(457 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the Oscillometric method, a traditional blood pressure measurement technique.
No
The device measures vital signs (blood pressure, pulse rate) and arterial stiffness, which are diagnostic indicators rather than therapeutic interventions. It does not treat or cure any medical condition.
Yes
The device is designed to measure physiological parameters (blood pressure and H-Value/arterial stiffness index) which are used to assess a patient's health status, fitting the definition of a diagnostic device.
Unknown
The provided text describes the function of a device that derives physiological parameters using the Oscillometric method. This method typically requires a physical component (like a cuff and pressure sensor) to acquire the initial signals. The summary does not explicitly state whether the device is purely software processing data from an external source or if it includes hardware for signal acquisition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description states the device measures blood pressure (systolic and diastolic), H-Value (arterial stiffness index), and pulse rate using the Oscillometric method. These measurements are taken directly from the patient's body (likely via a cuff on the arm), not from a sample taken from the body.
- Lack of Sample Analysis: There is no mention of analyzing biological samples.
Therefore, this device falls under the category of a non-IVD medical device that measures physiological parameters directly from the patient.
N/A
Intended Use / Indications for Use
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- The device is designed to provide signals from which systolic, diastolic pressures and H-Value (arterial stiffness index) can be derived through the use of the Oscillometric method. The device also measure pulse rate.
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- Adult Use Only
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- For use in the clinical setting or home use under the direction of a physician.
Product codes
DXN
Device Description
Not Found
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
clinical setting or home use under the direction of a physician.
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
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2004
Mars Medical Products Co. Ltd. c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 Crofton, MD 21114-4341
Re: K032825
Trade Name: Vital Vision Arterial Stiffness and Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: August 19, 2003 Received: September 10, 2004
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 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) 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, FDA 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 (301) 594-4648. 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,
Bram D/ Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K032825
Device Name: Vital Vision Arterial Stiffness and Blood Pressure Monitor
Indications for Use:
-
- The device is designed to provide signals from which systolic, diastolic pressures and H-Value (arterial stiffness index) can be derived through the use of the Oscillometric method. The device also measure pulse rate.
-
- Adult Use Only
-
- For use in the clinical setting or home use under the direction of a physician.
Warning: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| age of |
(Posted November 13, 2003)
| (Division Sign-Off) Division of Cardiovascular Devices | |
|---|---|
| 510(k) Number K0 32825 |