(87 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 Z40
The provided document is a 510(k) Pre-Market Notification decision letter from the FDA for a blood pressure monitor. It does not contain the detailed study information required to answer your request about acceptance criteria and device performance for an AI/algorithm-based device.
This document predates widespread AI in medical devices and focuses on the regulatory approval process based on "substantial equivalence" to existing predicate devices, rather than detailed performance metrics derived from a specific clinical study with ground truth and expert adjudication for an algorithm.
Therefore, I cannot provide the information requested in your numbered points based on the provided text. The document only states the device's indications for use:
Indications For 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.
To answer your request, you would typically need a separate clinical study report or performance summary submitted as part of the 510(k) application, which is not included in this decision letter. Such a report would detail the methods, results, and statistical analyses used to demonstrate the device's accuracy against a reference standard.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2000
Michael Yeh Managing Director Rossmax International Ltd. 5F., No. 6, Alley 20, Lane 106 Section 3, Nan Kang Road Taipei, Taiwan
K993429 Re: Rossmax Automatic Wristwatch Blood Pressure Monitors Requlatory Class: II (two) Product Code: DXN December 13, 1999 Dated: Received: December 15, 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, 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 requlations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (OS) 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 Register. 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 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 Also, please note the regulation entitled, (301) 594-4639. "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,
Sincerely yours,
Sof. Vretta & Semperle
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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ATTACHMENT 1
Indications for Use Statement
Rossmax Automatic Wristwatch Blood Pressure Monitor, model Device Names: Z40
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)
(Division Sign-Off)
Division of Cardiovascular, Respiratory and Neurological Devices 510(k) Number __
Prescription Use______________________________________________________________________________________________________________________________________________________________
or
Over-the-counter use__________________________________________________________________________________________________________________________________________________________
§ 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).