(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.
Not Found
This document is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and a study proving those criteria are met. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.
However, I can extract what is available and identify what's missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or detailed device performance metrics in a table format. For blood pressure monitors, acceptance criteria typically refer to accuracy standards set by organizations like the Association for the Advancement of Medical Instrumentation (AAMI) or the British Hypertension Society (BHS). These standards usually quantify the mean difference and standard deviation of the blood pressure readings compared to a reference method (e.g., auscultation). The document only states the device's intended function: "To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method."
Missing Information: Specific numerical acceptance criteria (e.g., AAMI/BHS standards) and the reported performance (e.g., mean difference and standard deviation for systolic and diastolic pressure).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document does not provide any details about a test set, its sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing Information: This information is not relevant for a blood pressure monitor study, as "ground truth" would typically be established by a validated reference measurement method performed by trained technicians, not by diagnostic experts like radiologists. The document does not mention any experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: Adjudication methods are not applicable to the measurement of blood pressure, which would rely on direct comparison to a reference standard rather than expert consensus on interpretive tasks.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Missing Information: This type of study (MRMC for AI-assisted human reading) is not relevant for a standalone blood pressure monitor. The device is a direct measurement tool, not an AI interpretation aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a "standalone" automatic blood pressure monitor. Its performance would be evaluated as a standalone device, measuring blood pressure without human interpretation of its internal algorithm beyond reading the displayed values. However, the document does not provide details about such a study or its results.
Missing Information: While the device is standalone, the document doesn't explicitly describe the standalone performance study or its results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a blood pressure monitor, the "ground truth" would almost certainly be a simultaneously measured blood pressure using a validated, non-invasive reference method, such as auscultation with a mercury sphygmomanometer (or an equivalent validated oscillometric device) performed by trained personnel.
Missing Information: The document does not explicitly state the type of ground truth used.
8. The sample size for the training set
Missing Information: The document does not mention a training set or its sample size. For traditional medical devices, especially those not employing machine learning, a "training set" in this context is often not applicable in the same way it would be for an AI algorithm.
9. How the ground truth for the training set was established
Missing Information: As no training set is mentioned (and it's likely not applicable in the AI sense), this information is not provided.
In summary:
This FDA 510(k) letter confirms the regulatory clearance of a blood pressure monitor, stating its substantial equivalence to predicate devices. It provides the device name, model, intended use, and limitations (patient age, wrist circumference). However, it does not include the detailed technical study data, acceptance criteria, or performance results that would be found in the actual 510(k) submission document or a separate clinical study report. The level of detail requested in the prompt is typical for AI/ML device clearances or more comprehensive clinical trial results, not generally for a 510(k) clearance letter for a device like a blood pressure monitor from 1999.
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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 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__
§ 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).