IXL-II DIABETES MANAGEMENT SYSTEM

K042792 · Insulet Corporation · LZG · Jan 3, 2005 · General Hospital

Device Facts

• Record ID: K042792
• Device Name: IXL-II DIABETES MANAGEMENT SYSTEM
• Applicant: Insulet Corporation
• Product Code: LZG · General Hospital
• Decision Date: Jan 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iXL-II Diabetes Management System with Blood Glucose Measurement is intended for continuous. subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro). It is available only by or on the order of a physician.

Device Story

System comprises two components: handheld Remote Controller with integrated blood glucose monitor and wearable insulin infusion Pod. Remote Controller features LCD, 10 buttons, and test strip reader; communicates with Pod via secure, bi-directional RF. Pod is microprocessor-controlled, worn on body, and delivers insulin based on user-programmed basal rates and bolus doses for up to 72 hours. System provides audio alarms, alerts, and reminders. Used by patients for diabetes management; requires physician prescription. Output includes insulin delivery and blood glucose readings, enabling patient to adjust therapy. Benefits include automated insulin delivery and integrated glucose monitoring.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

System includes battery-operated Remote Controller and microprocessor-controlled Pod. Connectivity via secure, bi-directional RF. Components include LCD, BG test strip reader, and audio alarm system. Materials include standard medical-grade plastics for Pod and controller housing. Sterilization and specific ASTM standards not detailed.

Indications for Use

Indicated for management of diabetes mellitus in persons requiring insulin; provides continuous subcutaneous insulin delivery and quantitative measurement of glucose in 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

• iXL Diabetes Management System
• TheraSense FreeStyle Blood Glucose Monitor

Submission Summary (Full Text)

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JAN - 3 2005

K\$\phi\$42792 (\$\rho\$ 1/2)

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of 21 CFR 807.92:

- Submitter: Insulet Corporation 9 Oak Park Drive Bedford, MA 01730-1413 Tel: [phone] Fax: [phone]
- Contact: Mr. A. Arthur Rankis Director of Quality and Requlatory Affairs [phone]

Date Prepared: October 6, 2004

Trade Name: iXL-II Diabetes Management System with Blood Glucose Measurement

Common Name: External insulin infusion Pump and blood glucose monitor

Classification Name: Infusion Pump 21CFR §880.5725

### Legally Marketed Devices to which we are claiming equivalence:

The iXL-II Diabetes Management System with Blood Glucose Measurement is substantially equivalent to the iXL Diabetes Management System and to the TheraSense FreeStyle Blood Glucose Monitor.

#### Intended Use:

The iXL-II Diabetes Management System with Blood Glucose Measurement is intended for continuous. subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro). It is available only by or on the order of a physician.

#### Summary Description of the iXL-II Diabetes Management System

The iXL-11 Diabetes Management System has two (2) components: a Remote Controller with integral blood glucose monitoring technology, and an insulin infusion Pod. Accessories include:

- Batteries and IFU packaged with the Remote Controller .
- . A fill syringe and fill needle packaged with each Pod.

Other accessories for use with the iXL-II Diabetes Management System will be available from Insulet Corporation. Accessories will include batteries, a Carry Case, a TheraSense FreeStyle Lancing Device, TheraSense FreeStyle lancets, TheraSense FreeStyle test strips, TheraSense FreeStyle Control Solution, commercially available site prep and adhesive removal wipes, etc. The IFU for the iXL-II Diabetes Management System will specify the use of only the TheraSense FreeStyle components for use with the iXL-II blood glucose measurement function.

The Remote Controller is a hand held, battery-operated device, with 10 functional buttons, an electroluminescent (EL) backlit liquid crystal display (LCD) and BG Test Strip Reader. The device provides audio alarms, alerts and reminders.

The Pod is activated and controlled exclusively through the use of the Remote Controller. The Pod and Remote Controller interact wirelessly using secure, bi-directional radio frequency (RF),

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The Pod is a microprocessor-controlled device worn directly on the same manner and general locations as a conventional insulin set. The Pod will deliver insulin based on the users custom programmed basal rate and bolus doses for up to 72 hours and provides audio alarms, alerts and reminders.

#### Comparison of the New Device to the Predicate Devices

The iXL-II Diabetes Management System with Blood Glucose Measurement is substantially equivalent to the iXL Diabetes Management System and to the TheraSense FreeStyle Blood Glucose Monitor

#### Conclusion:

The modifications discussed in this submission raise no new questions regarding the safety and effectiveness of the iXL-11 Diabetes Management System with Blood Glucose Measurement as compared 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 human figure with three arms reaching upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 3 2005

Mr. A. Arthur Rankis Director of Quality and Regulatory Affairs Insulet Corporation 9 Oak Park Drive Bedford, Massachusetts 01730-1413

Re: K042792

Trade/Device Name: iXL-I I Diabetes Management System with Blood Glucose Measurement Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: October 6, 2004 Received: October 7, 2004

Dear Mr. Rankis:

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. Rankis

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 mean that I Dr mas made statutes and regulations administered by other Federal agencies. or the rece of any I outs all the Act's requirements, including, but not limited to: registration r od intist comply with a 807); labeling (21 CFR Part 801); good manufacturing practice and ilsuing (21 CFR 1 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) Fine feter 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), rl you 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 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/dsma/dsmamain.html

Sincerely yours,

huite Mchue D. m.d.

FOR DR. CHILL LIV 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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## STATEMENT OF INDICATIONS FOR USE

510(k) Number KO42797 (if known)

Device Name iXL-II Diabetes Management System with Blood Glucose Measurement

Intended for subcutaneous delivery of insulin at set and variable rates Indications for Use for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro).

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Please DO NOT WRITE BELOW THIS LINE - Continue on another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suiste y. Michue O MD.

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental

510(k) Number: K154272