Fully Automatic Electronic Blood Pressure Monitor

K183535 · Andon Health Co, Ltd. · DXN · Jun 4, 2019 · Cardiovascular

Device Facts

• Record ID: K183535
• Device Name: Fully Automatic Electronic Blood Pressure Monitor
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 4, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm.

Device Story

Wrist-worn electronic blood pressure monitor; uses oscillometric method with silicon pressure sensor; measures systolic/diastolic pressure and pulse rate during cuff deflation. Operated by medical professionals or patients at home. Device displays results on LCD; includes irregular heartbeat (IHB) detection and blood pressure classification indicator. Data stored in internal memory; provides average of measurements. Output assists clinicians and patients in monitoring cardiovascular status; supports hypertension management.

Clinical Evidence

Clinical validation performed per ISO 81060-2. Study included 85 patients (40 male, 45 female). Accuracy verified against standard auscultation reference method; met criteria 1 and 2 of ISO 81060-2.

Technological Characteristics

Oscillometric measurement via silicon pressure sensor; 3 VDC power (2x AAA batteries); LCD display; wrist cuff (14-25cm). Complies with IEC 60601-1, IEC 60601-1-2, and IEC 80601-2-30. Connectivity: None specified.

Indications for Use

Indicated for adult individuals requiring non-invasive measurement of systolic/diastolic blood pressure and pulse rate via wrist-worn inflatable cuff (14cm-25cm circumference). Suitable for use by medical professionals or home users.

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-7920 Fully Automatic Electronic Blood Pressure Monitor (K162915)

Reference Devices

• KD-7901 Fully Automatic Electronic Blood Pressure Monitor (K092510)

Submission Summary (Full Text)

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June 4, 2019

Andon Health Co., Ltd. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, 300190 CN

Re: K183535

Trade/Device Name: KD-733, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 19, 2019 Received: May 9, 2019

Dear Liu Yi:

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.

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

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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 mediation-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,

for

Matthew Hillebrenner Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K183535

Device Name

KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor

#### Indications for Use (Describe)

KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure ment system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | 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 SMDA and 21 CFR 807.92.

#### 1.0 submitter's information

| Name: | Andon Health Co., Ltd. |
|----------------------|------------------------------------------------------------|
| Address: | No 3, Jinping Street Ya An Road, Nankai District, Tianjin, |
| | P.R. China |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Preparation: | 11/28/2018 |

#### 2.0 Device information

| Trade name: | KD-753, | KD-738BR, | KD-733 | Fully | Automatic |
|-----------------------------------|---------|-----------|--------|-------|-----------|
| Electronic Blood Pressure Monitor | | | | | |

Noninvasive blood pressure measurement system Common name:

Classification name: Noninvasive blood pressure measurement system

#### 3.0 Classification

Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: II Panel: Cardiovascular

#### 4.0 Predicate device information

#### Primary Predicate:

Manufacturer: Andon Health Co., Ltd. KD-7920 Fully Automatic Electronic Blood Pressure Monitor Device: 510(k) number: K162915

#### Reference Predicate:

Manufacturer: Andon Health Co., Ltd. Device: KD-7901 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K092510

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### 5.0 Intended use

KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm.

The intended use and the indication for use of KD-753, KD-738BR, KD-733 , as described in its labeling are the same as the predicate device KD-7920(K162915).

#### 6.0 Device description

KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.

## 7.0 Summary comparing technological characteristics with predicate device

| Item | Subject<br>Device | Predicate Device | Conclusion |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Name and<br>mode | Fully Automatic Electronic<br>Blood Pressure Monitor | Fully Automatic Electronic<br>Blood Pressure Monitor | Same |
| Model | KD-753<br>KD-738BR<br>KD-733 | KD-7920 | The model is<br>different |
| Rx or OTC | OTC | OTC | Same |
| Population | Adult | Adult | Same |
| Cuff Location | Wrist | Wrist | Same |
| | | | |
| Physical Attributes | | | |
| Weight | KD-753: 71g<br>KD-738BR: 80g<br>KD-733: 78.7g | 69.5g | Changed |
| Dimensions<br>(mm) | KD-753:<br>83mm x 74mm x 26mm<br>KD-738BR:<br>83mm x 64mm x 28mm<br>KD-733:<br>87mm×66.3mm×31.5mm | 80mm x 60mm x 31mm | changed |
| Memory | 1×120 times<br>1×60 times<br>2×60 times<br>4×30 times | 4 x 30 times | Added memory<br>function on meter |
| Displayed<br>Calculated<br>Parameters | SYS<br>DIA<br>Pulse<br>IHB | SYS<br>DIA<br>Pulse<br>IHB | Same |
| Display<br>component | LCD | LCD | Same |
| Average<br>function | KD-753:<br>1.Average value of all<br>results in the current user<br>memory zone.<br>2. Average the value of<br>the latest 3 times.<br>KD-738BR: Average the<br>value of the latest 3 times.<br>KD-733: Average value of<br>all results in the current<br>user memory zone. | Average value of all the<br>results which is measured<br>from 5 o'clock to 9 o'clock<br>and 18 o'clock to 20<br>o'clock in last 7 days. | Average function<br>is different |
| Other<br>Displayed<br>Information | Date<br>Time<br>Memory<br>Battery usage<br>Blood pressure<br>classification | Date<br>Time<br>Memory<br>Battery usage<br>Blood pressure<br>classification | Same |
| Electrical | | | |
| Power | | | |
| DC Mains | 3 VDC | 3 VDC | Same |
| Battery | 2 x 1.5 VDC AAA size | 2 x 1.5 VDC AAA size | Same |
| Environmental | | | |
| Operation | | | |
| Temperature | 10~40°C | 10~40°C | Same |
| Humidity | ≤85% | ≤85% | Same |
| Environmental<br>Storage | | | |
| Temperature | -20~50°C | -20~50°C | Same |
| Humidity | ≤85% | ≤85% | Same |
| Performance<br>NIBP | | | |
| Pulse Rate<br>Range | 40 --- 180times/min | 40 --- 180times/min | Same |
| Pulse Rate<br>Accuracy | Within ±5% | Within ±5% | Same |
| Technique/Method | Oscillometric | Oscillometric | Same |
| Measure process | Measure during deflating | Measure during deflating | Same |
| Systolic Range | 60-260mmHg | 60-260mmHg | Same |
| Diastolic Range | 40-199mmHg | 40-199mmHg | Same |
| Pressure<br>Accuracy | Within ±3mmHg | Within ±3mmHg | Same |
| Cuff Pressure<br>Range | 0-300mmHg | 0-300mmHg | Same |
| Over pressure<br>Limit | 300mmHg | 300mmHg | Same |
| Algorithm | Amplitude | Amplitude | Same |

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# K183535

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# K183535

KD-753 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

#### 8.0 Discussion of non-clinical and clinical test performed

#### Non-clinical Tests

Bench testing was conducted to demonstrate that the device meets its requirements and specification. The following performance tests were completed:

a. Electromagnetic compatibility test according to IEC 60601-1-2;

b. Electrical safety according test to IEC 60601-1;

c. Safety and performance characteristics of the test according to IEC 80601-2-30

The proposed devices KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor meets all the applicable requirements.

#### Clinical Tests

Clinical test has been performed in accordance with ISO 81060-2. 85 patients

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(40 males and 45 females) were invited for the study, standard auscultation method was used as the reference blood pressure monitor measuring, and same sequential method was chosen. Accuracy of the blood pressure monitors was verified by meeting criteria 1 and criteria 2 of ISO 81060-2.

#### 9.0 Performance summary

KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:

- IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- · IEC 60601-1-2:2014,Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
- · IEC 80601-2-30:2009 & A1:2013, Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers
- ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers Part 2: Clinical validation of automated measurement type

#### 10.0 Comparison to the predicate device and the conclusion

Our device KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor are substantially equivalent to the predicate device KD-7920 Fully Automatic Electronic Blood Pressure Monitor.

The intended use, the design principle, the material of the new devices is exactly the same as the predicate device, their appearance, memory capacity, average function and MCU used is different.

However, the test in this submission provides demonstrates that these small differences do not raise any new questions of safety and effectiveness.