BIONIME DIABETES MANAGEMENT SYSTEM VI.0

K113007 · Bionime Corporation · JQP · Feb 27, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113007
• Device Name: BIONIME DIABETES MANAGEMENT SYSTEM VI.0
• Applicant: Bionime Corporation
• Product Code: JQP · Clinical Chemistry
• Decision Date: Feb 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2100
• Device Class: Class 1
• Attributes: Software as a Medical Device

Indications for Use

The Bionime Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from Rightest® Glucose meter(s) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data. Bionime Rightest™ GM550 and GM250 meters are compatible with Bionime Diabetes Management System. The Bionime Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.

Device Story

System transfers blood glucose readings from Rightest GM550/GM250 meters to PC via USB cable and GP550 PC Link Adapter. Software (GP200 Diabetes Assistant) processes data to generate tables, trend charts, and pie charts for periods up to 90 days. Used by patients and healthcare professionals in home or clinical settings. Output allows visualization of glucose trends to assist in diabetes management. Device does not provide treatment decisions or diagnoses; intended as an aid for data review.

Clinical Evidence

No clinical trials were conducted. Evidence consists of a usability study with 29 lay-user participants to evaluate the ease of use of the data transmission feature, which yielded positive results. A Flesch-Kincaid readability study confirmed the user manual is at an 8th-grade level or below. Software verification and validation documentation, including hazard analysis, was reviewed and found acceptable.

Technological Characteristics

Software-based diabetes management system. Operates on Windows XP, Vista, or 7. Requires 550 MHz Pentium 3 CPU, 512 MB DRAM, 600 MB HD, and USB 2.0. Includes GP550 PC Link Adapter hardware. Complies with EN 61326-1, EN 61326-2-6, and EN 60601-1-2 for EMC. Risk management follows ISO 14971.

Indications for Use

Indicated for use by patients with diabetes and healthcare professionals as an aid in diabetes management via data transfer, analysis, and reporting of blood glucose readings.

Regulatory Classification

Identification

A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.

Predicate Devices

• Glucofacts® Deluxe Diabetes Management Software (k091820)

Submission Summary (Full Text)

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

A. 510(k) Number:
k113007

B. Purpose for Submission:
New 510(k) for diabetes data management software accessory for use with compatible cleared GM550 and GM250 Blood Glucose Monitoring Systems (k092052).

C. Manufacturer and Instrument Name:
Bionime Corporation. Bionime Diabetes Management System Software

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

E. System Descriptions:

1. Device Description:
The Bionime Diabetes Management System allows the transfer of blood glucose readings from a compatible Bionime Rightest Glucose Meter to a PC via USB cable.

The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal times or time periods up to 90 days. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots.

The system is comprised of two components. The first component is an Installation CD with setup files for Bionime GP200 Diabetes Assistant Software and Rightest PC Link Adapter Driver. The second component is GP550 PC Link Adapter.

2. Principles of Operation:
The Bionime Diabetes Management System is an accessory to compatible Rightest meters, which use specific test principles.

Operating System requirements for the Bionime Diabetes Management System are: Windows XP Professional, Windows Vista Professional or Windows 7 Professional. The system requirements are as follows: (1) Microsoft Windows personal computer, (2) CPU: 550 MHz Intel Pentium 3 or above, (3) DRAM: 512 or above, (4) HD: 600 MB or more, (5) Internet Explorer 7.0 or above, (6) USB 2.0 or above, (7) LCD screen with resolution of 1024x768 or above, (8) CD-ROM drive and (9) a printer (Optional).

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3. **Modes of Operation:**

Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?
Yes ☑ or No ☐

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

4. **Specimen Identification:**

Specimen identification is based on time and date of testing.

5. **Specimen Sampling and Handling:**

Data transmission from glucose meters using capillary whole blood samples

6. **Calibration:**

Glucose meter specific. See statement below under section J.

7. **Quality Control:**

Glucose meter specific. See statement below under section J.

8. **Software:**

FDA has reviewed applicant’s Hazard Analysis and Software Documentation:
Yes ☑ or No ☐

F. **Regulatory Information:**

| Device Name | Product Code | Classification | Regulation | Panel |
| --- | --- | --- | --- | --- |
| Glucose Test System | NBW: Blood Glucose Test System, Over-the-Counter | Class II | 21 CFR § 862.1345 | Clinical Chemistry (75) |
| Calculator/Data Processing Module for Clinical Use | JQP: Calculator/ Data Processing Module for Clinical Use | Class I | 21 CFR § 862.2100 | Clinical Chemistry (75) |

G. **Intended Use:**

1. **Indication(s) for Use:**

The Bionime Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from Rightest Glucose meter(s) to a personal computer for the purpose of viewing, analyzing

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and printing the glucose readings, as well as to backup and to recover users' profile and data.

The Bionime Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.

2. Special Conditions for Use Statement(s):
For Over-the-Counter (OTC) use.

H. Substantial Equivalence Information:

| Predicate device name | Predicate 510(k) number |
| --- | --- |
| Glucofacts Deluxe Diabetes Management Software | k091820 |

Comparison with predicate:

| Similarities and Differences | | |
| --- | --- | --- |
| Item | Candidate Device
Bionime Diabetes Management System | Predicate Device
(k091820) |
| Intended Use | The Bionime Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. | Same |
| Meter Compatibility | For use with supported glucose meters | Same |
| Download blood glucose meter readings via USB interface cable | Yes | Same |
| Set-up multiple patient databases | Yes | Same |
| Create trending graphs and reports | Yes | Same |

I. Special Control/Guidance Document Referenced (if applicable):

- EN 61326-1: 2006, Electrical equipment for measurement, control and laboratory use – EMC requirements Part 1: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and tests-Edition 2.1; Edition 2:2001 consolidated with amendment 1:2004
- EN 61326-2-6: 2006, Electrical equipment for measurement, control and laboratory use – EMC requirements Part 2-6: Particular requirements.

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- EN 60601-1-2:2001/A1: 2006, Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 14971: 2007, Medical Devices- Application of risk management to medical devices.

## J. Performance Characteristics:

### 1. Analytical Performance:
The performance characteristics listed below as applicable, were presented in the specific glucose meter clearance under k092052.

a. Accuracy:
See above statement under section J(1).

b. Precision/Reproducibility:
See above statement under section J(1).

c. Linearity:
See above statement under section J(1).

d. Carryover:
See above statement under section J(1).

e. Interfering Substances:
See above statement under section J(1).

### 2. Other Supportive Instrument Performance Data Not Covered Above:

a) A usability study was performed with 29 lay-user participants with varying demographics (age, sex, and education level) were included in a usability study. Those study participants also completed a questionnaire in response to whether the data transmission feature is easy to use. The sponsor concluded that the user's responses indicated that data transmission function was easy to operate by following the instructions provided with the system.

b) The following documentation related to the software was reviewed and found to be acceptable: level of concern, software description, device hazard analysis, software requirements specifications, software design specification, software development environment description, and verification and validation testing.

c) The sponsor provided the results of a Flesch-Kincaid readability study which indicated a Grade Level Score of 8th grade or below for the Bionime Diabetes Management System User Manual.

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d) The sponsors provided the appropriate documentation certifying that electromagnetic testing (EMC) had been performed and the GP550 PC-Link Adaptor were found compliant (EN 61326, EN 61326-2-6).

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.

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