HEALTHTRACKER

K110770 · Wistron Corporation · DXN · Nov 16, 2011 · Cardiovascular

Device Facts

• Record ID: K110770
• Device Name: HEALTHTRACKER
• Applicant: Wistron Corporation
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

HealthTracker is a software accessory for the BestShape Blood Pressure Monitoring System; transfers blood pressure measurement data from device memory to a personal computer or Health Vault via cable connection. Used in home and clinical settings by patients and healthcare professionals; enables review, analysis, and management of historical results. Software does not modify or change transferred data; provides data management capabilities to assist in clinical decision-making and patient monitoring.

Clinical Evidence

No clinical data. Bench testing and software validation were performed to verify functional performance.

Technological Characteristics

Software accessory; operates on personal computers; utilizes cable-based data transmission; compatible with BestShape Blood Pressure Monitoring System; data management functionality.

Indications for Use

Indicated for users of the BestShape Blood Pressure Monitoring System in home or clinical settings to review, analyze, and manage historical blood pressure data.

Regulatory Classification

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.

Predicate Devices

• TaiDoc Technology Corporation (K070941)

Submission Summary (Full Text)

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# KII0770

NOV 16 2011

## Attachment A2

## 510(k) Summary

1. Submitter Information Application Correspondent Contact person Address

Phone FAX E-mail Date Prepared

Applicant Contact person Company Name Address

Phone FAX E-mail

2. Name of Device Trade/Proprietary Name Product Code Classification Panel Regulations

3. 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 ([phone] ext.1176 ([phone] [e-mail] March 4, 2011

Brian Chong Wistron Corporation 21F, No. 88, Sec.1, Hsin Tai Wu Rd., Hsichih, New Taipei City 221, Taiwan ([phone] ([phone] brian [e-mail]

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 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.

#### 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 [phone] or [phone] 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,

f

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)

İ

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

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