DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP

K973044 · Disetronic Medical Systems · LZG · Sep 15, 1997 · General Hospital

Device Facts

• Record ID: K973044
• Device Name: DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP
• Applicant: Disetronic Medical Systems
• Product Code: LZG · General Hospital
• Decision Date: Sep 15, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Disetronic H-TRON V 100 Plus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician.

Device Story

The Disetronic H-TRON Plus V 100 is an insulin infusion pump designed for controlled insulin delivery. It functions as a modification of the H-TRON V 100. The device is used by patients with insulin-dependent diabetes mellitus to manage blood glucose levels. Patients operate the device themselves, requiring training and support from healthcare professionals. The pump delivers insulin based on physician-prescribed regimens. It incorporates safety systems and electronic/mechanical designs to ensure accurate infusion. The device is tested for electrical safety and electromagnetic interference to ensure reliable performance in a home or clinical setting.

Clinical Evidence

Bench testing only. The device was tested in accordance with IEC 601-2-24 (particular requirements for safety of infusion pumps and controllers), including IEC 601-1, IEC 801-2, and IEC 801-3 for EMI and ESD. Results demonstrated that system specifications and functional requirements were met.

Technological Characteristics

Infusion pump for insulin delivery. Complies with IEC 601-2-24, IEC 601-1, IEC 801-2, and IEC 801-3. Electronic and mechanical design consistent with predicate. Software developed under Good Quality Assurance procedures.

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, capable of operating the pump, perform frequent self-glucose monitoring, adhere to diet/exercise regimens, 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 V 100 Insulin Infusion Pump (K905693)

Submission Summary (Full Text)

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SEP 1 5 1997 510(K) SUMMARY

# 9.0 Summary of Safetv and Effectiveness

- 9.1 Trade/Probrietarv Name: Disetronic H-TRON Plus Insulin Infusion Pump
- Insulin Infusion Pump and Accessories 9.2 Common/Usual Name:
- Infusion Pump 9.3 Classification Name:
- 9.4 Substantial Equivalence: The Disetronic H-TRON Plus V 100 Insulin Infusion Pump is substantially equivalent to the Disetronic H-TRON V 100 Insulin Infusion Pump (K905693).

### 9.5 Device Description

The physical dimensions and specifications, pumping method, safety systems, accuracy and basic design and operation of the device have not been changed by the modifications.

#### 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

ﻤﺴﻌ

The Disetronic H-TRON Plus V 100 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 Date: August 29, 1994 - 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 801-2 and 801-3 for Electromagnetic Interference (EMI)) and Electrostatic Discharge (ESD).

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. All test results demonstrate that the system specifications and functional requirements were met.

### 9.9 Conclusion

Based on the functional comparison, design equivalency and the functional and safety testing, Disetronic has determined that the H-TRON Plus V 100 Insulin Infusion Pump is substantially equivalent to the un-modified device.

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Image /page/1/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 image of an eagle with three human profiles embedded within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 1997

Mr. Jim Myers Vice President Disetronic Medical Systems 5201 East River Road, #312 Minneapolis, Minnesota 55421-1014

K973044 Re : Trade Name: Disetronic H-Tron Plus V 100 Insulin Infusion Pump Regulatory Class : II Product Code: LZG Dated: August 12, 1997 Received: August 15, 1997

Dear Mr. Myers:

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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The qeneral controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, and 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) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Druq Administration (FDA) action. may publish further announcements concerning your device in the Federal Register. Please note: this response to your

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Page 2 - Mr. Myers

premarket notification submission does not affect any obligation you might have under section 531 through 542 of the for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Reqister, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires Because the device is subject to tracking, you are tracking. required to adopt a method of tracking that follows the devices throuqh the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the requlation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.

This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in anyway represent your device or its labeling as being approved by FDA. 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), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at [phone]. 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 at [phone].

Sincerely yours,

Clurist

Timoty A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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## INDICATIONS FOR USE

510(k) File Number:

Disetronic H-Tron Plus V 100 Insulin Infusion Pump Device Name:

Indications For Use: The Disetronic H-TRON V 100 Plus 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.

Patricio Cisternas

(Division Sign-Off) Division of Dental, Infection Control, and General Hospita