Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The operational principle is based on traditional pressure sensing and calculation.

Therapeutic

No
This device is described as a non-invasive blood pressure measurement system used for monitoring, not for treating any condition.

Diagnostic

Yes

The device is intended to measure diastolic and systolic blood pressures and pulse rate, and it can detect irregular heartbeats. These activities involve obtaining information about a patient's health status, which is a form of diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Fully Automatic Electronic Blood Pressure Monitor" and describes hardware components like an inflatable cuff, pressure sensor technology, and an LCD display. It also mentions being designed and manufactured according to hardware standards like IEC 80601-2-30.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
This device's function: The description clearly states that this device is a "non-invasive blood pressure measurement system" that measures blood pressure and pulse rate by using a cuff wrapped around the wrist. This is a measurement taken on the body (in vivo), not on a specimen taken from the body.

Therefore, based on the provided information, the Fully Automatic Electronic Blood Pressure Monitor is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 wrist. The cuff circumference is limited to 14cm-25cm.

Product codes

DXN

Device Description

Fully Automatic Electronic Blood Pressure Monitor (KD-743V, KD-743B, KD-752) 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

wrist

Indicated Patient Age Range

Adult

Intended User / Care Setting

medical professionals or at home

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with IEC 60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And . A2:2010/(R)2012, IEC 60601-1-2:2014, IEC 60601-1-11 Edition 2.0 2015-01, and IEC 80601-2-30:2009 & A1:2013. None of the tests demonstrate that the new Blood Pressure Monitors raise new questions of safety and effectiveness as compared to the predicate.

Clinical Test: Comparison and evaluation are carried out between the subject device and cleared devices. The proposed devices KD-743V and KD-743B have the same algorithm and design principle as cleared device KD-7961 (K090769), so its clinical test report can be used as a reference. The proposed device KD-752 has the same algorithm and design principle as cleared device KD-972 (K121470), and so its clinical test report can be used as a reference. Accuracy of the blood pressure monitors for the clinical test report was verified by meeting criteria 1 and criteria 2 of ISO 81060-2.

Key Metrics

Not Found

Predicate Device(s)

K183535, K163276

Reference Device(s)

K090769, K121470

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 30, 2021

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

Re: K210768

Trade/Device Name: Wrist Blood Pressure Monitor, Wireless Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 24, 2021 Received: July 1, 2021

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer Shih Kozen 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) K210768

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 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)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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K210768

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,
300190, P.R. China
Phone Number:	86-22-87611660
Fax Number:	86-22-87612379
Contact:	Mr. Liu Yi
Date of Preparation:	March 1, 2021

2.0 Device Information

Device Name:	Fully Automatic Electronic Blood Pressure Monitor
Common Name:	Non-Invasive Blood Pressure Measurement System
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.	Andon Health Co., Ltd.
Device:	Fully Automatic Electronic Blood
Pressure Monitor	Wireless Blood Pressure Wrist
Monitor
510(k)
Number:	K183535	K163276
Classification	II	II
Product Code	DXN	DXN

5.0 Indications for 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 wrist. The cuff circumference is limited to 14cm-25cm.

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6.0 Device Descrintion

Fully Automatic Electronic Blood Pressure Monitor (KD-743V, KD-743B, KD-752) 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
(KD-743V,
KD-743B,
KD-752) | Predicate
Device
(KD-753
K183535) | Predicate
Device
(KD-721)
(K163276) | Comparison Result |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Name and
mode | Fully Automatic
Electronic Blood
Pressure Monitor | Fully
Automatic
Electronic
Blood Pressure
Monitor | Fully Automatic
Electronic Blood
Pressure Monitor | Same |
| Model | KD-743V, KD-743B
KD-752 | KD-753 | KD-721 | -- |
| Rx or OTC | OTC | OTC | OTC | Same |
| Population | Adult | Adult | Adult | Same |
| Cuff Location | Wrist | Wrist | Wrist | Same |
| Physical Attributes | | | | |
| Weight
(exclude
batteries and
cuff) | KD-743V: 80g
KD-743B: 78g
KD-752: 80g | 71g | About 67g | Changed |
| Dimensions | KD-743V:
87mm×66.3mm×33.3mm
KD-743B:
87mm×66.3mm×33.3mm
KD-752:
100mm×70mm×23.5mm | 83mm×74mm
×26mm | 78mm×60mm
×28mm | Changed |
| Item | Subject Device
(KD-743V,
KD-743B,
KD-752) | Predicate
Device
(KD-753
K183535) | Predicate
Device
(KD-721)
(K163276) | Comparison Result |
| Memory | KD-743V& KD-743B:
1×120 times
1×60 times
2×60 times
4×30 times

Average value of all
results in the current user
memory zone.
Average the value of
the latest 3 times

KD-752:

Average value of all
results in the current user
memory zone.
Average the value of
the latest 3 times
Average value of all
the results in last 7 days
AM
Average value of all | 1.Average
value of all
results in the
current user
memory zone.
Average the
value of the
latest 3 times | average value of
all the results
measured from 5
o'clock to 9
o'clock in last 7
days | KD-743V&
KD-743B are same
with predicate
device KD-753
KD-752 add more
functions |
| Item | Subject Device
(KD-743V,
KD-743B,
KD-752)
the results in last 7 days PM | Predicate Device
(KD-753
K183535) | Predicate Device
(KD-721)
(K163276) | Comparison Result |
| Other
Displayed
Information | Date
Time
Memory
Battery usage
Blood pressure
classification | Date
Time
Memory
Battery usage
Blood pressure
classification | Date
Time
Memory
Battery usage
Bluetooth
symbol
Blood pressure
classification
(Displayed on
device) | Similar |
| Electrical Power | | | | |
| DC Mains | 3V | 3V | 3V | Same |
| Battery | 2 ×1.5V SIZE AAA | 2 ×1.5V SIZE AAA | 2 ×1.5V SIZE AAA | Same |
| Environmental Operation | | | | |
| Temperature | 1040°C | 1040°C | 1040°C | Same |
| Humidity | ≤85% | ≤85% | ≤85% | Same |
| Environmental Storage | | | | |
| Temperature | -2050°C | -20~~50°C | -20~~50°C | Same |
| Humidity | ≤85% | ≤85% | ≤85% | Same |
| Performance NIBP | | | | |
| Pulse Rate
Range | 40 -180times/min | 40 -180times/min | 40 -180times/min | Same |
| Pulse Rate
Accuracy | Within ±5% | Within ±5% | Within ±5% | Same |
| Technique/
Method | Oscillometric | Oscillometric | Oscillometric | Same |
| Measure
process | KD-743V&
KD-743B:
Measure during deflating

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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:

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 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 80601-2-30:2009 & A1:2013,Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers

None of the tests demonstrate that the new Blood Pressure Monitors raise 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-743V and KD-743B has the same algorithm and design principle with cleared device KD-7961 (K090769), so the clinical test report of KD-7961 can be used as a reference when considering the clinical effect of KD-743V and KD-743B.

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The proposed devices KD-752 has the same algorithm and design principle with cleared device KD-972 (K121470), and so the clinical test report of KD-972 can be used as a reference when considering the clinical effect of KD-752.

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-743V, KD-743B, KD-752), is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-753 whose 510(k) number is K183535 and KD-721 whose 510(k) number is K163276.

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, the average function is different, and MCU used is different.

However, the tests in this submission demonstrates that these differences do not raise any new questions of safety and effectiveness and the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate K183535 and K163276.