ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA

K060876 · Disetronic Medical Systems AG · LZG · Jun 15, 2006 · General Hospital

Device Facts

• Record ID: K060876
• Device Name: ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA
• Applicant: Disetronic Medical Systems AG
• Product Code: LZG · General Hospital
• Decision Date: Jun 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.

Device Story

Ambulatory, battery-operated insulin pump for continuous subcutaneous insulin delivery; manages diabetes mellitus. Delivers 0.0–25.0 units/hour basal and up to 25.0 units bolus of U100 insulin. Constructed of impact-resistant plastic; compatible with standard female luer connector subcutaneous administration sets. Includes IR-Interface for data transmission to personal computer. ACCU-CHEK Insulin Pump Configuration Software enables monitoring and programming of pump settings. Used by patients under physician prescription. Output allows healthcare providers and patients to review pump data and adjust insulin delivery parameters to improve glycemic management.

Clinical Evidence

Bench testing only. Software verification and validation performed; no clinical data presented.

Technological Characteristics

Ambulatory, battery-operated infusion pump. Impact-resistant plastic housing. Standard female luer connector for administration sets. IR-Interface for PC connectivity. Software-based configuration and monitoring.

Indications for Use

Indicated for persons with diabetes mellitus requiring insulin therapy. For subcutaneous continuous delivery of insulin at set and variable rates.

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

• ACCU-CHEK Spirit Insulin Infusion Pump (K042887)

Submission Summary (Full Text)

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Disetronic Medical Systems AG Special 510(k) Premarket Notification Submission ACCU-CHEK Spirit Insulin Infusion Pump

| SECTION 3 - 510(k) SUMMARY | K060876 | JUN 15 2006 |
|---------------------------------------|------------------------------------------------------------------------------------------------|-------------|
| Submission Correspondent:<br>Address: | Roche Diagnostics<br>9115 Hague Road<br>P.O. Box 50457<br>Indianapolis, IN 46250-0457<br>USA | |
| Contact:<br>Phone:<br>Fax: | Scott Thiel<br>Regulatory Affairs Project Principal<br>[phone] X13362<br>[phone] | |
| E Mail: | [e-mail] | |
| Submission Sponsor: | Disetronic Medical Systems AG<br>Kirchbergstrasse 190<br>CH-3401 Burgdorf<br>Switzerland | |
| Date Prepared: | March 30, 2006 | |
| Trade Name: | ACCU-CHEK® Spirit Insulin Infusion Pump | |
| Common Name: | Insulin infusion pump and accessories | |
| Classification: | Pump, infusion, insulin | |
| Regulation # | 21 CFR 880.5725 | |
| Product Code | LZG<br>Class II device | |

Description: The ACCU-CHEK Spirit Insulin Infusion Pump is an ambulatory, battery operated insulin pump designed for continuous delivery of insulin. The design allows for delivery of 0.0 to 25.0 units of U100 insulin per hour in basal rates and up to 25.0 units of U100 insulin per meal or meal bolus. The pump is made of impact resistant plastic. The pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors.

> The ACCU-CHEK Spirit Insulin Infusion Pump is equipped with an IR-Interface in order to enable data transmission between the

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Disetronic Medical Systems AG Special 510(k) Premarket Notification Submission ACCU-CHEK Spirit Insulin Infusion Pump

pump and a personal computer. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.

- Intended Use: The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.
- Predicate Devices: The ACCU-CHEK Spirit Insulin Infusion Pump in this submission is a modification to the predicate device of the same name with 510(k):

510(k) #: K042887 ACCU-CHEK Spirit Insulin Infusion Pump Disetronic Medical Systems AG Cleared on March 18, 2005

#### Safety and Effectiveness:

The ACCU-CHEK Spirit Insulin Infusion Pump has the same indications for use, and features as the previously cleared device. The addition of the ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings. The software has been verified and validated and no new issues were raised regarding safety and effectiveness.

### Summary and Conclusion Regarding Substantial Equivalence:

By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.

The ACCU-CHEK Spirit Insulin Infusion Pump has the same indications for use, and features as the previously cleared device, with the addition of the Insulin Pump Configuration Software for use in programming the ACCU-CHEK Spirit Insulin Infusion Pump and monitoring data collected on the ACCU-CHEK Spirit Insulin Infusion Purmp. Based on the design equivalency and the software testing performed, we have determined that the implementation of the ACCU-CHEK Insulin Pump Configuration Software for the ACCU-CHEK Spirit Insulin Infusion Pump to be substantially equivalent to the predicate device currently cleared via K042887.

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JUN 1 5 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Disetronic Medical Systems AG C/O Mr. Scott Thiel Regulatory Affairs Project Principal Roche Diagnostics 9115 Hague Road Indianapolis, Indiana 46250-0457

Re: K060876

Trade/Device Name: ACCU-CHEK® Spirit Insulin Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: March 30, 2006 Received: March 31, 2006

Dear Mr. Thiel:

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.

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.

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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 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), 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/industry/support/index.html.

Sincerely yours.

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

Enclosure

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### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

# Device Name: ACCU-CHEK® Spirit Insulin Infusion Pump

The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.

Prescription Use _X (Per 21 CFR 801.109) OR

Over the Use

Counter

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Centa V.m

1977 - 1171)
Anesthesiology, General Hospital,
Control. Dental Devices

tor K4648JL

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