Fully Automatic Electronic Blood Pressure Monitor

K162915 · Andon Health Co, Ltd. · DXN · Feb 8, 2017 · Cardiovascular

Device Facts

• Record ID: K162915
• Device Name: Fully Automatic Electronic Blood Pressure Monitor
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Feb 8, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-7920 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

The KD-7920 is a fully automatic, wrist-worn electronic blood pressure monitor. It utilizes an inflatable cuff and an integrated silicon pressure sensor to perform oscillometric measurements during cuff deflation. The device calculates systolic and diastolic blood pressure and pulse rate, displaying results on an LCD. It includes an irregular heartbeat detection feature and a blood pressure classification indicator. Designed for use by medical professionals or patients at home, the device provides immediate feedback to the user. The output assists in monitoring cardiovascular health and tracking blood pressure trends. The device is battery-powered and portable.

Clinical Evidence

Clinical accuracy was verified by meeting Criteria 1 and 2 of ISO 81060-2. Non-clinical testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance requirements for automated noninvasive sphygmomanometers (IEC 80601-2-30).

Technological Characteristics

Oscillometric measurement principle using silicon integrated pressure sensors. Powered by 3VDC (2x AAA batteries). Wrist-worn form factor (80 x 60 x 31 mm). Conforms to IEC 60601-1, IEC 60601-1-2, and IEC 80601-2-30. Memory capacity: 4 x 30 measurements. Algorithm: Amplitude-based (same as K092510).

Indications for Use

Indicated for adult individuals requiring non-invasive measurement of systolic/diastolic blood pressure and pulse rate via a wrist-worn inflatable cuff (14cm-25cm 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

• KD-7964 Fully Automatic Electronic Blood Pressure Monitor (K102906)

Reference Devices

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

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be emerging from a single base. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 17, 2017

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

Re: K162915

Trade/Device Name: 7920 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 23, 2016 Received: December 29, 2016

Dear Liu Yi:

This letter corrects our substantially equivalent letter of February 8, 2017.

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, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

Mude Jellm
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 (if known) K162915

Device Name

7920 Fully Automatic Electronic Blood Pressure Monitor

#### Indications for Use (Describe)

KD-7920 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a noninvasive 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 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) | <span style="font-size: 20px;">☐</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☑</span> |

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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: | 9/23/2016 |

#### 2.0 Device information

| Trade name: | 7920 Fully Automatic Electronic Blood Pressure Monitor |
|-------------|--------------------------------------------------------|
|-------------|--------------------------------------------------------|

Common name: Noninvasive blood pressure measurement system

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. Device: KD-7964 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K102906

## 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-7920 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-7920, as described in its labeling are the same as the predicate device KD-7964(K102906).

## 6.0 Device description

KD-7920 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 Device (K162915) | Predicate Device (K102906) | Conclusion |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Models | KD-7920 | KD-7964 | – |
| Population | Adult | Adult | Same |
| Cuff location | Wrist | Wrist | Same |
| Indications<br>for Use | KD-7920 Fully Automatic<br>Electronic Blood Pressure<br>Monitor is for use by<br>medical professionals or<br>at home and is a<br>non-invasive blood<br>pressure measurement<br>system intended to<br>measure the diastolic and<br>systolic blood pressures<br>and pulse rate of an adult<br>individual by using a | KD-7964 Fully Automatic<br>Electronic Blood Pressure<br>Monitor is for use by<br>medical professionals or<br>at home and is a<br>non-invasive blood<br>pressure measurement<br>system intended to<br>measure the diastolic and<br>systolic blood pressures<br>and pulse rate of an adult<br>individual by using a | Same |
| | non-invasive technique in<br>which an inflatable cuff is<br>wrapped around the wrist.<br>The cuff circumference is<br>limited to 14cm-25cm. | non-invasive technique in<br>which an inflatable cuff is<br>wrapped around the wrist.<br>The cuff circumference is<br>limited to 14cm-25cm. | |
| RX or OTC | OTC | OTC | Same |
| Physical attributes | | | |
| Weight | 69.5g | 133g (w/o batteries) | The appearance of<br>the new<br>device is changed,<br>so the weight<br>and dimension are<br>also changed,<br>the electrical<br>safety test report<br>and<br>the EMC test<br>report confirm that<br>all<br>the new device is<br>as safe and<br>effective as the<br>predicate device |
| Dimensions (mm) | 80 x 60 x 31 | 90 x 68 x 30 | |
| Memory | 4 x 30 times | 2 x 60 times | The memory times<br>of the new<br>devices is<br>changed, but the<br>software validation<br>documentation<br>confirms that all<br>the new device is<br>the same effective<br>and safe as the<br>predicate device |
| Displayed and<br>calculated<br>parameters | Systolic, Diastolic, Pulse,<br>Irregular heartbeat | Systolic, Diastolic, Pulse,<br>Irregular heartbeat | Same |
| Display | LCD | LCD | Same |
| Electrical | | | |
| Power rating | 3VDC | 3VDC | Same |
| Battery | 2 x 1.5 VDC AAA size | 2 x 1.5 VDC AAA size | Same |
| Performance | | | |

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7920 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

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7920 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

| Pulse rate | 40 – 180 times/min | 40 – 180 times/min | Same |
|----------------------|-----------------------------|-----------------------------|------|
| Pulse rate accuracy | ±5% | ±5% | Same |
| BP monitoring method | Oscillometric | Oscillometric | Same |
| Measurement process | Taken during deflation | Taken during deflation | Same |
| Systolic range | 60 – 260 mmHg | 60 – 260 mmHg | Same |
| Diastolic range | 40 – 199 mmHg | 40 – 199 mmHg | Same |
| Overpressure limit | 300 mmHg | 300 mmHg | Same |
| Algorithm | Amplitude (Same as K092510) | Amplitude (same as K092510) | Same |

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

#### Non-clinical Tests have been done as follows:

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

#### Clinical Tests were done as follows:

Accuracy of the electronic blood pressure monitors was verified by meeting Criteria 1 and 2 of ISO 81060-2

None of the test demonstrates that KD-7920 Fully Automatic Electronic Blood Pressure Monitor bring new questions of safety and effectiveness.

#### 9.0 Performance summary

KD-7920 Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:

- IEC 60601-1:2005/(R)2012 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 60601-1-2:2007, Medical Electrical Equipment -- Part 1-2: General

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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
- · ISO 81060-2: Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type

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

Our device KD-7920 Fully Automatic Electronic Blood Pressure Monitor are substantially equivalent to the predicate device KD-7964 Fully Automatic Electronic Blood Pressure Monitor.

KD-7920 is very similar with its predicate device in the intended use, the design principle, the data transmission mode, the material, the performance and the applicable standards. Only their appearance, the memory capacity, the average function, the power and the MCU are different.

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

KD-7920 uses the same design principle, blood pressure cuff and same algorithm as the KD-7901 blood pressure monitor. KD-7901 is also manufactured by Andon Health Co., Ltd and has been cleared by FDA with 510K number of K092510.