The HealthTracker is a software accessory for use with a blood pressure monitor with data transmission capabilities. This software is able to transfer data from the device's memory to a computer.

The HealthTracker is intended for use at home and clinical settings as an aid for users and their healthcare professionals to review, analyze and manage the historical results.

The HealthTracker is intended for use with BestShape Blood Pressure Monitoring System.

Device Description

The HealthTracker is an optional software accessory for use with a blood pressure monitoring system with data management capabilities. The HealthTracker transfers data from the device's memory to a computer for enhanced data management.

The proposed software includes functions of managing personal account information on computer and data upload from blood pressure monitor to a personal computer or Health Vault.

The HealthTracker is for use with BestShape Blood Pressure Monitoring System. The HealthTracker can control BestShape Blood Pressure Monitoring System in its recording of blood pressure measurements and transmitting of the data to a computer with the subject software.

AI/ML Overview

The provided document describes the HealthTracker software, an accessory for blood pressure monitoring systems. However, it does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) for a diagnostic or AI-driven decision support tool.

The document primarily focuses on:

Device Description: The HealthTracker transfers blood pressure data from the monitor to a computer for management.
Intended Use: Aid users and healthcare professionals to review, analyze, and manage historical blood pressure results.
Comparison to Predicate Device: States both use cable connection and data cannot be modified.
Performance Studies: A generic statement that "Risk analysis and software validation was performed to verify and validate the HealthTracker works functionally."

Therefore, based solely on the provided text, I cannot generate a comprehensive table of acceptance criteria and reported device performance, nor can I provide information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The document does not describe a study in the sense of a clinical trial or performance evaluation with quantitative metrics.

Below is a response outlining what can be extracted or inferred and explicitly stating what cannot.

This document (K110770) describes the HealthTracker software, an accessory for blood pressure monitoring systems. The "Performance Studies" section states that "Risk analysis and software validation was performed to verify and validate the HealthTracker works functionally." This indicates that the validation focused on the software's functionality and safety, rather than a clinical performance study measuring diagnostic accuracy or clinical outcomes.

Given the nature of the device as a data transfer and management software, detailed performance metrics (like sensitivity, specificity, or AUC) typically associated with diagnostic AI systems are not relevant or reported in this submission. The acceptance criteria would likely be related to successful data transfer, data integrity, user interface functionality, and compliance with software design specifications.

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from "functional" validation)	Reported Device Performance (Inferred from "functional" validation)
Data Transfer	Successful transmission of blood pressure data from monitor to computer.	Verified to transfer data successfully.
Data Integrity	Data transferred without modification or corruption.	Data transferred cannot be changed or modified in any way.
Account Management	Ability to manage personal account information on the computer.	Works functionally for managing personal account information.
Compatibility	Works with BestShape Blood Pressure Monitoring System.	Intended for use with BestShape Blood Pressure Monitoring System.
Risk Management	Risks associated with software usage are identified and mitigated.	Risk analysis was performed.
Software Validation	Software meets its specifications and intended use.	Software validation was performed to verify functionality.

2. Sample size used for the test set and the data provenance:
Not specified in the provided document. The validation appears to be a functional software validation rather than a clinical test with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not specified. For a diagnostic or AI device, ground truth would refer to expert-verified diagnoses or pathology results. For this data transfer software, "ground truth" would relate to the correctness of data transfer and software functions, which would be verified by software testers and quality assurance personnel against requirements, rather than medical experts.

4. Adjudication method for the test set:
Not applicable/Not specified. Adjudication methods (like 2+1) are common in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. This is not described for this software validation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The HealthTracker is software for data management, not an AI-driven diagnostic or decision support tool that assists human readers in interpreting medical cases. No MRMC study was conducted or is relevant for this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not directly applicable in the typical sense of a diagnostic algorithm. The software's "standalone" function is to transfer and display data, which was validated functionally. Its performance is in data handling and display, not in making clinical determinations that would be compared to human performance.

7. The type of ground truth used:
For the software validation, the "ground truth" would be the predefined functional and performance requirements for the software (e.g., "data must transfer accurately," "interface must respond within X milliseconds," "all specified fields must be present after transfer"). Verification would compare the software's behavior against these requirements. It does not involve medical ground truth like pathology or expert consensus on patient conditions.

8. The sample size for the training set:
Not applicable. The HealthTracker is not an AI/machine learning device that requires a "training set" of data. It is a deterministic software for data transfer and management.

9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of software.

Summary

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KII0770

NOV 16 2011

Attachment A2

510(k) Summary

Submitter Information Application Correspondent Contact person Address

Phone FAX E-mail Date Prepared

Applicant Contact person Company Name Address

Phone FAX E-mail

Name of Device Trade/Proprietary Name Product Code Classification Panel Regulations
Predicate Device Trade/Proprietary Name: Common/Usual Name: Submitter 510 (k) Number

Teling Hsu 6F, No. 127, Wugong 2nd Rd., Wugu Township, Taipei County 24888, Taiwan (+886-2) 6625-8188 ext.1176 (+886-2) 6625-0288 teling.hsu@taidoc.com.tw March 4, 2011

Brian Chong Wistron Corporation 21F, No. 88, Sec.1, Hsin Tai Wu Rd., Hsichih, New Taipei City 221, Taiwan (+886-2) 6612-1344 (+886-2) 6612-2384 brian chong@wistron.com

HealthTracker DXN Cardiovascular Class II, 21 CFR 870.1130

Health Care System Software Blood pressure test system TaiDoc Technology Corporation K070941

SHERRY(商雅珍)

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4. Device Description

The proposed software includes functions of managing personal account information on computer and data upload from blood pressure monitor to a personal computer or Health Vault.

5. Intended Use

The HealthTracker is a software accessory for use with a blood pressure monitor with data transmission capabilities. This software is able to transfer data from the device's memory to a computer.

The HealthTracker is intended for use at home and clinical settings as an aid for users and their healthcare professionals to review, analyze and manage the historical results.

The HealthTracker is intended for use with BestShape Blood Pressure Monitoring System.

6. Comparison to Predicate Device

The HealthTracker and the predicate device both use the cable connection to the personal computer and the data transferred from the device cannot be changed or modified in any way.

7. Performance Studies

Risk analysis and software validation was performed to verify and validate the HealthTracker works functionally.

8. Conclusion

The HealthTracker software is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

NOV 1 6 2011

Winstron Corporation c/o Ms. Teling Hsu TaiDoc Technology Corporation 6th Floor, No. 127, Wugong 2nd Road Wugu Township, Taipei County 24888 TAIWAN

Re: K110770

Trade/Device Names: HealthTracker Version 1.4.3.0 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: September 27, 2011 Received: October 17, 2011

Dear Ms. Hsu:

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, 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.

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.

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Page 2 - Ms. Teling Hsu

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 (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.

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/ucm1.15809.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/ReportaProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

Sincerely yours,

Bram D. Zuckerman M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment A1

Indications for Use

510(k) Number: K110770

Device Name: HealthTracker

Indications for Use:

The HealthTracker is a software accessory for use with a blood pressure monitor with data transmission capabilities. This software is able to transfer data from the device's memory to a computer.

The HealthTracker is intended for use at home and clinical settings as an aid for users and their healthcare professionals to review, analyze and manage the historical results.

The HealthTracker is intended for use with BestShape Blood Pressure Monitoring System.

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

Over the Counter Use _ X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K110270

Page 1 of 1

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).