FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM

K083225 · Abbott Diabetes Care, Inc. · LZG · Feb 20, 2009 · General Hospital

Device Facts

• Record ID: K083225
• Device Name: FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: LZG · General Hospital
• Decision Date: Feb 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System is intended for continuous delivery of insulin at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin. The FreeStyle Aviator System is also intended for the quantitative measurement of glucose in fresh whole capillary blood (in vitro). The system is available by prescription only.

Device Story

System comprises Aviator Insulin Pump and wireless Aviator Companion remote controller. Companion provides alternate user interface for pump control and status monitoring; incorporates integrated FreeStyle Lite blood glucose meter. Inputs: user commands via jogwheel/push buttons; blood glucose samples via test strip port. Outputs: insulin delivery, glucose readings, pump status on graphical LCD. Used by patients for diabetes management. Bi-directional RF transceiver enables remote pump operation. Companion architecture utilizes dual CPUs for UI and glucose/RF processing. Benefits: improved usability for pump management when worn under clothing.

Clinical Evidence

Evidence includes design verification testing, a blood glucose clinical study, software validation, and a human factors study to validate user interface design. Environmental testing for electromagnetic compatibility was also performed.

Technological Characteristics

System includes insulin pump and wireless remote controller (Companion) with RF transceiver for bi-directional communication. Companion hardware features dual CPUs (one for UI, one for glucose/RF). Interface includes graphical LCD, jogwheel, and tactile buttons. Integrated glucose meter uses FreeStyle Lite test strips. Battery-powered. Software-controlled.

Indications for Use

Indicated for persons with diabetes mellitus requiring insulin for continuous insulin delivery and quantitative blood glucose monitoring using fresh whole capillary blood.

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

• Symphony Glucose Management System (K080639)
• iXL-II Diabetes Management System with Blood Glucose Meter (K042792)
• Aviator Insulin Pump (K071788)
• FreeStyle Lite Blood Glucose Monitoring System (K070850)

Submission Summary (Full Text)

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K083225

FEB 2 0 2009

## Section 5: 510(k) Summary

(as required by 21 CFR 807.92)

Submitted by:

Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502

Company Contact:

Sarah Harrington Senior Regulatory Specialist [phone] [e-mail]

Date Prepared:

October 31, 2008

Trade Name:

FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System

Common/Usual Namc: External insulin infusion pump and blood glucose meter

Classification Name:

Insulin infusion pump and blood glucose meter Class II: LZG, 21 CFR 880.5725 Class II: LFR, 21 CFR 862.1345

## Substantially Equivalent

Devices:

Symphony Glucose Management System, K080639 iXL-II Diabetes Management System with Blood Glucose Meter, K042792 Aviator Insulin Pump, K071788 FreeStyle Lite Blood, K070850

## Device Description

The FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System consists of an insulin infusion pump (Aviator Pump) and a wireless remote controller (Aviator Companion). The Aviator Pump was previously cleared by the FDA on January 11, 2008 (K071788).

The Aviator Companion is a handheld, microprocessor controlled, battery powered, remote control device for the FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System. The Aviator Companion provides an alternate user interface to the Aviator Pump which is useful when the pump is hidden under clothing.

The Aviator Companion user interface can control specific pump functions and receive pump status information. The Companion contains a large graphical LCD, jogwheel and

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tactile push buttons. Both the Aviator Companion UI and the Aviator Pump UI consistently utilize text, icon and graphical presentations to prompt the user through the menus and to present data.

The Ayiator Companion incorporates the FreeStyle Lite Blood Glucose Monitoring System (BGMS). The Aviator Companion has a built-in test strip port that utilizes the FreeStyle Lite Test strip. The FreeStyle Lite BGMS received FDA clearance on April 10, 2007 (K070850).

#### Intended Use

The FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System is intended for continuous delivery of insulin at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin. The FreeStyle Aviator System is also intended for the quantitative measurement of glucose in fresh whole capillary blood (in vitro). The system is available by prescription only.

#### Technological Characteristics

The Aviator Companion and Aviator Pump's electronic hardware includes a radio frequency (RF) transceiver that facilitates bi-directional communication between the devices. The communication allows the user to operate the pump via the Aviator Companion. The Aviator Companion hardware architecture includes two CPUs, one primarily for user interface interactions and the other for blood glucose measurements and RF link communications.

### Performance Data

Design verification testing, a blood glucose clinical study and software validation have verified the requirements stated in the specification documents. A Human Factors Study. was conducted to validate the overall design of the FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System in the hands of the user. Environmental testing includes testing for electromagnetic compatibility.

#### Conclusion

The performance data demonstrates substantial equivalence between the FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System and the Symphony Glucose Management System and the iXL-II Diabetes Management System with Blood Glucose Meter. When compared to the legally marketed predicate devices, the FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System is safe and effective for its intended use ·

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is depicted in a simple, line-art style.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sarah Harrington Senior Regulatory Specialist Abbott Diabetes Care Incorporated 1360 South Loop Road Alameda, California 94502

3 9.0 2009

Re: K083225

Trade/Device Name: FreeStyle Aviator Insulin Delivery and Blood Glucose

್ತಾ Monitoring System - ಒಂದು ,就是 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG, LFR Dated: February 5, 2009 Received: February 6, 2009

Dear Ms. Harrington:

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 - Ms. Harrington

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 (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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Antson V. Michaud, M.D.

Ginette Y. Michaud, M.D. Acting 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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Aviator Companion

# Indications for Use

# 510(k) Number (if known):

Device Name: Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring System

Indications For Use:

The FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System is intended for continuous delivery of insulin at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin. The FreeStyle Aviator System is also intended for the quantitative measurement of glucose in fresh whole capillary blood (in vitro). The system is available by prescription only.

(Part 21 CFR 801 Subpart D)

Prescription Use

(21 CFR 801 Subpart C)

Over-The-Counter Use

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

ANDIOR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

| Traditional 510(k) | |
|------------------------------|-----------------------------------------------------------------------------------|
| Proprietary and Confidential | (Division Sign-Off) |
| | Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices |
| | 510(k) Number: 10083225 |