Arm Blood Pressure Monitor

K222869 · Andon Health Co, Ltd. · DXN · Feb 15, 2023 · Cardiovascular

Device Facts

• Record ID: K222869
• Device Name: Arm Blood Pressure Monitor
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Feb 15, 2023
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

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 upper arm. The cuff circumference is limited to 22cm-48cm.

Device Story

Fully Automatic Electronic Blood Pressure Monitor (models KD-5811A, KD-5811V, KD-5815) measures systolic/diastolic blood pressure and pulse rate; utilizes oscillometric method with silicon integrated pressure sensor; operates by inflating cuff around upper arm and measuring pressure during deflation; displays results on LCD; includes irregular heartbeat (IHB) detection and blood pressure classification indicator; intended for home or clinical use by adults; provides data for monitoring cardiovascular health; results displayed to user for clinical decision-making support.

Clinical Evidence

No new clinical testing performed. Clinical performance relies on reference device (K083246) which shares the same algorithm and design principle. Accuracy verified against ISO 81060-2 criteria.

Technological Characteristics

Oscillometric measurement; silicon integrated pressure sensor; 4x1.5V AA battery or DC mains power; LCD display; upper arm cuff (22-48cm); compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 80601-2-30.

Indications for Use

Indicated for adult individuals requiring non-invasive measurement of systolic and diastolic blood pressure and pulse rate via an upper arm cuff (22cm-48cm circumference). Suitable 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

• Fully Automatic Electronic Blood Pressure Monitor (K210770)

Reference Devices

• Fully Automatic Electronic Blood Pressure Monitor (K083246)

Submission Summary (Full Text)

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February 15, 2023

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

Re: K222869

Trade/Device Name: 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: December 26, 2022 Received: January 4, 2023

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

Robert T. Kazmierski -S

for

LCDR Stephen Browning Assistant Director 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) K222869

Device Name

Fully Automatic Electronic Blood Pressure Monitor

Indications for Use (Describe)

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 blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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K222869

# 510(K) SUMMARY

(In accordance with 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,<br>300190, P.R. China |
| Phone Number: | 86-22-87611660 |
| Fax Number: | 86-22-87612379 |
| Contact: | Mr. Liu Yi |
| Date of Preparation: | September 15, 2022 |

#### 2.0 Device Information

| Device Name: | Fully Automatic Electronic Blood Pressure Monitor |
|----------------------|---------------------------------------------------|
| Common Name: | Arm Blood Pressure Monitor |
| Classification Name: | Non-Invasive Blood Pressure Measurement System |

#### 3.0 Classification

| Product Code: | DXN |
|--------------------|--------------------|
| Regulation Number: | 21 CFR 870.1130 |
| Classification: | II |
| Review Panel: | 870 Cardiovascular |

#### 4.0 Predicate Device Information

| Manufacturer: | Andon Health Co., Ltd. |
|----------------|---------------------------------------------------|
| Device: | Fully Automatic Electronic Blood Pressure Monitor |
| 510(k) Number: | K210770 |
| Classification | II |
| Product Code | DXN |

#### 5.0 Intended Use

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 upper arm. The cuff circumference is limited to 22cm-48cm.

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## 6.0 Device Description

Fully Automatic Electronic Blood Pressure Monitor ( KD-5811A, KD-5811V and KD-5815) 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 Comparison of Technological Characteristics with Predicate Device

The following table is the summary of the technological characteristics of the proposed subject device and predicate device.

| Item | Subject Device | Predicate Device<br>(KD-5811<br>K210770) | Comparison<br>Result |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Name and<br>mode | Fully Automatic Electronic<br>Blood Pressure Monitor | Fully Automatic Electronic<br>Blood Pressure Monitor | -- |
| Model | KD-5811A, KD-5811V,<br>KD-5815 | KD-5811 | -- |
| Rx or OTC | OTC | OTC | Same |
| Population | Adult | Adult | Same |
| Cuff<br>Location | Upper arm | Upper arm | Same |
| Physical Attributes | | | |
| Weight<br>(exclude<br>batteries and<br>cuff) | KD-5811A: About 223g<br>KD-5811V:About 239g<br>KD-5815:About 189g | About 239g | KD-5811V is<br>same with<br>predicate.<br>KD-5811A and<br>KD-5815 are<br>changed. |
| Dimensions | KD-5811A:<br>139.4mm×93.8mm×42mm<br>KD-5811V:<br>139.4mm×93.8mm×43.4mm<br>KD-5815:<br>138mm×98mm×48.9mm | 139.4mm×93.8mm×43.4mm | KD-5811V is<br>same with<br>predicate.<br>KD-5811A and<br>KD-5815 are<br>changed. |
| Memory | KD-5811A, KD-5811V:<br>2×120 times<br>2×60 times<br>2×30 times | 2×120 times<br>2×60 times<br>2×30 times | KD-5811A and<br>KD-5811V are<br>same with<br>predicate. |
| Item | Subject Device | Predicate Device<br>(KD-5811<br>K210770) | Comparison<br>Result |
| | KD-5815:<br>1×60 times | | KD-5815 is less<br>memory times<br>than predicate.. |
| Displayed<br>Calculated<br>Parameters | SYS | SYS | Same |
| | DIA | DIA | |
| | Pulse | Pulse | |
| | IHB | IHB | |
| Display<br>component | KD-5811A, KD-5811V:<br>LCD with backlight<br><br>KD-5815: LCD | LCD with backlight | KD-5811A and<br>KD-5811V are<br>same with<br>predicate.<br>KD-5815 is<br>without<br>backlight. |
| Average<br>function | 1.Average value of all results in<br>the current user memory zone.<br>2.Average the value of the latest<br>3 times. | 1.Average value of all results<br>in the current user memory<br>zone.<br>2.Average the value of the<br>latest 3 times | Same |
| Other<br>Displayed<br>Information | KD-5811A:<br>Date<br>Time<br>Memory<br>Battery usage<br>Blood pressure classification<br>Bodymove<br><br>KD-5811V:<br>Date<br>Time<br>Memory<br>Battery usage<br>Blood pressure classification<br><br>KD-5815<br>Memory<br>Battery usage<br>Blood pressure classification | Date<br>Time<br>Memory<br>Battery usage<br>Blood pressure classification | KD-5811A is<br>more function<br>than predicate.<br><br>KD-5811V is<br>same with<br>predicate.<br><br>KD-5815 is less<br>function than<br>predicate. |
| Electrical Power | | | |
| DC Mains | 5V | 6V | Changed |
| Battery | 4 ×1.5V SIZE AA | 4 ×1.5V SIZE AA | Same |
| Item | Subject Device | Predicate Device<br>(KD-5811<br>K210770) | Comparison<br>Result |
| Environmental Operation | | | |
| Temperature | 10~40°C | 10~40°C | Same |
| Humidity | <85% | <85% | Same |
| Environmental Storage | | | |
| Temperature | -20~50°C | -20~50°C | Same |
| Humidity | <85% | <85% | Same |
| Performance NIBP | | | |
| Pulse Rate<br>Range | 40 -180times/min | 40 -180times/min | Same |
| Pulse Rate<br>Accuracy | Within ±5% | Within ±5% | Same |
| Technique/<br>Method | Oscillometric | Oscillometric | Same |
| Measure<br>process | Measure during deflating | Measure during deflating | Same |
| Pressure<br>Accuracy | Within ±3mmHg | Within ±3mmHg | Same |
| Cuff | | | |
| Pressure<br>Range | 0-300mmHg | 0-300mmHg | Same |
| Overpressure<br>Limit | 300mmHg | 300mmHg | Same |
| Algorithm | Amplitude | Amplitude | Same |

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There are no significant differences between the two products and they are identical in terms of intended use, materials, design, manufacturing methods.

## 8.0 Discussion of Non-Clinical Testing

Non-clinical tests conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

- 60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And . IEC 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

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- IEC 60601-1-11 Edition 2.0 2015-01 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
- IEC 80601-2-30: Edition 2.0 2018-03 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

None of the test demonstrate that the new Blood Pressure Monitors raises new questions of safety and effectiveness as compared to the predicate.

# 9.0 Clinical Test

Comparison and evaluation are carried out between the subject device and cleared devices, and it is showed that:

The proposed devices KD-5811A, KD-5811V and KD-5815 has the same algorithm and design principle with cleared device KD-5961 (K083246), so the clinical test report of KD-5961 can be used as a reference when considering the clinical effect of KD-5811A, KD-5811V and KD-5815.

Accuracy of the blood pressure monitors for the clinical test report was verified by meeting criteria 1 and criteria 2 of ISO 81060-2.

## 10. Comparison to the Predicate Device and Conclusion

The conclusion drawn from the nonclinical tests and clinical test demonstrate that the subject device Fully Automatic Electronic Blood Pressure Monitor (KD-5811A , KD-5811V, and KD-5815) is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5811 (K210770).

The subject devices are very similar with its predicate device in the intended use, design principle, materials, performance and applicable standards. Their appearance, the memory capacity,displayed information, DC mains and MCU is different.

However, the tests in this submission demonstrates that these small differences do not raise any new questions of safety and effectiveness. And the subject device is as safe and effective as the legally marketed predicate K210770.