(109 days)
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.
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 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).
This is a 510(k) premarket notification for the FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System. The document focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a full study report with precise performance metrics.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not include a specific table of acceptance criteria or quantified device performance metrics for the blood glucose monitoring component beyond stating that a "blood glucose clinical study" was conducted. It emphasizes that design verification testing, a blood glucose clinical study, and software validation verified the requirements stated in the specification documents. However, the actual performance values that met those requirements are not provided in this summary.
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for the blood glucose clinical study.
- Data Provenance: Not explicitly stated, but the submission is from Abbott Diabetes Care in Alameda, CA, USA, suggesting the study likely took place in the US, but this is not confirmed. It does not mention if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided in the document. For a blood glucose monitoring system, the "ground truth" would typically be established by a reference laboratory method, not by expert consensus from individuals like radiologists.
4. Adjudication Method
This information is not applicable and therefore not provided, as the ground truth for blood glucose measurements is typically a laboratory reference method, not an expert panel requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable to a blood glucose monitoring system. MRMC studies are typically used to assess the effectiveness of diagnostic imaging systems where human readers interpret medical images.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was implicitly done for the blood glucose monitoring component. The document states "a blood glucose clinical study" was conducted, and the Aviator Companion incorporates the FreeStyle Lite Blood Glucose Monitoring System (BGMS) which "received FDA clearance on April 10, 2007 (K070850)." This indicates that the performance of the blood glucose monitoring function itself was evaluated independently. However, specific performance metrics from this study are not detailed in this 510(k) summary. The summary refers to the fact that the BGMS component was previously cleared, suggesting its standalone performance was established in its own prior submission.
7. Type of Ground Truth Used
While not explicitly detailed in this document for this submission, for a blood glucose monitoring system, the ground truth for the "blood glucose clinical study" would almost certainly be laboratory reference measurements (e.g., from a YSI analyzer or similar gold-standard laboratory instrument) on the same blood samples.
8. Sample Size for the Training Set
This information is not provided. Blood glucose meters typically do not use machine learning in the conventional sense that would require a "training set." Performance is evaluated against clinical samples. If any calibration or algorithm development involved data, it's not described as a "training set" here.
9. How the Ground Truth for the Training Set Was Established
As above, this information is not provided and is likely not applicable in the typical sense of a machine learning "training set" for a blood glucose monitor. Ground truth for performance evaluation would be established by laboratory reference methods.
{0}------------------------------------------------
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 (510) 239-2732 sarah.harrington@abbott.com
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
{1}------------------------------------------------
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 ·
{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 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.
{3}------------------------------------------------
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 (800) 638-2041 or (240) 276-3150 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
{4}------------------------------------------------
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 HospitalInfection Control, Dental Devices | |
| 510(k) Number: 10083225 |
§ 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).