(202 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is consistent with a standard digital blood pressure monitor.
No
The device is described as a monitor intended for measuring blood pressure and pulse rate, and detecting irregular heartbeats, which are diagnostic/monitoring functions, not therapeutic.
No
The device is described as a "digital monitor intended for use in measuring blood pressure and pulse rate." While it can "detect the appearance of irregular heartbeats during measurement and gives a warning signal," this is a detection feature, not a diagnostic one. A diagnostic device would typically provide a specific diagnosis or help in determining the nature of a disease, rather than just signaling an irregular finding.
No
The description refers to a "digital monitor" and mentions measuring blood pressure and pulse rate using an arm cuff (implied by arm circumference range). This strongly suggests a hardware component is involved in the measurement process, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure blood pressure and pulse rate. This is a physiological measurement taken directly from the patient's body, not an analysis of a sample (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The description reinforces that it's a digital monitor for measuring blood pressure and pulse rate, consistent with a non-IVD device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would be performed in vitro.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device measures a physiological parameter directly.
N/A
Intended Use / Indications for Use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 inches to 17 inches (22 cm to 42 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
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
adult patient population
Intended User / Care Setting
Not Found
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)
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 logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it. The text is written in all capital letters and is arranged in a circular fashion to follow the shape of the circle.
Public Health Service
APR - 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Omron Healthcare, Inc. c/o Mr. Iwao Kojima Director of Technology 1200 Lakeside Drive Bannockburn, IL 60015
Re: K042506
K042300
Trade Name: OMRON Automatic Blood Pressure Monitor HEM-780N Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: February 7, 2005 Received: February 8, 2005
Dear Mr. Kojima:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(tr) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule, to regally manatise of the Medical Device American walls of the local Food. Drug commerce prior to May 28, 1770, the encordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UMA devices that have been reclassified in accordance what approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval one of and Cosment Act (Act) that to not require approvial of the general controls provisions of the Act. The You may, therefore, market the device, belower to the more of the may be and general Controls provisions of the rice, 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 i If your device is classifica (sec above) me exist ones a comments of except of the can
may be subject to such additional controls. Existing major regulations FDA mov may be subject to such additional controller stations, "Parts 800 to 898. In addition, FDA may be found in the Code of Pouchal Ingerning your device in the Federal Register.
1
Page 2 - Mr. Iwao Kojima
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I teast of advised that I Drissantes cour device complies with other requirements of the Act that I DTT has Intact a actions administered by other Federal agencies. You must of any I cochar sundres and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality bybelins (Sections 531-542 of the Act); 21 CFR 1000-1050. product lastiation control pro receins (sice as described in your Section 510(k) I mis letter will and in your he FDA finding of substantial equivalence of your device to a legally premailer notification: "The PDF and sification 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 for Jour 2011) 276-0120. Also, please note the regulation entitled, Connact the Orthou of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,
Blumuma for
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
K042506 510(k) Number:
Device Name: OMRON AUTOMATIC BLOOD PRESSURE MONITOR MODEL: HEM-780N
Indications For Use:
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 inches to 17 inches (22 cm to 42 cm).
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blumman
(Division Sign-Off) (Division of Cardlovascular Devices 510(K) Number_KO40504
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