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 (13.5 cm to 21.5 cm).

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

Environments of Use: Home Patient Population: Adult

Device Description

This device originally received clearance under 510(k) K123498.

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 device has a memory function that automatically stores up to 100 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.

As originally submitted under 510(k) K123498, the device contained the APS feature. The feature was removed prior to clearance.

This submission is for the addition of the Advanced Positioning Sensor (APS) into the device. The APS is an aid to help the user determine if the cuff is at the correct height in relationship to the heart. The addition of APS does not change the intended use of the device. The addition of APS does not alter the fundamental scientific technology. There are no changes in hardware. There are no changes in the software algorithm which determines blood pressure or pulse rate. The addition of the APS feature is an optional feature which the user can elect to use. The APS feature does not alter the accuracy of the device, but serve to assist the user in positioning the device at the level of the heart.

AI/ML Overview

The provided text describes the Omron BP652N (HEM-6300-Z) with APS, a noninvasive blood pressure measurement system. The submission (K142917) is for the addition of the Advanced Positioning Sensor (APS) feature.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Value (from ANSI/AAMI/ISO 81060-2:2013)	Reported Device Performance (Omron BP652N with APS)
Accuracy of pressure indicator	+/- 3 mmHg or 2% of reading (from predicate device's specification)	+/- 3 mmHg or 2% of reading
Accuracy of pulse rate	+/-5% (from predicate device's specification)	+/-5%
Compliance with standards	SP10, IEC 60601-1, IEC 60601-1-2, ISO 10993-1	Declared compliance with all listed standards
Clinical Accuracy (Mean Diff.)	Standard: Mean difference between device and reference <= +/-5 mmHg	Not explicitly stated, but clinical study performed
Clinical Accuracy (Standard Dev.)	Standard: Standard deviation between device and reference <= 8 mmHg	Not explicitly stated, but clinical study performed

Note: The document explicitly states device specifications like "Accuracy of pressure indicator" and "Accuracy Pulse Rate" are identical to the predicate device. For clinical accuracy, it states a clinical study was performed in accordance with ANSI/AAMI/ISO 81060-2:2013. This standard typically defines specific criteria for mean difference and standard deviation of blood pressure measurements compared to a reference method (e.g., intra-arterial measurement or auscultation). While the exact numerical results for the Omron BP652N with APS are not provided in this specific excerpt, the submission implies that the device met the criteria of ANSI/AAMI/ISO 81060-2:2013.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document mentions a "clinical study in accordance with ANSI/AAMI/ISO 81060-2:2013 was performed to validate the clinical accuracy of the device when the arm is positioned by use of the APS" (Page 4). However, the sample size of this clinical study is not explicitly stated in the provided text.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. ANSI/AAMI/ISO 81060-2:2013 usually mandates prospective clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For non-invasive blood pressure measurement devices cleared under ANSI/AAMI/ISO 81060-2, the "ground truth" (reference measurement) is typically established by trained observers (experts) using a standardized auscultatory method. The standard typically requires a minimum of two trained observers to independently measure and record blood pressure, often blinded to each other's readings and the device's readings.
The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, for compliance with ANSI/AAMI/ISO 81060-2, these would implicitly be highly trained individuals, often clinicians or technicians specifically trained in auscultatory blood pressure measurement.

4. Adjudication Method for the Test Set

For clinical studies following ANSI/AAMI/ISO 81060-2, if the two independent observers' readings differ by more than a pre-defined threshold (e.g., 4 mmHg or 5 mmHg), a third expert or an adjudication process is usually employed to resolve the discrepancy or additional measurements are taken.
The document does not explicitly state the adjudication method used. However, compliance with ANSI/AAMI/ISO 81060-2 would imply a standardized method for managing observer discrepancies. A common method is for a third observer to perform a measurement, or for the initial two observers to reconcile their differences.

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

No, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor with an Advanced Positioning Sensor (APS). The APS is described as an "aid to help the user determine if the cuff is at the correct height in relation to the heart" and provides "visual feedback" (Page 4). It is not an AI algorithm that assists human readers in interpreting complex medical images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done for the core blood pressure measurement algorithm.
The document states, "Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2: 2013 is documented in Section 20." (Page 9). This standard is specifically for evaluating the accuracy of automated sphygmomanometers (blood pressure monitors) against a reference method, which is a standalone performance assessment of the device's ability to accurately measure blood pressure.
It also explicitly states, "The APS has no interface to the software algorithm which determines blood pressure or pulse rate, it is a visual feedback to the user indicating whether the device is positioned appropriately" (Page 4). This confirms that the blood pressure measurement algorithm operates independently of the APS feature.

7. The Type of Ground Truth Used

For the clinical accuracy study performed in accordance with ANSI/AAMI/ISO 81060-2:2013, the ground truth for blood pressure measurements is typically established by a standardized auscultatory method. This involves skilled observers using a mercury sphygmomanometer or another validated reference method to listen for Korotkoff sounds.

8. The Sample Size for the Training Set

The document describes the device already having a clearance (K123498) and this submission is for the re-addition of the APS feature. The core blood pressure algorithm was presumably "trained" or developed prior to these submissions.
The document does not provide any information regarding a training set size for the blood pressure measurement algorithm or the APS, as it implies the algorithm itself is unchanged from the predicate device (K123498).

9. How the Ground Truth for the Training Set Was Established

As the document does not provide information on a specific "training set" for the blood pressure algorithm in the context of this submission, it does not describe how ground truth for any training set was established. The algorithm's development and initial validation would have occurred prior to this 510(k) submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, stacked on top of each other. The profiles are depicted in a flowing, wave-like design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 1, 2014

Omron Healthcare, Inc. % Mr. Paul Dryden Consultant ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

Re: K142917

Trade/Device Name: Omron BP652N (HEM-6300-Z) with APS Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: October 2, 2014 Received: October 7, 2014

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 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

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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.htm for 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 Industry and Consumer Education 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,

Melissa A. Torres -S

For 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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K142917

Page 1 of__1_

510(k) Number (if known): __ K142917

Device Name : __ Omron BP652N (HEM-6300-Z) with APS_____

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 (13.5 cm to 21.5 cm).

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

Environments of Use: Home Patient Population: Adult

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-The-Counter Use

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510(k) Summary Page 1 of 7 10/2/2014

Omron Healthcare, Inc.
1925 West Field Court	Tel - 847-247-5626
Lake Forest, IL 60045 USA	Fax- 847-680-5626
Official Contact:	Renee Thornborough – Director QA/RA
Proprietary or Trade Name:	Model BP652N(HEM-6300-Z) with APS
Common/Usual Name:	Noninvasive blood pressure measurement system
Classification Name/Code: system.	DXN - Noninvasive blood pressure measurement
	21CFR 870.1130
	Class II
Device:	Model BP652N(HEM-6300-Z) with APS
Predicate Device:	Model BP652N (HEM-6300-Z) K123498Braun Series BP 200 Series K003732
Device Description:

This device originally received clearance under 510(k) K123498.

The device has a memory function that automatically stores up to 100 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.

As originally submitted under 510(k) K123498, the device contained the APS feature. The feature was removed prior to clearance.

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510(k) Summary Page 2 of 7 10/2/2014

determines blood pressure or pulse rate. The addition of the APS feature is an optional feature which the user can elect to use. The APS feature does not alter the accuracy of the device, but serve to assist the user in positioning the device at the level of the heart. Though there is no change in algorithm a clinical study in accordance with ANSI/AAMI/ISO 81060-2:2013 was performed to validate the clinical accuracy of the device when the arm is positioned by use of the APS, see Section 20.

Description of APS:

The Advanced Positioning Sensor is an aid to help the user determine if the cuff is at the correct height in relation to the heart. It makes this determination based on the reading of an accelerometer (to measure the angle of the arm in relation to the table) integral to the device.

The APS has no interface to the software algorithm which determines blood pressure or pulse rate, it is a visual feedback to the user indicating whether the device is positioned appropriately in accordance with the APS angle measurement criteria as below.

Image /page/4/Picture/7 description: The image shows three Omron blood pressure monitors on wrists, demonstrating correct and incorrect positioning. The first monitor, labeled "Too Low," displays a reading with the indicator light positioned below the heart symbol. The second monitor, labeled "Correct," shows the indicator light aligned with the heart symbol. The third monitor, labeled "Too High," shows the indicator light above the heart symbol.

As above, there are no changes to the hardware, blood pressure or pulse rate algorithms.

Intended User Home user

Patient Population

This device is intended for use on adults.

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510(k) Summary Page 3 of 7 10/2/2014

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.

Environment of Use: Home

Contraindications

There are no known contraindications.

Predicate Device Comparison

The BP652N(HEM-6300-Z) with APS was compared to the predicates Model BP652N (HEM-6300-Z) K123498 and Braun Series BP 200 Series K003732 as in the device comparison table below.

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510(k) Summary Page 4 of 7 10/2/2014

Device Comparison

	PREDICATE	PREDICATE	Device Under Review	Comment
	Omron BP652N (HEM-6300-Z)K123498	Braun BP2000 series K003732	Omron BP652N (HEM-6300-Z) withAPS
Indications for Use	The device is a digital monitorintended for use in measuring bloodpressure and pulse rate in adultpatient population with wristcircumference ranging from 5 1/4inches to 8 1/2 inches (13.5 cm to21.5 cm).The device detects the appearance ofirregular heartbeats duringmeasurement and gives a warningsignal with readings.	The Braun PrecisionSensor™ (BP2000series) wrist blood pressure monitor isindicated for use for the noninvasivemeasurement of blood pressure (systolicand diastolic} and pulse rate in adults, ina home use setting. Use may be initiatedby the individual or as part of ahypertension monitoring andmanagement program supervised by ahealth care provider.	The device is a digital monitor intendedfor use in measuring blood pressure andpulse rate in adult patient populationwith wrist circumference ranging from 51/4 inches to 8 1/2 inches (13.5 cm to21.5 cm).The device detects the appearance ofirregular heartbeats during measurementand gives a warning signal withreadings.	Identical K123498
Patient Population	Adult	Adult	Adult	Identical K123498 and K003732
Environment ofUse	Home	Home	Home	Identical K123498 and K003732
Prescriptive	OTC	OTC	OTC	Identical K123498 and K003732
Patient Connection	Yes via cuff	Yes via cuff	Yes via cuff	Identical K123498 and K003732
Technology	Oscillometric	Oscillometric	Oscillometric	Identical K123498 and K003732
AdvancedPositioning Sensor	-	Device has position Sensor	Added*	Identical in function to K003732Braun BP2000 series
Measurementrange	Pressure: 0-299 mmHgPulse rate: 40 to 180 bpm	Pressure: 0-300 mmHgPulse rate: 40 to 160 bpm	Pressure: 0-299 mmHgPulse rate: 40 to 180 bpm	Identical K123498
Accuracy ofpressure indicator	+/- 3 mmHg or 2% of reading	+/- 3 mmHg	+/- 3 mmHg or 2% of reading	Identical K123498
Pressure sensor	Piezo resistance sensor	Not specified	Piezo resistance sensor	Identical K123498
Accuracy PulseRate	+/-5%	+/-5%	+/-5%	Identical K123498 and K003732
Inflation Method	Piezo-electric pump	Not specified	Piezo-electric pump	Identical K123498
Deflation Method	Internal valve	Electronic control valve	Internal valve	Identical K123498 and K003732
Display Type	LCD	LCD	LCD	Identical K123498 and K003732
Irregular pulsedetection	Yes	No	Yes	Identical K123498
Power Source	AAA batteries	AAA batteries	AAA batteries	Identical K123498 and K003732
OperatingConditions	Temperature: 10° to 40° CHumidity: 15 to 85% RH	Temperature: 10° to 40° CHumidity: <85%	Temperature: 10° to 40° CHumidity: 15 to 85% RH	Identical K123498
Storage Conditions	Temperature: -20° to 60° CHumidity: 10 to 95% RH	Temperature: -20° to 60° CHumidity: <85%	Temperature: -20° to 60° CHumidity: 10 to 95% RH	Identical K123498
Dimensions	89(W) x 61(D) x 13(H) mm	Not specified	89(W) x 61(D) x 13(H) mm	Identical K123498
Weight	80g	Not specified	80g	Identical K123498

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510(k) Summary Page 5 of 7 10/2/2014

By "added" we mean that the feature was re-enabled thus restoring it to the state it was in when originally submitted under 510(k) K123498 .

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510(k) Summary Page 6 of 7 10/2/2014

Differences Between Other Legally Marketed Predicate Devices

The Omron BP652N (HEM-6300-Z) with APS is viewed as substantially equivalent to the predicate devices because: The BP652N (HEM-6300-Z) with APS 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 are identical.

Prescriptive - The BP652N (HEM-6300-Z) with APS and predicates are OTC.

Design and Technology - The BP652N (HEM-6300-Z) with APS has equivalent design and technology when compared to the predicates.

Performance and Specifications - The BP652N (HEM-6300-Z) with APS has equivalent specifications of performance compared to the predicates.

Compliance with standards - The BP652N (HEM-6300-Z) with APS and predicate device (Omron BP652N (HEM-6300-Z) K123498) declare compliance with the identical standards: 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 and are identical to Omron BP652N (HEM-6300-Z) K123498 . Section 15 contains a Materials Certification attesting to this.

Patient Population -

The BP652N (HEM-6300-Z) with APS and predicates are indicated for adults

Non-Clinical Testing Summary:

We have performed bench tests and found that the BP652N (HEM-6300-Z) with APS 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 ●
Testing for compliance to IEC 60601-1-2
Testing for compliance to AAMI SP10 ●

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510(k) Summary Page 7 of 7 10/2/2014

Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2: 2013 is documented in Section 20.

Substantial Equivalence Conclusion

Omron maintains that the BP652N (HEM-6300-Z) with APS is substantially equivalent to the predicate devices Model BP652N (HEM-6300-Z) K123498 and Braun Series BP 200 Series K003732 in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards

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).