IXL DIABETES MANAGEMENT SYSTEM

K031373 · Insulet Corp. · LZG · Dec 19, 2003 · General Hospital

Device Facts

• Record ID: K031373
• Device Name: IXL DIABETES MANAGEMENT SYSTEM
• Applicant: Insulet Corp.
• Product Code: LZG · General Hospital
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iXL™ Diabetes Management System is intended for continuous, subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Device Story

iXL Diabetes Management System is a portable, external insulin infusion device for diabetes management. System consists of a wearable insulin pump and a handheld remote controller. Pump is worn on the body; delivers insulin via subcutaneous infusion based on user-programmed basal rates and bolus doses for up to 72 hours. Remote controller, featuring an LCD and 9 buttons, provides the user interface for pump activation and control. Pump and remote communicate via secure radio frequency (RF). Device provides audio alarms, alerts, and reminders. Designed for use by patients requiring insulin therapy to manage diabetes mellitus.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparison to the predicate device.

Technological Characteristics

External, wearable insulin infusion pump with handheld remote controller. Microprocessor-controlled pump. Wireless RF communication between pump and remote. Electro-luminescent backlit LCD on remote. Battery-operated. Syringe-style reservoir. Integrated infusion set and insertion system.

Indications for Use

Indicated for persons with diabetes mellitus requiring insulin for continuous, subcutaneous insulin delivery 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

• Medtronic MiniMed System (508 Insulin Pump, Reservoir, Sil-serter Infusion Set Insertion System, and Silhouette Infusion Set)

Submission Summary (Full Text)

{0}------------------------------------------------

remarket Notification [510(k)] iXLTM Diabetes Management System

12/19/03
K031373

#### Section P: 510(k) Summary iXLTM Diabetes Management System

Submitter: Insulet Corporation 100 Cummings Center Suite 239G Beverly, MA 01915

Contact: A. Arthur Rankis Director of Quality and Regulatory Affairs 978-299-0203

Device Name: iXL™ Diabetes Management System

#### Predicate Devices:

The iXL Diabetes Management System is substantially equivalent to the Medtronic MiniMed® System, consisting of the 508 Insulin Pump, Reservoir, Sil-serter Infusion Set Insertion System, and the Silhouette Infusion Set.

#### Intended Use:

The iXL™ Diabetes Management System is intended for continuous, subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

## Description of the iXL™ Diabetes Management System

The iXL Diabetes Management System has two (2) components: a Remote Controller, and an insulin infusion Pump, and two accessories; a fill syringe, and fill needle.

The Remote Controller is a hand held, battery-operated device, with 9 functional buttons and an electro-luminescent (EL) backlit liquid crystal display (LCD). The device provides audio alarms, alerts and reminders.

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

The Pump is a microprocessor controlled device. The Pump is worn directly on the body in the same manner and general locations as a conventional insulin infusion set. The Pump will leliver insulin based on the users custom programmed basal rate and bolus does for up to 72 houvs. The Pump provides audio alarms, alerts and reminders.

{1}------------------------------------------------

Insulet Corporation Premarket Notification [510(k)} iXLTM Diabetes Management System

## Comparison of the New Device to the Predicate Devices

The iXL Diabetes Management System is substantially equivalent to the commercially available (predicate) Medtronic MiniMed System, consisting of the 508 Insulin Pump, the Sil-Setter infusion set insertion system, the Silhouette infusion set and Reservoir. Both systems are portable, external insulin infusion devices that deliver insulin from a syringe style reservair and include a remote controller.

The difference between the systems is the arrangement of the elements. The user interface on the iXL Diabetes Management System has been moved from the Pump to the Remote Controller, and the insertion system and infusion set have been integrated into the Pump.

A. Arthur Rechnitz

A.Arthur Rankis Director of Quality and Regulatory Affairs Insulet Corporation

December 18, 2003

Date

## CONFIDENTIAL

{2}------------------------------------------------

## 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 features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Insulet Corporation C/O Mr. A. Arthur Rankis Director of Quality and Regulatory Affairs 100 Cummings Center Suite 239G Beverly, Massachusetts 01915

Re: K031373

Trade/Device Name: iXL Diabetes Management System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: September 24, 2003 Received: September 25, 2003

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.

{3}------------------------------------------------

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 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/dsma/dsmamain.html

Sincerely vours.

Chi-Lien, Ph.D.

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

{4}------------------------------------------------

Insulet Corporation Premarket Notification [510(k)] iXL Diabetes Management System

### Indications for Use Statement

510(k) Number (if known)

Device Name

iXL™ Diabetes Management System

Indications for Use

For the continuous, subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Patricio Cucenta
(Division Sign-Off)

(Profileion Olgh-Olt)
Division of Anesthesiology, General Hospital, The Chon of Anesthesiology, Gene

510(k) Number: /\/03/375