(163 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related technologies, and the device description is not provided.
No
The device is a monitor for measuring blood pressure and pulse rate; it does not provide any therapy or treatment.
Yes
The device is described as a "wrist pressure monitor" intended for "noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate." This involves measuring physiological parameters to provide information relevant to a health condition (hypertension), which aligns with the definition of a diagnostic device.
No
The device is described as a "wrist pressure monitor," which strongly implies a hardware component for measuring blood pressure. The summary does not mention it being software-only.
Based on the provided information, the MW-300 series wrist pressure monitor 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 MW-300 series wrist pressure monitor measures blood pressure and pulse rate non-invasively from the wrist. It does not analyze samples taken from the body.
Therefore, this device falls under the category of a non-invasive medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The model MW-300 series wrist pressure monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.
Product codes
DXN
Device Description
Wrist Digital Blood Pressure Monitor (Digital Sphygmomanometer), Model MW-300 Series
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Wrist
Indicated Patient Age Range
adults
Intended User / Care Setting
home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures, rendered in black. The overall design is simple and conveys the official nature of the organization.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 2004
Hangzhou Hua'an Medical & Health Instruments Co., Ltd. c/o Mr. Ji Bo Manager Building 2, Baimiao Industrial Park Economic Development Zone Wuchang Hangzhou, Zheijiang 310023 CHINA
Re: K041693
Trade Name: Wrist Digital Blood Pressure Monitor (Digital Sphygmomanometer) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: October 20, 2004 Received: October 22, 2004
Dear Mr. Bo:
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 such additional controls. Existing major regulations affecting your device can may or daysee Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Ji Bo
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised mat 1 Dris issualles complies with other requirements of the Act that I Dri has made a devel regulations administered by other Federal agencies. You must of ally I coleral statutes and regulations and limited to: registration and listing (21 Comply with an the Act 3 requirements, 01); good manufacturing practice requirements as set CFN in the quality systems (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Section your device as described in your Section 510(k) I mis icher wif anow you to ough inding of substantial equivalence of your device to a legally premarket notification: "The PDF intems sification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acries 101) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. INhisoranums of reference to promresponsibilities under the Act may be obtained from the Other general information on your respectional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bhimiman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Wrist digital blood pressure monitor (Digital Sphygmomanometer), Device Name: Model MW-300 Series
Indications For Use:
The model MW-300 series wrist pressure monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B.A.mmelar
510íki Number
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