(270 days)
Not Found
None
No
The provided text does not mention AI, ML, or any related concepts like image processing, deep learning, or training/test sets, which are typically associated with AI/ML-powered medical devices. The description focuses on standard blood pressure measurement.
No
The device is indicated for measurement and determination of blood pressure and pulse rate, which are diagnostic/monitoring functions, not therapeutic.
Yes
Explanation: The device is used for "noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate," which are measurements taken to assess a physiological state and can indicate potential health issues, fitting the definition of a diagnostic device.
No
The device is described as a "Digital Blood Pressure Monitor Model D11" and is indicated for "noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate from user's arm." This description strongly implies a physical device that interacts with the user's arm to take measurements, which is characteristic of hardware, not software-only. The lack of a "Device Description" section prevents definitive confirmation, but the intended use points away from a software-only device.
Based on the provided information, the DIGIBIO Digital Blood Pressure Monitor Model D11 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate from user's arm." This describes a device that measures physiological parameters directly from the body, not a device that examines specimens (like blood, urine, or tissue) outside of the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body to detect diseases, conditions, or infections.
The description clearly indicates a device for direct physiological measurement, which falls outside the scope of IVDs.
N/A
Intended Use / Indications for Use
DIGIBIO Digital Blood Pressure Monitor Model D11 is indicated for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate from user's arm.
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
arm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SFP 1 3 2002
Digibio Technology Corporation c/o Eric Luo, Ph.D. 6833 Saint Lawrence Street Plano, TX 75024
Re: K014141
Trade Name: DIGIBIO Digital Blood Pressure Monitor Model D11 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 17, 2002 Received: June 18, 2002
Dear Dr. Luo:
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.
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Page 2 – Eric Luo, Ph.D.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
J. Odlaten
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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Page 1 of 1
510(k) Number (if known):
Device Name: DIGIBIO Digital Blood Pressure Monitor Model D11
Indications For Use:
DIGIBIO Digital Blood Pressure Monitor Model D11 is indicated for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate from user's arm.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
y. Oelatin
on of Cardiovascular & Respiratory Devices
Division of Cardiovascular & Respiratory Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)