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 to 17 inches (22 -42 cm) via an "arm in" cuff.

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 guidelines of 135/85 mm Hg.

The Omron 1500Pro model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

It is intended as an OTC device for home use.

Device Description

The Omron 1500Pro blood pressure monitor is a slightly modified version of the HEM-780N3 (K061822) blood pressure monitor.

The 1500Pro blood pressures monitor is intended to monitor:

. Blood pressure
. Pulse rate

The difference between the proposed 1500 Pro and the HEM-780N3 has to do with the cuff design. All other features, functions and technologies are identical to the predicate.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Omron 1500 Pro blood pressure monitor. It serves as a declaration of substantial equivalence to a predicate device (Omron HEM 780N3, K061822) rather than a study demonstrating the device meets specific acceptance criteria through a clinical trial. Therefore, many of the requested elements for a study proving acceptance criteria will not be found as this is a regulatory submission for substantial equivalence.

Based on the provided text, here's an attempt to answer the questions:

1. Table of acceptance criteria and the reported device performance

The document defines "Accuracy of pressure indicator" and "Accuracy of pulse rate" as specifications, which function as de facto acceptance criteria for the device's accuracy.

Acceptance Criteria	Reported Device Performance (Omron 1500 Pro)
Accuracy of pressure indicator	Within ±3 mmHg or 2 % of reading
Accuracy of pulse rate	Within ±5 % of reading
Measurement method	Cuff oscillometric method
Measurement range (Pressure)	0 to 294 mmHg
Measurement range (Pulse Rate)	40 to 180 beats/min.
Irregular heart beat indication	Displays an irregular heart beat symbol when 2 irregular heart beats were detected during a measurement.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not report on a specific test set, its sample size, or data provenance for evaluating the Omron 1500 Pro's performance. The submission relies on demonstrating substantial equivalence to a predicate device (Omron HEM 780N3), implying that the predicate's performance data, which is not detailed here, is sufficient as the core technology and functionality are stated to be identical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No independent test set with expert-established ground truth is described for the Omron 1500 Pro in this document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No independent test set is described.

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

Not applicable. The device is an automated blood pressure monitor; it does not involve human readers interpreting its output in a way that would necessitate an MRMC study related to AI assistance.

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

The document implicitly describes the standalone performance of the device by stating its measurement accuracy specifications. However, it does not present a standalone study with specific results but rather states the inherent performance characteristics of the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the accuracy specifications ("Within ±3 mmHg or 2 % of reading" for pressure and "Within ±5 % of reading" for pulse rate), the ground truth would typically be established by a reference standard measurement (e.g., a mercury sphygmomanometer or an accepted standard for pulse rate measurement, often following a standard like ISO 81060-2). However, the document does not specify how these accuracy figures were derived for this particular device or its predicate. It merely states the published specifications which are common for such devices.

8. The sample size for the training set

Not applicable. This device is based on oscillometric technology, not a machine learning or AI algorithm that would typically require a "training set." The engineering and calibration of such devices are based on established physiological principles and extensive testing, not a machine learning training paradigm.

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

Not applicable. As above, there is no "training set" in the context of an AI/ML algorithm for this device.

Summary

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Omron 1500 Pro

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 4 1-Feb-08

Omron Healthcare, Inc.
1200 Lakeside Dr.	Tel - 847-247-5609
Bannockburn, IL 60015	Fax - 847-680-6269
Official Contact:	Ranndy Kellogg - VP Marketing & Product Development
Proprietary or Trade Name:	1500 Pro monitor
Common/Usual Name:	Monitor, Physiological, Patient (without arrhythmia detection oralarms)
Classification Name/Code:	DXN - System, Measurement, Blood-pressure, Non-invasive
Device:	Model - 1500 Pro
Predicate Devices:	Omron – HEM 780N3 – K061822

Device Description:

The Omron 1500Pro blood pressure monitor is a slightly modified version of the HEM-780N3 (K061822) blood pressure monitor.

The 1500Pro blood pressures monitor is intended to monitor:

. Blood pressure
. Pulse rate

The difference between the proposed 1500 Pro and the HEM-780N3 has to do with the cuff design. All other features, functions and technologies are identical to the predicate.

Indications for Use:

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 guidelines of 135/85 mm Hg.

The Omron 1500Pro model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. It is intended as an OTC device for home use.

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Non-Confidential Summary of Safety and Effectiveness

Page 2 of 3 1-Feb-08

Adults Patient Population:

Environment of Use: Home settings

Contraindications: None

Summary of substantial equivalence

Model Name:Specification	New device1500 PRO	Predicate - K061822HEM-780N3
Measurement method	Cuff oscillometric method	Cuff oscillometric method
Measurement range	Pressure: 0 to 294 mmHgPulse Rate: 40 to 180 beats/min.	Pressure: 0 to 299 mmHgPulse Rate: 40 to 180 beats/min.
Pressure sensor	Electrostatic capacitive sensor	Electrostatic capacitive sensor
Applicable cuff	Arm-in / Mounted cuff	Wrap around cuff
Accuracy of pressure indicator	Within ±3 mmHg or 2 % of reading	Within ±3 mmHg or 2 % of reading
Accuracy of pulse rate	Within ±5 % of reading	Within ±5 % of reading
Cuff inflation	Automatic inflation with air pump	Automatic inflation with air pump
Pressure sensor	Semiconductor pressure sensor forwrapping cuff.	None
Slow cuff deflation (bleeding)	Deflation rate is controlled by an activeelectronic control valve by 4 to 11mmHg/s depending on pulse rate.	Deflation rate is controlled by an activeelectronic control valve by 4 to 11mmHg/s depending on pulse rate.
Rapid air release	By an active electronic control valve	By an active electronic control valve
Automatic shutting-down time	5 minutes after a measurementcompletion	5 minutes after a measurementcompletion
Irregular heart beat indication	displays an irregular heart beat symbolwhen 2 irregular heart beats weredetected during a measurement.	displays an irregular heart beat symbolwhen 2 irregular heart beats weredetected during a measurement.
Power source	AC adapter only	Battery (type "AA" × 4) or AC adapter
Display	Liquid crystal digital display	Liquid crystal digital display
Operating conditions	10 to 40 °C (50 to 104 °F)15 to 90 %RH	10 to 40 °C (50 to 104 °F)15 to 90 %RH
Storage conditions	-20 to 60 °C (-4 to 140 °F)10 to 95 %RH	-20 to 60 °C (-4 to 140 °F)10 to 95 %RH
Dimensions (mm)	294 (W) × 286 (D) × 271 (H) mm	131 (W) × 155 (D) × 85 (H) mm
Weight (not including batteries)	Approx. 2600g	Approx. 350g

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Non-Confidential Summary of Safety and Effectiveness Page 3 of 3 1-Feb-08

Differences Between Other Legally Marketed Predicate Devices

The Model 1500 Pro is viewed as substantially equivalent to the following predicate device - Omron HEM 780N3 - K061822.

The difference between the two devices is the style of cuff. 1500 pro has an "arm-in" style and the predicate a wrap around style cuff. All other features, specifications, etc. are otherwise identical.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

FEB 2 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Omron Healthcare, Inc. c/o Mr. Paul Dryden President ProMedic, Inc. 3460 Pointe Creek Court # 102 Bonita Springs, FL 34134

Re: K080289

1 500 Pro Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: February 01, 2008 Received: February 06, 2008

Dear Mr. Dryden:

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 - Mr. Paul Dryden

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 procced 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bfhimmerforfr

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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KO80289

Indications for Use Statement

Page 1 of 1

510(k) Number: (To be assigned)

Device Name: 1500 Pro

Indications for Use:

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 guidelines of 135/85 mm Hg.

The Omron 1500Pro model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

It is intended as an OTC device for home use.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-the-counter use XX (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummen

Division of Cardiovascular Devices
510(k) Number K080289

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).