(82 days)
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Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities.
No
The device is described as a blood pressure monitor, which measures physiological parameters, but it does not treat or alleviate a medical condition, which is the definition of a therapeutic device.
Yes
Explanation: The device is described as a blood pressure monitor that measures systolic and diastolic pressures and pulse rate, which are used to assess a patient's health status.
No
The device description explicitly states "MS-753 Mars Inflate-Read Blood Pressure Monitor," which strongly implies a hardware component (an inflate-read blood pressure monitor). The summary does not provide any information to suggest it is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device measures blood pressure and pulse rate using the oscillometric method. This is a non-invasive measurement taken directly from the body, not from a specimen.
- Intended Use: The intended use is for monitoring blood pressure and pulse rate in adults at home or while traveling. This aligns with a general health monitoring device, not a diagnostic test performed on a sample.
The information provided focuses on the device's function in measuring physiological parameters directly from the patient, which is characteristic of a non-IVD medical device.
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.
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- The device is for adult use only.
- The device is for use at home or while traveling. 3.
Product codes
DXN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
adult
Intended User / Care Setting
home or while traveling
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
MAR 3 0 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: K050040
Trade Name: MS-930 Mars Inflate-Read Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: March 14, 2005 Received: March 15, 2005
Dear Mr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstatc 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, I'DA may publish further announcements concerning 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 does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Bhimmer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K050040
INDICATIONS FOR USE
Applicant: Mars Medical Products Co., Ltd.
K050040 510(k) Number (if known):
Device Name: MS-753 Mars Inflate-Read Blood Pressure Monitor
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.
- The device is for use at home or while traveling. 3.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over the Counter Use__X__
For FDA Use Only
Blummenstor
vision Sign-Off) Division of Cardiovascular Devices 510(k) Number KOD DOYD