MODIFICATION TO D-TRONPLUS

K043000 · Disetronic Medical Systems AG · LZG · Dec 1, 2004 · General Hospital

Device Facts

• Record ID: K043000
• Device Name: MODIFICATION TO D-TRONPLUS
• Applicant: Disetronic Medical Systems AG
• Product Code: LZG · General Hospital
• Decision Date: Dec 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 professionals experienced in insulin pump therapy.

Device Story

External, portable insulin infusion pump; provides continuous subcutaneous insulin delivery. User programs basal rates (0.0–25.0 units/hr, 0.1 unit increments) and bolus doses (up to 25.0 units, 0.1–1.0 unit increments). Operated by patient; used in home or clinical settings. Device assists in managing blood glucose levels for patients with insulin-dependent Diabetes Mellitus. Healthcare providers use output (pump settings/history) to guide therapy adjustments. Benefits include improved glycemic control compared to conventional injection therapy.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

External, portable insulin infusion pump. Delivers U100 insulin. Basal rate range: 0.0–25.0 units/hr (0.1 unit increments). Bolus range: up to 25.0 units (0.1, 0.2, 0.5, or 1.0 unit increments).

Indications for Use

Indicated for patients with insulin-dependent Diabetes Mellitus requiring insulin pump therapy due to suboptimal control on conventional injections. Requires patient motivation for frequent self-glucose monitoring, ability to adjust insulin based on glucose levels/meals/activity, and capability to operate the device with professional 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 D-TRONplus Insulin Infusion Pump (K022831)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 6 2004

Disetronic Medical Systems AG C/O Mr. Scott Thiel Regulatory Affairs Roche Diagnostics 9115 Hague Road Indianapolis, Indiana 46250

Re: K043000

Trade/Device Name: D-TRONplus Insulin Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: October 29, 2004 Received: November 1, 2004

Dear Mr. Thiel:

This letter corrects our substantially equivalent letter of December 1, 2004 regarding the incorrect Indications for Use statement that was sent to you.

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 (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 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.

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Page 2 - Mr. Thiel

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. 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 continue 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html

कुछ

Sincerely yours,

Sura Russo

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use -

510 (k) Number (if known) : K043000

Device Name: D-TRONplus insulin infusion pump

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 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 professionals experienced in insulin pump therapy.

Prescription Use X (Part 21 CFR 801 Subpart D) AND / OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Ko43000

DEC - 1 2004

## 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
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| 1) Submitter<br>name, address,<br>contact | Submitted by:<br>Disetronic Medical Systems AG<br>Kirchbergstrasse 190, Postfach<br>CH-3401 Burgdorf, Switzerland<br><br>United States Contact Person:<br>Scott Thiel<br>Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, Indiana 46250<br>317-521-3362<br>[e-mail]<br>Date Prepared: October 29, 2004 |
| 2) Device name | Proprietary name: D-TRONplus<br>Common name: Insulin infusion pump and accessories<br>Classification name: Pump, infusion, insulin<br>Product Code: LZG |
| 3) Predicate<br>device | We claim substantial equivalence to the following legally marketed insulin<br>infusion pumps:<br>Disetronic D-TRONplus Insulin Infusion Pump (K#022831) |
| 4) Device<br>Description | The D-TRONplus Insulin Infusion Pump is an external, portable insulin pump<br>designed for continuous delivery of insulin. The design allows settings of 0.0<br>to 25.0 units in 0.1 unit increments of U100 insulin per hour in basal rates and<br>up to 25.0 units of U100 insulin per bolus in 0.1, 0.2, 0.5, or 1.0 unit<br>increments. |
| | Continued on next page |

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## 510(k) Summary, Continued

The Disetronic D-TRONplus Insulin Infusion Pump is intended for the 5) Intended use 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. 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 professionals experienced in insulin pump therapy.

| 6) Data<br>demonstrating<br>substantial<br>equivalence | Testing of the D-TRONplus demonstrated that the device meets the<br>requirements for its intended use. The data also demonstrates that the D-<br>TRONplus is substantially equivalent to the predicate device. |
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