 Device Description

The pump uses a commercially available insulin reservoir that holds reqular insulin into which the pump drives a piston rod that displaces precise amounts of insulin at exact times throughout the day. Insulin is delivered from the insulin reservoir of the pump to the body through a thin, plastic tube called an "infusion set." The infusion set has a small needle or flexible catheter that the user inserts under the skin (most commonly in the subcutaneous tissue of the abdomen). Insulin passes through the infusion set into a needle or a soft Teflon cannula into the body. The pump is compatible with all commercially available subcutaneous insulin infusion sets with female luer lock connectors.

The insulin reservoirs and catheters are sterile and single use (disposable). The pump itself is not sterile as it does not come in contact with the insulin.

Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a motor driving a piston forward into the cartridge. The frequency of the motor revolution is controlled by the pump according to the information entered into the pump by the user or his care provider. The rate of the basal infusion, initiation of boluses, any dosage limitations or modifications can be simply entered using the buttons on the pump. Additionally, the user controls infusion start, infusion stop and has access to information important to the proper monitoring of the pump and the therapy. An optional IR adapter allows the user to send 42 days of history into a standard IBM compatible Personal computer.

9.6 Intended Use

The Indications for use and intended use are the same as those for the predicate device.

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9.0 Summary of Safety and Effectiveness Continued

9.7 Technological Characteristics

The DAHEDI Insulin Infusion Pump incorporates a proprietary digital control chip that has been hardwired to operate all functional and safety control parameters. This function has been accomplished by software resident in a microprocessor in other equivalent devices. All other functional and technological characteristics are similar to the predicate device.

9.8 Performance Data

The DAHEDI Insulin Infusion Pump has been designed and tested in accordance with IEC 601-2-24 of the International Electrotechnical Commission Technical Committee No. 62: Electrical Equipment in Medical Practice Sub-Committee 62D: Electromedical Equipment -Draft - Part 2: Particular requirements for safety of infusion pumps and controllers. IEC 601-2-24 incorporates the requirements of IEC 601-1 for all general safety requirements including IEC 601-1-2 Electromagnetic Interference (EMI).

Disetronic has adhered to Good Design, Manufacturing and Quality Assurance procedures. All test results demonstrate that the system specifications and functional requirements were met.

9.9 Conclusion

Based on the functional comparison and the performance and safety testing, Disetronic has determined that the DAHEDI Insulin Infusion Pump is substantially equivalent to the Disetronic H-TRON Plus V 100 Insulin Infusion Pump.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract design of three human profiles facing right, with flowing lines above and below them. The design is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 15 1999

Disetronic Medical Systems, Incorporated c/o Lee Leichter P/L Biomedical 7690 Cameron Circle Fort Meyers, Florida 33912

Re: K991376 DAHEDI Insulin Infusion Pump Trade Name: Regulatory Class: II Product Code: LZG Dated: April 21, 1999 Received: April 21, 1999

Dear Lee Leichter:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Page 2 - Lee Leichter

Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 ene regaracion choicess, "https://www.bbcananty-by-sother general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaggov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

14991376 510(k) File Number:

DAHEDI Insulin Infusion Pump Device Name:

The DAHEDI Insulin Infusion Pump is intended for the controlled Indications For Use: 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 therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis, as well as adhere to a proper diet and exercise regiment. 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.

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 801.19)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number_**_

Over-The-Counter Use_**_

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).