K Number

Device Name

Automatic Arm Electronic Blood Pressure Monitor

Manufacturer

Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.

Date Cleared

2021-05-12

(89 days)

Product Code

DXN

Regulation Number

870.1130

Intended Use

The device is a digital monitor intended to measure the diastolic, systolic blood pressures and pulse rate in adult patient population by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm of which the circumference includes 22 cm to 32 cm (8.7 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches). It can be used in hospital environment or at home.

Device Description

The Automatic Arm Electronic Blood Pressure Monitor, including LBP70C and LBP70D, can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult patient with arm circumference ranging from 22 cm to 32 cm (8.7 inches to 12.6 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches) by the oscillometric technique. User can select the blood pressure unit mmHg or KPa. The device has irregular heat beat (IHB) indicator which can indicate a rhythm 25% less or 25% more than the average rhythm detected while measuring the systolic and diastolic blood pressure. The subject device consists of the PCBA, pressure sensor, operation keys, pump, control valve, LCD screen, cuff, batteries and optional accessory AC adapter. The two models have same intended use, working principle, measuring range, accuracy, cuff, component and appearance. They are only different in power supply. Model LBP70C is powered by 4 AA alkaline batteries or AC adapter, while model LBP70D is powered by rechargeable lithium-polymer battery or AC adapter. The device has a memory function that can automatically store up to 90 sets of data for each user. It can also display the latest measurement result.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K183058

Reference Devices

K192609

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard oscillometric blood pressure measurement technology and does not mention any AI or ML components. The "irregular heat beat (IHB) indicator" is a rule-based feature, not indicative of AI/ML.

Therapeutic

No.
The device is a digital monitor for measuring blood pressure and pulse rate, not for providing therapy.

Diagnostic

Yes

Explanation: The device is intended to measure diastolic and systolic blood pressures and pulse rate, which are physiological parameters used to assess a patient's health status and can indicate medical conditions like hypertension or hypotension. The "Irregular Heart Beat (IHB) indicator" also suggests it provides information that can be used directly for diagnostic purposes (identifying potential arrhythmias).

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as PCBA, pressure sensor, operation keys, pump, control valve, LCD screen, cuff, batteries, and AC adapter.

IVD (In Vitro Diagnostic)

Based on the provided information, 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 for diagnosis, monitoring, or screening.
Device Function: The described device is a blood pressure monitor that measures blood pressure and pulse rate non-invasively by wrapping a cuff around the upper arm. It does not analyze any specimens taken from the body.
Intended Use: The intended use is to measure blood pressure and pulse rate in adult patients, not to analyze biological samples.

Therefore, this device falls under the category of a non-invasive medical device rather than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DXN

Device Description

The device has irregular heat beat (IHB) indicator which can indicate a rhythm 25% less or 25% more than the average rhythm detected while measuring the systolic and diastolic blood pressure.

The subject device consists of the PCBA, pressure sensor, operation keys, pump, control valve, LCD screen, cuff, batteries and optional accessory AC adapter. The two models have same intended use, working principle, measuring range, accuracy, cuff, component and appearance. They are only different in power supply. Model LBP70C is powered by 4 AA alkaline batteries or AC adapter, while model LBP70D is powered by rechargeable lithium-polymer battery or AC adapter.

The device has a memory function that can automatically store up to 90 sets of data for each user. It can also display the latest measurement result.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper arm

Indicated Patient Age Range

Adult

Intended User / Care Setting

It can be used in hospital environment 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench test: Were conducted to verify that the subject device met all design specifications, as was Substantially Equivalent (SE) to the predicate device.
Biocompatibility Testing: The Automatic Arm Electronic Blood Pressure Monitor was assessed against the International Standard ISO 10993-1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." The subject device would be classified as a Surface Medical Device in contact with the intact skin for a Limited Duration (

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

Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

May 12, 2021

Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. % Arthur Goddard President FDA Regulatory and Quality Systems Consultant 31853 Cedar Road Mayfield Heights, Ohio 44124-4445

Re: K210435

Trade/Device Name: Automatic Arm 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 8, 2021 Received: February 12, 2021

Dear Arthur Goddard:

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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Quality Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K210435

Device Name

Automatic Arm Electronic Blood Pressure Monitor

Indications for Use (Describe)

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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Section 5: 510(K) Summary

This summary of 510(K) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1900 and 21 CFR 807.92.

The assigned 510(K) Number: K210435

5. 510(K) Summary

5.1. Date of Preparation: February 8th, 2021

5.2. Sponsor

Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. North side of floor 3, BLD 9 BaiWangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District 518055 Shenzhen, Guangdong, CHINA. Tel: + 86-0755-86952278 Fax: + 86-0755-86952287

Contact Person: Aaron Lin Position: General Manager Email: aaron.lin@lepu-medical.com

5.3. Official Correspondent

Mr. Arthur Goddard 31853 Cedar Road, Cleveland, Ohio, 44124-4445, U.S.A. Tel: (216) 233-5722 Email: asjgoddard@aol.com

5.4. Subject Device Identification

Subject Device Name: Automatic Arm Electronic Blood Pressure Monitor Model: LBP70C, LBP70D Common name: Noninvasive Blood Pressure Measurement System Classification Name(s): Noninvasive Blood Pressure Measurement System Product Code: DXN Regulation Number: 21 CFR 870.1130 Review Panel: Cardiovascular Classification: II

5.5. Predicate Device

510(k) Number: K183058 Device Name: Arm-type Electronic Blood Pressure Monitor Manufacturer: Shenzhen BSX Technology Electronics Co., Ltd.

5.6. Indications for use

The device is a digital monitor intended to measure the diastolic, systolic blood pressures and pulse rate in adult patient population by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm of which the circumference includes 22 cm to 32 cm (8.7 inches to 12.6 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches). It can be used in hospital environment or at home.

5.7. Device Description

The device has irregular heat beat (IHB) indicator which can indicate a rhythm 25% less or 25% more than the average rhythm detected while measuring the systolic and diastolic blood pressure.

The device has a memory function that can automatically store up to 90 sets of data for each user. It can also display the latest measurement result.

5.8. Predicate Devices and Subject Device Comparison

Table 5-1 Feature Comparison with Predicate Devices
Item	Subject Device	Predicate Device
K183058	Remark
Product Name	Automatic Arm Electronic
Blood Pressure Monitor	Arm-type Electronic Blood
Pressure Monitor	SE
Product Code	DXN	DXN
Regulation
Number	21 CFR 870.1130	21 CFR 870.1130
Classification
Name(s)	Noninvasive Blood Pressure
Measurement System	Noninvasive Blood Pressure
Measurement System
Classification	II	II
Indications for	The device is a digital monitor	The blood pressure monitor	Discussion 1
Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.		Traditional 510(k) Premarket Notification
Item	Subject Device	Predicate Device
K183058	Remark
use	intended to measure the
diastolic, systolic blood
pressures and pulse rate in
adult patient population by
using a non-invasive
oscillometric technique in
which an inflatable cuff is
wrapped around the upper
arm of which the
circumference includes 22 cm
to 32 cm (8.7 inches to 12.6
inches) or 22 cm to 42 cm
(8.7 inches to 16.5 inches). It
can be used in hospital
environment or at home.	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
oscillometric technique in
which an inflatable CUFF is
wrapped around the arm of
which the circumference
includes 22 cm~32 cm. It is
intended to be used in
hospital environment or at
home.
Discussion 1:
The indications for use of the subject device and predicate device are compared from the
following aspects:
Item	Subject Device	K183058	Discussion
Intended
patient
population	Adult	Adult	SE
Intended
application
site	Upper arm	Upper arm	SE
Intended use
environment	hospital or home	hospital or home	SE
Measurement
Principle	non-invasive oscillometric	non-invasive oscillometric	SE
Arm
Circumference	22 cm~~32 cm or 22 cm~~42 cm	22 cm~32 cm	A
Basic
functions	Measure the diastolic, systolic
blood pressures and pulse rate	Measures the diastolic and
systolic blood pressures and
pulse rate	SE
A. The subject device and the predicate device are different in arm circumference. The

Table 5-1 Feature Comparison with Predicate Devi

22-32cm of the arm circumference of subject device is substantially equivalent to the predicate device, and the 22-42cm of the arm circumference of subject device is substantially equivalent to the reference device (K192609, produced by Globalcare Medical

------	----------------	-----------------------------	--------

Technology Co., Ltd). Additionally, LEPU Intelligent Medical has verified the accuracy of the measurement within 22-32cm and 22-42cm of the arm circumference accordance to the requirements of ISO 81060-2, and the results meet the requirements. Please refer to Section 20 for details. So, the difference does not raise any new issues of safety or efficacy.

Per the comparison and discussion above, the subject device and predicate device have same intended patient population, intended application site, intended use environment, measurement principle and basic functions. Arm circumference of the subject and the predicate device are substantially the same. Therefore, the noted difference in indications for use does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.

------------------------	-------------------------------------------------------	------------------	--------------

Discussion 2:

The cuff of the two devices are made of same materials of the enclosure of the predicate device are not mentioned. The materials used in subject device have excellent performance and safety, and can meet the requirements of the device for the material. The biological safety of all the materials has been verified, including cytotoxicity, sensitization and irritation tests. The test results meet the requirements of the ISO10993 series of standards. Please refer to Section 15 for detail. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.

| Power Source | 4x1.5V AA alkaline batteries
or AC adapter (LBP70C)
3.7V 2200mAh Rechargeable
lithium battery or AC adapter
(LBP70D) | 4x1.5V AAA Alkaline
Battery (BSX516, BSX525,
BSX583, BSX593 and
BSX595)
3.7V 400mAh Li-ion
Battery (BSX523) | Discussion 3 |

--------------	----------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------	--------------

Discussion 3:

The subject device and the predicate device are different in power source. For the alkaline battery power supply method, although the power supply battery model is different, the voltage of the two devices is both 6V. For the lithium battery power supply method, the voltage of the two devices is both 3.7V. The battery capacity of the subject device is 2200mAh, which is better than the 400mAh of the predicate device. Regardless of the power supply method, the voltage of the two devices is the same, so the difference does not raise any new issues of safety. Additionally, LEPU Intelligent Medical has verified the power source requirements of the device in accordance with the requirements in IEC 80601-2-30 and IEC 60601-1, and the results meet the requirements. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate

Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.		Traditional 510(k) Premarket Notification
Item	Subject Device	Predicate Device	Remarks
Item	Subject Device	Predicate Device	Remark
		K183058
device

| Item | Subject Device | Predicate Device
K183058 | Remark | |
|----------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------|
| Measurement
Range | Blood
Pressure | Static pressure:
0280 mmHg/
037.3 kPa;
SYS:(60255)
mmHg/
(8.034.0) kPa
DIA: (30195)
mmHg/
(4.026.0) kPa | Blood
Pressure
0-299mmHg | Discussion 4 |
| | Pulse rate | 40 to 199 bpm | Pulse rate
40 to 180 bpm | |

Discussion 4:

The subject device and predicate device are different in measurement range.

The blood pressure measurement range (0~~280mmHg) of subject device is within that of predicate device (0~~299mmHg). According to the table below, the systolic and diastolic blood pressure measurement range can meet the requirement of IEC 80601-2-30.

Item	IEC 80601-2-30 Requirement	Subject Device
Systolic
blood
pressure	At least
60~230mmHg	60~255mmHg	Meet the requirement
Diastolic
blood
pressure	At least
40~130mmHg	30~195mmHg	Meet the requirement

The PR measurement range of the subject device is 40~~199bpm, which is greater than the 40~~180bpm of the predicate device. For this reason, LEPU Intelligent Medical has verified the accuracy of the measurement within the measurement range, and the results meet the requirements, please refer to Section 18 for details. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.

| Accuracy | Blood
Pressure | $\pm 3 mmHg$ /
$\pm 0.4 kPa$ | Blood
Pressure | $\pm 3 mmHg$ | SE |
|--------------------------|-------------------|---------------------------------|-------------------|--------------|--------------|
| | Pulse rate | $\pm 5%$ | Pulse rate | $\pm 5%$ | |
| Operating
Temperature | 5°C~~40°C | | 5°C~~40°C | | Discussion 5 |
| Operating | 15%RH~~85%RH | | 15%RH~~85%RH | | |

Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.	Traditional 510(k) Premarket Notification
-------------------------------------------------------	-------------------------------------------

| Item | Subject Device | Predicate Device
K183058 | Remark |
|--------------------------------------|-----------------|-----------------------------|--------|
| humidity | | | |
| Operating
atmospheric
pressure | 70 kPa ~~106 kPa | 80 kPa~~106kPa | |
| Storage
temperature | -20°C~~55°C | -20°C~~55°C | |
| Storage humidity | ≤93%RH | 10%RH~93%RH | |
| Storage
atmosphere
pressure | 50 kPa ~~106kPa | 70 kPa~~106kPa | |

Discussion 5:

The subject device and the predicate device are different in operating/storage atmospheric pressure and storage humidity. LEPU Intelligent Medical has verified the environmental requirements of the device in accordance with the requirements in IEC 80601-2-30, and the results meet the requirements. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.

Table 5-3 Performance and Safety Comparison
Item	Subject Device
Finger pulse oximeter	Predicate Device
K161560
Fingertip Pulse Oximeter	Remark
Particular
requirements for
basic safety and
essential
performance	Meeting the requirements of
IEC 80601-2-30	Meeting the requirements
of IEC 80601-2-30	SE
Electrical Safety	Meeting the requirements of
IEC 60601-1 and IEC
60601-1-11	Meeting the requirements
of IEC 60601-1 and IEC
60601-1-11	SE
Electromagnetic
Compatibility	Meeting the requirements of
IEC 60601-1-2	Meeting the requirements
of IEC 60601-1-2	SE
Biocompatibility	Meeting the requirements of
ISO 10993-1, ISO 10993-5,
ISO 10993-10	Meeting the requirements
of ISO 10993-1, ISO
10993-5, ISO 10993-10	SE
Clinical study	Meeting the requirements of
ISO 81060-2	Meeting the requirements
of ISO 81060-2	SE

Table 5-3 Performance and Safety Comparison

5.9. Performance Tests Summary

Bench test were conducted to verify that the subject device met all design specifications, as was Substantially Equivalent (SE) to the predicate device.

A Biocompatibility Testing

The Automatic Arm Electronic Blood Pressure Monitor was assessed against the International Standard ISO 10993-1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." The subject device would be classified as a Surface Medical Device in contact with the intact skin for a Limited Duration ( Non-clinical Tests

The Automatic Arm Electronic Blood Pressure Monitor is tested per the following standard, to evaluate its performance. The test results demonstrated that the proposed device comply with the standard requirements.

IEC 60601-1: 2005+AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

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: Edition 2.0 2018-03 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated

Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. Traditional 510(k) Premarket Notification

non-invasive sphygmomanometers.

> Clinical data

A clinical study was conducted per the requirement of ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type to validate the accuracy of blood pressure measurements by subject device based on an oscillometric method. In this clinical study, 85 patients (46 males and 39 females) participated in the clinical study. Same arm sequential method was adopted during the clinical study. The manual Mercury Sphygmomanometer was used as a reference sphygmomanometer. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect. The results showed the accuracy of the subject device is within acceptable scope specified in ISO 81060-2.

A Software

The software embedded in Automatic Arm Electronic Blood Pressure Monitor has been developed, documented, and validated in accordance with industry standards (IEC 62304 - Medical device software - Software life cycle processes) and FDA guidance (GUIDANCE FOR THE CONTENT OF PRE-MARKET SUBMISSIONS FOR SOFTWARE CONTAINED IN DEVICES).

5.10. Substantially Equivalent Conclusion

The subject device, Automatic Arm Electronic Blood Pressure Monitor, is determined to be Substantially Equivalent (SE) to the predicate device, in respect of safety and efficacy.