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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# 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: [phone] 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) #

K023219

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.

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# 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<br>Management Software | Becton Dickinson Diabetes<br>Software |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | | K023219 |
| Indications for Use | The Prodigy® Diabetes<br>Management Software is<br>indicated for use as a data<br>management tool for the<br>acceptance, transfer,<br>display, storage, processing<br>(e.g., averaging). Reporting,<br>and printing of patient<br>blood glucose monitoring<br>data.<br>The Prodigy® Diabetes<br>Management Software is<br>indicated for use with the<br>Prodigy Blood Glucose<br>Monitoring Systems only. | The BD™ Diabetes<br>Software is intended for use<br>as a data management tool<br>for acceptance, transfer,<br>display, storage, processing<br>(e.g. averaging), reporting,<br>and printing for patient<br>blood glucose monitoring<br>data.<br>The device is intended for<br>use with the BD Blood<br>Glucose Monitoring<br>Systems only. |
| Download blood glucose<br>meter readings via USB<br>interface cable | Yes | Yes |
| Electronic Log Book | Yes | Yes |
| Create User Profile | Yes | Yes |
| Create reports | | |
| Create trending graphs | Yes | Yes |
| Option for printing<br>reports | Yes | Yes |
| Features of the Software<br>System | | |
| Set Target - target blood<br>glucose range | Yes | Yes |
| Average reading for each<br>meal over the past several | Yes | Yes |

#### COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

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| TELO COLLECT<br>An and Party<br>LA-A-8-800 | - - - - - - - - - - - - - - | 1<br>Householder, Burnet of Art<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Acres of the comparism<br>The Active References of the Regional Concession of the Comments of Children<br>--------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --------<br>1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>1 |
| 1<br>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.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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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).

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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 [phone]. 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 [phone]. 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 [phone] 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

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# 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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