DISETRONIC D-TRON INSULIN INFUSION PUMP

K021725 · Disetronic Medical Systems AG · LZG · Aug 2, 2002 · General Hospital

Device Facts

• Record ID: K021725
• Device Name: DISETRONIC D-TRON INSULIN INFUSION PUMP
• Applicant: Disetronic Medical Systems AG
• Product Code: LZG · General Hospital
• Decision Date: Aug 2, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for use as prescribed by a physician. Indicated for patients with insulin dependent diabetes mellitus who do not have optimum control on conventional insulin injection therapy. Patients for insulin pump therapy must be capable of self glucose monitoring on a frequent and regular basis, as well as be able to follow a proper diet and exercise regiment. Patients must also have access to the educational training, support, and follow-up of health care professional experienced in insulin pump therapy.

Device Story

Ambulatory, battery-operated insulin infusion pump; administers insulin via reservoir piston mechanism driven by stepper motor. User programs basal rates (two 24-hour profiles) and bolus doses (up to 25 I.U.) via four-button interface. Pump features IR-interface for data transmission to PC; DiaLog PC-software enables monitoring, programming, and setting adjustments. Used by patients in home/ambulatory settings; operated by patient or care provider. Provides continuous insulin delivery to manage diabetes; PC-software facilitates therapy monitoring and optimization by healthcare providers.

Clinical Evidence

Bench testing only. Device designed and tested in accordance with IEC 60601-2-24 (particular requirements for safety of infusion pumps and controllers), including IEC 60601-1 (general safety) and IEC 60601-1-2 (electromagnetic compatibility). No clinical data presented.

Technological Characteristics

Ambulatory infusion pump; impact-resistant plastic housing; IP X7 rated. Stepper motor-driven piston mechanism. IR-interface for PC connectivity. Powered by battery. Software-controlled basal/bolus delivery. Complies with IEC 60601-2-24, IEC 60601-1, and IEC 60601-1-2.

Indications for Use

Indicated for insulin-dependent diabetes mellitus patients lacking optimum control on conventional insulin injection therapy. Requires patient capability for frequent self-glucose monitoring, adherence to diet/exercise, and access to professional training/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

• D-TRON Pump (K994186)

Submission Summary (Full Text)

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# 9 510(k) Summary

K021225

AUG 0 2 2002

## 9.1 Trade/Proprietary Name

Disetronic D-TRON Insulin Infusion Pump

## 9.2 Common/Usual Name

Infusion Pump and Accessories

## 9.3 Classification Name

Infusion Pump

#### 9.4 Substantial equivalence

The modified Disetronic D-TRON Insulin Infusion Pump is substantially equivalent to the currently marketed D-TRON Pump K994186.

## 9.5 Device Description

The Disetronic D-TRON 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 and custom reservoir kit. The 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 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 directly on the pump.

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.

The D-TRON Insulin Infusion pump is equipped with an IR-Interface in order to enable data transmissions between the pump and a personal computer. The DiaLog PC-Software facilitates the monitoring and programming of the pump settings. Current pump settings can be displayed on the computer monitor, adjustments can be made and re-stored into the pump.

## 9.6 Indications for Use

The Indications for Use and Intended Use have not changed.

## 9.7 Technological Characteristics

The technological characteristics have not been affected by these modifications.

#### 9.8 Performance Data

The Disetronic D-TRON 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 an therefore the specifications fully address pump performance. The device modifications are consistent with the requirements of these standards.

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# 9.9 Conclusion

Based on the design equivalency and performance and safety testing, Disetronic Medical Systems has determined that the implementation of the DiaLog PC software for the Disetronic D-TRON Insulin Infusion Pump is substantially equivalent to the devices currently marketed in the United States.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with three lines extending from its head, representing the department's mission to protect and promote the health of all Americans.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K021725

Trade/Device Name: Distetronic D-Tron Insulin Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: July 9, 2002 Received: July 11, 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.

AUG 0 2 2002

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 (OS) 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 [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" (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 [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

and the may be any and the commended to the commended to the commended to the commended to the commended to the commended to the commended to the comments of the comments of

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) File Number:

Device Name: Disetronic D-TRON Insulin Infusion Pump

Indications For Use:

indications For Soc. as prescribed by a physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cusente
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K021725

Prescription Use (Per 21 CFR 801.19) OR

Over-The-Counter Use