U80 Series Upper Arm Electronic Blood Pressure Monitor

K160019 · Shenzhen Urion Technology Co., Ltd. · DXN · Apr 22, 2016 · Cardiovascular

Device Facts

• Record ID: K160019
• Device Name: U80 Series Upper Arm Electronic Blood Pressure Monitor
• Applicant: Shenzhen Urion Technology Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The U80 Series Upper Arm Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-36 cm. Suitable for persons who over the age of 12.

Device Story

Battery-powered automatic blood pressure monitor; uses oscillometric technique via inflatable upper arm cuff. Measures systolic/diastolic blood pressure and pulse rate. Used in medical facilities or home settings by adults (age 12+). Device automatically inflates cuff, performs measurement, and displays results. User selects units (mmHg or kPa). Provides objective physiological data to assist in monitoring cardiovascular status. Models (U80A, U80AH, U80B, U80BH) differ in appearance, data storage, and time display; core measurement principle remains identical.

Clinical Evidence

Bench testing only. Compliance verified against IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ANSI/AAMI/IEC 80601-2-30 (automated sphygmomanometers), and ANSI/AAMI/ISO 81060-2 (clinical validation of automated measurement). No clinical trial data reported.

Technological Characteristics

Battery-powered (4 AA) or AC adapter; oscillometric sensing; upper arm cuff (22-36 cm circumference); digital display. Software level of concern: Moderate. Standards: IEC 60601-1:2005, IEC 60601-1-2:2007, ANSI/AAMI/IEC 80601-2-30:2009, ANSI/AAMI/ISO 81060-2:2009.

Indications for Use

Indicated for adults over age 12 with upper arm circumference of 22-36 cm for non-invasive measurement of systolic/diastolic blood pressure and pulse rate.

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

• Electronic Blood Pressure Monitor, HEM-757 (K001670)

Submission Summary (Full Text)

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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

April 22, 2016

Shenzhen Urion Technology Co., Ltd. Ms. Autumn Liu Sales Manager 4th Building, Hi-tech Industrial Zone, Heping Community, Fuyong Street, Baoan Shenzhen, 518103 CN

Re: K160019

Trade/Device Name: Upper Arm Electronic Blood Pressure Monitor U80 Series, including: U80A, U80AH, U80B, U80BH Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 28, 2015 Received: January 15, 2016

Dear Ms. Autumn Liu,

We have reviewed vour 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

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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 (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.

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stei

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

### 510(k) Number (if known) K160019

### Device Name

Upper Arm Electronic Blood Pressure Monitor U80 Series, including: U80A, U80AH, U80B, U80BH

### Indications for Use (Describe)

The U80 Series Upper Arm Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-36cm.Suitable for adults who over the age of 12.

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.

### FOR FDA USE ONLY

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

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K160019 Page 1 of 4

#### Section III 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number:

- 1. Date of Submission: Dec 28, 2015
- 2. Sponsor

Shenzhen Urion Technology Co., Ltd 4th building, Hi-tech Industrial Zone, Heping Community,Fuyong street, Baoan District, Shenzhen, Guangdong, China 518103

Establishment Registration Number: not yet;

Contact Person: MS. Autumn Liu Position: Sales Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- Submission Correspondent 3. MS. Autumn Liu Shenzhen Urion Technology Co., Ltd. 4th building, Hi-tech Industrial Zone, Heping Community, Fuyong street, Baoan District, Shenzhen, Guangdong, China 518103 Tel: [phone] Fax: [phone] Email: [e-mail]
- 4. Proposed Device Identification

Proposed Device Name: Electronic Blood Pressure Monitor;

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K160019 Page 2 of 4

Proposed Device Model: U80 Series, including: U80A, U80AH, U80B, U80BH

Classification Name: System, measurement, blood-pressure, non-invasive; Common Name: Electronic Blood Pressure Monitor; Classification: 2 Product Code: DXN; Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular;

Intended Use Statement:

The U80 Series Upper Arm Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-36 cm. Suitable for persons who over the age of 12.

- 5. Predicate Device Identification
510(k) Number: K001670 Product Name: Electronic Blood Pressure Monitor, HEM-757 Manufacturer: Omron Healthcare, Inc

- 6. Device Description
The proposed device, U80 Series Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa.

All the models included in this submission follow the same measurement principle and same specifications. The main differences are appearance, data storage and time display. These three differences will not affect the safety and effectiveness of the device.

- 7. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance.

IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

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K160019 Page 3 of 4

ANSI/AAMI/IEC 80601-2-30:2009 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.

ANSI/AAMI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.

- 8. Substantially Equivalent

| ITEM | U80 Series<br>Electronic Blood Pressure Monitor | Electronic Blood<br>Pressure Monitor<br>HEM-757, K001670 | Comparison |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Product Code | DXN | DXN | Same |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | Same |
| Class | II | II | Same |
| Intended Use | U80 Series Electronic Blood Pressure<br>Monitor is intended to measure the<br>systolic and diastolic blood pressure as<br>well as the pulse rate of adult person<br>via non-invasive oscillometric<br>technique in which an inflatable cuff is<br>wrapped around the upper arm. It can<br>be used at medical facilities or at<br>home. The intended upper arm<br>circumference is 22-36 cm. | Measure the systolic and<br>diastolic blood pressure<br>and pulse rate in adult<br>patients with arm<br>circumference between<br>7inches to 15 inches. | SE<br>Analysis 1 |
| Measurement<br>Type | Upper arm | Upper arm | Same |
| Patient<br>Population | Adults<br>Person<br>over<br>12 | Adult | Same |
| Measurement<br>Item | SYS, DYS, Pulse Rate | SYS, DYS, Pulse Rate | Same |
| Principle | Oscillometric | Oscillometric | Same |
| BP Range | 0 ~ 299 mmHg | 0 ~ 280mmHg | SE<br>Analysis 2 |
| BP Accuracy | $\u00b13$ mmHg | $\u00b13$ mmHg or 2% of reading | SE<br>Analysis 3 |
| PR Range | 40-199 bpm | 40-180 bpm | SE<br>Analysis 4 |

Table III-1 Substantially Equivalent Comparison

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| Premarket Notification 510(k) Submission | Section III 510(k) Summary | Project #: 201401K |
|------------------------------------------|----------------------------------|----------------------------------------------------|
| Cuff Size | 63 cm (length) x 14.4 cm (width) | 48 cm (length) x 14 cm (width)<br>SE<br>Analysis 1 |
| Power Supply | Four AA batteries or AC adapter | Four AA batteries or AC adapter<br>Same |
| Software Level<br>Concern | Moderate | Moderate<br>Same |

#### SE Analysis 1

The intended arm circumferences (22-36 cm VS about 17.8-38 cm) and cuff size (63 X 14.4cm VS 48 X 14 cm) of the proposed and predicate device are difference are very slight, and the cuff size is appropriate to the claimed intended arm circumference per ANSI/AAMI/IEC 80601-2-30. Therefore, this point is considered as substantially equivalent.

#### SE Analysis 2

The blood pressure measurement range of the proposed is a little larger than that of the predicate device. (0-299 mmHg VS 0-280 mmHg). But the difference parts of the range 280-299 mmHg are happened very rare and abnormal, and the range is clearly stated on the label of the container and instructions manual, the operator can select whether to use this product per the actual conditions. Therefore, this difference is considered to be not affect the substantially equivalent conclusion.

### SE Analysis 3

The blood pressure measurement accuracy of the proposed is a little different compared with that of the predicate device. (±3 mmHg VS ±3 mmHg or 2% of reading). For the predicate device's measurement accuracy with ±3 mmHg or 2% of reading, the larger shall be taken, that is, for the actual measurement range 0-300mmHg, the accuracy is more than ±3 mmHg. Therefore, this point is considered as substantially equivalent.

#### SE Analysis 4

The pulse rate measurement range of the proposed is a little different compared with that of the predicate device. (40 - 199 bpm VS 40 - 180 bpm). The difference parts, 180-199 bpm, is very rare and abnormal, and the the range is clearly stated on the label of the container and instructions manual, the operator can select whether to use this product per the actual conditions. Therefore, this difference is considered to be not affect the substantially equivalent conclusion.

The proposed device, U80 Series Upper Arm Electronic Blood Pressure Monitor, is determined to be Substantially Equivalent (SE) to the predicate device, Electronic Blood Pressure Monitor HEM-757 (k001670), in respect of safety and effectiveness.