(356 days)
Not Found
No
The description focuses on data management, storage, and basic processing (averaging). There is no mention of AI, ML, or advanced analytical techniques that would typically indicate their use.
No
The text explicitly states it is "a data management tool" for blood glucose monitoring data and "a moderate level of concern software management system that allows the user an additional method of tracking their blood glucose level." It does not mention any therapeutic function or intervention.
No
The software is described as a "data management tool" for blood glucose monitoring data, and it explicitly states its functions are for "acceptance, transfer, display, storage, processing (e.g., averaging), reporting, and printing." It does not mention any medical or clinical diagnosis capabilities.
Yes
The device description explicitly states it is a "software management system" that operates on a PC and interacts with a blood glucose monitor via a USB cable. While it connects to a hardware device (the blood glucose monitor), the 510(k) focuses solely on the software's function of data management and processing. There is no indication that the software itself includes or is dependent on any specific hardware components beyond the standard PC and USB connection.
Based on the provided information, the Prodigy® Diabetes Management Software is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The software's intended use is described as a "data management tool" for processing and reporting blood glucose monitoring data. It does not perform any diagnostic testing or analysis on biological samples itself.
- Device Description: The description reinforces that it's a software system for tracking blood glucose levels and connecting to a blood glucose monitor. It doesn't mention any components or functions related to in vitro diagnostic procedures.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, etc.)
- Measurement of analytes in those samples
- Providing diagnostic information based on those measurements
The software's function is to manage and display data generated by a separate device (the blood glucose monitor), which is an IVD. The software itself is a tool for organizing and presenting that IVD data.
N/A
Intended Use / Indications for Use
The Prodigy® Diabetes Management Software is indicated for use as a data management tool for the acceptance, transfer, display, storage, processing (e.g., averaging). Reporting, and printing of patient blood glucose monitoring data.
The Prodigy® Diabetes Management Software is indicated for use with the Prodigy Blood Glucose Monitoring Systems only.
Product codes
NBW, JQP
Device Description
The Prodigy® Diabetes Management Software is a moderate level of concern software management system that allows the user an additional method of tracking their blood glucose level. The software allows for an accident member of their blood Glucose Monitor via a USB cable. The Prodigy® Diabetes Management Software is designed to operate on the patient's PC with Microsoft SQL Server 2005 or later operating system. Prodigy® Diabetes Care LLC website will provide a link to download the Microsoft SQL Server 2005 Server 2005.
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)
A clinical usability study was performed to verify ease of use and label comprehension.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
K103115
OCT 1 2 2011
510(k) Summary 807.92(c)
SPONSOR
Company Name:
Prodigy Diabetes LLC
807.92(a)(1)
Company Address:
9300 Harris Corners Parkway Suite 450 Charlotte, NC 28269
Telephone: Fax: Contact Person:
704-285-6400 Fax: 704-285-6475 Rick Admani
Summary Preparation Date: October 14, 2010
DEVICE NAME
Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class: Panel:
807.92(a)(2) Prodigy® Diabetes Management Software Blood Glucose Meter and Data Management System, Test, Blood Glucose, Over the Counter 862.1345 NBW:JOP II Clinical Chemistry
PREDICATE DEVICE
807.92(a)(3)
Legally Marketed Equivalent Device Company Product Becton Dickinson BD™ Diabetes Software
DEVICE DESCRIPTION
807.92(a)(4)
510(k) #
The Prodigy® Diabetes Management Software is a moderate level of concern software management system that allows the user an additional method of tracking their blood glucose level. The software allows for an accident member of their blood Glucose Monitor via a USB cable. The Prodigy® Diabetes Management Software is designed to operate on the patient's PC with Microsoft SQL Server 2005 or later operating system. Prodigy® Diabetes Care LLC website will provide a link to download the Microsoft SQL
Server 2005 Server 2005.
1
DEVICE INTENDED USE
807.92(a)(5)
The Prodigy® Diabetes Management Software is indicated for use as a data management tool for the acceptance, transfer, display, storage, processing (e.g., averaging). Reporting, and printing of patient blood glucose monitoring data.
The Prodigy® Diabetes Management Software is indicated for use with the Prodigy Blood Glucose Monitoring Systems only.
| Parameters | Prodigy Diabetes
Management Software | Becton Dickinson Diabetes
Software |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | | K023219 |
| Indications for Use | The Prodigy® Diabetes
Management Software is
indicated for use as a data
management tool for the
acceptance, transfer,
display, storage, processing
(e.g., averaging). Reporting,
and printing of patient
blood glucose monitoring
data.
The Prodigy® Diabetes
Management Software is
indicated for use with the
Prodigy Blood Glucose
Monitoring Systems only. | The BD™ Diabetes
Software is intended for use
as a data management tool
for acceptance, transfer,
display, storage, processing
(e.g. averaging), reporting,
and printing for patient
blood glucose monitoring
data.
The device is intended for
use with the BD Blood
Glucose Monitoring
Systems only. |
| Download blood glucose
meter readings via USB
interface cable | Yes | Yes |
| Electronic Log Book | Yes | Yes |
| Create User Profile | Yes | Yes |
| Create reports | | |
| Create trending graphs | Yes | Yes |
| Option for printing
reports | Yes | Yes |
| Features of the Software
System | | |
| Set Target - target blood
glucose range | Yes | Yes |
| Average reading for each
meal over the past several | Yes | Yes |
COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)
2
| TELO COLLECT
An and Party
LA-A-8-800 | - - - - - - - - - - - - - - | 1
| Householder, Burnet of Art |
|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Acres of the comparism |
| The Active References of the Regional Concession of the Comments of Children |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --------
1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1 |
| 1
I | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
SUBSTATIAL EQUIVALENCE
The software feature comparisons above of the BD™ Diabetes Software and the Prodigy® Diabetes Management Software demonstrate that the Prodigy® software system is substantially equivalent to the predicate device based on the following similarities:
- Patient can create personal and meter profiles .
- Patient can import data from the Prodigy Blood Glucose Meter, .
- Patient can set blood glucose target ranges and personal schedule, .
- Patient has a Log book to view recorded data, .
- Patient can retrieve reports and trending graphs, and .
- . Patient can print Trend graphs and reports
PERFORMANCE DATA
A clinical usability study was performed to verify ease of use and label comprehension.
CONCLUSION
807.92(b)(3)
21
Based on the product comparison and the Human Factor Study Prodigy® Diabetes Care LLC concludes that the Prodigy® Diabetes Management Software does not raise any new issues concerning safety and effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/13 description: The image shows a logo with a circular border containing text, though the text is too blurry to read. Inside the circle is a stylized bird-like figure with three curved lines representing its wings or feathers. The logo appears to be a symbol for an organization or service, possibly related to health or nature.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Prodigy Diabetes Care, LLC. c/o Smith Associates E.J. Smith, Consultant 1468 Harwell Avenue, Crofton. MD 21114
OCT 1 2 2011
Re: K103115
Trade/Device Name: Prodigy Diabetes Management Software Regulation Number: 21 CFR 862.1345 Regulation Name:Glucose test system. Regulatory Class: II Product Code: NBW, JQP Dated: September 28, 2011 Received: September 28, 2011
Dear Mr. Smith:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 796-5760. For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
103115
510(k) Number (if known):
Device Name: Prodigy® Diabetes Management Software
Indications for Use:
The Prodigy® Diabetes Management Software is intended for use as a data management tool for acceptance, transfer, display, storage, processing (e.g. averaging), reporting and printing of patient blood glucose monitoring data.
The device is intended for use with the Prodigy® Blood Glucose Monitoring Systems only.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Que
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k). 103115
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