(285 days)
The Mars MS-900S, MS-900SFM & MS-900SPM Auto Inflation Wrist Blood Pressure Monitors are designed to provide signals from which systolic and diastolic pressures can be derived through the use of the oscillometric method. The devices also measure pulse rate.
Mars MS-900S, MS-900SFM & MS-900SPM Auto Inflation Wrist Digital Blood Pressure Monitors
The provided text is a 510(k) clearance letter from the FDA for the Mars Medical Products MS-900S, MS-900SPM, and MS-900SFM Automatic Blood Pressure Monitors. It confirms the substantial equivalence of these devices to existing ones. However, this document does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a clinical study.
The letter acknowledges the submission and clearance but does not provide the underlying data or results of the performance studies. Therefore, I cannot extract the information requested.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 1998
Mars Medical Products c/o Mr. E.J. Smith Consultant Smith Associates P.O. Box 4341 Crofton, MD 21114
K980845 Re : Mars Medical Products, MS-900S, MS-900SPM and MS-900SFM Automatic Blood Pressure Monitor Requlatory Class: II (Two) Product Code: DXN Dated: September 14, 1998 Received: September 16, 1998
Dear Mr. Smith:
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 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 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 requlations.
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Page 2 - Mr. E.J. Smith
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 requlation (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 Other general information on your responsibilities CFR 807.97). 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 Radioloqical Health
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510(k) Number (if Known):
Device Name: Mars MS-900S, MS-900SFM & MS-900SPM Auto Inflation Wrist Digital Blood Pressure Monitors
Classification Panel:
Indication for Use:
The Mars MS-900S, MS-900SFM & MS-900SPM Auto Inflation Wrist Blood Pressure Monitors are designed to provide signals from which systolic and diastolic pressures can be derived through the use of the oscillometric method. The devices also measure pulse rate.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ or Over the Counter Use
(Division Sign-Om
Division of Cardiovascular, Respiratory,
and Neurological Devices
5101) Mu
§ 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).