(71 days)
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No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components.
No
This device is a blood pressure monitor, which measures and monitors a physiological parameter. It does not provide any therapy or treatment.
Yes
The device measures systolic and diastolic blood pressure and heart rate, which are physiological parameters used to assess a patient's health status and aid in diagnosing conditions like hypertension.
No
The device description explicitly states "Rossmax Automatic Wristwatch Blood Pressure Monitor, model V46", indicating a hardware device (wristwatch blood pressure monitor) that uses the oscillometric method, which is a hardware-based measurement technique.
Based on the provided information, this device 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 description clearly states the device measures systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. This is a non-invasive measurement taken directly from the body, not a test performed on a sample outside the body.
Therefore, the Rossmax Automatic Wristwatch Blood Pressure Monitor, model V46, is a non-invasive medical device for measuring vital signs, not an in vitro diagnostic device.
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
DXN
Device Description
Rossmax Automax WristWatch Blood Pressure Monitor, model V46
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
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 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" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, featuring three curved lines.
DEC 2 9 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Yeh Managing Director Rossmax Intl. LTD. 5F. NO.6, Alley 20 Lane 106 Section 3, Nan Kang Road Taipei, Taiwan
Re: K993542 Rossmax Automax WristWatch Blood Pressure Monitor Regulatory Class: II Product Code: DXN Dated: December 13, 1999 Received: December 16, 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of The general controls provisions of the Act include the Act. 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 (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Please note: this response to your premarket 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 continue 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
for L. Bette R. Lempirle
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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ATTACHMENT 1
K 993542
Intl. LTD Kossmax
Indications for Use Statement
Rossmax Automatic Wristwatch Blood Pressure Monitor, model Device Names: V46
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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bura L. Kemperle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K993542 510(k) Number
Prescription Use_
or
Over-the-counter use