OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 by OMRON HEALTHCARE, INC.

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.

Device Description

Automatic Blood Pressure Monitor Model: HEM 780N3

AI/ML Overview

This document is a 510(k) clearance letter for the OMRON Automatic Blood Pressure Monitor Model: HEM-780N3. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain the acceptance criteria, study details, or performance data that would typically be found in a clinical study report or a more detailed submission document.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or stated based on the provided text, and what information is missing:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Not provided in the document.	Not provided in the document.
(Typically criteria would involve accuracy against a reference standard, e.g., agreement within a specified mmHg range, or particular sensitivity/specificity for certain conditions.)	(Typically performance would include mean difference, standard deviation of difference, and/or accuracy within specified thresholds.)

2. Sample size used for the test set and the data provenance:

Sample size: Not provided.
Data provenance: Not provided (e.g., country of origin, retrospective/prospective). This document only covers the FDA's decision on substantial equivalence, not the details of the studies conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not provided.
Qualifications of experts: Not provided.

4. Adjudication method for the test set:

Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human "readers" interpreting output. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, implicitly. As an automatic blood pressure monitor, its core function is to produce a blood pressure reading without human interpretation of raw data. The performance study (which is not detailed here) would have assessed the device's accuracy in a standalone capacity.

7. The type of ground truth used:

Not explicitly stated, but highly likely to be a reference standard blood pressure measurement. For blood pressure monitors, the ground truth is typically established by simultaneous measurement using a highly accurate, often invasive or a standardized auscultatory method (e.g., Korotkoff sounds by trained observers with a mercury sphygmomanometer), following protocols like ISO 81060-2 or AAMI standards.

8. The sample size for the training set:

Not applicable/Not provided. As an automatic blood pressure monitor, the term "training set" is usually associated with machine learning devices. While there is likely calibration data used during development, it is not referred to as a "training set" in the context of traditional medical device validation. If the device uses any form of adaptive algorithm, details of its development data would be in a separate study report.

9. How the ground truth for the training set was established:

Not applicable/Not provided. (See point 8).

Summary of what the document does provide:

Device Name: OMRON AUTOMATIC BLOOD PRESSURE MONITOR MODEL: HEM-780N3
Intended Use: Measuring blood pressure and pulse rate in adult patients with arm circumference 9-17 inches (22-42 cm).
Additional features: Detects irregular heartbeats and provides a warning signal. Compares average readings to AHA hypertension guidelines (135/85 mmHg).
Limitation: Not intended to be a diagnostic device.
Regulatory Class: Class II (two)
Product Code: DXN
Predicate Device: Substantially equivalent to devices marketed prior to May 28, 1976.

Summary

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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.

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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

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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

Regulation Number and Section

§ 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).