(77 days)
- The device is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the Oscillometric method. The device also measure pulse rate.
- The device is for adult use only.
- The device is for use at home or while traveling.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the MS-930 Mars Inflate-Read Blood Pressure Monitor. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria, nor other requested information such as MRMC study details or training set information.
The letter primarily focuses on the regulatory clearance and general requirements for marketing the device. It states the basic indications for use (measuring systolic, diastolic pressures, and pulse rate using the oscillometric method, for adult, home, or travel use) but doesn't provide specific performance metrics.
Therefore, I cannot fulfill your request for:
- A "table of acceptance criteria and the reported device performance."
- "Sample size used for the test set and the data provenance."
- "Number of experts used to establish the ground truth."
- "Adjudication method."
- "If a multi reader multi case (MRMC) comparative effectiveness study was done."
- "If a standalone (i.e. algorithm only without human-in-the-loop performance) was done."
- "The type of ground truth used."
- "The sample size for the training set."
- "How the ground truth for the training set was established."
This type of detailed study information is typically found in the 510(k) submission itself (which is often much more extensive than the clearance letter) or in associated clinical study reports, none of which are present in the provided text.
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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 Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three wing-like shapes extending from its body.
MAR 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mars Medical Products c/o Mr. E. J. Smith Smith Associates P.O. Box 4341 Crofton, MD 21114
Re: K050039
K050039
Trade Name: MS-930 Mars Inflate-Read Blood Pressure Monitor
11-11-11-11-11-11-11-11-2011-11-11 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: February 21, 2005 Received: February 23, 2005
Dear Mr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(ts) premaint is substantially equivalent (for the indications
referenced above and have determined the device is substantials; in interstate referenced above and have determined the devices marketed in interstate for use stated in the encrosule) to regally mances promotical Device Ameral ments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chactinene with the provisions of the Federal Food. Drug, devices that have been recuire approval of a proval of a proval application (PMA).
and Cosmetic Act (Act) that do not require approval estaurations of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, seejoer of the Securements for annual registration, listing of
general controls provisions of the Act include requirements for annual r general controls provisions of the Fet merade requires.
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 (PMA), it if your device is classified (sec above) nils Existing major regulations affecting your device can
may be subject to such additional controls. Box may be subject to such additional controls. Existing may organts 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Peachartergening your device in the Federal Register.
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Page 2 -- Mr. E. J. Smith
Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised fill I DA s issualled of a success complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decormmancis an administered by other Federal agencies. You must light or any Federal Statutes and regulations daminders but not limited to: registration and listing (21 comply with an the Act s requirements, mercedes, and manufacturing practice requirements as set CFK Part 807), labeling (21 CFRT art 820); and If applicable, the electronic forth in the quanty systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control provisions (Doctions on 2 evice as described in your Section 510(k) I his felter will anow you to oegin maneting your antial equivalence of your device to a legally premarket notification. The PDF miding of castination 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), please If you desire specific advice ion your don'te en earline of the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note of Compli contact the Office of Compullion at (210) = if = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Missionaling by reference to premaixevitibilities under the Act from the Division of Small other general information on your respensed its toll-free number (800) 638-2041 or Manufacturers, International and Goless http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bhimima for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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05003
INDICATIONS FOR USE
| Applicant: | Mars Medical Products Co., Ltd. |
|---|---|
| ------------ | --------------------------------- |
K050039 510(k) Number (if known): ___
Device Name: MS-930 Mars Inflate-Read Blood Pressure Monitor
Indications For Use:
-
- The device is designed to provide signals from which systolic and diastolic pressures can be The device also measure pulse rate. derived through the use of the Oscillometric method.
-
- The device is for adult use only.
- The device is for use at home or while traveling. 3.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over the Counter Use X__
For FDA Use Only
B.J. Simmon
ivision Sign-Off) Division of Cardlovascular Devices 510(k) Number 050039
§ 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).