(89 days)
iXL Diabetes Management System, TheraSense FreeStyle Blood Glucose Monitor
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No
The description focuses on hardware components, basic programming (basal rates, bolus doses), and wireless communication. There is no mention of adaptive algorithms, learning from data, or any terms associated with AI/ML.
Yes
The device is intended for the subcutaneous delivery of insulin for the management of diabetes mellitus and for the quantitative measurement of glucose, both of which are therapeutic interventions aimed at treating a medical condition.
Yes
The device quantitatively measures glucose in fresh whole capillary blood, which is a diagnostic function.
No
The device description clearly outlines two hardware components: a Remote Controller with integral blood glucose monitoring technology and an insulin infusion Pod. It also mentions various physical accessories.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for the "quantitative measurement of glucose in fresh whole capillary blood (in vitro)." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The "Device Description" mentions that the Remote Controller has an "integral blood glucose monitoring technology" and a "BG Test Strip Reader." It also specifies the use of "TheraSense FreeStyle test strips" and "TheraSense FreeStyle Control Solution," which are components typically used in in vitro blood glucose testing.
- Predicate Device: One of the listed predicate devices is the "TheraSense FreeStyle Blood Glucose Monitor," which is a known IVD.
While the device also has an insulin delivery function, the inclusion of the blood glucose monitoring component and its intended use for in vitro glucose measurement classifies it as an IVD. It's a combination device with both drug delivery and IVD functions.
N/A
Intended Use / Indications for 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.
Product codes
LZG
Device Description
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).
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
iXL Diabetes Management System, TheraSense FreeStyle Blood Glucose Monitor
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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: (781) 457-5000 Fax: (781) 457-5001
- Contact: Mr. A. Arthur Rankis Director of Quality and Requlatory Affairs (781) 457-4743
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),
1
$\Psi$42792 (P.2of2)
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 (301) 594-0115. 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 (800) 638-2041 or (301) 443-6597 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