The device is an automatic non-invasive blood pressure system. The device is battery powered and can also be powered from an IEC 60601-1 compliant AC adaptor. The device inflates a cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During deflation 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 is intended to be used with an Omron specified cuff to encompass arms ranging from 9 to 17 inches in circumference.

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

The device has provisions for selecting two users, measurements from these users are stored in memory. The memory stores up to 100 of the latest measurements. It can also display an average of the last three values.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Omron HEM-7311, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
Accuracy of pressure indicator	Within $\pm$ 3 mmHg or 2 % of reading	Within $\pm$ 3 mmHg or 2 % of reading (Identical to predicate)
Accuracy of pulse rate	Within $\pm$ 5% of reading	Within $\pm$ 5% of reading (Identical to predicate)

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

Sample Size for Test Set: 85 patients (39 males, 46 females)
Data Provenance: Not explicitly stated, but the study was conducted to demonstrate clinical accuracy based on ANSI/AAMI/ISO 81060-2. This standard is an international standard for non-invasive sphygmomanometers, suggesting the study adheres to globally recognized clinical validation protocols. The document is from Omron Healthcare, Inc., located in Lake Forest, IL, USA, but this doesn't definitively indicate the country of origin for the clinical data itself.
Retrospective or Prospective: The description "Eighty five patients... were recruited for the study" indicates a prospective study design.

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

The document states that the "Standard auscultation method was used as the reference blood pressure (BP) measuring." This implies that trained medical professionals, such as physicians or nurses, performed the auscultatory measurements and served as the 'experts' in establishing the ground truth. However, the specific number of experts and their qualifications (e.g., number of years of experience, specific certifications) are not detailed in the provided summary.

4. Adjudication Method for the Test Set

The study followed a protocol where "BP measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in AAMI." This description suggests a direct comparison method rather than a multi-reader adjudication process typically seen in image-based diagnostics. For blood pressure measurements, the auscultatory method itself is considered the "ground truth" reference, and the device's readings are compared against it. Therefore, a formal adjudication method like "2+1" or "3+1" that resolves discrepancies between multiple readers is not applicable in this context, as the reference is a clinical measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging devices where human readers interpret images with and without AI assistance. The Omron HEM-7311 is a blood pressure monitor, and its accuracy is validated directly against a reference measurement method (auscultation), not against human interpretation of an output that could be assisted by AI.

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

Yes, the clinical accuracy testing described in "Clinical Testing Summary" is a standalone evaluation of the device's algorithm performance. The device takes measurements, and its reported values are compared directly against the auscultatory reference. There is no human involved in interpreting the device's output to make a diagnosis; the device itself provides the numerical blood pressure and pulse rate readings.

7. The Type of Ground Truth Used

The ground truth used was expert clinical measurement (auscultation). The summary states: "Standard auscultation method was used as the reference blood pressure (BP) measuring in the left upper arm."

8. The Sample Size for the Training Set

The provided text does not specify a separate "training set" sample size or details about a training process for the device's algorithm. The available information describes the clinical validation study (test set). For a blood pressure monitor based on oscillometric methods, the core algorithm is typically developed and refined during the product development phase using engineering data and potentially internal, non-clinical datasets, rather than reporting a specific "training set" in the context of a 510(k) summary for clinical accuracy.

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

Since no specific "training set" or its ground truth establishment is mentioned in the provided 510(k) summary, this information is not available in the given text.

Summary

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

510(k) Summary Page 1 of 7 11/1/2013

JAN 16 2014

Omron Healthcare, Inc.1925 West Field CourtLake Forest, IL 60045 USA	Tel - 847-247-5626Fax- 847-680-6269
Official Contact:	Renee Thornborough – Director QA/RA
Proprietary or Trade Name:	Model HEM-7311
Common/Usual Name:	Noninvasive blood pressure measurement system.
Classification Name/Code:	DXN - Noninvasive blood pressure measurementsystem.21CFR 870.1130Class II
Device:	Model HEM-7311
Predicate Devices:	Omron -BP742 (HEM-7200-Z) - K121932

Device Description:

The device is intended to be used with an Omron specified cuff to encompass arms ranging from 9 to 17 inches in circumference.

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

Intended User

Home user

Patient Population

This device is intended for use on adults.

PDF PAGE 38 of 1228

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510(k) Summary Page 2 of 7 11/1/2013

Indications for Use:

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.

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-7311was compared to the predicate BP742 (HEM-7200-Z) -- K121932 in the device comparison table below.

Note that a number of documents in this submission include reference to the Cuff Wrapping Guide (or Cuff Wrapping Check). This feature has been removed from the device and is not part of this submission

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Premarket Notification 510(

Omron HEM-731

510(k) Summary

evice Compariso

	Predicate Device	New Device
Model Name:	BP742(HEM-7200-Z)	HEM-7311
510(k) Number	K121932	TBD
Indications	The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.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.The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.Identical to predicate
Environment of Use	Home	Home Identical to predicate
Patient Population	Adult	Adult Identical to predicate
Specifications / Features
Measurement method /Principal of operation	BP742(HEM-7200-Z)Cuff oscillometric method	HEM-7311Cuff oscillometric method. Identical to predicate
Measurement range	Pressure: 0 to 299 mmHgPulse Rate: 40 to 180 beats/min.	Pressure: 0 to 299 mmHgPulse Rate: 40 to 180 beats/min.Identical to predicate
Pressure sensor	Semiconductor pressure sensor	Semiconductor pressure sensor. Identical to predicate
Applicable cuff(Arm Circumference)	22-42cm	(small 17-22cm), standard (22-32cm) and (large 22-42cm), similar to predicate, additional range clinically validated
Accuracy of pressure indicator	Within $\pm$ 3 mmHg or 2 % of reading	Within $\pm$ 3 mmHg or 2 % of reading Identical to predicate
Accuracy of pulse rate	Within $\pm$ 5% of reading	Within $\pm$ 5% of readingIdentical to predicate

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

Omron HEM-731

510(k) Summary	Page 4 of 7	11/1/2012
----------------	-------------	-----------

Page 4 of 711/1/2013
	BP742(HEM-7200-Z)	HEM-7311
Inflation method	Automatic by electric pump	Automatic by electric pump.Identical to predicate
Deflation method	Automatic pressure release valve	Automatic pressure release valve Identical to predicate
Display	LCD digital display	LCD digital displayIdentical to predicate
Power Source	4"AA"batteries or AC adapter	4"AA" batteries or AC adapterIdentical to predicate
Operating conditions	10 to 40 °C15 to 90 %RH	10 to 40 °C15 to 90 %RHIdentical to predicate
Storage conditions	-25 to 60 °C10 to 95 %RH	-20 to 60 °C10 to 95 %RHsimilar to predicate
Dimensions (mm)	123(W) × 141(D) × 85 (H) mm	183 (W) × 230 (D) × 99 (H) mm, size is not a factor infunction of the device
Weight	Approx. 340g(not including battery)	Approx. 640g (22 5/8 oz) (not including battery), weight is not afactor in function of the device.
Irregular Heart beat Feature	Yes	Yes, Identical to predicate
Body movement detection	Yes	Yes, Identical to predicate
Hypertension indicator	Yes	Yes, Identical to predicate
TruRead™	No	Provides an average of 3 measurements
Technology / Features Comparison
Power supply	BP742(HEM-7200-Z)Regulates power voltage regardless of battery voltage.	HEM-7311Regulates power voltage regardless of battery voltage. Identicalto predicate
	Page 5 of 711/1/2013
	BP742(HEM-7200-Z)	HEM-7311
Microprocessor	determines blood pressure and pulse ratecontrols the pump, the valve, and the displaydetects switch operationsstores measurement resultsmanages date and time	determines blood pressure and pulse ratecontrols the pump, the valve, and the displaydetects switch operationsstores measurement resultsmanages date and time
		Identical to predicate
Pressure sensor	Semiconductor pressure sensor	Semiconductor pressure sensor, Identical to predicate
Rapid exhaust Valve	Automatic rapid air release valve.
Deflation Valve	Automatic pressure release valve	Active electronic control valve that performs cuff air bleeding andrelease, identical in function to predicate
Inflation source	DC rolling pump	DC rolling pump Identical to predicate
Display	LCD (Liquid Crystal Display) displays;	LCD (Liquid Crystal Display) displays;
	current cuff pressure	current cuff pressure
	systolic blood pressure	systolic blood pressure
	diastolic blood pressure	diastolic blood pressure
	pulse rate	pulse rate
	error messages	error messages
	measurement results in the memory	measurement results in the memory
		Identical to predicate
Controls	START/STOP ButtonDate/Time setting ButtonUp/Down ButtonUser ID Selections Button	START/STOP ButtonDate/Time setting ButtonUp/Down ButtonUser ID Selections Button
		Identical to predicate
Cuff		Wide Range Cuff, Standard Adult Arm Cuff, Large Cuff HEM-CS24 (small 17-22cm), HEM-CR24 (standard 22-32cm)and Soft Cuff HEM-RML31 (large 22-42cm)
Materials	Patient contact materials of the cuff have been clearedin the referenced 510(k)	Patient contact materials of the cuff have been tested inaccordance with ISO 10993 and FDA guidance

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

Omron HEM-7311

510(k) Summary

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510(k) Summary Page 6 of 7 11/1/2013

Differences Between Other Legally Marketed Predicate Devices:

The Omron HEM-7311 is viewed as substantially equivalent to the predicate device because: The HEM-7311 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 device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.

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 BP742 (K121932).

Prescriptive - The HEM-7311 and predicate are OTC.

Design and Technology - The HEM-7311 has equivalent design and features when compared to the predicate and has the identical technology to the predicate.

Performance and Specifications - The HEM-7311 has equivalent specifications of performance when compared to the predicate.

Compliance with standards - The predicate device complies with SP10, IEC 60601-1 and IEC 60601-1-2. The HEM-7311 complies with AAMI ANSI ES6060-1 (which replaced IEC 60601-1), IEC 60601-1-2 and ANSI/AAMI/ISO 81060-2 (which replaced SP10). The HEM-7311 also complies with IEC 80601-2-30 and IEC 60601-1-11 for home healthcare.

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-7311 and predicate are indicated for adults

Environment of Use - Home, Identical to the predicate

Non-Clinical Testing Summary: .

We have performed bench tests and found that the HEM-7311 met all requirements specifications and standards requirements and were found to be equivalent in comparison to the predicate. Testing includes the following:

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510(k) Summary Page 7 of 7 11/1/2013

Verification Testing to insure the device meets its specifications .
Testing of hazard mitigations .
Testing for compliance to AAMI ANSI ES 60601-1 .
Testing for compliance to IEC 60601-1-2 .
Testing for compliance to IEC 80601-2-30 .
Testing for compliance to IEC 60601-1-11 .
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 (39males and 46 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-7311 is substantially equivalent to the predicate device in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards

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Public Health Service

Image /page/7/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 three stripes forming its body and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

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

January 16, 2014

Omron Healthcare, Inc. c/o Paul Dryden ProMedic. Inc 24301 Woodsage Dr. Bonita Springs, FL 34134 US

Re: K133379

Trade/Device Name: Hem-7311 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 19, 2013 Received: November 20, 2013

Dear 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Paul Dryden

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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. 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 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, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page I of I

510(k) Number: (To be assigned)

Device Name:

Omron HEM-7311

Indications for Use:

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.

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)

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: 2014.01.16
10:10:39-05'00'

Page 4.2

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).