(77 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on a standard oscillometric method for blood pressure measurement.
No
Explanation: The device measures blood pressure and pulse rate, which are diagnostic indicators, not therapeutic actions. Therapeutic devices actively treat or manage a condition.
Yes
The device is designed to derive systolic and diastolic pressures and measure pulse rate, which are physiological parameters used to assess and monitor health conditions. These measurements provide information that can aid in the diagnosis or monitoring of medical conditions related to blood pressure and heart rate.
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only. The intended use describes a function typically performed by hardware (oscillometric method for blood pressure), but it doesn't explicitly state whether the device itself is software or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to measure blood pressure and pulse rate directly from the patient using the oscillometric method. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use describes a direct physiological measurement. The device is designed to provide signals related to blood pressure and pulse rate, which are physiological parameters measured directly from the body.
The description clearly indicates a device for non-invasive physiological monitoring, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
-
- 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.
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- The device is for use at home or while traveling.
Product codes
DXN
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult use only.
Intended User / Care Setting
Home or while traveling (Over the Counter Use).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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