(71 days)
K1109428
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components or capabilities.
No
The device is used for measuring blood pressure, and there is no indication that it provides therapy or treatment. Its stated purpose is measurement.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The device is not to be used for the diagnosis or screening of hypertension or for testing on newborns." While it measures blood pressure, which can be an indicator, the device's intended use specifically excludes diagnostic purposes.
No
The device description explicitly states it uses an "inflatable wrist cuff" and the performance studies mention testing for "electrical safety, EMC and biocompatibility," which are associated with hardware components, not software-only devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BestShape system measures blood pressure non-invasively using a wrist cuff. This is a physical measurement taken directly from the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is to measure blood pressure, not to analyze a biological sample for diagnostic purposes.
- Lack of Biological Sample Analysis: The description does not mention the collection or analysis of any biological samples.
Therefore, the BestShape Blood Pressure Monitoring System falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BestShape system is a system designed to measure blood pressure non-invasively. It is intended for use at home and in clinical settings. The measurement position of the device is the wrist of the subject. This system should be used for the testing on people over age of 18.
The device is not to be used for the diagnosis or screening of hypertension or for testing on newborns
Product codes
DXN
Device Description
The BestShape Blood Pressure Monitoring System uses the oscillometric method to measure the systolic, diastolic blood pressure and pulse rate with an inflatable wrist cuff on adults.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
over age of 18
Intended User / Care Setting
home and in 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)
The Best Shape Blood Pressure Monitoring System was validated by the tests according to IEC80601-2-30:2009 and met the requirements of ANSI/AAMI/ISO 81060-2:2009.
Software validation was performed to verify and validate the system works functionally.
Testing performed also included electrical safety, EMC and biocompatibility. The proposed device met the requirements of IEC/EN 60601-1 and IEC/EN 60601-1-2. The materials of wrist cuff met the requirements of ISO 10993-5 and 10993-10.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K1109428
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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NOV 2 2 2011
K112647
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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
Common Names Product Code Classification Panel Regulations
- Predicate Device Trade/Proprietary Name: Common/Usual Name: Submitter 510 (k) Number
Teling Hsu 3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 24888, Taiwan
(+886-2) 6625-8188 ext.1176 (+886-2) 6625-0288 teling.hsu@taidoc.com.tw September 5, 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
BestShape Blood Pressure Monitoring System Blood pressure test system DXN Cardiovascular Class II, 21 CFR 870.1130
CLEVER TD-3018ATM Blood Pressure Monitor Blood pressure test system TaiDoc Technology Corporation K051703
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K112647
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4. Device Description
The BestShape Blood Pressure Monitoring System uses the oscillometric method to measure the systolic, diastolic blood pressure and pulse rate with an inflatable wrist cuff on adults.
5. Intended Use
The BestShape system is a system designed to measure blood pressure non-invasively. It is intended for use at home and in clinical settings. The measurement position of the device is the wrist of the subject. This system should be used for the testing on people over age of 18.
The device is not to be used for the diagnosis or screening of hypertension or for testing on newborns
6. Comparison to Predicate Device
The BestShape Blood Pressure Monitoring System and the predicate device both use the oscillometric method within the software algorithm to determine the systolic, diastolic blood pressure and pulse rate with an inflatable wrist cuff.
The major difference between the two devices is the physical appearance of device including outer casing design, printing and buttons. The minor software change has added the data transmission function with USB data port which connects the device and Personal Computer. User may use the compatible software program, the Health Care Software System (cleared under: K1109428), and review the test results on Personal Computer.
7. Performance Studies
The Best Shape Blood Pressure Monitoring System was validated by the tests according to IEC80601-2-30:2009 and met the requirements of ANSI/AAMI/ISO 81060-2:2009.
Software validation was performed to verify and validate the system works functionally.
Testing performed also included electrical safety, EMC and biocompatibility. The proposed device met the requirements of IEC/EN 60601-1 and IEC/EN 60601-1-2. The
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KII2647
materials of wrist cuff met the requirements of ISO 10993-5 and 10993-10.
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8. Conclusion
The BestShape Blood Pressure Monitoring System demonstrates the safety and effectiveness for its intended use and it is substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 2 2 2011
Wistron Corporation c/o Mr. Teling Hsu Regulatory Affairs Specialist TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City Taiwan, 24888
Re: K112647
Trade/Device Name: Bestshape blood pressure monitoring system (model TD-3028) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: September 5, 2011 Received: September 12, 2011
Dear Mr. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 - Mr. 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/ucm115809.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/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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address 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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Indications for Use
510(k) Number: K112647
Device Name: BestShape Blood Pressure Monitoring System
Indications for Use:
The BestShape system is a system designed to measure blood pressure non-invasively. It is intended for use at home and in clinical settings. The measurement position of the device is the wrist of the subject. This system should be used for the testing on people over age of 18.
The device is not to be used for the diagnosis or screening of hypertension or for testing on newborns
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 Device Evaluation (ODE)
Division Sign-Off Office of Device Evaluation (ODE) 510(k)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K112647
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