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 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 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.

AI/ML Overview

The provided text describes a software device, the BroadMaster HealthCare System, an accessory to glucose meters. The document asserts that the device meets performance requirements but does not provide specific acceptance criteria or detailed results from a study proving these criteria are met.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "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."

However, no specific acceptance criteria (e.g., accuracy metrics, specific thresholds for data integrity, speed of processing, or reliability measures) are listed, nor are any quantitative performance results reported. Therefore, such a table cannot be constructed from the provided text.

2. Sample Size for the Test Set and Data Provenance:

The document mentions "laboratory settings" for performance studies. However, it does not specify the sample size used for any test set or the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

The document describes a software system that processes glucose meter data. In this context, "ground truth" would likely refer to the accuracy of the glucose meter readings themselves or the correct interpretation of data for display and reporting. The text does not mention the use of any human experts to establish ground truth for the test set, nor does it detail their qualifications.

4. Adjudication Method for the Test Set:

Given that there's no mention of experts establishing ground truth, there is no information provided on any adjudication method (e.g., 2+1, 3+1, none) for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The BroadMaster HealthCare System is a data management and analysis software for glucose readings. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or complex data with and without AI assistance. Therefore, it is highly unlikely that an MRMC comparative effectiveness study was done, and the document does not report any such study or effect size related to human reader improvement with AI assistance.

6. Standalone Performance Study:

The document states, "The performance of the BroadMaster HealthCare System Software was studied in the laboratory settings." This implies a standalone study of the algorithm's performance in processing and presenting data. However, no specific performance metrics or outcomes of such a study are provided beyond the general statement that it "meets the performance requirements."

7. Type of Ground Truth Used:

For a system that handles glucose data, the "ground truth" would be the actual glucose readings from the connected meters, and the software's ability to accurately store, display, and report these values. The document does not explicitly state how this "ground truth" was established, but it implicitly relies on the accuracy of the legally marketed glucose meters it interfaces with. It is not expert consensus, pathology, or outcomes data in the usual sense.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. This type of software, performing data storage, display, and basic trend analysis, is typically rule-based or uses standard data processing algorithms rather than machine learning that requires large training datasets.

9. How the Ground Truth for the Training Set Was Established:

As there's no mention of a training set, there's no information provided on how ground truth for a training set was established.

Summary of Missing Information:

The provided document offers a high-level overview of the BroadMaster HealthCare System and its intended use but lacks specific technical details regarding its performance studies, including:

Quantitative acceptance criteria.
Actual performance results against these criteria.
Sample sizes of test and training data.
Methods for establishing ground truth or expert involvement.
Details on study design (e.g., retrospective/prospective).
Any mention of AI, MRMC studies, or specific standalone performance metrics beyond a general statement of compliance.

Summary

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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., ZhongheDist, 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	roger@broadmaster-biotech.com rosa@broadmaster-biotech.com
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 CounterCalculator/data processing module, for clinical use
Classification Panel	75, Clinical Chemistry
Product Code	NBW, JQP
Regulation Number	21 CFR 862.1345 Glucose Test System21 CFR 862.2100 Calculator/data processing modulefor 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

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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

6. Comparison to Predicate Device

Items	BroadMaster HealthCareSystem Software	Clever Check HealthSystem 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 thedevice cannot be changed ormodified.	Same
	Differences
Meter Compatibility	For use with BroadMasterBiotech 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 (800) 638-2041 or (301) 796-7100 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:

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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Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.