LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE

K130657 · All Medicus Co., Ltd. · NBW · Jul 15, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130657
• Device Name: LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE
• Applicant: All Medicus Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The LinkDr 2.0 Diabetes Management Software is a PC-based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for effective diabetes management. It is intended for use as an accessory to compatible All Medicus brand blood glucose monitoring systems such as the GlucoDr Supersensor blood glucose meter, GlucoDr Plus blood glucose meter and GlucoDr auto blood glucose meter.

Device Story

LinkDr 2.0 is PC-based data management software; functions as accessory to All Medicus blood glucose meters (GlucoDr Supersensor, GlucoDr Plus, GlucoDr auto). System includes USB cable and software CD. Device transfers glucose test data from meters to PC; provides graphic displays and analysis tools for review of glucose results. Used in home and professional settings by patients and healthcare providers. Output allows visualization of glucose trends; assists in diabetes management decision-making. Data integrity maintained; transferred data cannot be modified.

Clinical Evidence

Bench testing only. Verified data transmission accuracy for glucose values, flags (pre-meal, post-meal, exercise, stress, control solution), and time stamps. Memory rollover functionality confirmed. Usability study (n=unspecified) of lay and professional users reported 100% satisfaction and ease of use.

Technological Characteristics

PC-based software; requires Windows XP/Vista/7, Pentium 4 2.4 GHz, 256 MB RAM. Connectivity via USB cable. Compliant with EN 61010-1 and EN 61326-1 (EMC).

Indications for Use

Indicated for people with diabetes and their healthcare professionals in home and professional settings to review, analyze, and evaluate glucose test results for diabetes management. Compatible with All Medicus brand blood glucose monitoring systems (GlucoDr Supersensor, GlucoDr Plus, GlucoDr auto).

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

• LifeScan IN TOUCH® Diabetes Management Software (k984527)

Submission Summary (Full Text)

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

A. 510(k) Number:
k130657

B. Purpose for Submission:
New diabetes data management software accessory for use with GlucoDr Supersensor (k050985), GlucoDr Plus (k082328), and GlucoDr auto (k083628) blood glucose meters.

C. Manufacturer and Instrument Name:
All Medicus Co., Ltd.

LinkDr 2.0 Diabetes Management Software

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

E. System Descriptions:

1. Device Description:
The LinkDr 2.0 Diabetes Management Software is an optional accessory for use with compatible All Medicus brand blood glucose meters with data management capabilities. The subject device consists of a USB data transfer cable and software. The system allows the users to download blood glucose results from their glucose meter to their computer, maintain a history of their glucose test results, and convert them into graphs, charts and reports. The software does not recommend any medical treatment or medication dosage level.

2. Principles of Operation:
The LinkDr 2.0 Diabetes Management Software is an accessory to compatible All Medicus meters, which use specific test principles.

Operating System requirements for the LinkDr 2.0 Diabetes Management Software are as follows: Windows XP, Windows Vista or Windows 7, 32 bit. The system requirements are as follows: (1) Microsoft Windows personal computer, (2) video monitor and adapter with at least 800 x 600 pixels and 256 colors, (3) USB port, (4) CD-ROM drive, (5) Pentium 4 2.4 GHz processor, (6) 256 MB minimum of free RAM, and (7) 300~500 MB minimum of free hard disk space before installation, 100MB after installation.

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The software provides the following features for the user:

- Transfers data from compatible All Medicus glucose meters to LinkDr 2.0 Diabetes Management Software via USB cable.
- Displays tables and charts for blood glucose data of registered members.
- Prompts registered members to login to access the software.
- Displays a preview page for printing the current page.
- Displays daily glucose readings in the Log book, meal block table and trend graph.
- Graphically displays the number of glucose values that fall above, below and within a specified target range.
- Displays the statistics report including trend chart and histogram.
- Calculates glucose averages and standard deviations in a statics table.
- Provides options to manage accounts of registered members.

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:

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 the applicant’s Hazard Analysis and software Documentation: Yes ☐ X or No ☐

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## 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 LinkDr 2.0 Diabetes Management Software is a PC-based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for effective diabetes management. It is intended for use as an accessory to compatible All Medicus brand blood glucose monitoring systems such as the GlucoDr Supersensor blood glucose meter, GlucoDr Plus blood glucose meter and GlucoDr auto blood glucose meter.

2. Special conditions for use statement(s): Over-the-counter use

## H. Substantial Equivalence Information:

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

LifeScan IN TOUCH® Diabetes Management Software (k984527)

2. Comparison with Predicate Device:

| Similarities and Differences | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate Device |
| | LinkDr 2.0 Data Management Software | LifeScan IN TOUCH® Diabetes Management Software (k984527) |

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| Intended Use | The LinkDr 2.0 Diabetes Management Software is a PC-based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for effective diabetes management. It is intended for use as an accessory to compatible All Medicus brand blood glucose monitoring systems such as the GlucoDr Supersensor blood glucose meter, GlucoDr Plus blood glucose meter and GlucoDr auto blood glucose meter. | Same |
| --- | --- | --- |
| Over-the-Counter | Yes | Same |
| Accessory to Glucose meter | Yes | Same |
| Intended user | Home Users/HCPs, single or multiple users | Same |
| Data Use | Data transferred from device cannot be changed or modified; manually entered data can be deleted or modified | Same |
| Setting target ranges | Yes | Same |
| Connectivity to Meter | USB Cable | Serial Cable |
| Manual Data Entry | Yes | Same |
| Logbook | Yes | Same |

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

ISO 14971 Medical Devices – Applications of Risk Management to Medical Devices 2007

J. Performance Characteristics:

1. The performance characteristics listed below as applicable, are presented in the specific glucose clearances under k050985, k082328, and k083628.

- Analytical Performance:
a) Accuracy:
See above statement under section J(1).
b) Precision/Reproducibility:
See above statement under section J(1).

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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 One hundred (100) lay and professional users with varying demographic characteristics (age, sex, and education level). The intent of the study was to verify software ease of use and label comprehension. Study participants also completed a questionnaire in response to whether the software, USB cable, and labeling are easy to use. The sponsor concluded that 100% of users were either somewhat satisfied or very satisfied with the software, USB cable, and user manual.

b) In an additional usability study with 20 lay users and 20 professional users, of various age, gender, educational background, and computer experience, software installation, connectivity and data transmission as intended to be used, was assessed and verified to achieve 100% accuracy for data transmission.

c) Bench Testing was performed on data from three meters for each meter type to test meter memory rollover and data transmission, this included full memory data transmission, plus additional data to validate correct data rollover in the app. All data fields were 100% accurate.

e) 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, architecture design chart, software design specification, traceability analysis, software development environment description, verification and validation testing, and revision level history. The sponsor reports that no unresolved anomalies are known to exist in the release version of the software.

f) The sponsor provided the results of a Flesch-Kincaid readability study which indicated a Grade Level Score of 7.3 for the LinkDr 2.0 Diabetes Management Software User Manual.

g) The sponsors provided the appropriate documentation certifying that electromagnetic testing (EMC) had been performed and the GP550 PC-Link Adaptor were found compliant (EN 61010-1, EN 61326-1).

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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.