Automatic Arm Electronic Blood Pressure Monitor

K210435 · Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. · DXN · May 12, 2021 · Cardiovascular

Device Facts

• Record ID: K210435
• Device Name: Automatic Arm Electronic Blood Pressure Monitor
• Applicant: Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: May 12, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

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 Story

Automatic Arm Electronic Blood Pressure Monitor (models LBP70C, LBP70D) measures systolic/diastolic blood pressure and pulse rate using non-invasive oscillometric technique. Device consists of PCBA, pressure sensor, pump, control valve, LCD, cuff, and power source (batteries or AC adapter). User wraps cuff around upper arm; device automatically performs inflation/deflation cycles. Includes irregular heart beat (IHB) indicator detecting rhythm variations >25% from average. Memory stores up to 90 readings per user. Used in clinical or home settings by adults. Healthcare providers or patients view results on LCD to monitor cardiovascular status. Benefits include convenient, automated blood pressure tracking for hypertension management.

Clinical Evidence

Clinical validation study conducted per ISO 81060-2:2018 with 85 adult subjects (46 male, 39 female). Used same-arm sequential method comparing subject device against manual mercury sphygmomanometer. Results confirmed accuracy within acceptable limits specified by ISO 81060-2. No adverse events or side effects reported.

Technological Characteristics

Oscillometric measurement principle. Materials: ABS+PMMA enclosure, polyester cuff, PVC air tube. Power: 4xAA alkaline or AC adapter (LBP70C); rechargeable Li-polymer or AC adapter (LBP70D). Connectivity: Standalone. Standards: IEC 80601-2-30, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-1/5/10, ISO 81060-2.

Indications for Use

Indicated for adult patients requiring non-invasive measurement of systolic/diastolic blood pressure and pulse rate via oscillometric technique using an upper arm cuff (22-42 cm circumference). Suitable for hospital or home use.

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

• Arm-type Electronic Blood Pressure Monitor (K183058)

Reference Devices

• K192609 (Globalcare Medical Technology Co., Ltd)
• K161560 (Fingertip Pulse Oximeter)

Submission Summary (Full Text)

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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

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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,

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

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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)

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.

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: [e-mail]

## 5.3. Official Correspondent

Mr. Arthur Goddard 31853 Cedar Road, Cleveland, Ohio, 44124-4445, U.S.A. Tel: [phone] Email: [e-mail]

## 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.

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### 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 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.

5.8. Predicate Devices and Subject Device Comparison

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

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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

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| Item | Subject Device | Predicate Device<br>K183058 | Remark |
|------|----------------|-----------------------------|--------|
|------|----------------|-----------------------------|--------|

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.

| Contacting<br>Material | Enclosure-ABS+PMMA<br>Cuff- Polyester<br>Air tube-PVC | Cuff - Polyester | Discussion 2 |
|------------------------|-------------------------------------------------------|------------------|--------------|
|------------------------|-------------------------------------------------------|------------------|--------------|

## 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<br>or AC adapter (LBP70C)<br>3.7V 2200mAh Rechargeable<br>lithium battery or AC adapter<br>(LBP70D) | 4x1.5V AAA Alkaline<br>Battery (BSX516, BSX525,<br>BSX583, BSX593 and<br>BSX595)<br>3.7V 400mAh Li-ion<br>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

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| 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<br>K183058 | Remark | |
|----------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------|
| Measurement<br>Range | Blood<br>Pressure | Static pressure:<br>0~280 mmHg/<br>0~37.3 kPa;<br>SYS:(60~255)<br>mmHg/<br>(8.0~34.0) kPa<br>DIA: (30~195)<br>mmHg/<br>(4.0~26.0) kPa | Blood<br>Pressure<br>0-299mmHg | Discussion 4 |
| | Pulse rate | 40 to 199 bpm | Pulse rate<br>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 | Conclusion |
|--------------------------------|----------------------------|----------------|----------------------|
| Systolic<br>blood<br>pressure | At least<br>60~230mmHg | 60~255mmHg | Meet the requirement |
| Diastolic<br>blood<br>pressure | At least<br>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<br>Pressure | $\pm 3 mmHg$ /<br>$\pm 0.4 kPa$ | Blood<br>Pressure | $\pm 3 mmHg$ | SE |
|--------------------------|-------------------|---------------------------------|-------------------|--------------|--------------|
| | Pulse rate | $\pm 5%$ | Pulse rate | $\pm 5%$ | |
| Operating<br>Temperature | 5°C~40°C | | 5°C~40°C | | Discussion 5 |
| Operating | 15%RH~85%RH | | 15%RH~85%RH | | |

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

| Item | Subject Device | Predicate Device<br>K183058 | Remark |
|--------------------------------------|-----------------|-----------------------------|--------|
| humidity | | | |
| Operating<br>atmospheric<br>pressure | 70 kPa ~106 kPa | 80 kPa~106kPa | |
| Storage<br>temperature | -20°C~55°C | -20°C~55°C | |
| Storage humidity | ≤93%RH | 10%RH~93%RH | |
| Storage<br>atmosphere<br>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<br>Finger pulse oximeter | Predicate Device<br>K161560<br>Fingertip Pulse Oximeter | Remark |
| Particular<br>requirements for<br>basic safety and<br>essential<br>performance | Meeting the requirements of<br>IEC 80601-2-30 | Meeting the requirements<br>of IEC 80601-2-30 | SE |
| Electrical Safety | Meeting the requirements of<br>IEC 60601-1 and IEC<br>60601-1-11 | Meeting the requirements<br>of IEC 60601-1 and IEC<br>60601-1-11 | SE |
| Electromagnetic<br>Compatibility | Meeting the requirements of<br>IEC 60601-1-2 | Meeting the requirements<br>of IEC 60601-1-2 | SE |
| Biocompatibility | Meeting the requirements of<br>ISO 10993-1, ISO 10993-5,<br>ISO 10993-10 | Meeting the requirements<br>of ISO 10993-1, ISO<br>10993-5, ISO 10993-10 | SE |
| Clinical study | Meeting the requirements of<br>ISO 81060-2 | Meeting the requirements<br>of ISO 81060-2 | SE |

# Table 5-3 Performance and Safety Comparison

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### 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 (<24 hours). The following test were performed for any user contacting material:

| Test | Standard | Results |
|-------------------------------------------------------------|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity Study using<br>MTT Method | ISO 10993-5 | Under the conditions of this study, the MEM<br>extracts of test article would be considered<br>no cytotoxicity potential. The negative<br>controls, blank controls, and the positive<br>controls performed as anticipated. |
| Skin Sensitization Study<br>Guinea Pig Maximization<br>Test | ISO 10993-10 | Under the condition of this study, the test<br>article extracts showed no evidence of<br>causing delayed dermal contact sensitization<br>in the guinea pig. The test article was not<br>considered a sensitizer in the guinea pig<br>maximization test. |
| Skin Irritation Study | ISO 10993-10 | Under the conditions of this study, the<br>irritation response category of the test article<br>is classified as Negligible for polar extract<br>and Negligible for non-polar extract. |

#### > 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

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#### 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.