DISETRONIC D-TRON INSULIN INFUSION PUMP

K994186 · Disetronic Medical Systems · LZG · Dec 30, 1999 · General Hospital

Device Facts

• Record ID: K994186
• Device Name: DISETRONIC D-TRON INSULIN INFUSION PUMP
• Applicant: Disetronic Medical Systems
• Product Code: LZG · General Hospital
• Decision Date: Dec 30, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Ambulatory, battery-operated insulin infusion pump; administers insulin via reservoir piston mechanism driven by stepper motor. User programs basal rates (up to 25 I.U./hr) and bolus doses (up to 25 I.U.) via four-button interface; LCD displays data; audible/vibratory alarms confirm actions and signal faults. Used by patients in home or clinical settings; requires physician prescription. Microprocessor controls motor revolution frequency based on user-programmed profiles. Safety features include watertight, shock-resistant housing and comprehensive alarm system for fault conditions. Benefits include precise, controlled insulin delivery to improve glycemic control.

Clinical Evidence

Bench testing only. Device design verified against IEC 60601-2-24 (infusion pump safety), IEC 60601-1 (general safety), and IEC 60601-1-2 (electromagnetic compatibility). No clinical trial data presented.

Technological Characteristics

Ambulatory infusion pump; impact-resistant plastic housing; watertight per IEC standards. Stepper motor-driven piston mechanism. Battery-operated. Microprocessor-controlled delivery. Compatible with standard female luer connector subcutaneous administration sets. Complies with IEC 60601-2-24, IEC 60601-1, and IEC 60601-1-2.

Indications for Use

Indicated for patients with insulin-dependent diabetes mellitus who lack optimum blood glucose control on conventional injection therapy. Patients must be highly motivated, perform frequent self-glucose monitoring, adhere to diet/exercise regimens, be capable of operating the pump, and have access to professional training and support.

Regulatory Classification

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.

Predicate Devices

• Disetronic H-TRON Plus V100 Insulin Infusion Pump (K973044)

Submission Summary (Full Text)

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DEC 3 0 1999

510(K) SUMMARY

K994186

9.0 Summary of Safety and Effectiveness

| 9.1 Trade/Proprietary Name: | Disetronic D-TRON Insulin Infusion Pump |
|-----------------------------|-----------------------------------------|
| 9.2 Common/Usual Name: | Insulin Infusion Pump and Accessories |
| 9.3 Classification Name: | Infusion Pump |

- 9.4 Substantial Equivalence: The Disetronic D-TRON Infusion Pump is substantially equivalent to the Disetronic H-TRON Plus V100 Insulin Infusion Pump (K973044).
#### 9.5 Device Description

The Disetronic D-TRON Insulin Infusion Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, watertight and shock resistant to maximize patient convenience. The total system consists of the pump and custom reservoir kit. The pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors. The labeling provided in the appendices contain detailed pictorial representations, descriptions and instructions that are adequate to facilitate evaluation of the nature and operation of the device.

Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a stepper motor driving a rubber piston 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 basal infusion each hour 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.

Two separate 24-hour profiles for the delivery of insulin can be programmed independently for each hour of the day. The hourly dose can be incremented to a maximum of 25 I.U. per hour. The basal delivery can be supplemented by a bolus up to 25 I.U.

Four push buttons on the pump let the patient manage the pump's functions and access current and historical information. The data entered or information accessed is displayed on a Liquid Crystal Display (LCD) and all actions are audibly confirmed. For safety and convenience, the user enters data in insulin units, eliminating the need to convert units to volume.

The pump is designed with a comprehensive set of safety systems, alarms and alerts. When the pump senses any of the specified conditions it notifies the user with an intermittent beep (and/or vibration) and a visual display of the fault. The audible alarm can be canceled by pressing a button acknowledgment of the fault condition. The indication remains on the LCD until the fault is eliminated.

The pump housing is made of impact resistant plastic. All screw connections and buttons are sealed making the pump watertight per IEC standards.

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# 9.6 Intended Use

The Indications for use and intended use have not changed.

# 9.7 Technological Characteristics

The technological characteristics of the device have not been affected by these modifications.

# 9.8 Performance Data

The Disetronic D-TRON Insulin Infusion Pump has been designed in accordance with IEC 60601-2-24 of the International Electrotechnical Commission First Edition 1998-02: 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 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. Disetronic has adhered to all software development procedures and Good Quality Assurance procedures.

# 9.9 Conclusion

Based on the functional comparison, design equivalency and the functional and safety testing, Disetronic has determined that the D-TRON Insulin Infusion Pump is substantially equivalent to the un-modified device.

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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 depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 1999

Mr. David E. Chadwick, Ph.D. Director, Regulatory Affairs Disetronic Medical Systems, Inc. 5151 Program Avenue St. Paul, Minnesota 55112-1014

Re : K994186 Disetronic H-TRON Plus Infusion Pump Trade Name: Requlatory Class: II LZG Product Code: December 6, 1999 Dated: Received: December 10, 1999

Dear Mr. Chadwick:

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 reqistration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Regulations, 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Chadwick

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 diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Yurke W. Shypm

Timothy A. Ulatowski Director 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

510(k) File Number:

Device Name:

Indications For Use:

Disetronic D-TRON Insulin Infusion Pump

The Disetronic D-TRON 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 reqular 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)

.escription Use (Per 21 CFR 801.19)

Over-The-Counter Use

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K994184