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

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.

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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K130657

## 510(k) Summary

· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

JUL 1 5 2013

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

05/13/2013 Date: ________________________________________________________________________________________________________________________________________________________________________

#### Submitter: 1.

| Name: | Allmedicus Co., Ltd,<br>No. 7608 Dongil-techno town 7th,<br>823 Gwanyang 2-dong, Dongan-gu<br>Anyang, Gyeonggi-do, Republic of Korea 431-062 |
|----------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ha, Chun-hwa<br>Tel : [phone]<br>Fax : [phone] |

#### Submission Correspondent: 2.

Priscilla Chung LK Consulting Group USA, Inc. 1515 E. Katella Ave. Unit 2115, Anaheim, CA 92805 Phone: [phone] Fax: [phone] Email: [e-mail]

#### 3. Device:

| Proprietary Name: | LinkDr 2.0 Diabetes Management Software |
|------------------------------|------------------------------------------------------|
| Common Name: | Data Management Software |
| | Glucose test system |
| Classification Name: | Calculator / Data processing module for clinical use |
| Classification: | Class II, 21CFR 862.1345<br>21CFR 862.2110 |
| Classification Product Code: | NBW, JQP |

#### Predicate Device: 4.

IN TOUCH® Diabetes Management Software (k984527) by LIFESCAN, INC.

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#### Device Description: 5.

The LinkDr 2.0 Diabetes Management Software is optional data management software for use with All Medicus brand blood glucose meters: GlucoDr Supersensor(K050985), GlucoDr Plus(K082328), and GlucoDr auto(K083628). The subject device consists of a LinkDr USB cable and software (provided in a CD). The LinkDr 2.0 Diabetes Management Software allows the transfer of data from the mentioned blood glucose meters to a personal computer (PC) for enhanced data management using graphic displays and analysis tools.

#### Intended Use: 6.

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.

#### Performance Data(Non-Clinical): 7.

All Medicus Co, Ltd. conducted bench testing to demonstrate data accuracy transmission for each meter. Meter flags/functions were tested such as control solution, post- meal, pre-meal, exercise and stress to verify the information properly downloads from the meters to the data management software. Memory data rollover was also tested by adding five (5) data points to meters that were pre-loaded with full memory. Test results show that all glucose values, flags, data, and time properly downloaded from the meters to the software. Memory data rollover also functioned properly where the new glucose values replaced the oldest glucose values.

In addition, a study intended to assess personal lay users and professional healthcare users in the setup and use of the LinkDr 2.0 Diabetes Management Software was conducted. Overall, they rated the LinkDr 2.0 Diabetes Management Software at 100% for overall program as easy or somewhat easy. There were no users that rated the software program as somewhat difficult or difficult. 100% of them also responded that they are satisfied with the LinkDr 2.0 Diabetes Management Software and its manual.

The study results supports that the LinkDr 2.0 Diabetes Management Software is effective and provides accurate data management system as other predicate devices in the market.

#### Substantial Equivalence 8.

Both management software programs can be described as follows:

- have the same intended use
- an optional software accessory for use with blood glucose monitors with data management capability.
- data transferred from the meter cannot be hanged or modified in any way.

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.' • •

There are some minor differences between the subject device and the predicate device in transmission port, software operation options, settings and some other features, but it does not constitute a new intended use. Despite the differences, the validation testing results presented in this 510K supports that the LinkDr 2.0 Diabetes Management Software is safe and effective as the predicate device.

#### Conclusion: 9.

Based on the testing results, All Medicus Co, Ltd concludes that the LinkDr 2.0 Diabetes Management Software is safe and effective also, substantially equivalent to predicate device, LifeScan IN TOUCH® Diabetes Management Software (k984527).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by a staff with two snakes entwined around it, topped with a symbol that resembles a stylized flame or torch.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Conter - WO66-G609 Silver Spring, MD 20993-0002

July 15, 2013

All Medicus Co., Ltd. c/o Priscilla Chung c/o LK Consulting Group USA, Inc. 1515 E. Katella Ave., Unit 2115 ANAHEIM CA 92805

Re: K130657

Trade/Device Name: LinkDr 2.0 Diabetes Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JQP Dated: May 28, 2013 Received: June 4, 2013

Dear Ms. Chung:

We have reviewed your Section 510(k) promarket 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 10 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Chung

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number: K130657

Device Name: LinkDr 2.0 Diabetes Management Software

Indication 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.

Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Devices and Radiological Health (OIR)

Katherine Serrano -S :

Division Sign-Off Office of In Vitro Devices and Radiological Health

510(k) k130657

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