Electronic Blood Pressure Monitor, model: HTD6602US

K223170 · Hetaida Technology Co., Ltd. · DXN · Dec 5, 2023 · Cardiovascular

Device Facts

• Record ID: K223170
• Device Name: Electronic Blood Pressure Monitor, model: HTD6602US
• Applicant: Hetaida Technology Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 5, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia)

Device Story

Electronic blood pressure monitor (model HTD6602US) uses oscillometric method to measure systolic/diastolic blood pressure and pulse rate. Device consists of main unit and upper arm cuff (22-32cm or 22-42cm). Operation: cuff inflates above systolic pressure; as it deflates, arterial wall vibrations are detected by internal semiconductor pressure sensor; transducer converts vibrations into electrical signals. Device automatically calculates results, displays them on LCD, and stores measurements. Used in home or medical facilities by patients or clinicians. Provides automated blood pressure/pulse readings to assist in health monitoring.

Clinical Evidence

Clinical accuracy testing conducted per ISO 81060-2:2018 on 85 subjects (38 male, 47 female, all >12 years old). Study compared subject device against auscultatory reference method. Results confirmed compliance with ISO 81060-2 requirements for blood pressure and pulse measurement accuracy across specified ranges.

Technological Characteristics

Oscillometric non-invasive blood pressure monitor. Components: PCBA, crystal oscillator, pump, valve, LCD. Power: 4x1.5V AA batteries or 5V 1A USB. Sensing: Semiconductor pressure sensor. Connectivity: None. Software: Embedded firmware. Biocompatibility: Tested per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization/irritation).

Indications for Use

Indicated for individuals over 12 years old for non-invasive measurement of systolic/diastolic blood pressure and pulse rate on the upper arm in home or medical settings. Contraindicated for neonates, pregnant patients, and patients with pre-eclampsia.

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

• Electronic blood pressure monitor, Model: YE680B (K200939)

Reference Devices

• Sphygmomanometer - Stethoscope health box (Auscultatory reference equipment)

Submission Summary (Full Text)

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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 5, 2023

HeTaiDa Technology Co., Ltd. % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd. RM.406, Building C, Run Science Park, No.18 Shenzhou Road, Huangpu, Guangzhou, Guangdong 510663 China

Re: K223170

Trade/Device Name: Electronic Blood Pressure Monitor, model: HTD6602US Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 14, 2023 Received: November 14, 2023

Dear You Yijie:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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3

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

Sincerely,

# Stephen C. Browning -S

LCDR 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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### Indications for Use

510(k) Number (if known) K223170

Device Name

Electronic Blood Pressure Monitor, model: HTD6602US

Indications for Use (Describe)

This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (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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## Section 5: 510(k) Summary

510(k) Number: K223170

### 1. Submitter's Information

#### Establishment Registration Information

Name: Hetaida Technology Co., Ltd.

Address: Room 801,802,803,804,901, 2# Building Scientific Research Center, Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, Dongquan City, Guangdong Province Dongguan Guangdong, CN 523423.

#### Establishment registration number: 3017493034

Contact Person of applicant:

Name: Tom Chen

Address: Room 801,802,803,804,901, 2# Building Scientific Research Center, Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, Dongguan City, Guangdong Province Dongguan Guangdong, CN 523423

TEL: [phone]

Email: [e-mail]

### Correspondent (510(k) preparer) Information:

Name: You Yijie

Address: RM.406, Building C, Run Science Park, No.18 Shenzhou Road, Huangpu, Guangzhou, Guangdong 510663 P.R.China.

TEL: [phone]

FAX: [phone]

Email: [e-mail]

Date prepared: 11/15/2022

### 2. Device Information

Device Common Name: Noninvasive Blood Pressure Measurement System

Trade Name: Electronic blood pressure monitor

Model: HTD6602US

Classification name: Noninvasive Blood Pressure Measurement System

Review panel: Cardiovascular

Product code: DXN

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Regulation Class: II Requlation Number: 870.1130

### 3. Predicate Device Information

| 510(k) submitter/holder: | Jiangsu Yuyue Medical Equipment & Supply Co., |
|--------------------------|-----------------------------------------------|
| | Ltd. |
| 510(K) Number: | K200939 |
| Trade Name: | Electronic blood pressure monitor |
| Model: | YE680B |
| Classification name: | Noninvasive Blood Pressure Measurement |
| | System |
| Review panel: | Cardiovascular |
| Product code: | DXN |
| Regulation Class: | II |
| Regulation Number: | 870.1130 |
| | |

### 4. Device description

Electronic blood pressure monitor, model: HTD6602US is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The proposed device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited.

It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The HTD6602US is small, portable and used in home or medical facilities environment. The Electronic blood pressure monitor consists of two parts: main unit and cuffs. The HTD6602US is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm~32cm and cuff of size 22cm~42cm.

#### Principle of operation:

This product uses the Oscillometric Measuring method to detect blood pressure. When the cuff is fully inflated to reach a pressure above systolic pressure, no blood flow occurs through the artery. As the cuff is deflated below the systolic pressure, the reducing pressure exerted on the artery allows blood to flow through it and sets up a detectable vibration in the arterial wall. When the cuff pressure falls below the patient's diastolic pressure, blood flows smoothly through the artery in the usual pulses, without any vibration being set up in the wall. Vibrations occur at any point where the cuff pressure is sufficiently high that the blood has to push the arterial wall open in order to flow through the artery. The vibrations are transferred from the arterial wall, through the air inside the cuff, into a transducer in the monitor that converts the measurements into electrical signals. Hence when it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations

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generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and pulse rate.

## 5. Indications for Use

This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia).

## 6. Summary of technological characteristics of device compared to the

| SE<br>Comparisons | Subject device<br>(Electronic blood pressure monitor,<br>model: HTD6602US) | Predicate device<br>(Electronic blood pressure monitor,<br>Model: YE680B) | Discussion of<br>difference | | |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------|
| 510K Number | K223170 | K200939 | / | | |
| Model | HTD6602US | YE680B | / | | |
| Classification | 21CFR 870.1130 | 21CFR 870.1130 | Same | | |
| Product Code | DXN | DXN | Same | | |
| FDA Class | II | II | Same | | |
| Indications for<br>Use | This product is intended to measure<br>systolic and diastolic blood pressure<br>and pulse on upper arm. | This product is intended to measure<br>systolic and diastolic blood pressure and<br>pulse on upper arm | Same | | |
| Patient<br>Population | population over 12 years old | Adult | Different<br>(Discussion is<br>indicated in D1) | | |
| Environment of<br>Use | Home or medical facilities | Home or medical facilities | Same | | |
| Design | table type | table type | Same | | |
| Design Method | Oscillometric | Oscillometric | Same | | |
| Measurement<br>Site | Upper Arm | Upper Arm | Same | | |
| Cuff<br>Circumference | 22cm~32cm;<br>22cm~42cm. | 22cm~32cm;<br>22~45cm. | Different<br>(Discussion is<br>indicated in D2) | | |
| Inflation Method | Inflation Method | Inflation Method | Same | | |
| Deflation Method | Automatic Pressure Release Valve | Automatic Pressure Release Valve | Same | | |
| Display | Backlight LCD<br>Digital Display | Backlight LCD<br>Digital Display | Same | | |
| Memory Size | 180 groups | Up to 99x2 sets of data | Different<br>(Discussion is<br>indicated in D3) | | |
| Blood Pressure<br>Indication<br>Range | DIA: 30 mmHg~195mmHg<br>SYS: 60 mmHg~255mmHg | Diastolic:20~210 mmHg<br>Systolic:40~260 mmHg | Different<br>(Discussion is<br>indicated in D4) | | |
| Measurement<br>Pressure Range | 0~299mmHg (0~39.9kPa) | 0 ~ 300 mmHg (0 kPa ~ 40 kPa) | Same | | |
| Range<br>Accuracy | ±3 mmHg (±0.4kPa) | ±3 mmHg (±0.4kPa) | Same | | |
| Measurement<br>Pulse Range | 40~180 beats/min | 40 ~ 200 beats/min | Different<br>(Discussion is<br>indicated in D5) | | |
| Pulse Accuracy | ±5% of reading value | ±5% of reading value | Same | | |
| Pressurization<br>Source | Automatic Internal Pump | Automatic Internal Pump | Same | | |
| Pressure<br>Sensor | Semiconductor Pressure Sensor | Semiconductor Pressure Sensor | Same | | |
| Operating<br>Environment | Ambient temperature: +5°C ~ +40°C<br>Relative humidity (RH): ≤85%<br>Atmospheric pressure: 800 hPa~1050<br>hPa | Temperature: +5℃ ~ +40 ℃<br>Humidity: 15% RH ~ 90% RH (no<br>condensation) | Different<br>(Discussion is<br>indicated in D6) | | |
| Storage<br>Environment | Ambient temperature: -20 °C ~+55 °C<br>Relative humidity (RH): 10%~93%<br>Atmospheric pressure: 800 hPa~1050<br>hPa | Temperature: -20 °C ~ +55 °C<br>Humidity: 15% RH ~ 90% RH (no<br>condensation) | Different<br>(Discussion is<br>indicated in D7) | | |
| Energy Source | Internal power supply DC 6V (4X1.5V<br>(AA) Alkaline battery/ IEC Type LR06);<br>External power supply: USB interface<br>DC 5V 1A | 4 AA batteries or 6V/600mA AC adapter | Different<br>(Discussion is<br>indicated in D8) | | |
| Display Content | 1, User Group<br>2,Over pressure Alarm<br>3, Low battery symbol<br>4, Unit mmHg<br>5, WHO (icon)<br>6, Pulse Rate (Measuring mode)<br>Memory group (Memory mode)<br>7, Unit kPa<br>8, Memory<br>9, Average of last 3 measurements<br>10, Pulse signal<br>11, Body movement<br>12, Cuff inflation abnormal<br>13, Pulse Rate (Memory mode)<br>14, Diastolic pressure<br>15, Systolic pressure | Cuff Pressure,<br>Pulse, Date,<br>Time,<br>Systolic/Diastolic<br>Pressure, error<br>message,<br>measurements<br>results in<br>memory,<br>Irregular Heart<br>Beat Feature,<br>Body movement<br>detection, Cuff<br>Wrapping<br>Detection, Dual<br>user switching | Different<br>(Discussion is<br>indicated in D9) | | |
| Controls | Set button<br>Start/Stop button<br>Memory button | Memory Button,<br>START/PULSE Button,<br>Member Button | Different<br>(Discussion is<br>indicated in D10) | | |
| Performance | ANSI/IAAMI/ISO81060-2:2013 | ANSI/IAAMI/ISO81060-2:2013 | Same | | |
| Performance | IEC80601-2-30 | IEC80601-2-30 | Same | | |
| | Biocompatibility | ISO 10993-1, FDA Guidance, Tests<br>included Cytotoxicity, Sensitization and<br>Intracutaneous Reactivity | ISO 10993-1, FDA Guidance, Tests<br>included Cytotoxicity, Sensitization and<br>Intracutaneous Reactivity | Same | |
| Electrical<br>Safety | | IEC60601-1 | IEC60601-1 | Same | |
| EMC | | IEC60601-1-2 | IEC60601-1-2 | Same | |
| Usability | | IEC 60601-1-6 | IEC 60601-1-6 | Same | |
| Home Use | | IEC 60601-1-11 | IEC 60601-1-11 | Same | |
| Material of<br>Patient contact<br>components | | Top Cover: ABS757<br>Bottom Cover: ABS757<br>Battery door: ABS757<br>Window cover: PMMA<br>Female connector: ABS757<br>Start/Stop button: ABS757<br>Set button: ABS757<br>Memory button: ABS757<br>Decoration ring(button): ABS757<br>Cuff connector: ABS757<br>Cuff: 1. cuff: Two layers of 420D<br>Polyester;<br>2.air bag: PVC.<br>3.Velcro: nylon.<br>4.Ring: metal.<br>5.air tube: PVC. | Not public | Different<br>(Discussion is<br>indicated in D11) | |
| | Patient<br>Interface | | Cuff, button | Cuff, button | Same |
| | Dimensions | | 141mm×106mm×70mm<br>(Length×Width×Height) | 127x93x74 (mm) | Different<br>(Discussion is<br>indicated in D12) |
| | Weight | | Approximate 323g. (Without battery) | Approx.330g | Different<br>(Discussion is<br>indicated in D13) |
| | Principle of<br>operation | | Oscillometric Measuring method | Oscillometric Measuring method | Same |
| | User Interface | | Cuff, button | Cuff, button | Same |
| | Software | | Embedded | Embedded | Same |

### predicate devices (K200939)

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#### The discussion of differences exist between the subject and predicate devices is listed in following:

- D1: The difference of Patient Population between subject device and predicate device is that the intended age range of subject device is over 12 years old and predicate device is intended for adults, this difference is addressed through clinical trial conducted with subject device and contains population over 12 years old according to ISO 81060-2 Third Edition 2018-11, the results of clinical trial meet the requirements of ISO 81060-2 Third Edition 2018-11, therefore, the difference of subject device with predicate device YE680B (K200939) will not affect the safety and effectiveness.

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- D2: The difference of Cuff Circumference between subject device and predicate device is that the intended Cuff Circumference range of subject device is 22~42cm and predicate device is 22~45cm, the Cuff Circumference range of subject device is in the range of predicate device, and this difference is also addressed through clinical trial conducted with subject device according to ISO 81060-2 Third Edition 2018-11, the results of clinical trial meet the requirements of ISO 81060-2 Third Edition 2018-11, therefore, the difference of subject device with predicate device YE680B (K200939) will not affect the safety and effectiveness.
- D3: The Memory Size of subject device is different with predicate device predicate device YE680B (K200939) will not affect the safety and effectiveness.
- D4: The difference of Blood Pressure Indication Range between subject device and predicate device is that the Blood Pressure Indication Range of subject device is DIA: 30 mmHq~195mmHq & SYS: 60 mmHg~255mmHg and predicate device is Diastolic:20~210 mmHg & Systolic:40~260 mmHg, the Blood Pressure Indication Range of subject device is in the range of predicate device and meets the IEC 80601-2-30: Edition 2.0 2018-03, and this difference is also addressed through requirements of clinical trial conducted with subject device according to ISO 81060-2 Third Edition 2018-11, the results of clinical trial meet the requirements of ISO 81060-2 Third Edition 2018-11, therefore, the difference of subject device with predicate device YE680B (K200939) will not affect the safety and effectiveness.
- D5: The Measurement Pulse Range of subject device is in the range of predicate device, and this difference is also addressed through clinical trial conducted with subject device according to ISO 81060-2 Third Edition 2018-11, therefore, the difference of subject device with predicate device YE680B (K200939) will not affect the safety and effectiveness.
- D6: The operating Environment of subject device are different with predicate device YE680B (K20033), the difference introduces risks mitigated by testing in accordance with IEC 60601-1-11 and ANSI AAMI ES60601-1 provided in this submission, therefore the difference does not raise new questions of safety and effectiveness.
- D7: The Storage Environment of subject device is different with predicate device YE680B (K200939), the difference introduces risks mitigated by testing in accordance with IEC 60601-1-11 and ANSI AAMI ES60601-1 provided in this submission, therefore the difference does not raise new questions of safety and effectiveness.
- D8: The Energy Source of subject device are different with predicate devices, the difference introduces risks mitigated by the electromagnetic compatibility and electrical safety testing in accordance with IEC 60601-1-2 and ANSI AAMI ES60601-1 provided in this submission, therefore the difference does not raise new questions of safety and effectiveness.
- D9: The Display Content between subject device and predicate device is that excluding the same parts, the Display Content of subject device additionally includes "User Group and Average of last 3 measurements" which are not included by predicate device, and the predicate device additionally includes "Cuff Pressure, Date, Time, Irreqular Heart, Beat Feature, Dual user switching" which are not included by predicate device, since the subject device meets the requirements of IEC 80601-2-30: Edition 2.0 2018-03 and ISO 81060-2 Third Edition 2018-11, therefore, the difference of subject device with predicate device YE680B (K200939) will not affect the safety and effectiveness.
- D10: The Controls of subject device are different with predicate device, the difference does not raise new questions of safety and effectiveness.

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- D11: The Material of Patient contact components of subject device has been validated for Cytotoxicity though testing against ISO 10993- 5, for Sensitization though testing against ISO 10993-10 tested and all test results are positive, the difference of subject device with predicate device YE680B (K200939) do not raise new questions of safety and effectiveness.
- D12: The Dimensions of subject device is different with predicate device predicate device YE680B (K200939) will not affect the safety and effectiveness.
- D13: The Weight of subject device is different with predicate device YE680B (K200939) will not affect the safety and effectiveness.

### 7. Discussion of Non-Clinical Tests Performed are as follows

The recognized consensus standards for safety of medical electrical equipment: ANSI AAM ES 60601- 1: 2005 / (R) 2012 and A1: 2012, IEC 60601-1-11 Edition 2.0 2015-01. IEC 60601-1-8 Edition 2.1 2012-11 for safety, IEC 60601-1-2: 2014 for electromagnetic compatibility, IEC 80601-2-30: Edition 2.0 2018-03, ISO 81060-2 Third Edition 2018-11 for performance, IEC 62304 Edition 1.1 2015-06 for software verification, IEC 62366-1 Edition 1.0 2015-02, IEC 60601-1-6 Edition 3.1 usability and 2013-10 for for ട്രി 10993-10:2010 for Sensitization and Irritation endpoints are complied. See below table for details:

| Standards | Standards Name |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI AAMI ES60601-<br>1:2005/(R)2012 and A1:2012 | Medical Electrical Equipment - Part 1: General Requirements For<br>Basic Safety And Essential Performance |
| IEC 60601-1-2: 2014 | Medical Electrical Equipment - Part 1-2: General Requirements For<br>Basic Safety And Essential Performance -- Collateral Standard:<br>Electromagnetic Disturbances - Requirements And Tests |
| IEC 60601-1-11 Edition 2.0<br>2015-01 | Medical Electrical Equipment - Part 1-2: General Requirements For<br>Basic Safety And Essential Performance - Collateral Standard:<br>Electromagnetic Disturbances - Requirements And Tests |
| IEC 60601-1-8 Edition 2.1<br>2012-11 | Medical electrical equipment - Part 1-8: General requirements for<br>basic safety and essential performance - Collateral Standard:<br>General requirements, tests and guidance for alarm systems in<br>medical electrical equipment and medical electrical systems |
| IEC 80601-2-30: Edition 2.0<br>2018-03 | Medical electrical equipment - Part 2-30: Particular requirements for<br>the basic safety and essential performance of automated non-<br>invasive sphygmomanometers |
| ISO 81060-2 Third Edition<br>2018-11 | Non-invasive sphygmomanometers - Part 2: Clinical investigation of<br>intermittent automated measurement type |
| IEC 62366-1 Edition 1.0<br>2015-02 | Medical devices - Part 1: Application of usability engineering to<br>medical devices |
| IEC 60601-1-6 Edition 3.1<br>2013-10 | Medical electrical equipment - Part 1-6: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Usability |

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| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
|-----------------------------------|-------------------------------------------------------------------------------------------------|
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
| IEC 62304 Edition 1.1 2015-<br>06 | Medical device software - Software life cycle processes |

#### ● Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the subject device HTD6602US. The system complies with the AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, IEC 80601-2-30: Edition 2.0 2018-03, ISO 81060-2 Third Edition 2018-11, standards for electrical safety and the IEC 60601-1-2 standard for EMC.

#### ● Software Verification and Validation Testing

Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005.

#### Software Description:

The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could result in Minor Injury, either to a patient or to a user of the device. The software of the system, on the whole, is accountable for the system scheduler of the device, including Pressure and pulse signal acquisition, calculation and display, the button presses of end user, display the result of the measurement data storage and average calculation, memory data query, prompt of error message, low battery voltage detection and prompt, measurement Unit conversion, user Account Switching.

- V Programming language C Programming Language.
Hardware Requirements A Microprocessors: HME062

## 8. Discussion of Clinical Accuracy Testing Performed

The clinical accuracy test report and data analysis followed the requirements of the ISO 81060-2 Third Edition 2018-11.

| Subjects requirement | Number specified in ISO<br>81060-2 Third edition 2018-<br>11 Amendment 1 2020-01 | Actual number |
|----------------------|----------------------------------------------------------------------------------|---------------|
| Total | A minimum of 85 | 85 |
| Male | At least 26 | 38 |
| Female | At least 26 | 47 |
| Age > 12 | 100% | 100% |

The clinical accuracy testing evaluated 85 of subjects, division of all subjects:

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| arm circumference in the range of 22-<br>27cm; | ≥20% | 31.76% |
|-----------------------------------------------------------------------|--------------|--------|
| arm circumference in the range of 27-<br>32cm; | ≥20% | 23.53% |
| arm circumference in the range of 32-<br>37cm; | ≥20% | 23.53% |
| arm circumference in the range of 37-<br>42cm; | ≥20% | 21.18% |
| arm circumference in the range of 22-<br>24.5cm; | ≥10% | 21.18% |
| arm circumference in the range of 39.5-<br>42cm | ≥10% | 11.76% |
| subjects shall be tested through the cuff<br>with specified (22-32cm) | At least 25% | 32.94% |
| subjects shall be tested through the cuff<br>with specified (22-42cm) | At least 50% | 67.06% |
| Systolic BP ≤ 100mmHg | ≥5% | 17.65% |
| Systolic BP ≥ 160mmHg | ≥5% | 12.94% |
| Systolic BP ≥140mmHg | ≥20% | 30.59% |
| Diastolic BP ≤ 60mmHg | ≥5% | 14.12% |
| Diastolic BP ≥ 100mmHg | ≥5% | 10.59% |
| Diastolic BP ≥ 85mmHg | ≥20% | 27.06% |

The test data showed the clinical accuracy of the subject device complied with the requirements of ISO 81060-2 Third Edition 2018-11.

| Name | Sphygmomanometer - Stethoscope health box |
|------------------|-------------------------------------------------------|
| Model | A Type |
| Manufacturer | Jiangsu Yuyue Medical Equipment & Supply<br>Co., Ltd. |
| Measuring Method | Auscultatory |

Reference equipment used for measurements:

### 9. Conclusions

The Electronic blood pressure monitor, model: HTD6602US, have the same intended use and similar characteristics as the cleared predicate device Electronic Blood Pressure Monitor, Model: YE680B. Moreover, bench testing contained in this submission supplied demonstrate that the differences existed between HTD6602US and YE680B do not raise any new questions of safety or effectiveness.

The non-clinical tests support the safety of the device and the hardware and software verification and validation demonstrate that the Electronic blood pressure monitor, model: HTD6602US performs as intended in the specified use conditions are same with predicate device. The clinical performance tests demonstrate that the Electronic blood pressure monitor, model: HTD6602US performs comparably to the predicate device that is currently marketed for the same intended use. Thus, the Electronic blood pressure monitor, model: HTD6602US is Substantially Equivalent (SE) to the predicate device.