Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details standard signal processing and analysis of pulse waveform data to determine blood pressure and pulse rate, which is typical for non-AI/ML blood pressure monitors. There is no mention of AI, ML, or related concepts.

Therapeutic

No
The device is a digital monitor that measures blood pressure and pulse rate, and detects irregular heartbeats, but it does not treat or cure any condition.

Diagnostic

Yes

The device measures blood pressure and pulse rate, and it detects irregular heartbeats, which are all diagnostic indicators of a patient's health status.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components such as a battery, AC adaptor, pump, electronically controllable valve, and a cuff. While software is used for analysis, the device is not solely software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
Device Function: The device described is a blood pressure monitor. It measures blood pressure and pulse rate by applying a cuff to the arm and analyzing the pressure changes and pulse waveform. This is a non-invasive measurement performed on the living body.
Lack of Sample Analysis: The description does not mention the collection or analysis of any biological samples.

Therefore, based on the intended use and device description, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DXN

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

arm

Indicated Patient Age Range

Adult

Intended User / Care Setting

Home user, Home

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy of pressure indicator: Within 卤 3 mmHg or 2 % of reading
Accuracy of pulse rate: Within 卤 5% of reading

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K061822, K121932

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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

MAR 0 4 2014

| Omron Healthcare, Inc.
1925 West Field Court
Lake Forest, IL 60045 USA | Tel - 847-247-5626
Fax- 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 measurement
21CFR 870.1130
Class II | |
| Device: | Model HEM-7320 | |
| Predicate Devices: | Omron – HEM -780N3 (HEM-7080-Z)- K061822
Omron – BP742 (HEM-7200-Z) – K121932 | |

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.

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

1

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.

2

evice Compariso.

| Model Name:
510(k) Number | Predicate Device
HEM-780N3 (HEM-7080-Z)
K061822 | Predicate Device
BP742(HEM-7200-Z)
K121932 | New Device
HEM-7320
TBD |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | 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 inches
to 17 inches (22 cm - 42 cm).
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 guideline of
135/85 mmHg. The Omron 780N3 model
is not intended to be a diagnostic device.
Contact your physician if hypertensive
values are indicated. | 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 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-7320
Cuff oscillometric method. Identical to
both predicates |
| Measurement range | Pressure: 0 to 294 mmHg
Pulse Rate: 40 to 180 beats/min. | Pressure: 0 to 299 mmHg
Pulse Rate: 40 to 180 beats/min. | Pressure: 0 to 299 mmHg
Pulse Rate: 40 to 180 beats/min.
Identical to K121932 |
| Pressure sensor | Electrostatic capacitive sensor | Semiconductor pressure sensor | Semiconductor pressure sensor. Identical
to K121932 |

PDF Page 21 of 158

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| , Summary 1/30/2014
ist d (1)0
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5
---------------------------------------------

	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 reading
Identical to both predicates
Accuracy of pulse rate	Within $\pm$ 5% of reading	Within $\pm$ 5% of reading	Within $\pm$ 5% of reading
Identical 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 Identical
to K121932
Display	LCD digital display	LCD digital display	LCD digital display
Identical to both predicates
Power Source	4"AA"batteries or AC adapter	4"AA"batteries or AC adapter	4"AA"batteries or AC adapter
Identical to both predicates
Operating conditions	10 to 40 °C (50 to 104 °F)
30 to 85 %RH	10 to 40 °C
15 to 90 %RH	10 to 40 °C
15 to 90 %RH
Identical to K121932
Storage conditions	-20 to 60 °C
10 to 95 %RH	-20 to 60 °C
10 to 95 %RH	-20 to 60 °C
10 to 95 %RH
Identical to K121932
Dimensions (mm)	131 (W) x 155 (D) ×84 (H) mm
without cuff and battery	124(W)×161(D)×90(H) mm	124 (W) x 161 (D) × 90 (H) mm, size is
not 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 including
battery), weight is not a factor in function
of 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

Page 4

PDF Page 22 of 158

4

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 rate
controls the pump, the valve, and the display
detects switch operations
stores measurement results
manages date and time	determines blood pressure and pulse rate
controls the pump, the valve, and the display
detects switch operations
stores measurement results
manages date and time	determines blood pressure and pulse rate
controls the pump, the valve, and the display
detects switch operations
stores measurement results
manages date and time
Identical 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 pressure
systolic blood pressure
diastolic blood pressure
pulse rate
error messages
measurement results in the memory	LCD (Liquid Crystal Display) displays;
current cuff pressure
systolic blood pressure
diastolic blood pressure
pulse rate
error messages
measurement results in the memory	LCD (Liquid Crystal Display) displays;
current cuff pressure
systolic blood pressure
diastolic blood pressure
pulse rate
error messages
measurement results in the memory
Identical to both predicates
Controls	START/STOP Button
Setting Button
Memory button
User ID Selections Button
Morning/Evening Average Buttons	START/STOP Button
Date/Time setting Button
Up/Down Button
User ID Selections Button	START/STOP Button
Date/Time setting Button
Up/Down Button
User ID Selections Button
Identical 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 has
The cuff is applied to the arm circumference
an elasticity board to hold the arm.
A PRODUCTION CONTROLLERS CONTRACT CONTROLLET
A 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 cuff
Large Cuff	to reduce dependence on bladder placement
relative to the brachial artery
Materials	Patient contact materials of the cuff have
been cleared in the referenced 510(k)	Patient contact materials of the cuff have been
cleared in the referenced 510(k)	been tested in accordance with ISO 10993 and
Patient contact matcrials of the cuff have
FDA guidance
	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

K133383 Page 5 of 8

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Page 5

5

510(k) Summary

Page 6

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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

7

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

8

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.

9

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

10

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)

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.

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)

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