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.

Device Description

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 an analysis of the Omron HEM-7320's acceptance criteria and the study conducted, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Omron HEM-7320 are based on industry standards for non-invasive blood pressure monitors, specifically ANSI/AAMI/ISO 81060-2 (which replaced SP10). The reported device performance is that it met all requirements.

Acceptance Criteria (Standard: ANSI/AAMI/ISO 81060-2)	Reported Device Performance
Clinical accuracy of blood pressure measurement	Met requirements

Note: The document states the device "met all requirements specifications and standards requirements and were found to be equivalent in comparison to the predicate" and "Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2 as documented in Section 20." However, specific numerical results like mean difference and standard deviation of differences as per the standard (e.g., AAMI's ±5 mmHg mean difference and 8 mmHg standard deviation for validation) are not explicitly detailed in this summary. The table infers "Met requirements" based on the general statement provided.

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

Sample Size: Eighty-five patients (40 males and 45 females) were recruited for the clinical study.
Data Provenance: Not explicitly stated regarding country of origin. The study appears to be prospective as patients were "recruited" for the study.

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

Number of Experts: Not explicitly stated, but the reference method was "Standard auscultation method." This implies human observers (clinicians/technicians) were performing the auscultation.
Qualifications of Experts: Not explicitly stated, but they would be trained in performing standard auscultatory blood pressure measurements.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly mentioned. The "Standard auscultation method" was used as the reference.
- Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm. The sequence followed AAMI guidelines. This suggests a direct comparison method rather than an adjudication process between multiple experts for the ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone accuracy of the device against a reference method (auscultation), not on how human readers' performance might improve with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Standalone Study: Yes, a standalone performance study was conducted. The clinical testing assessed the accuracy of the HEM-7320 device itself against the standard auscultation method, as per ANSI/AAMI/ISO 81060-2. This is a measure of the device's algorithmic performance.

7. Type of Ground Truth Used

Type of Ground Truth: Expert consensus via "Standard auscultation method" was used as the reference blood pressure measurement.

8. Sample Size for the Training Set

Sample Size: The document does not provide a sample size for a training set. This is a blood pressure monitor, and while it uses software and signal analysis, the typical development process for such a device (especially from 2014) would involve engineering development, calibration, and validation against a reference standard, rather than a "training set" in the machine learning sense. The clinical study described is a validation study.

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

Ground Truth Establishment for Training Set: Not applicable as a distinct training set (in the machine learning context) is not mentioned. The device's underlying algorithm is based on the oscillometric method, which is a well-established principle for blood pressure measurement, not typically "trained" on a dataset in the way an AI model would be. The clinical study serves to validate the device's accuracy against recognized standards.

Summary

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510(k) Summary Page 1 of 8 1/30/2014

MAR 0 4 2014

Omron Healthcare, Inc.1925 West Field CourtLake Forest, IL 60045 USA	Tel - 847-247-5626Fax- 847-680-6269	MAR 0 4 201
Official Contact:	Renee Thornborough – Director QA/RA
Proprietary or Trade Name:	Model HEM-7320
Common/Usual Name:	Noninvasive blood pressure measurement system.
Classification Name/Code:system.	DXN – Noninvasive blood pressure measurement21CFR 870.1130Class II
Device:	Model HEM-7320
Predicate Devices:	Omron – HEM -780N3 (HEM-7080-Z)- K061822Omron – BP742 (HEM-7200-Z) – K121932

Device Description:

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.

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.

Intended User Home user

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510(k) Summary Page 2 of 8 1/30/2014

Patient Population

This device is intended for use on adults.

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-7320was compared to the predicates HEM -780N3 (HEM-7080-Z) - K061822 and BP742 (HEM-7200-Z) - K121932 in the device comparison table below.

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evice Compariso.

Model Name:510(k) Number	Predicate DeviceHEM-780N3 (HEM-7080-Z)K061822	Predicate DeviceBP742(HEM-7200-Z)K121932	New DeviceHEM-7320TBD
Indications	The device is a digital monitor intendedfor use in measuring blood pressure andpulse rate in adult patient population witharm circumference ranging from 9 inchesto 17 inches (22 cm - 42 cm).The device detects the appearance ofirregular heartbeats during measurementand gives a warning signal with readings.This blood pressure monitor comparesaverage blood pressure results to pre-established AHA (American HeartAssociation) hypertension guideline of135/85 mmHg. The Omron 780N3 modelis not intended to be a diagnostic device.Contact your physician if hypertensivevalues are indicated.	The device is a digital monitor intendedfor use in measuring blood pressure andpulse rate in adult patient population.The device detects the appearance ofirregular heartbeats during measurementand gives a warning signal with readings.	The device is a digital monitor intendedfor use in measuring blood pressure andpulse rate in adult patient population.The device detects the appearance ofirregular heartbeats during measurementand gives a warning signal with readings.Identical to K121932
Environment of Use	Home	Home	Home Identical to both predicates
Patient Population	Adult	Adult	Adult Identical to both predicates
Specifications / Features
Measurement method /Principal of operation	HEM-7080-Z(HEM 780N3)Cuff oscillometric method	BP742(HEM-7200-Z)Cuff oscillometric method	HEM-7320Cuff oscillometric method. Identical toboth predicates
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: 0 to 299 mmHgPulse Rate: 40 to 180 beats/min.Identical to K121932
Pressure sensor	Electrostatic capacitive sensor	Semiconductor pressure sensor	Semiconductor pressure sensor. Identicalto K121932

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, Summary 1/30/2014ist d (1)0l5
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	HEM-7080-Z(HEM 780N3)	BP742(HEM-7200-Z)	HEM-7320
Applicable cuff(Arm Circumference)	22-42cm	22-42cm	22-42cm, identical to both predicates
Accuracy of pressure indicator	Within $\pm$ 3 mmHg or 2 % of reading	Within $\pm$ 3 mmHg or 2 % of reading	Within $\pm$ 3 mmHg or 2 % of readingIdentical to both predicates
Accuracy of pulse rate	Within $\pm$ 5% of reading	Within $\pm$ 5% of reading	Within $\pm$ 5% of readingIdentical to both predicates
Inflation method	Automatic by electric pump	Automatic by electric pump	Automatic by electric pump.Identical to both predicates
Deflation method	Active electronic control valve	Automatic pressure release valve	Automatic pressure release valve Identicalto K121932
Display	LCD digital display	LCD digital display	LCD digital displayIdentical to both predicates
Power Source	4"AA"batteries or AC adapter	4"AA"batteries or AC adapter	4"AA"batteries or AC adapterIdentical to both predicates
Operating conditions	10 to 40 °C (50 to 104 °F)30 to 85 %RH	10 to 40 °C15 to 90 %RH	10 to 40 °C15 to 90 %RHIdentical to K121932
Storage conditions	-20 to 60 °C10 to 95 %RH	-20 to 60 °C10 to 95 %RH	-20 to 60 °C10 to 95 %RHIdentical to K121932
Dimensions (mm)	131 (W) x 155 (D) ×84 (H) mmwithout cuff and battery	124(W)×161(D)×90(H) mm	124 (W) x 161 (D) × 90 (H) mm, size isnot a factor in function of the device
Weight	Approx. 420g(not including cuff and batteries)	Approx. 340g(not including battery)	Approx. 380g (13 3/8 oz) (not includingbattery), weight is not a factor in functionof the device.
Irregular Heart beat Feature	Yes	Yes	Yes, identical to both predicates
Body movement detection	Yes	Yes	Yes, identical to both predicates
Hypertension indicator	No	No	Yes, identical to K121932
TruRead™	Yes	Yes	Yes identical to K061822

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Technology / Features Comparisons

Technology / Features Comparison	HEM-7080-Z(HEM 780N3)	BP742(HEM-7200-Z)	HEM-7320
Power supply	Regulates power voltage regardless of battery voltage.	Regulates power voltage regardless of battery voltage.	Regulates power voltage regardless of battery voltage. Identical to both predicates
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	determines blood pressure and pulse ratecontrols the pump, the valve, and the displaydetects switch operationsstores measurement resultsmanages date and timeIdentical to both predicates
Pressure sensor	Electrostatic capacitive sensor	Semiconductor pressure sensor	Semiconductor pressure sensor, identical to K121932
Rapid exhaust valve	Active electronic control valve that performs cuff air bleeding and release	Automatic rapid air release valve.	Active electronic control valve that performs cuff air bleeding and release, identical to K061822
Deflation Valve		Automatic pressure release valve
Inflation source	DC rolling pump	DC rolling pump	DC rolling pump Identical to both predicates
Display	LCD (Liquid Crystal Display) displays;current cuff pressuresystolic blood pressurediastolic blood pressurepulse rateerror messagesmeasurement results in the memory	LCD (Liquid Crystal Display) displays;current cuff pressuresystolic blood pressurediastolic blood pressurepulse rateerror messagesmeasurement results in the memory	LCD (Liquid Crystal Display) displays;current cuff pressuresystolic blood pressurediastolic blood pressurepulse rateerror messagesmeasurement results in the memoryIdentical to both predicates
Controls	START/STOP ButtonSetting ButtonMemory buttonUser ID Selections ButtonMorning/Evening Average Buttons	START/STOP ButtonDate/Time setting ButtonUp/Down ButtonUser ID Selections Button	START/STOP ButtonDate/Time setting ButtonUp/Down ButtonUser ID Selections ButtonIdentical to K121932
			And American Manager States of State Annual Property of Children
	HEM-7080-Z(HEM 780N3	BP742(HEM-7200-Z)	HEM-7320
Cuff	between 9-17 inches(22- 42 cm). The cuff hasThe cuff is applied to the arm circumferencean elasticity board to hold the arm.A PRODUCTION CONTROLLERS CONTRACT CONTROLLETA A M A M A M A B A B A B A B A B A L A L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L	Wide Range Cuff, Standard Adult Arm Cuff ComFit Cuff(HEM-FL31) 22-42cm, new cuffLarge Cuff	to reduce dependence on bladder placementrelative to the brachial artery
Materials	Patient contact materials of the cuff havebeen cleared in the referenced 510(k)	Patient contact materials of the cuff have beencleared in the referenced 510(k)	been tested in accordance with ISO 10993 andPatient contact matcrials of the cuff haveFDA guidance
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K133383 Page 5 of 8

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510(k) Summary

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510(k) Summary Page 7 of 8 1/30/2014

Differences Between Other Legally Marketed Predicate Devices:

The Omron HEM-7320 is viewed as substantially equivalent to the predicate devices because: The HEM-7320 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-7320 and predicates are all OTC.

Design and Technology - The HEM-7320 has equivalent design and features when compared to the predicates and has the identical technology to the predicate.

Performance and Specifications - The HEM-7320 has equivalent specifications of performance when compared to the predicate.

Compliance with standards - The predicate devices declare compliance with SP10, IEC 60601-1 and IEC 60601-1-2. The HEM-7320 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-7320 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 Intracutancous Reactivity.

Patient Population -

The HEM-7320 and predicates are indicated for adults

Environment of Use - Home, Identical to the predicates

Non-Clinical Testing Summary:

We have performed bench tests and found that the HEM-7320 met all requirements specifications and standards requirements and were found to be equivalent in comparison to the predicate. Testing includes the following:

. Verification Testing to insure the device meets its specifications

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510(k) Summary Page 8 of 8 1/30/2014

Testing of hazard mitigations .
Testing for compliance to AAMI ANSI ES60601-1 .
. 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 predicates .

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 (40 males and 45 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-7320 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

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

March 4, 2014

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

Re: K133383

Trade/Device Name: HEM-7320 Regulation Number: 21 CFR 870.11307 Regulation Name: Noninvasive Blood Pressure Regulatory Class: Class II Product Code: DXN Dated: January 31, 2014 Received: November 6, 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.

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Page 2 - 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); medical device reporting of medical devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 its Internet address 796-7100 or at 638 2041 or (301) (800) http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Image /page/9/Picture/7 description: The image shows the phrase "Sincerely yours,". Below the phrase is a signature that is illegible. The signature is written in black ink. The background is white.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133383

Device Name Omron HEM-7320

Indications for Use (Describe)

K133383 Page 1 of 1

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

THE CONSULTION CONSULTION FOR FOR FOR FOR FOR CONLY CONLY - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2 - 1 - 3 -

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/10/Picture/14 description: The image shows a signature and a date stamp. The date on the stamp reads "2014.03.04" and the time is "14:53:17-05'00'". The text "for Bram Zuckerman" is printed below the date stamp.

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).