(71 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 V46
The provided text is a 510(k) premarket notification decision letter from the FDA regarding a blood pressure monitor. It does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or validation protocol.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The letter explicitly states: "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..." This indicates that the device's approval is based on substantial equivalence to existing devices, not on a new, independently presented and detailed clinical study report within this document.
What can be extracted from the text related to this request:
- Device Name: Rossmax Automax WristWatch Blood Pressure Monitor, model V46
- Intended Use: To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method.
- Limitations: Limited to patients over 18 years and wrist circumference between 5.3 to 7.7 inches.
- Regulatory Basis: Substantial equivalence to legally marketed predicate devices.
To answer your request comprehensively, one would need access to the actual 510(k) submission documentation, which would include the testing and comparison performed to demonstrate substantial equivalence to the predicate device, likely referencing a standard like ISO 81060-2 (Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type).
In summary, based only on the provided text, the answer is: the document does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
§ 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).