Upper Arm Electronic Blood Pressure Monitor

• K Number: K202372
• Device Name: Upper Arm Electronic Blood Pressure Monitor
• Manufacturer: Conmo Electronic Company Limited
• Date Cleared: 2020-12-30 ( 133 days)
• Product Code: DXN
• Regulation Number: 870.1130

Intended Use

Upper Arm Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia).

Device Description

The Upper Arm Electronic Blood Pressure Monitor, Model BM100-EN operation is based on the oscillometric method. This method takes advantage of the pressure pulsations taken during measurements. An occluding cuff is placed on the left arm and is connected to an air pump and a pressure sensor. The cuff is inflated until a pressure higher than the typical systolic value is reached, then the cuff is slowly deflated. As the cuff deflates, when systolic pressure value approaches, pulsations start to appear. These pulsations represent the pressure changes due to heart ventricle contraction and can be used to calculate the heartbeat rate. Pulsations grow in amplitude until mean arterial pressure (MAP) is reached, then decrease until they disappear. The blood pressure information is displayed as digital information on the device's screen.

Predicate Devices

K170605

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard oscillometric blood pressure monitor and does not mention any AI or ML components or algorithms.

Therapeutic

No.
The device is used to measure blood pressure, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate a medical condition.

Diagnostic

Yes
The device is intended to measure blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components like an occluding cuff, air pump, pressure sensor, and a screen for displaying information. This indicates it is a physical medical device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
• Device Function: This device measures blood pressure and pulse rate by applying a cuff to the upper arm and using the oscillometric method. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
• Intended Use: The intended use is to measure blood pressure and pulse rate, which are physiological parameters, not to analyze a biological sample.

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

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Upper Arm Electronic Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adults at a household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia).

Product codes

DXN

Device Description

The Upper Arm Electronic Blood Pressure Monitor, Model BM100-EN operation is based on the oscillometric method. This method takes advantage of the pressure pulsations taken during measurements. An occluding cuff is placed on the left arm and is connected to an air pump and a pressure sensor. The cuff is inflated until a pressure higher than the typical systolic value is reached, then the cuff is slowly deflated. As the cuff deflates, when systolic pressure value approaches, pulsations start to appear. These pulsations represent the pressure changes due to heart ventricle contraction and can be used to calculate the heartbeat rate. Pulsations grow in amplitude until mean arterial pressure (MAP) is reached, then decrease until they disappear.

The blood pressure information is displayed as digital information on the device's screen.

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

household or medical center

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)

Clinical Study: We conducted a comparative clinical study to verify the performance of the subject device and predicate device as well as a mercury sphygmomanometer according to ISO 81060-2:2013. The study demonstrates a correlation in the performance of subject device and predicate device. was significantly correlated

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K170605

Reference Device(s)

Not Found

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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December 30, 2020

Conmo Electronic Company Limited % Charlie Mack Principal Engineer International Regulatory Consultants 2950 E Lindrick Drive Chandler, Arizona 85249

Re: K202372

Trade/Device Name: Upper 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: November 23, 2020 Received: December 1, 2020

Dear Charlie Mack:

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for LT Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K202372

Device Name

Upper Arm Electronic Blood Pressure Monitor, BM100-EN

Indications for Use (Describe)

Upper Arm Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia).

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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510(k) Summary

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

Date: August 13, 2020

• 1. Company and Correspondent submitting this 510(k):
     Name – Conmo Electronic Company Limited Address – Room 1402, Building No.10 Shenzhen Biomedicine Innovations Industrial Park Jinhui Road No.14, Kengzi Street Pingshan District Shenzhen City, Guangdong, China 518126 Tel: [phone] Fax: [phone] Contact - Mrs. Alice Qi General Manager

US Agent and Correspondent Mr. Charles Mack Principal Engineer IRC USA 2950 E Lindrick Drive, Chandler, Arizona 85249 USA Tel: [phone] Email: [e-mail]

• 2. Device:

| Trade/proprietary name: | Upper Arm Electronic Blood Pressure Monitor
Model BM100-EN | |
|-------------------------|---------------------------------------------------------------|--|
| Common Name: | Non-invasive blood pressure measurement system | |
| Classification Name: | System, measurement, blood-pressure, non-invasive | |
| Product Code: | DXN | |
| Regulation Number: | 21CFR870.1130 | |
| Device Class: | 2 | |

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• 3. Predicate Device :

| Manufacturer | Predicate Device | 510(k)
Number |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------|
| Jiangsu Yuyue
Medical
Equipment&
Supply Co., Ltd | Upper Arm Type
Electronic Blood
Pressure Monitor
Series, Electronic
Blood Pressure
Monitor: YE670D | K170605 |

4. Reason for Submission: New Device

5. Device Description:

The Upper Arm Electronic Blood Pressure Monitor, Model BM100-EN operation is based on the oscillometric method. This method takes advantage of the pressure pulsations taken during measurements. An occluding cuff is placed on the left arm and is connected to an air pump and a pressure sensor. The cuff is inflated until a pressure higher than the typical systolic value is reached, then the cuff is slowly deflated. As the cuff deflates, when systolic pressure value approaches, pulsations start to appear. These pulsations represent the pressure changes due to heart ventricle contraction and can be used to calculate the heartbeat rate. Pulsations grow in amplitude until mean arterial pressure (MAP) is reached, then decrease until they disappear.

The blood pressure information is displayed as digital information on the device's screen.

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• 6. Indication for use:
     The Upper Arm Electronic Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adults at a household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia).
• 7. Comparison with the predicate device:
     Conmo Electronic Company Limited believes that the Upper Arm Electronic Blood Pressure Monitor, BM100-EN is substantially equivalent to the Jiangsu Yuyue Medical Equipment& Supply Co., Ltd Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE670D, FDA 510(k) clearance K170605.

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Characteristics	Submitted Device	Predicate Device	Difference Discussion
Device Name and model	Upper Arm Electronic Blood Pressure
Monitor, BM100-EN	Upper Arm Type Electronic Blood Pressure
Monitor YE670D	N/A
Manufacturer	CONMO ELECTRONIC COMPANY
LIMITED	Jiangsu Yuyue Medical Equipment & Supply
Co., Ltd	N/A
510(K) Number	Pending	K170605	N/A
Indication for Use	The Upper Arm Electronic Blood Pressure
Monitor is intended to measure the blood
pressure and pulse rate of adults at a
household or medical center. (Not suitable
for neonate, pregnancy or pre-eclampsia).	Electronic blood pressure monitor is
intended to measure the blood pressure and
pulse rate of adult at household or medical
center. (Not suitable for neonate, pregnancy
or pre-eclampsia).	Identical
Clinical Use	household or medical center	household or medical center	Identical
Patient Population	Adult	Adult	Identical
Measurement Type	Upper arm	Upper arm	Identical
Measurement Method	Non-invasive, Sociometric	Non-invasive, Sociometric	Identical
Cuff Circumference	220mm ~ 320mm	220mm ~ 320mm	Identical
Power Source	4x1.5V	4x1.5V	Identical
Measurement Pressure
Range	0~295mmHg (0-39.3kPa)	0~280mmHg (0-37.3kPa)	The Pressure Range of BM100-EN is wider
than Predicate Devices, but still complies
with IEC 80601-2-30
Range Accuracy	±3 mmHg
(±0.4kPa)	±3 mmHg
(±0.4kPa)	Identical
Measurement Pulse
Range	40 ~ 180 beats/min	40 ~ 200 beats/min	The Pulse Range of BM100-EN is narrower
than Predicate Devices, but still complies with
IEC 80601-2-30
Pulse Rate Measurement
Accuracy	±5% of reading
value	±5% of reading
value	Identical
Number of Users	2	2	Identical
Memory Space	99	60	The difference does not raise any new
questions of safety and effectiveness.
Number of buttons	3	3	Identical
Characteristics	Submitted Device	Predicate Device	Difference Discussion
Controls	User 1/ Confirm
Guest/Setting
User 2/Plus	SET Button,
Plus/Minus Button,
START/PULSE Button	The control difference does not raise any new
questions of safety and effectiveness.
Display Type	LCD	LCD	Identical
Pressurization Mode	Automatic Inflation	Automatic Inflation	Identical
Deflation Mode	Automatic Pressure Release Valve	Automatic Pressure Release Valve	Identical
Display Content	Cuff Pressure, Pulse,
Date,
Time,
Systolic/Diastolic
Pressure, error message,
Measurements result in memory,
Irregular Heart Beat
Feature, Body
movement detection
Cuff Wrapping Detection	Cuff Pressure, Pulse,
Date,
Time,
Systolic/Diastolic
Pressure, error message,
Measurements result in memory,
Irregular Heart Beat
Feature, Body
movement detection
Cuff Wrapping Detection	Identical
Operation Environments	Temperature: +10 °C~ +40 °C
Humidity: 15% RH~ 85% RH(no
condensation)	Temperature: +10 °C~ +40 °C
Humidity: 15% RH~ 90% RH(no
condensation)	The operating environment difference does
not raise any new questions of safety and
effectiveness.
Storage Environments	Temperature: -20 °C~ +55 °C
Humidity: 15% RH~ 85% RH(no
condensation)	Temperature: -20 °C~ +55 °C
Humidity: 15% RH~ 90% RH(no
condensation)	The storage environment difference does not
raise any new questions of safety and
effectiveness.
Performance	ANSI/AAMI/ISO 81060-2
IEC 80601-2-30	ANSI/AAMI/ISO 81060-2
IEC 80601-2-30	Identical
Biocompatibility	ISO 10993-1, FDA Guidance, Tests
included Cytotoxicity, Sensitization and
Intracutaneous Reactivity	ISO 10993-1, FDA Guidance, Tests included
Cytotoxicity, Sensitization and
Intracutaneous Reactivity	Identical
Electrical Safety	IEC 60601-1	IEC 60601-1	Identical
EMC	IEC 60601-1-2	IEC 60601-1-2	Identical
Home Use	IEC 60601-1-11	IEC 60601-1-11	Identical
Prescription or OTC	OTC	OTC	Identical

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Testing Summary:

The following performance data is provided in support of the substantial equivalence determination.

Non-Clinical Study:

Non-clinical tests were conducted to verify that the proposed device meets the same design specifications as the predicate Yuyue Medical Equipment device. The test results demonstrate that the proposed device complies with the following standards:

Safety and EMC

Testing was performed to verify the basic safety and essential performance of the Upper Arm Electronic Blood Pressure Monitor. BM100-EN. The following tests were performed:

• IEC 60601-1: 2005+A1: 2012 Medical electrical equipment Part 1: - General requirements for basic safety and essential performance
• IEC 60601-1-2: 2014 Medical devices part 1-2: General requirements for basic safety and essential performance – Collateral standards: electromagnetic compatibility - Test and requirements
• 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.

The test results demonstrate the device complies with the necessary safety and essential performance standards requirements.

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Performance Data:

The subject Upper Arm Electronic Blood Pressure Monitor, BM100-EN was subjected to the following tests and passed all test criteria:

• IEC 80601-2-30 Edition 2.0 Medical electrical equipment Part 2-30: Particular Performance 2018-03 requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
• ISO 81060-2 Non-invasive sphygmomanometers Part 2: Clinical validation NIBP Performance Second edition 2013-05-01 of automated measurement type
• FDA Guidance Non-Invasive Blood Pressure (NIBP) Monitor Guidance -

Software Verification and Validation

Software documentation, including verification & validation, was provided following FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern.

Cleaning Validation

The device was cleaned following the procedure defined in the User's Manual. The device was checked for performance following the cleaning and met all performance requirements following the cleaning.

Shelf Life:

The Upper Arm Blood Pressure Monitor BM100-EN, is not subject to the shelf life, as the device doesn't contain any sterile or degradable components.

Biocompatibility

The subject Upper Arm Electronic Blood Pressure Monitor, BM100-EN, uses similar material to the predicate Yuyue Medical Equipment device. Biocompatibility testing was performed to demonstrate compliance with the same biocompatibility standards as performed by the predicate device.

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The Upper Arm Blood Pressure Monitor, Model BM100-EN device is classified per ISO 10993-1: 2009 Annex 1 Biological evaluation tests as follows: Surface Device - Contact Skin - Contact Duration