(603 days)
Not Found
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and lacks any mention of AI, ML, image processing, or data training/testing, which are typical indicators of AI/ML integration.
No.
The device measures blood pressure and heart rate, which are diagnostic functions, not therapeutic.
Yes
The device measures systolic and diastolic blood pressure, which are vital signs used in diagnosing medical conditions related to cardiovascular health.
No
The summary describes a device that measures blood pressure using the oscillometric method at the wrist. This method inherently requires hardware components (like a cuff and pressure sensor) to function, even if controlled by software. The lack of a "Device Description" section prevents confirmation, but the described function strongly implies hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure blood pressure and heart rate from the wrist using the oscillometric method. This is a physiological measurement taken directly from the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
This device does not involve the analysis of specimens taken from the body. It directly measures a physiological parameter (blood pressure and heart rate) on the patient.
N/A
Intended Use / Indications for Use
To measure systolic and diastolic blood pressure and heart rate of the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between of 5.3 to 7.7 inches.
Product codes
DXN
Device Description
Rossmax RM 4000 Wristwatch Blood Pressure Monitor
Mentions image processing
Not Found
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
Not Found
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
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
§ 870.1130 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).
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care.
JUN 11 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Yeh President Rossmax International, Ltd. 2F., No.8, Alley 20 Lane 106 Section 3, Nan Kang Road Taipei, Taiwan
Re : K964153 Rossmax - Automatic Wristwatch Blood Pressure Monitor - RM 4000 Regulatory Class: II (Two) Product Code: DXN Dated: May 12, 1998 Received: May 14, 1998
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 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 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 (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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket 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 requlations.
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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" (21 CFR 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/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, 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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INDICATIONS FOR USE
Page 1 of 1
| 510(k) Number: | K964153 |
|---|---|
| Device Name: | Rossmax RM 4000 Wristwatch Blood Pressure Monitor |
| Intended Use : | To measure systolic and diastolic blood pressure and heart rate of |
| the wrist using the oscillometric method. Limited to patient over | |
| 18 years and wrist circumference between of 5.3 to 7.7 inches. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sue R. Dempersle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
Karatis 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per CFR 801.109)
or
Over-the-counter use