(243 days)
Not Found
No
The description focuses on data transfer and management, with no mention of AI/ML terms or functionalities like analysis beyond simple review.
No.
The HealthTracker is a software accessory that aids in reviewing, analyzing, and managing historical blood pressure results, but it does not treat or prevent any medical condition.
No
Explanation: The device is a software accessory that transfers and manages historical blood pressure data. It is intended as an aid for reviewing, analyzing, and managing results, not for diagnosing conditions or generating diagnostic interpretations.
Yes
The device is described as an "optional software accessory" that transfers data and manages information on a computer. While it interacts with a blood pressure monitor, the device itself is explicitly defined as software.
Based on the provided information, the HealthTracker software is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The HealthTracker software's intended use and device description clearly state that it is used to transfer and manage data from a blood pressure monitor. It does not interact with or analyze any biological specimens (like blood, urine, etc.).
- The function is data management and review. The software's purpose is to help users and healthcare professionals review, analyze, and manage historical blood pressure results. This is a data management function, not a diagnostic test performed on a specimen.
The HealthTracker is a software accessory for a medical device (blood pressure monitor) that facilitates data handling and review. It does not perform any diagnostic testing itself.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and clinical settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk analysis and software validation was performed to verify and validate the HealthTracker works functionally.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
. . ਾ ਕ
. .
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)
1
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.
2
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.
3
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,
f
Bram D. Zuckerman M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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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