The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Device Description

The device is an automatic non-invasive blood pressure system. The device is battery powered by 2 "AAA" batteries, there is no connection to external power. The device inflates a wrist cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During inflation the cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic pressure. The algorithm used to determine pulse rate, systolic and diastolic pressure is identical to the predicate. The device has a memory function that automatically stores up to 60 of the latest measurements. It can also display an average of the last three values. The device also detects the appearance of irregular heartbeats during measurement.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Omron HEM-6131, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Measurement range for Pressure	0-299 mmHg
Measurement range for Pulse rate	40 to 180 bpm
Accuracy of pressure indicator	+/-3 mmHg or 2% of reading
Accuracy of Pulse Rate	+/-5%
Irregular pulse detection	Yes
Patient safety (Biocompatibility)	Materials tested according to ISO 10993-1 and FDA Guidance (Cytotoxicity, Sensitization, Intracutaneous Reactivity)
Electrical Safety	Compliant with IEC 60601-1 and IEC 60601-1-2
Performance of NIBP measurement	Compliant with AAMI SP10 and ANSI/AAMI/ISO 81060-2
Indication for Use	Measuring blood pressure and pulse rate in adult patient population with wrist circumference 5 1/4" to 8 1/2" (13.5 cm to 21.5 cm). Detects irregular heartbeats.
Patient Population	Adult
Environment of Use	Home
Technology	Oscillometric
Prescriptive	OTC

Note: The document primarily highlights compliance with standards and equivalence to the predicate device, rather than providing specific test results against numerical performance targets for accuracy within the summary. However, it explicitly states "Accuracy or pressure indicator: +/-3 mmHg or 2% of reading" and "Accuracy Pulse Rate: +/-5%" as specifications in the device comparison table, implying these are the acceptance criteria.

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

Sample Size for Test Set: 85 patients (36 males and 49 females).
Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, clinical testing for medical devices is typically prospective.

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

Number of Experts: Not explicitly stated, however, the "Standard auscultation method" was used as the reference blood pressure (BP) measurement. This implies that trained medical professionals (likely physicians or nurses) performed the auscultation, but the specific number and qualifications are not detailed.

4. Adjudication method for the test set

Adjudication Method: Not explicitly stated. The "Standard auscultation method" was used as the reference, suggesting a direct comparison, rather than a multi-expert adjudication process.

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

MRMC Study: No, this was not an MRMC comparative effectiveness study involving human readers and AI assistance. This device is a standalone non-invasive blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by humans.

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

Standalone Performance: Yes, the clinical accuracy study directly evaluated the device's measurements (algorithm only) against the standard auscultation method without human intervention in the device's measurement process.

7. The type of ground truth used

Ground Truth Type: Expert consensus using the "Standard auscultation method" for blood pressure measurement.

8. The sample size for the training set

Training Set Sample Size: Not provided in the summary. The document mentions that "The algorithm used to determine pulse rate, systolic and diastolic pressure is identical to the predicate," which suggests the algorithm was already developed and potentially trained on other data, but this information is not included for the HEM-6131 specifically.

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

Training Set Ground Truth: Not provided in the summary. Given that the algorithm is "identical to the predicate," the ground truth establishment for its training would have occurred during the development of the predicate device, and those details are not within this submission.

Summary

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510(k) Summary K131742 Page 1 of 5

Omron Healthcare, Inc.1925 West Field CourtLake Forest, IL 60045 USA	Tel - 847-247-5626Fax- 847-680-6269		JUL 2 4 2003
Official Contact:	Renee Thornborough - Director QA/RA
Proprietary or Trade Name:	Model HEM-6131
Common/Usual Name:	Noninvasive blood pressure measurement system.
Classification Name/Code:	DXN - Noninvasive blood pressure measurementsystem.21CFR 870.1130Class II
Device:	Model HEM-6131

Note that the device is sometimes referred to as the HEM-6131-LA in this submission, this is just an Omron internal name the HEM-6131 and HEM-6131-LA are identical

Device Description:

The device has a memory function that automatically stores up to 60 of the latest measurements. It can also display an average of the last three values

The device also detects the appearance of irregular heartbeats during measurement.

Intended User Home user

Patient Population

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510(k) Summary K131742 Page 2 of 5

This device is intended for use on adults.

Indications for Use:

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Environment of Use: Home

Contraindications: There are no known contraindications.

Predicate Device Comparison:

The HEM-6131was compared to the predicate HEM-609N (K042505) in the device comparison table below.

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Premarket Notification 510(k)
Section 5 – 510(k) Summary

Omron HEM-6131

510(k) Summary

Device Comparisor

	Omron HEM-6131	Omron HEM-609N 510(k) K042505	Comment
Indications for Use	The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm).The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.	The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm).The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.	Identical
Patient Population	Adult	Adult	Identical
Environment of Use	Home	Home	Identical
Prescriptive	OTC	No	Identical
Patient Connection	Yes via cuff	Yes via cuff	Identical
Technology	Oscillometric	Oscillometric	Identical
Measurement range	Pressure: 0-299 mmHgPulse rate: 40 to 180 bpm	Pressure: 0-299 mmHgPulse rate: 40 to 180 bpm	Identical
Accuracy or pressure indicator	+/-3 mmHg or 2% of reading	+/-3 mmllg	Similar
Pressure sensor	Piezo resistance sensor	Silicone capacitive sensor	Similar, identical function
Accuracy Pulse Rate	+/-5%	+/-5%	Identical
Inflation Method	Electric pump	Electric pump	Identical
Deflation Method	Internal valve	Internal valve	Identical
Display Type	LCD	LCD	Identical
Irregular pulse detection	Yes	Yes	Identical
Power Source	AAA batteries	AAA batteries	Identical
Operating Conditions	Temperature: 10° to 40° CHumidity: 15 to 85% RH	Temperature: 10° to 40° CHumidity: 30 to 85% RH	Similar
Storage Conditions	Temperature: -20° to 60° CHumidity: 10 to 95% RH	Temperature: -20° to +60°CHumidity: 10 to 95% RH	Identical
Dimensions	78(W) x 60(D) x 21(H) mm	70(W) x 54(D) x 37(H) mm	Similar
Weight	Approximately 101g	110g	Similar

Page 5.3

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510(k) Summary K131742 Page 4 of 5

Differences Between Other Legally Marketed Predicate Devices:

The Omron HEM-6131 is viewed as substantially equivalent to the predicate device because: The HEM-6131 uses the exact same technology and has identical indications for use. The differences that exist between the devices are insignificant in the terms of safety or effectiveness.

Indications -

The indications for use measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Discussion ~ These indications are identical to the predicate Omron HEM-609N (K042505).

Prescriptive - The HEM-6131 and predicate are both OTC.

Design and Technology - The HEM-6131 has equivalent design and features as the predicate and has the identical technology to the predicate.

Performance and Specifications - The HEM-6131 has equivalent specifications of performance as the predicate.

Compliance with standards - The HEM-6131 and predicate device declare compliance with SP10, IEC 60601-1 and IEC 60601-1-2.

Materials -

The patient contacting materials of the cuffs has been tested in accordance with ISO 10993-1 and FDA Guidance. The tests included Cytotoxicity, Sensitization, and Intracutaneous Reactivity.

Patient Population -

The HEM-6131 and predicate are indicated for adults

Non-Clinical Testing Summary:

We have performed bench tests and found that the HEM-6131 met all requirements specifications and standards requirements and were found to be equivalent in comparison to the predicate. Testing includes the following:

Verification Testing .
. Testing for compliance to IEC 60601-1

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510(k) Summary K131742 Page 5 of 5

. Testing for compliance to IEC 60601-1-2
. Testing for compliance to AAMI SP10
. Comparative Testing to the Predicate

Clinical Testing Summary:

Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2 as documented in Section 20.

Eighty five patients (36 males and 49 females) were recruited for the study. Standard auscultation method was used as the reference blood pressure (BP) measuring in the left upper arm. BP measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in AAMI.

Substantial Equivalence Conclusion

Omron maintains that the HEM-6131 is substantially equivalent to the predicate HEM-609N (K042505) in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 24, 2013

Omron Healthcare, Inc. c/o Mr. Paul Dryden Consultant 24301 Woodsage Drive Bonita Springs, FL 34134 US

Re: K131742

Trade/Device Name: Hem-6131 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 11, 2013 Received: June 13, 2013

Dear Mr. Paul 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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Page 2 - Mr. Paul Dryden

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htmfor the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

for

Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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K131742

Indications for Use Statement

Page 1 of 1

(To be assigned) 510(k) Number:

Device Name:

Omron HEM-6131

Indications for Use:

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Environments of Use: Home Patient Population: Adult

Prescription Use (Part 21 CFR 801 Subpart D) or

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)

Digitally signed by
Owen P. Faris -S
Date: 2013.07.24
14:08:08--04'00'

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).