BLOOD PRESSURE MONITOR, MODEL MD200A

K093013 · Beijing Choice Electronic Technololgy Co., Ltd. · DXN · Jan 8, 2010 · Cardiovascular

Device Facts

• Record ID: K093013
• Device Name: BLOOD PRESSURE MONITOR, MODEL MD200A
• Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

MD200A Blood Pressure Monitor is an automatic electronic blood pressure monitor intended to measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.

Device Story

Handheld automatic electronic blood pressure monitor; utilizes non-invasive oscillometric technique via inflatable upper arm cuff. Device measures systolic, diastolic, mean blood pressure, and pulse rate. Intended for use on adult, pediatric, and neonatal patients. Operates by inflating cuff, sensing pressure oscillations, and processing signals to derive blood pressure and pulse values. Output displayed to user for clinical assessment. Used in clinical or home settings.

Clinical Evidence

Performance validated through clinical and bench testing to verify design specifications and substantial equivalence to the predicate device.

Technological Characteristics

Handheld electronic monitor; non-invasive oscillometric sensing; inflatable upper arm cuff; automatic operation. Technical specifications and materials not detailed beyond general electronic blood pressure monitor classification.

Indications for Use

Indicated for measurement of systolic, diastolic, mean blood pressure, and pulse rate in adult, pediatric, and neonatal populations using non-invasive oscillometric technique via upper arm cuff.

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

• Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K082881)

Submission Summary (Full Text)

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Attachment 1 510(k) Summary

K093013

This 510(k) Summary is prepared per the request of 21 CFR 807.92.

The assigned 510(k) Number is K093013

JAN - 8 2010

Date of Preparation December 22, 2009 Sponsor Beijing Choice Electronic Technology Co., Ltd Bailangyuan Bldg B 1127-1128, Fuxing road, A36, Beijing, 100039, China Contact Person: Mr. Lei Chen; Correspondent Ms. Diana Hong / Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 5D, No.19, Lane 999, Zhongshan Road (S-2), Shanghai, 200030, China Proposed Device Blood Pressure Monitor, MD 200A System, Measurement, Blood-pressure, Non-invasive Classification DXN, 870.1130, Class II MD200A Blood Pressure Monitor is an automatic electronic blood pressure monitor intended to Intended Use measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals. MD200A Blood Pressure Monitor is a handheld device, which can connected to the blood pressure Device Description cuff with various specifications, intended for measuring the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique. Performance testing including clinical and bench testing was conducted to validate and verify that Testing the proposed device, MD200A Blood Pressure Monitor met all design specifications and was substantially equivalent to the predicate device. Predicate Device Microlife Upper Arm Automatic Digital Blood Pressure Monitor, K082881 The proposed device, MD200A Blood Pressure Monitor is substantially equivalent (SE) to the SE Conclusion predicate device, Microlife Upper Arm Automatic Digital Blood Pressure Monitor, K082881.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JAN - 8 2010

Beijing Choice Electronic Technology Co., Ltd c/o Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 5D, No. 19, Lane 999, Zhongshan Road Shanghai 200030 CHINA

Re: K093013

Trade/Device Name: MD200A Blood Pressure Monitor Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: December 22, 2009

Received: December 24, 2009

Dear Mr. Fu:

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 - Mr. Lee Fu

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bran

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 II Indication for Use Form

510(k) Number: K093013 Device Name: MD200A Blood Pressure Monitor

Indications for Use:

MD200A Blood Pressure Monitor is an automatic electronic blood pressure monitor intended to measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over -The-Counter Use

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Cardiovascular Devices

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