(101 days)
Not Found
No
The document describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components or capabilities.
No
The device is a blood pressure monitor used for diagnostic purposes (measuring blood pressure and pulse rate), not for treating a condition.
No
Explanation: A diagnostic device is used to identify a disease, condition, or injury. This device measures blood pressure and pulse rate, which are physiological parameters, not diagnostic indicators themselves. While these measurements can contribute to a diagnosis, the device itself is for monitoring, not diagnosis. The "Intended Use" states it is "intended to measure" and does not claim diagnostic capabilities.
No
The device description explicitly states it is a "handheld device" and connects to a "blood pressure cuff," indicating it includes hardware components beyond just software.
Based on the provided information, the MD200A Blood Pressure Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device measures blood pressure and pulse rate via a non-invasive technique using a cuff wrapped around the upper arm. This is a physiological measurement taken directly from the body, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The description reinforces that it's a handheld device connected to a cuff for non-invasive measurement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MD200A Blood Pressure Monitor does not fit this definition.
N/A
Intended Use / 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.
Product codes
DXN
Device Description
MD200A Blood Pressure Monitor is a handheld device, which can connected to the blood pressure cuff with various specifications, intended for measuring the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
upper arm
Indicated Patient Age Range
adult, pediatric and neonatal
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing including clinical and bench testing was conducted to validate and verify that the proposed device, MD200A Blood Pressure Monitor met all design specifications and was substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
0
Attachment 1 510(k) Summary
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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Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized emblem, possibly representing a symbol of health or human services. The emblem consists of three abstract figures that are connected.
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 (800) 638-2041 or (301) 796-7100 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)
Page 1 of _1
(Division/Sign-Off)
Division of Cardiovascular Devices
1 0(k) Number