(15 days)
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.
ROSSMAX Automatic Wristwatch Blood Pressure Monitor, model RM-4200
This FDA clearance letter for the ROSSMAX Automatic Wristwatch Blood Pressure Monitor (Model RM-4200) indicates that the device has been found substantially equivalent to predicate devices. However, it does not provide the detailed information about the acceptance criteria or the specific study that proves the device meets (or met) those criteria.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be stated based on the provided text:
- Device Name: ROSSMAX Automatic Wristwatch Blood Pressure Monitor, Model RM-4200
- Intended Use: To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patients over 18 years and wrist circumference between 5.3 to 7.7 inches.
The document does not contain the following information:
- A table of acceptance criteria and the reported device performance: This letter is a clearance for market, not the study report itself.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and generally not applicable for a blood pressure monitor.
- If a standalone performance (algorithm only) was done: The device is a physical product directly measuring blood pressure; "algorithm only" performance would not be its primary evaluation.
- The type of ground truth used: Not mentioned. For blood pressure monitors, ground truth typically involves simultaneous measurements with a validated reference device (e.g., mercurial sphygmomanometer by a trained observer).
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Conclusion: The provided FDA clearance letter attests to the device's substantial equivalence to a predicate device, allowing it to be marketed. However, it does not include the detailed technical study results, acceptance criteria, or methodological specifics of the validation studies that led to this clearance. Such information would typically be found in the 510(k) submission itself, not in the clearance letter.
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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 consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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: K992388 ROSSMAX Automatic Wristwatch Blood Pressure Monitor, Model RM-4200 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 leqally 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 Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 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 leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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. 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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ATTACHMENT 1
Indications for Use Statement
ROSSMAX Automatic Wristwatch Blood Pressure Monitor, Device Names: model RM-4200
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)
Sute L. Sayersle
Prescription Use______________________________________________________________________________________________________________________________________________________________
or
Over-the-counter use
ר .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
§ 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).