HEM-4030

K110501 · Omron Healthcare, Inc. · DXN · Mar 21, 2011 · Cardiovascular

Device Facts

• Record ID: K110501
• Device Name: HEM-4030
• Applicant: Omron Healthcare, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 21, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The HEM-4030 is a digital monitor intended for measuring systolic and diastolic blood pressure and pulse rate in adults. The Omron HEM-4030 is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Device Story

HEM-4030 is a non-invasive, oscillometric blood pressure monitor; user manually inflates cuff via squeeze bulb. Device powered by 2 AAA batteries. Used in home environment by patients. Input: pressure oscillations from cuff. Output: systolic/diastolic blood pressure and pulse rate displayed to user; device stores up to 21 measurements. Includes indicator for high blood pressure readings. Healthcare provider uses output to monitor patient status; device not intended for diagnosis. Modifications from predicate include updated pulse rate/pressure range, physical dimensions, packaging, and memory capacity.

Clinical Evidence

Bench testing only. Verification activities performed for all modifications, including pressure measurement accuracy, drift correction, battery indicator, memory error detection, and various error condition checks (e.g., no arm, unstable sensor, out of range). No clinical investigation required as hardware/software changes do not impact fundamental performance.

Technological Characteristics

Non-invasive oscillometric blood pressure monitor. Powered by 2 AAA batteries. Features include 21-measurement memory, high blood pressure indicator, and manual cuff inflation. Software supports updated pulse rate and pressure ranges. No changes to core blood pressure/pulse rate algorithms.

Indications for Use

Indicated for measuring systolic and diastolic blood pressure and pulse rate in adults. Not intended as a diagnostic device.

Regulatory Classification

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.

Predicate Devices

• Omron - HEM-405C - K903133

Submission Summary (Full Text)

{0}------------------------------------------------

K110501
Pi/3

## MAR 2 1 2011

510(k) Summary Page 3 of 3 3/14/2011

| Omron Healthcare, Inc.<br>1200 Lakeside Drive<br>Bannockburn, IL 60015 USA | Tel - 847-247-5626<br>Fax - 847-680-6269 |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Official Contact: | Mirna DiPano - Director, Quality & Regulatory |
| Proprietary or Trade Name: | Model HEM-4030 |
| Common/Usual Name: | Noninvasive blood pressure measurement system. |
| Classification Name/Code: | DXN -<br>Noninvasive blood pressure measurement system.<br>CFR 870.1130 |
| Device: | HEM-4030 |
| Modified Device: | Omron - HEM-405C - K903133 |

#### Device Description:

The HEM-4030 is a non-invasive blood pressure monitor that determines blood pressure by the oscillometric method. The cuff is manually inflated by the user with a squeeze bulb. The device is powered by 2 "AAA" batteries. It is a minor modification of the Omron - HEM-405C - 510(k) K903133 non-invasive blood pressure monitor.

The modifications to the device and labeling do not change the intended use of the predicate device. The modifications to the device do not alter the fundamental scientific technology. As there are no changes in hardware or software that will impact performance there is no need to validate the changes through a clinical investigation.

#### Indications for Use:

The HEM-4030 is a digital monitor intended for measuring systolic and diastolic blood pressure and pulse rate in adults.

The Omron HEM-4030 is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated

Environment of Use: Home

{1}------------------------------------------------

#### 510(k) Summary Page 2 of 3 3/14/2011

#### Contraindications

None

#### Summary of Modifications

The modifications to the device and labeling do not change the intended use of the predicate device. The modifications to the device do not alter the fundamental scientific technology. As there are no changes in hardware or software that will impact performance, there is no need to validate the changes through a clinical investigation.

#### Modifications:

- Minor changes to environmental specifications .
- . Changes to physical dimensions
- Change to packaging for the physical characteristics of the new device. .
- Change in pulse rate specification .
- . Change in pressure range
- . Change in operating humidity
- Change in weight .
- Minor changes to hardware .
- Minor changes to software in support of new pulse rate and pressure range .
- Change in cuff material .
- Stores up 21 measurements in memory .
- Electrical and mechanical changes to support change to operation on 2 "RO3" . ("AAA") batteries instead of 4 "AA" batteries.
- Indicator if blood pressure is above certain limits .

There are changes in the instructions for use to update and support the new model name and characteristics. Note there is no change in intended use, including patient population and environment of use. There is no change in contraindications.

Change to packaging for the physical characteristics of the new device.

There are no changes to the blood pressure or pulse rate algorithms.

#### Performance Testing

Verification activities, as required by the risk analysis, for the modification were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met. Table 5.1 summarizes the testing.

10501

{2}------------------------------------------------

## 10501 p 3/3

# 510(k) Summary

### Table 5.1 – Performance Testing Performed

| Parameter |
|--------------------------------------|
| Pressure Measurement Performance |
| Blood Pressure Measurement Accuracy |
| Re-inflation |
| Drift Correction |
| Battery Indicator Testing |
| Automatic Power Off |
| Clear and Display Memory |
| Memory Error Detection |
| Average Values |
| Indication of High Blood Pressure |
| Setting of pressure units of measure |
| Pressure unit of measure conversion |
| Saving units of measure |
| Communication Errors |
| RAM Testing |
| ROM Testing |
| No Blood Pressure determined |
| Blood Pressure out of range |
| Pulse Rate out of range |
| Pulse rate can't be determined |
| Deflation rate error |
| Cannot inflate cuff |
| Artifact |
| Unstable sensor |
| No arm |
| Measurement time exceeded |
| Pressure sensor errors |
| Test mode |
| Waveform checks |

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

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

MAR 2 1 2011

Re: K110501

Trade/Device Name: Omron HEM-4030 Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: February 19, 2011 Received: February 22, 2011

Dear Mr. 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.

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.

{4}------------------------------------------------

Page 2 – Mr. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

http://www.lda.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum.

Sincerely yours,

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

Enclosure

{5}------------------------------------------------

# <110501

#### Indications for Use Statement

Page 1 of 1

K110201 510(k) Number:

HEM-4030 Device Name:

Indications for Use:

The HEM-4030 is a digital monitor intended for measuring systolic and diastolic blood pressure and pulse rate in adults.

The Omron HEM-4030 is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Prescription Use or (Part 21 CFR 801 Subpart D)

Over-the-counter use X (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)

(Division Sign-Off)

/RD Zuckermar

3/21/204

Division of Cardiovascular Devices

Division of Cardiovascular Devices
510(k) Number K116501