(15 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on standard oscillometric blood pressure measurement.
No.
The device is intended to measure blood pressure and heart rate, which is a diagnostic or monitoring function, not a therapeutic one. It does not actively treat, cure, mitigate, or prevent disease.
No
This device measures blood pressure and heart rate, which is a monitoring function, not a diagnostic one. While the measurements can be used by a healthcare professional for diagnosis, the device itself does not diagnose a condition.
No
The description explicitly states the device measures blood pressure and heart rate using the oscillometric method on the wrist. This method requires a physical cuff and pressure sensor, indicating a hardware component is necessary for the device's function. The lack of a "Device Description" section prevents confirmation of specific hardware details, but the measurement method itself implies hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device directly measures physiological parameters (blood pressure and heart rate) on the patient's wrist. It does not analyze any biological specimens.
Therefore, this device falls under the category of a non-IVD medical device, specifically a blood pressure monitor.
N/A
Intended Use / Indications for Use
To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.
Product codes
DPW
Device Description
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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
wrist
Indicated Patient Age Range
over 18 years
Intended User / Care Setting
Over-the-counter use
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
Not Found
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
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle with its wings spread.
AUG -3 1999
Mr. Michael Yeh Managing Director ROSSMAX International Ltd. 2F. No. 10, Alley 20 Lane 106 Section 3, Nan Kang Road TAIPEI , CHINA (TAIWAN)
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re : K992387 ROSSMAX Automatic Wristwatch Blood Pressure Monitor, Model RM-4100 Requlatory Class: II (TWO) Product Code: DPW Dated: July 16, 1999 Received: July 19, 1999
Dear Mr. Yeh:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act), 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Michael Yeh
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Call han, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 1
Indications for Use Statement
ROSSMAX Automatic Wristwatch Blood Pressure Monitor, Device Names: model RM-4100
To measure systolic and diastolic blood pressure and heart rate on Indications For Use: the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
or
Over-the-counter use__