BROADMASTER HEALTHCARE SYSTEM

K130621 · Broadmaster Biotech Corporation · NBW · Jul 30, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130621
• Device Name: BROADMASTER HEALTHCARE SYSTEM
• Applicant: Broadmaster Biotech Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The BroadMaster HealthCare System is a software accessory compatible with legally marketed BroadMaster Biotech glucose meters, such as the Glucose Shepherd Blood Glucose Monitoring System and ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose Monitoring System and is intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The BroadMaster HealthCare System receives via USB, stores, and uses patient data for display and reporting, sets meter date, time and alarm. The software is designed for multiple users use and only compatible with personal computer. It's not compatible with other devices such as PDAs or smartphones.

Device Story

BroadMaster HealthCare System is PC-based software for diabetes management; collects raw blood glucose data via USB from compatible BroadMaster Biotech glucose meters; stores data in local database under user profiles; transforms raw data into trend graphs and reports; exports data to .csv files; allows configuration of meter date, time, and alarms; used by patients in home settings; provides visual data representation to assist in diabetes management decisions.

Clinical Evidence

Bench testing verified data upload accuracy (100%) and meter memory rollover across Windows XP, Vista, and 7. Human factors study (n=36, ages 48-88) evaluated software installation, data syncing, transmission, and report generation. Participant-generated reports matched stored meter data in 100% of cases. Usability survey (14 items) yielded average response rate of 3.86 (>3 criterion).

Technological Characteristics

PC-based software; requires USB connectivity to compatible glucose meters. Compatible with Windows XP, Vista, and 7. Minimum requirements: 1GHz Pentium processor, 256MB RAM, 600MB hard drive space, 1024x768 resolution. Standards: IEC 601-1-4, IEC 60601-1-4, IEC 62304, ISO 13485:2009.

Indications for Use

Indicated for people with diabetes in the home setting to aid in review, analysis, and evaluation of patient data to support diabetes management.

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

• Clever Check Health System Software (k070941)

Submission Summary (Full Text)

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### 510(k) Summary (Per 21 CFR 807.92)

### JUL 3 0 2013

#### 1. Submitter Information

| Company Name | BroadMaster Biotech Corporation | |
|----------------|-----------------------------------------------------------------------------------------------|--|
| Address | 7F, NO. 168-1, NO. 168-2, Liancheng Rd., Zhonghe<br>Dist, New Taipei City 235, Taiwan (R.O.C) | |
| Contact Person | Roger Lai/Rosa Chen | |
| Phone | 886-987-111105/886-2-66375859 | |
| Fax | 886-2-22428332 | |
| Email | [e-mail]<br>[e-mail] | |
| Date Prepared | 2013/1/18 | |

#### 2. Device Name

| Proprietary Name | BroadMaster HealthCare System |
|-----------------------|---------------------------------------------------------------------------------------------------------------|
| Common Name | BroadMaster HealthCare System |
| Classification Number | System, Test, Blood Glucose, Over the Counter<br>Calculator/data processing module, for clinical use |
| Classification Panel | 75, Clinical Chemistry |
| Product Code | NBW, JQP |
| Regulation Number | 21 CFR 862.1345 Glucose Test System<br>21 CFR 862.2100 Calculator/data processing module<br>for clinical use. |

#### 3. Predicate Device

Proprietary Name Common Name Manufacturer 510(k) Number

Clever Check Health System Software Clever Check Health System Software TaiDoc Technology Corporation k070941

#### 4. Device Description

The BroadMaster HealthCare System is a software designed to collect user glucose raw data, analyze results with easy-to-read trend graphs and save glucose raw data to .csv file for report. This system is very easy and friendly to use, even if user has a little computer experience. The BroadMaster HealthCare System Software works with its own behind-the-scene database to store glucose raw data from the glucose device. Glucose raw data downloaded to the software system are

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stored under the user profile that was selected before the download. In short, the BroadMaster HealthCare System will help user to store the blood glucose device readings, analyze results with easy-to-read trend graphs, and save glucose raw data to .csv file for report.

#### 5. Intended Use

The BroadMaster HealthCare System is a software accessory compatible with legally marketed BroadMaster Biotech glucose meters, such as the Glucose Shepherd Blood Glucose Monitoring System and ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System and is intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The BroadMaster HealthCare System receives via USB, stores, and uses patient data for display and reporting, sets meter date, time and alarm. The software is designed for multiple users use and only compatible with personal computer. It's not compatible with other devices such as PDAs or smartphones.

#### 6. Comparison to Predicate Device

| Items | BroadMaster HealthCare<br>System Software | Clever Check Health<br>System Software |
|---------------------------|-------------------------------------------|----------------------------------------|
| 510(k) number | k130621 | k070941 |
| Personal Information | V | V |
| Current User | V | V |
| New User | V | V |
| Delete User | V | V |
| Download Glucose Raw Data | V | V |
| Show Glucose Raw Data | V | V |
| Export .csv file | V | V |
| Trend Graph | V | V |
| Print Trend Graph | V | V |
| Print Glucose Raw Data | V | V |
| PC Reminder | V | V |
| Set Device Time | V | V |
| Set Device Alarm Time | V | V |
| Delete Device Memory | | V |

Table 1 Software function Comparison

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| Instrument Settings | | V |
|------------------------|---|---|
| Software Settings | | V |
| Help button | | V |
| Maximum screen button | V | |
| Minimize screen button | V | V |
| Close button | V | V |

#### Table 2 Similarities and Differences

| | Similarities | |
|---------------------|-----------------------------------------------------------------------|----------------------------|
| Item | Device | Predicate |
| Intended Use | Same intended use | Same intended use |
| Data Use | Data transferred from the<br>device cannot be changed or<br>modified. | Same |
| | Differences | |
| Meter Compatibility | For use with BroadMaster<br>Biotech Corp. meters | For use with TaiDoc meters |
| Software function | See Table 1 | See Table 1 |

#### 7. Performance Studies

The performance of the BroadMaster HealthCare System Software was studied in the laboratory settings. The studies have demonstrated that this system meets the performance requirements of its intended use.

#### 8. User Studies

The user studies of the BroadMaster HealthCare System Software indicate that BroadMaster Healthcare System Software is not difficult to be operated by lay-users.

#### 9. Conclusion

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

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### DEPARTMENT OF HEALTII & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 30, 2013

BroadMaster Biotech Corporation C/O Roger Lai 7F, No. 168-1, No.168-2, Liancheng Rd., Zhonghe Dist. New Taipei City 23553, Taiwan (R.O.C.)

Rc: K130621

Trade/Device Name: BroadMaster HealthCarc system Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JQP Dated: June 04, 2013 Received: June 28, 2013

Dear Mr. Lai:

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, Or 10 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, fisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and its warranties. We remind you, however, that device labeling must be truthful and not midlers

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, Paris 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. Your must comply with all the Act's requirements, including, but not limited to: registration and liating (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.lda.gov/AboutFDA/CentersOfTices/CDRH/CDRHOffices/ucm1 115809.html for

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Page 2-Mr. Lai

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.lda.gov/McdicalDevices/Safcty/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 ofre number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Courtney H. Lias, Ph.D.

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 Form

510(k) Number (if known): k130621

Device Name: The BroadMaster HealthCare System

Indications for Use:

The BroadMaster HealthCare System is a software accessory compatible with legally marketed BroadMaster Biotech glucose meters, such as the Glucose Shepherd Blood Glucose Monitoring System and ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System and is intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The BroadMaster HealthCare System receives via USB, stores, and uses patient data for display and reporting, sets meter date, time and alarm. The software is designed for multiple users use and only compatible with personal computer. It's not compatible with other devices such as PDAs or smartphones.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ / 165chption 080 _____________________________________________________________________________________________________________________________________________________________ AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

# Katherine Serrano -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health 510(k) k130621

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