PRODIGY DIABETES MANAGEMENT SOFTWARE

K103115 · Prodigy Diabetes Care, LLC · NBW · Oct 12, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103115
• Device Name: PRODIGY DIABETES MANAGEMENT SOFTWARE
• Applicant: Prodigy Diabetes Care, LLC
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Software accessory for Prodigy Blood Glucose Monitoring Systems; enables data transfer from meter to PC via USB cable. Functions as electronic logbook; creates user profiles, trending graphs, and reports; calculates averages for meal periods. Used by patients in home setting. Healthcare providers review printed reports to assist in diabetes management decisions. Benefits include improved tracking and visualization of glucose trends.

Clinical Evidence

Bench testing verified data transfer compatibility and accuracy using full memory capacity. Human factors study (n=20) verified ease of use, label comprehension, and meter data transfer by lay users.

Technological Characteristics

Software-based data management system operating on PC platforms (Microsoft SQL Server 2005 or later). Features include USB interface for meter connectivity, electronic logbook, data averaging, and report generation. No specific hardware materials or sterilization methods applicable as it is a software-only device.

Indications for Use

Indicated for use by patients as a data management tool for blood glucose monitoring data, including acceptance, transfer, display, storage, processing, reporting, and printing. Intended for use with Prodigy Blood Glucose Monitoring Systems only. Over-the-counter use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Becton Dickinson, BD™ Diabetes Software (k023219)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
k103115

B. Purpose for Submission:
New 510(k) for diabetes data management software accessory for use with compatible cleared Prodigy (k060467) and Prodigy Voice (k073118) Blood Glucose Meter.

C. Manufacturer and Instrument Name:
Prodigy Diabetes Care, LLC. Prodigy Diabetes Management Software

D. Type of Test or Tests performed:
Diabetes data management system

E. System Descriptions:

1. Device Description:
The Prodigy® Diabetes Management Software allows the user an additional method of tracking their blood glucose level. The software allows for data transfer from a Prodigy 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.

2. Principles of Operation:
Prodigy Diabetes Management Software is an accessory to compatible Prodigy meters, which use specific test principles.

3. Modes of Operation:
Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?:
Yes ☐ X or No ☐

Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?:
Yes ☐ or No ☐ X

4. Specimen Identification:
Meter controlled download to data manager

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5. Specimen Sampling and Handling: Not Applicable
6. Calibration: Not Applicable
7. Quality Control: Not Applicable
8. Software:
FDA has reviewed the applicant’s Hazard Analysis and software
Documentation: Yes ☑ or No ☐

F. Regulatory Information:

1. Regulation Section:
21CFR §862.1345 -Glucose test system.
21CFR §862.2100 - Calculator/data processing module for clinical use.

2. Classification:
Class II and I respectively

3. Product Code:
NBW - System, Test, Blood Glucose, Over the Counter
JQP - Calculator/Data Processing Module, for Clinical Use

4. Panel:
Chemistry (75)

G. Intended Use:

1. Indication(s) 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.

2. Special Condition for use Statement(s):
Over the Counter (OTC) use

H. Substantial Equivalence Information:

1. Predicate device name(s) and 510(k) numbers:

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Becton Dickinson, BD™ Diabetes Software
k023219

2. Comparison with Predicate Device:

| Parameters | Prodigy Diabetes Management Software | Becton Dickinson Diabetes Software |
| --- | --- | --- |
| 510(k) Number: | k103115 | 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. | Same |
| Compatibility | for use with the Prodigy Blood Glucose Monitoring Systems only. | 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 weeks | Yes | Yes |
| Over the Counter | Yes | Yes |

I. Standard/Guidance Document Referenced (if applicable):

ISO 14971:2007, Medical Devices – Application of risk management to medical devices

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## J. Performance Characteristics:

1. Analytical Performance:
a. Accuracy: Not Applicable
b. Precision/Reproducibility: Not Applicable
c. Linearity: Not Applicable
d. Carryover: Not Applicable
e. Interfering Substances: Not Applicable

2. Other Supportive Instrument Performance Data Not Covered Above:

A Human Factors study of 20 participants was performed to verify ease of use, label comprehension meter data transfer in the hands of lay users. Additionally, all meters were bench tested to verify data transfer compatibly and accuracy utilizing full memory capacity.

## K. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

## L. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.