Automatic Upper Arm Blood Pressure Monitor

K193624 · Dongguan E-Test Technology Co., Ltd. · DXN · Jul 10, 2020 · Cardiovascular

Device Facts

• Record ID: K193624
• Device Name: Automatic Upper Arm Blood Pressure Monitor
• Applicant: Dongguan E-Test Technology Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jul 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.

Device Story

Device measures systolic/diastolic blood pressure and pulse rate via non-invasive oscillometric method. Input: cuff pressure changes detected by electronic capacitive pressure sensor. Processing: sensor converts pressure alterations to electrical signals; algorithm analyzes signals to determine blood pressure and pulse rate. Output: digital display of systolic/diastolic pressure, pulse rate, date, time, WHO BP classification bar, and low battery indicator. Used in clinical or home settings by medical professionals or patients. Benefits: enables convenient, non-invasive blood pressure monitoring.

Clinical Evidence

Bench testing only. Device conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30, ISO 10993-5, ISO 10993-10, and AAMI/ANSI/ISO 81060-2.

Technological Characteristics

Materials: ABS plastic, Nylon, Latex. Sensing: Electronic capacitive pressure sensor. Energy: 6V DC (4x AA alkaline batteries). Form factor: Upper arm cuff. Connectivity: Standalone. Software: Version V01. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30, ISO 10993-5/10, AAMI/ANSI/ISO 81060-2.

Indications for Use

Indicated for adult patients to monitor and display systolic/diastolic blood pressure and pulse rate using an upper arm cuff. Intended for use by medical professionals or at home.

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

• AGE Automatic Upper Arm Blood Pressure Monitor (K172895)

Submission Summary (Full Text)

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July 10, 2020

Dongguan E-Test Technology Co., Ltd % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, 510000 CHINA

Re: K193624

Trade/Device Name: Automatic Upper Arm Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 25, 2020 Received: April 13, 2020

Dear Cassie Lee:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K193624

Device Name

Automatic Upper Arm Blood Pressure Monitor

Indications for Use (Describe)

Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.

| 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)

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## 510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

#### 1. Submitter's Information

510(k) Owner's Name: DONGGUAN E-TEST TECHNOLOGY CO., LTD

Establishment Registration Number: Applying

Address: Room 201,301, Building 1, Changping Section No.1, Dongshen Road, Changping Town, Dongguan City, Guangdong, China.

Tel: [phone]

Contact Person (including title): Victor Wan (Vice-president)

E-mail: [e-mail]

#### Application Correspondent:

Contact Person: Cassie Lee

DONGGUAN E-TEST TECHNOLOGY CO., LTD

Address: Room 201,301, Building 1, Changping Section No.1, Dongshen Road, Changping Town, Dongguan City, Guangdong, China.

Tel: [phone]

Email: [e-mail]

#### 2. Subject Device Information

Type of 510(k): Traditional

Common Name: Noninvasive blood pressure measurement systems

Classification Name: System, Measurement, Blood-Pressure, Non-Invasive

Trade Name: Automatic Upper Arm Blood Pressure Monitor

Model Name: BA-815, BA-816

Review Panel: Cardiovascular

Product Code: DXN

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Regulation Number: 870.1130

Requlatory Class: 2

#### 3. Predicate Device Information

| Sponsor | Dongguan Ageless Health Industrial Co., Ltd |
|--------------------------|------------------------------------------------------------------------------------------|
| Device Name and<br>Model | AGE Automatic Upper Arm Blood Pressure Monitor<br>Models: BA-815, BA-816, BA-818, BA-819 |
| 510(k) Number | K172895 |
| Product Code | DXN |
| Regulation<br>Number | 870.1130 |
| Regulation Class | II |

#### 4. Device Description

Automatic Upper Arm Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable cuff is wrapped around upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but using an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic and calculating pulse rate is a well-known technique in the market so called "oscillometric method". The device also has low voltage indication, which will be triggered when the battery is low.

### 5. Intended Use / Indications for Use

Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.

### 6. Test Summary

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#### K193624

The whole product and manufacturing used for the Automatic Upper Arm Blood Pressure Monitor are identical to those of the predicate device, which were demonstrated to conform with the following standards:

- � IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005 + A1:2012
- � IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and tests, 2014
- ◆ ◆ IEC 60601-1-11, Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment [Including: Technical Corrigendum 1 (2011)]
- � IEC 80601-2-30, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers
- � ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
- � ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010
- � AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type. (Cardiovascular)

### 7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Automatic Upper Arm Blood Pressure Monitor is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

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| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----|
| Company | DONGGUAN E-TEST<br>TECHNOLOGY CO., LTD | Dongguan Ageless Health<br>Industrial Co., Ltd | -- | |
| Product Name | Automatic Upper Arm Blood<br>Pressure Monitor | AGE Automatic Upper Arm Blood<br>Pressure Monitor | -- | |
| Model Name | BA-815, BA-816 | BA-815, BA-816, BA-818, BA-819 | -- | |
| Classification<br>Name | System, Measurement, Blood-<br>Pressure, Non-Invasive | System, Measurement, Blood-<br>Pressure, Non-Invasive | SE | |
| 510(k) Number | Applying | K172895 | -- | |
| Product Code | DXN | DXN | SE | |
| Intended Use /<br>Indications for<br>Use | Automatic Upper Arm Blood<br>Pressure Monitor is intended for<br>use by medical professionals or<br>at home to monitor and display<br>diastolic, systolic blood pressure<br>and pulse rate on adult each<br>time, with an air cuff buckled<br>around one's arm according to<br>the instruction in the user's<br>guide manual. | AGE Automatic Upper Arm Blood<br>Pressure Monitor is intended for<br>use by medical professionals or<br>at home to monitor and display<br>diastolic, systolic blood pressure<br>and pulse rate on adult each time,<br>with an air cuff buckled around<br>one's arm according to the<br>instruction in the user's guide<br>manual. | SE | |
| Energy source | DC 6V (4 X AA 1.5V alkaline<br>batteries) | DC 6V (4 X AA 1.5V alkaline<br>batteries) | SE | |
| Design<br>Software | Same version software | | SE | |
| ign<br>hardware | Same version hardware | | | |
| Material | ABS plastic, Nylon, Latex | ABS plastic, Nylon, Latex | SE | |
| Measurement<br>Site | Upper Arm | Upper Arm | SE | |
| Measuring range | Pressure: 0~280 mmHg<br>Pulse: 40~199 beats/minute | Pressure: 0~280 mmHg<br>Pulse: 40~199 beats/minute | SE | |
| Pressure<br>resolution | 1 mmHg or 0.1kPa | 1 mmHg or 0.1kPa | SE | |
| Measuring<br>accuracy | Pressure: ± 3mmHg<br>Pulse: ±5% | Pressure: ± 3mmHg<br>Pulse: ±5% | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict | |
| Cuff<br>Circumference | For BA-815: 22-34 cm; | For BA-815: 22-34 cm; | SE | |
| | For BA-816: 28-42 cm; | For BA-816: 28-42 cm; | | |
| | | For BA-818 and BA-819, there<br>are 6 size:<br>size A: 17cm--22cm (SMALL<br>ADULT CUFF)<br>size B: 22cm--30cm (ADULT<br>CUFF-1)<br>size C: 24cm--34cm (ADULT<br>CUFF-2)<br>size D: 22cm--42cm (L-LARGE<br>ADULT CUFF)<br>size E: 30cm--42cm (LARGE<br>ADULT CUFF)<br>size F: 42cm--50cm (EXTRA<br>LARGE ADULT CUFF) | | |
| Size and Weight<br>of model BA-815 | About 1150g (not include<br>battery)<br>(L) 235mm X (D)182mm X<br>(H)210mm | About 1150g (not include battery)<br>(L) 235mm X (D)182mm X<br>(H)210mm | SE | |
| | | | | |
| Size and Weight<br>of model BA-816 | About 1150g (not include<br>battery)<br>(L) 255mm X (D)201mm X<br>(H)228mm | About 1150g (not include battery)<br>(L) 255mm X (D)201mm X<br>(H)228mm | SE | |
| Inflation and<br>Deflation | Automatic | Automatic | SE | |
| Measuring<br>Method | Oscillometry | Oscillometry | SE | |
| Patient<br>Population | Adult | Adult | SE | |
| Display | Blood Pressure (Systolic and<br>Diastolic), Pulse, Date, Time,<br>WHO BP Classification<br>Indicating Bar, Low Battery Icon, | Blood Pressure (Systolic and<br>Diastolic), Pulse, Date, Time,<br>WHO BP Classification Indicating<br>Bar, Low Battery Icon, Heart Icon,<br>Memory Record Number | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict | |
| | Heart Icon, Memory Record<br>Number | | | |
| Software<br>Version | V01 | V01 | SE | |
| Operation<br>condition | Temperature: 5°C ~ 40°C<br>Humidity: 15~90%RH<br>Atmospheric Pressure:86 kPa~106 kPa | Temperature: 5°C ~ 40°C<br>Humidity: 15~90%RH<br>Atmospheric Pressure:86 kPa~106 kPa | SE | |
| | Transport/storage environment | Temperature: -20°C ~ +65°C<br>Humidity: 10~95%RH<br>Atmospheric Pressure:86 kPa~106 kPa | Temperature: -20°C ~ +65°C<br>Humidity: 10~95%RH<br>Atmospheric Pressure:86 kPa~106 kPa | SE |
| Safety | | IEC 60601-1<br>IEC 60601-1-11<br>IEC 80601-2-30 | IEC 60601-1<br>IEC 60601-1-11<br>IEC 80601-2-30 | SE |
| | EMC | IEC 60601-1-2 | IEC 60601-1-2 | SE |
| | Biocompatibility | ISO 10993 series | ISO 10993 series | SE |

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#### Comparison in Detail(s):

### Final Conclusion:

The subject device noninvasive sphygmomanometer (Automatic Upper Arm Blood Pressure Monitor) (Model: BA-815, BA-816) has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.

All hardware and software of the subject device are based on that of the predicate device (K172895), since no new testing is presented in the submission.

#### 8. Date of the summary prepared: July 8, 2020