(35 days)
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Not Found
No
The summary describes a standard automatic blood pressure monitor with irregular heartbeat detection and comparison to AHA guidelines, with no mention of AI or ML technologies.
No
The device is a digital monitor for measuring blood pressure and pulse rate and is explicitly stated not to be a diagnostic device. While it detects irregular heartbeats and compares readings to hypertension guidelines, it does not treat or manage a disease state. Its function is primarily measurement and warning, not therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "The Omron 780N3 model is not intended to be a diagnostic device."
No
The device description explicitly states "Automatic Blood Pressure Monitor Model: HEM 780N3", indicating a hardware device. The intended use also describes measuring blood pressure and pulse rate, which requires physical interaction with the patient's arm, further confirming it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "measuring blood pressure and pulse rate" and is "not intended to be a diagnostic device."
- Nature of Measurement: Blood pressure and pulse rate measurements are physiological parameters taken directly from the body (in vivo), not from samples of bodily fluids or tissues (in vitro).
- IVD Definition: IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform such examinations.
The device is a medical device, specifically a blood pressure monitor, but it falls under a different regulatory category than IVDs.
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 - 42 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. This blood pressure monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. The Omron 780N3 model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
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
Arm
Indicated Patient Age Range
adult
Intended User / Care Setting
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 2 2006
OMRON Healthcare, Inc. c/o Ms. Donna Djinovich Regulatory Affairs Manager 1200 Lakeside Drive Bannockburn, IL 60015
Re: K061822
Automatic Blood Pressure Monitor Model: HEM 780N3 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 27, 2006 Received: June 28, 2006
Dear Ms. Djinovich:
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. Iisting 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 -- Ms. Donna Djinovich
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/industry/support/index.html.
Sincerely yours,
B. Hemmimer fer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
OMRON
Attachment 2
Indications for Use Statement
KOG1822 510(k) Number Device Name OMRON AUTOMATIC BLOOD PRESSURE MONITOR MODEL: HEM-780N3
Indication 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 - 42 cm).
The device detects the appearance of irreqular heartbeats during measurement and gives a warning signal with readings.
This blood pressure monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension quideline of 135/85 mmHq.
The Omron 780N3 model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Humana
(Division Sign-Cit) Division of Cardiovascular Devices 510(k) Nymber /
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use