BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM

K112647 · Wistron Corporation · DXN · Nov 22, 2011 · Cardiovascular

Device Facts

• Record ID: K112647
• Device Name: BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM
• Applicant: Wistron Corporation
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

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

Device Story

BestShape Blood Pressure Monitoring System uses oscillometric method to measure systolic/diastolic blood pressure and pulse rate; utilizes inflatable wrist cuff. Operated by patients at home or clinicians in clinical settings. Device includes USB port for data transmission to PC; compatible with Health Care Software System (K1109428) for result review. Output provides blood pressure and pulse readings to user/clinician to assist in monitoring cardiovascular health.

Clinical Evidence

Bench testing only. Device validated per IEC 80601-2-30:2009 and ANSI/AAMI/ISO 81060-2:2009. Electrical safety and EMC testing performed per IEC/EN 60601-1 and IEC/EN 60601-1-2. Biocompatibility of wrist cuff materials verified per ISO 10993-5 and 10993-10. Software validation confirmed functional system performance.

Technological Characteristics

Oscillometric measurement principle. Wrist cuff materials compliant with ISO 10993-5/10. Electrical safety per IEC/EN 60601-1; EMC per IEC/EN 60601-1-2. Connectivity via USB port for PC data transfer. Software-based algorithm for pressure/pulse calculation.

Indications for Use

Indicated for non-invasive blood pressure and pulse rate measurement in adults over 18 years of age. Intended for home and clinical use. Contraindicated for newborns and not for hypertension diagnosis or screening.

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

• CLEVER TD-3018ATM Blood Pressure Monitor (K051703)

Reference Devices

• Health Care Software System (K1109428)

Submission Summary (Full Text)

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# NOV 2 2 2011

# K112647

#### Page 1-of-3

### 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

Common Names Product Code Classification Panel Regulations

3. 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

([phone] ext.1176 ([phone] [e-mail] September 5, 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]

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 [phone] or [phone] 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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