(233 days)
Not Found
Not Found
No
The summary describes a standard insulin pump system with a remote controller and microprocessor, but there is no mention of AI, ML, or any learning or adaptive algorithms. The device delivers insulin based on user-programmed rates.
Yes
The device is described as "For the continuous, subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin," which explicitly states its therapeutic purpose in managing a medical condition.
No
The device description indicates it is an insulin delivery system designed for continuous subcutaneous insulin infusion, not for diagnosing a condition. Its function is to manage diabetes, not to detect or identify it.
No
The device description explicitly states it has two hardware components: a Remote Controller and an insulin infusion Pump, in addition to accessories. This indicates it is a hardware-based medical device with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of insulin for the management of diabetes. This is a therapeutic function, not a diagnostic one.
- Device Description: The device components (Remote Controller, Pump, syringe, needle) are all involved in the physical delivery of a substance (insulin) into the body.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (like blood, urine, etc.) to provide diagnostic information about a patient's condition. IVDs are designed to perform tests on samples taken from the body.
This device is clearly an insulin pump system, which is a medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for 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.
Product codes
LZG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic MiniMed® System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).
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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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