ACCU-CHEK SPIRIT

K042887 · Disetronic Medical Systems AG · LZG · Mar 18, 2005 · General Hospital

Device Facts

• Record ID: K042887
• Device Name: ACCU-CHEK SPIRIT
• Applicant: Disetronic Medical Systems AG
• Product Code: LZG · General Hospital
• Decision Date: Mar 18, 2005
• 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.

Device Story

ACCU-CHEK Spirit is an external, portable insulin infusion pump; provides continuous subcutaneous insulin delivery. Device delivers U100 insulin at basal rates (0.1 to 25.0 units/hour) and bolus doses (up to 25.00 units). Operated by patient for diabetes management; provides automated insulin delivery based on programmed settings. Healthcare providers prescribe the device and set delivery parameters. Benefits include precise, continuous insulin administration for glycemic control.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

External, portable insulin infusion pump. Delivers U100 insulin. Basal rate range: 0.1-25.0 units/hr; bolus capacity: up to 25.00 units. Product code: LZG. Regulation: 880.5725.

Indications for Use

Indicated for the management of diabetes mellitus in persons requiring insulin therapy via subcutaneous continuous insulin delivery as prescribed by a physician.

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

• Medtronic MiniMed Paradigm 712 Insulin Pump (K031390)
• Animas IR 1200 Insulin Pump (K032257)

Submission Summary (Full Text)

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## 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. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 15, 2004 |
| 2) Device name | Proprietary name: ACCU-CHEK Spirit<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>• Medtronic MiniMed Paradigm 712 Insulin Pump (K#031390)<br>• Animas IR 1200 Insulin Pump (K#032257) |
| 4) Device<br>Description | The ACCU-CHEK Spirit Insulin Infusion Pump is an external, portable<br>insulin pump designed for continuous delivery of insulin. The design allows<br>the delivery of 0.1 to 25.0 units of U100 insulin per hour in basal rates and up<br>to 25.00 units of U100 insulin per meal or meal bolus. |
| 5) Intended use | The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the<br>subcutaneous continuous delivery of insulin, at set and variable rates, for the<br>management of diabetes mellitus in persons requiring insulin as prescribed by<br>a physician. |

Continued on next page

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## 510(k) Summary, Continued

6) Data demonstrating substantial equivalence

:

Testing of the ACCU-CHEK Spirit demonstrated that the device meets the resuirements for its intended use. The data also demonstrates that the ACCU-CHEK Spirit is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, positioned to the right. To the left of the caduceus, the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2005

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

Re: K042887

Trade/Device Name: ACCU-CHEK Spirit Insulin Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: February 24, 2005 Received: March 10, 2005

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 moan that I DA mas mass statutes and regulations administered by other Federal agencies. of the Act of ally I outhal business requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CF R Part 067), laceling (QS) regulation (21 CFR Part 820); and if requirenches as set form in the qualify ijon 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) This teller will anow Jours of substantial equivalence of your device to a premarket notification. - Investication 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), rr you desire specific af 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 may obtain 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,

Quita Michie Davis

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

510(k) Number (if known):__K042887

Device Name: _ACCU-CHEK Spirit insulin infusion pump

Indications For Use:

The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous
Info ACCU-CHEK Spirit Insultancisco, for the management of o The ACCU-CHEK Spirit insulin musion i uniple internet of the management of diabetes
continuous delivery of insulin, as set and vacation the a physion continuous delivery of insulin, at set and issure issues and

Prescription Use (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)

(Signature)

TW Arlester, General Hosp
Dir Control, Dental Devices
Control, CA

Number K942887

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