(71 days)
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
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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: BestShape Blood Pressure Monitoring System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Standard | Reported Device Performance |
|---|---|
| IEC80601-2-30:2009 | Met the requirements |
| ANSI/AAMI/ISO 81060-2:2009 | Met the requirements |
| IEC/EN 60601-1 (Electrical Safety) | Met the requirements |
| IEC/EN 60601-1-2 (EMC) | Met the requirements |
| ISO 10993-5 (Biocompatibility - in vitro cytotoxicity) | Met the requirements |
| ISO 10993-10 (Biocompatibility - irritation and skin sensitization) | Met the requirements |
| Software Validation (functional) | Performed to verify and validate the system works functionally |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set used in the performance studies or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that the system "was validated by the tests according to IEC80601-2-30:2009 and met the requirements of ANSI/AAMI/ISO 81060-2:2009." These standards typically outline requirements for clinical validation, including population demographics and sample sizes, but the specific details for this device's study are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information regarding the number of experts or their qualifications used to establish ground truth for the test set. For blood pressure devices, ground truth is usually established through simultaneous measurements by a trained clinician using a calibrated sphygmomanometer, but this information is not explicitly stated.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or is not reported in this document. The device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was done. The entire premise of the submission is to demonstrate the safety and effectiveness of the device (BestShape Blood Pressure Monitoring System) itself, which operates autonomously to measure blood pressure. The performance studies detailed (adherence to IEC80601-2-30:2009 and ANSI/AAMI/ISO 81060-2:2009) are focused on the accuracy and reliability of the device's measurements.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. However, for blood pressure monitoring devices, the ground truth for validation against standards like IEC80601-2-30 and ANSI/AAMI/ISO 81060-2 is typically established through:
- Simultaneous auscultatory measurements by trained observers using a calibrated mercury or aneroid sphygmomanometer, or
- Invasive arterial pressure measurements in specific clinical scenarios (though less common for routine validation of consumer devices).
Given the context, it's highly probable that the ground truth was established by expert clinicians making simultaneous auscultatory measurements.
8. The Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This type of information is typically relevant for machine learning algorithms that require a distinct training phase. While the device utilizes an "oscillometric method within the software algorithm," the summary focuses on validation against established performance standards rather than detailing the internal development process of the algorithm's training.
9. How the Ground Truth for the Training Set Was Established
Since information about a specific "training set" is not provided, the document does not describe how its ground truth was established.
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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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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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§ 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).