QARDIOARM

K140067 · Qardio, Inc. · DXN · Jun 18, 2014 · Cardiovascular

Device Facts

• Record ID: K140067
• Device Name: QARDIOARM
• Applicant: Qardio, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

QardioArm, model A100 is a fully automatic, non-invasive, wireless blood pressure monitor. QardioArm, model A100 is a blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual. QardioArm, model A100 utilizes an inflatable cuff that is wrapped around the upper arm. This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to 22cm-37cm (8.7in -14.6in)

Device Story

QardioArm (model A100) is a non-invasive, wireless blood pressure monitor; measures systolic/diastolic blood pressure and pulse rate via oscillometric method. Device consists of a plastic enclosure with an integrated wraparound cuff; requires external smartphone/tablet for user interaction and result display. Operates by sensing pulse signal vibrations in a closed air pipe system; microcomputer processes signals to determine pressure values. Used by adult patients in home or clinical settings. Bluetooth 4.0 (BLE) transmits data to external device. Healthcare providers or patients view results on the paired device; output supports monitoring of blood pressure trends. Benefits include convenient, wireless, automated blood pressure tracking.

Clinical Evidence

Bench testing only. Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance standards (ANSI/AAMI ISO 81060-2:2009, EN 1060-4:2004) demonstrated. No clinical trial data provided.

Technological Characteristics

Oscillometric measurement; semiconductor gauge sensor; active electronic control valve for air release. Powered by 4x AAA alkaline batteries. Wireless connectivity via Bluetooth V4.0 (BLE). Cuff size 22-37cm. Materials include woven cotton sheeting. Standards: IEC 60601-1, EN 1060-1, EN 1060-3, IEC 60601-1-2, ANSI C63.4.

Indications for Use

Indicated for adult individuals to measure diastolic and systolic blood pressure and pulse rate via an upper arm inflatable cuff. Not for diagnostic use. Cuff circumference 22-37cm.

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

• KD-936 Fully Automatic Wireless Blood Pressure Monitor (K120672)
• Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W (K121025)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

(According to 21 CFR 807.92)

# 510(k) Summary for ___________________________________________________________________________________________________________________________________________________________

## Submitter's information

| Name | : Qardio, Inc. |
|--------------|-------------------------------------------------|
| Address | : 340 S Lemon Ave #1104F, Walnut, CA 91789, USA |
| Phone number | : +1-[phone] |
| Fax number | : +1-[phone] |

### Manufacturer's name

| Name | : YA HORNG ELECTRONIC CO., LTD. |
|---------------------|-----------------------------------------------------------------------------------------------|
| Address | : No.35, Shalun, Anding Dist., Tainan City 745, Taiwan (R.O.C.) |
| FDA Registration | : # 3001147827 |
| 510k Contact person | : Dr. Jen, Ke-Min<br>Tel: [phone] Fax:[phone]<br>Email: [e-mail] |

Date of preparation: December 29, 2013

## Device name

| Trade name : | QardioArm |
|---------------|------------------------|
| Device name : | QardioArm, model A100 |
| Common name : | Blood Pressure Monitor |

### Classification

| Classification name | : Non-Invasive Blood Pressure Monitoring System |
|---------------------|-------------------------------------------------|
| Regulation number | : 21CFR Section 870.1130 |
| Class | : II (Two) performance standards |
| Specialty | : Cardiovascular |
| Product code | : DXN |

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| Predicate devices |
|--------------------------------------------------------------------|
| • KD-936 Fully Automatic Wireless Blood Pressure Monitor (K120672) |
| • Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth |
| • Transmission BP-700W (K121025) |

#### Device Information

-

Device description : QardioArm, model A100 measures both systolic and diastolic blood pressure and heart pulse rate via a standard oscillometric method. The oscillometric method senses the vibrating signal via the closed air pipe system and utilizes a microcomputer to automatically sense the characteristics of the pulse signal. Unlike with the traditional measuring method, based on the Korotkov sound, with the oscillometric method the use of a stethoscope is not required. Through simple calculations, this method provides accurate blood pressure readings: the systolic pressure is defined as the blood pressure when the cuff pressure oscillating amplitude begins to increase, while the diastolic blood pressure is defined as the pressure when the cuff pressure oscillating amplitude stops decreasing.

> The device includes a plastic enclosure and an integrated wraparound cuff, and it requires an external device (e.g. a smartphone) to display results and perform user interaction.

Indication for use

:

QardioArm, model A100 is a fully automatic, non-invasive, wireless blood pressure monitor. QardioArm, model A100 is a blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual. QardioArm, model A100 utilizes an inflatable cuff that is wrapped around the upper arm.

This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to 22cm-37cm (8.7in -14.6in)

#### Test Summary:

- 1. ELECTRIC SAFETY, EMC and FCC test reports,

| General safety | IEC 60601-1:2005 | PASS |
|----------------|--------------------------------|------|
| | EN 1060-1:2002, EN 1060-3:2005 | PASS |
| EMC conformity | IEC 60601-1-2: 2007 | PASS |
| FCC conformity | ANSI C63.4 | PASS |

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### 2. WOVEN COTTON SHEETING:

(Same as the predicate devices: YA HORNG Upper Arm Blood Pressure Monitor, Bluetooth Transmission; Type: BP700W, K121025)

Uses the 510K Blood-Pressure Cuff: YA HORNG Blood-Pressure Cuff (K051539).

### 3. PERFORMANCE & CLINICAL TEST

ANSI/AAMI ISO 81060-2:2009

EN 1060-4:2004

### Comparison with predicate device and conclusion

| Comparison item | Proposed device | Predicate device | Predicate device |
|----------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Applicant | Qardio, Inc. | YA HORNG Electronic Co., Ltd. | Andon Health Co., Ltd. |
| Trade name | QardioArm | YA HORNG Upper Arm Blood<br>Pressure Monitor, Bluetooth<br>Transmission | iHealth BP5 Fully Automatic<br>Arm Cuff Wireless Blood<br>Pressure Dock |
| Model name | A100 | BP700W | KD-936 |
| 510K number | New listing | K121025 | K120672 |
| Technological<br>characteristics | Oscillometric method | Oscillometric method | Oscillometric method |
| Measuring method | Oscillometric method,<br>automatic inflation and<br>measurement | Oscillometric method,<br>automatic inflation and<br>measurement | Oscillometric method,<br>automatic inflation and<br>measurement |
| Sensor | Semiconductor gauge sensor | Semiconductor gauge sensor | Semiconductor gauge sensor |
| Rapid air release | By an active electronic control<br>valve | By an active electronic control<br>valve | By an active electronic control<br>valve |
| Pressure accuracy | Pressure: ±3mmHg or ±2% of<br>readout value | Pressure: ±3mmHg or ±2% of<br>readout value | Pressure: ±3mmHg |
| Pulse accuracy | ±5% of reading value | ±5% of reading value | ±5% of reading value |
| System architecture | Requires an external device to<br>constitute a complete blood<br>pressure measurement system | Independent operation | Requires an external device to<br>constitute a complete blood<br>pressure measurement system |
| Display and user<br>interaction | Requires an external device to<br>display results and perform<br>user interaction | LCD monitor and personal<br>computer | Requires an external device to<br>display results and perform<br>user interaction |
| Power source | Disposable 4 x AAA alkaline<br>batteries | Disposable 4 x AAA alkaline<br>batteries | Rechargeable batteries (Li-Ion<br>400 mAh) |
| Communication: | Wireless, based on Bluetooth<br>V4.0 (Bluetooth Low Energy) | Wireless, based on Bluetooth<br>V2.0 | Wireless, based on Bluetooth<br>V3.0 + EDR |
| Cuff type and size | Upper arm type, size: 22 to<br>37cm | Upper arm type, size: 23 to<br>33cm | Upper arm type, size: 22 to<br>48cm |
| Operating temp.<br>and humidity | 10 to 40°C, 15 to 90% RH,<br>atmospheric 86Kpa to 106kpa,<br>altitude: 2000m | 10 to 40°C, 15 to 90% RH,<br>atmospheric 86kpa to 106kpa,<br>altitude: 2000m | 5 to 40°C, < 90 %RH |
| Storage temp. and<br>humidity | -25 to 70°C, 10 to 95% RH,<br>atmospheric 86Kpa to 106kpa,<br>altitude: 2000m | -25 to 70°C, 10 to 95% RH,<br>atmospheric 86Kpa to 106kpa,<br>altitude: 2000m | -20 to 55°C < 90 %RH |

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#### Summary with predicate device and conclusion

The new device, QardioArm, model A100 is substantially equivalent to the KD-936 Fully Automatic Wireless Blood Pressure Monitor (K120672) and the YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W (K121025).

YA HORNG Electronic Co., Ltd. (FDA owner number 9040892) is the manufacturer of the QardioArm, model A100 and the predicate device YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W (K121025). Furthermore, the QardioArm, model A100 and the predicate device YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W share the same design specifications.

The intended use and the indications for use of the QardioArm, model A100 as described in its labeling are the same as the two predicate devices and all three devices are intended to be used in the same manner and environments.

The QardioArm, model A100 and the predicate devices are substantially equivalent in the technological characteristics of patient contact materials, performance, biocompatibility function, mechanical safety, standards met, electrical safety, and EMC.

Only the user interface and visual appearance, and the cuff size for the new device and the predicate devices are different. The QardioArm, model A100 and the two predicate devices use Bluetooth technology for wireless communications with an external device. However, QardioArm, model A100 uses Bluetooth V4.0 (Bluetooth Low Energy) to operate with wireless communications with an iPhone, iPod or iPad, while the KD-936 Fully Automatic Wireless Blood Pressure Monitor uses Bluetooth V3.0+EDR to operate with wireless communications with an iPhone, iPod or iPad, and the YA HORNG Upper Arm Blood Pressure Monitor, Bluetooth Transmission BP-700W uses Bluetooth V2.0 to operate with wireless communications with a personal computer.

Thus they are substantially equivalent.

Qardio, Inc. believes this information and the referred documentation to be sufficient for the FDA to find our proposed device substantially equivalent to the predicate products and other products currently in distribution.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 18, 2014

Qardio, Inc. c/o Dr. Jen, Ke-Min 340 S Lemon Ave #1104F Walnut, CA 91789 USA

Re: K140067

Trade/Device Names: QardioArm, Model A100 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: May 3, 2014 Received: May 9, 2014

Dear Dr. Jen:

i

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. Ilsting 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 - Dr. Jen. Ke-Min

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

Sincerely yours,

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

510(k) Number: K140067 Device Name: QardioArm, model A100

. Indications for use:

QardioArm, model A100 is a fully automatic, non-invasive, wireless blood pressure monitor. QardioArm, model A100 is a blood pressurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual. QardioArm, model A 100 utilizes an inflatable cuff that is wrapped around the upper arm.

This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to 22cm-37cm (8.7in~14.6in).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Us e _

(21 CFR 807 Subpart C)

t 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

ConcurrenceofCDRH,OfficeofDeviceEvaluation(ODE)

| Date | 2017.05.18 |
|------|------------------|
| | 07:30:53 -04'00' |

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