Arm-type Electronic Blood Pressure Monitor

K183058 · Shenzhen Bsx Technology Electronics Co., Ltd. · DXN · Jul 3, 2019 · Cardiovascular

Device Facts

• Record ID: K183058
• Device Name: Arm-type Electronic Blood Pressure Monitor
• Applicant: Shenzhen Bsx Technology Electronics Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jul 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The blood pressure monitor 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.

Device Story

Battery-powered, non-invasive oscillometric blood pressure monitor; measures systolic/diastolic pressure and pulse rate. User wraps inflatable cuff around upper arm; device automatically performs inflation, deflation, and measurement. Data stored for review (systolic/diastolic pressure, pulse, time). Used in hospitals or home settings by patients or clinicians. Provides digital output on LCD; assists healthcare providers in monitoring cardiovascular status. Models vary by battery type (AAA alkaline or Li-ion) and presence of backlight indicator.

Clinical Evidence

Clinical validation conducted per ISO 81060-2:2013. Non-clinical evidence includes biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and home healthcare environment standards (IEC 60601-1-11, ISO 80601-2-30). All testing passed pre-specified criteria.

Technological Characteristics

Oscillometric measurement principle. Components: LCD, keys, cuff (polyester), MCU, pump, batteries (AAA or Li-ion). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-30, ISO 81060-2. Non-sterile. Software level of concern: Major.

Indications for Use

Indicated for adult individuals requiring non-invasive measurement of systolic/diastolic blood pressure and pulse rate via oscillometric technique using an arm cuff (22-32 cm circumference). Intended for hospital or home use. Not established for pregnant or pre-eclamptic patients.

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

• Shenzhen Pango Electronic Co., Ltd., PG-800B36 Electronic Blood Pressure Monitor (K170151)

Submission Summary (Full Text)

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July 3, 2019

Shenzhen BSX Technology Electronics Co., Ltd. Zhijian Zhao Sales Director Rm301.3F&4F, 8th Building, LiHao Industrial Area No.78 AiNan Road, Longgang Shenzhen. 518116 CHINA

Re: K183058

Trade/Device Name: Arm-type Electronic Blood Pressure Monitor, Models BSX516, BSX523, BSX525, BSX583, BSX593 and BSX595 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 13, 2019 Received: May 29, 2019

Dear Zhijian Zhao:

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.

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

Sincerely,

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) K183058

#### Device Name

Arm-type Electronic Blood Pressure Monitor, Models BSX516, BSX525, BSX583, BSX593 and BSX595

Indications for Use (Describe)

The blood pressure monitor 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.

Type of Use (*Select one or both, as applicable*)

| <span style="float:left;">❏</span> Research Use ( <i>As 1 CFR 201 Subpart D</i> ) |
|-------------------------------------------------------------------------------------|
| <span style="float:left;">☑</span> Some Other Use ( <i>As 1 CFR 201 Subpart C</i> ) |

__ 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

# Prepared in accordance with the requirements of 21 CFR Part 807.92

| 1. Applicant | Shenzhen BSX Technology Electronics Co., Ltd. |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Rm301.3F&4F, 8th Building, LiHao Industrial Area, No.78 AiNan Road,<br>Longgang, Shenzhen 518116, Shenzhen, P.R. China |
| | Tel.: [phone]<br>Fax: [phone] |
| Contact Person | Zhijian Zhao |
| Prepare date | 2019-05-10 |
| 2. Device name<br>and classification | Device Name: Arm-type Electronic Blood Pressure Monitor<br>Models: BSX516, BSX523, BSX525, BSX583, BSX593 and BSX595 |
| | Classification Name: |
| | 21 CFR 870.1130 |
| | Noninvasive Blood Pressure Measurement System |
| | Product code: DXN |
| | Regulatory Class: Class II |
| 3. Predicate<br>Device(s) | Shenzhen Pango Electronic Co., Ltd., PG-800B36 Electronic Blood Pressure<br>Monitor / K170151 |
| 4. Device<br>Description | The Arm-type Electronic Blood Pressure Monitor is a battery powered automatic<br>non-invasive blood pressure monitor, of which BSX516, BSX525, BSX583,<br>BSX593 and BSX595 are powered by 4x1.5V AAA Alkaline Battery, and BSX523<br>is powered by 3.7V 400mAh Li-ion Battery. It can automatically complete the<br>inflation, deflation and measurement, which can measure systolic and diastolic<br>blood pressure and pulse rate of the adult person at upper arm within its claimed<br>range and accuracy via the oscillometric technique. User can select the unit of the<br>measurement: mmHg or kPa.<br>The difference between the six models include the battery type and the backlight<br>indicator. BSX516, BSX525, BSX583, BSX593 and BSX595 are powered by<br>4x1.5V AAA Alkaline Battery, while BSX523 is powered by 3.7V 400mAh Li-ion<br>Battery. Moreover, the subject device is equipped with backlight indicator except<br>models BSX516 and BSX525.<br>The device has the data storage function in order for data reviewing, including the<br>systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed<br>Arm-type Electronic Blood Pressure Monitor share the similar software,<br>measurement principle and NIBP algorithm.<br>The proposed device is intended to be used in medical facilities or at home. And the<br>effectiveness of this sphygmomanometer has not been established in pregnant<br>(including pre-eclamptic) patients.<br>The product is provided non-sterile, and not to be sterilized by the user prior to use. |

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The blood pressure monitor is a non-invasive blood pressure measurement system 5. Indications for intended to measure the diastolic and systolic blood pressures and pulse rate of an Use 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.

# 6. Predicate Device Comparison

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device.

Please refer to following table to find differences between the subject device and predicate device.

| ITEM | Proposed Device<br>BSX516, BSX523, BSX525,<br>BSX583, BSX593 and BSX595 | Predicate Device<br>PG-800B36/ K170151 | Comparison<br>Result |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacture | Shenzhen BSX Technology<br>Electronics Co., Ltd. | Shenzhen Pango Electronic Co., Ltd. | --- |
| Indications for<br>Use | The blood pressure monitor is a<br>non-invasive blood pressure<br>measurement system intended to<br>measure the diastolic and systolic<br>blood pressures and pulse rate of an<br>adult individual by using a<br>non-invasive oscillometric technique<br>in which an inflatable CUFF is<br>wrapped around the arm of which the<br>circumference includes 22 cm~32<br>cm. It is intended to be used in<br>hospital environment or at home. | The Electronic Blood Pressure<br>Monitor is intended to measure the<br>systolic and diastolic blood pressure<br>as well as the pulse rate of adult<br>person via non-invasive oscillometric<br>technique in which an inflatable cuff<br>is wrapped around the upper arm. It<br>can be used at medical facilities or at<br>home. The intended arm<br>circumference includes 22 cm~32 cm<br>and 32 cm~42 cm. | Different |
| Contraindications | Not Known | Not Known | Same |
| Clinical Use | Medical Facilities and Home Use | Medical Facilities and Home Use | Same |
| Patient Population | Adult | Adult | Same |
| Measurement<br>Type | Upper arm | Upper arm | Same |
| Measurement<br>Principle | Oscillometric | Oscillometric | Same |
| Components | LCD / Key / Cuff / MCU / Pump /<br>Batteries | LCD / Key / Cuff / MCU / Pump /<br>Batteries | Same |
| Power Source | 4x1.5V AAA Alkaline Battery<br>(BSX516, BSX525, BSX583,<br>BSX593 and BSX595) | 4x1.5V AAA Alkaline Battery | Same |
| | 3.7V 400mAh Li-ion<br>Battery(BSX523) | | Different |
| Physical<br>Dimensions(mm)(<br>Length*Width*He<br>ight) | Approx:<br>516: 110 x130 x 58<br>523: 106 x 145 x 68.5<br>525: 110 x130 x 58<br>583: 112 x 132 x 70.5<br>593: 112 x 132 x 70.5<br>595: 112 x 132 x 70.5 | Approx: 140 x100 x50 | Different |
| Weight | Approx: 370g, containing dry battery,<br>CUFF | Approx: 420 g, excluding battery | Different |

Table 1 Comparison between the predicate PG-800B36 and the subject device

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| Measurement | | | | | |
|-----------------------------|-----------------------------------------------------------------------------------|--------------|-----------------------------------------------------------------------------------|---------------|-----------|
| Range | Blood<br>Pressure | 0 ~ 299 mmHg | Blood<br>Pressure | 30 ~ 280 mmHg | Different |
| | Pulse Rate | 40 -180 bpm | Pulse Rate | 40-199 bpm | |
| Accuracy | Static<br>Pressure | $\pm3$ mmHg | Static<br>Pressure | $\pm3$ mmHg | Same |
| | Pulse | $\pm5%$ | Pulse | $\pm5%$ | |
| Arm<br>Circumference | 22 cm~32 cm | | 22 cm~42 cm | | Different |
| Patient Contact<br>Material | Cuff - Polyester | | Cuff -Nylon | | Different |
| Applied Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>80601-2-30:2009<br>81060-2:2013 | | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>80601-2-30:2009<br>81060-2:2013 | | Same |
| Operation<br>Environments | + 5℃~ + 40℃, 15%RH~85%RH<br>Atmospheric Pressure: 80 kPa~106<br>kPa | | + 5℃~ + 40℃, 15%RH~93%RH<br>Atmospheric Pressure: 50 kPa~106<br>kPa | | Different |
| Storage<br>Environments | - 20℃~ + 55℃, 10%RH~93%RH<br>Atmospheric Pressure: 70 kPa~106<br>kPa | | - 20℃~ + 55℃, 0%RH~93%RH<br>Atmospheric Pressure: 50 kPa~106<br>kPa | | |

As seen in the comparison tables, the subject and predicate devices have almost the same design features and performance specifications. The main technological differences between the subject and predicate devices are minor differences, which do not raise different questions of safety or effectiveness. Moreover, as demonstrated in the non-clinical testing, the different technological characteristics do not affect the safety and effectiveness of the system.

## 8. Performance Testing:

Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.

#### Non-Clinical Data:

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

#### Biocompatibility testing

The biocompatibility evaluation for the Arm-type Electronic Blood Pressure Monitor and the NIBP CUFF were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:

- □ Cytotoxicity
- □ Skin Sensitization
- □ Skin Irritation

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

Electrical safety and EMC testing were conducted on the Arm-type Electronic Blood Pressure Monitor, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2014 Medical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.

#### Bench Testing

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Bench testing was conducted on the Arm-type Electronic Blood Pressure Monitor, consisting of all the accessories in the system. The system complies with the IEC 60601-1-11: 2010 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. ISO 80601-2-30: 2009 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers standards for performance effectiveness.

#### Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

#### Clinical data:

Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement tvpe.

#### Summary

Based on the non-clinical and clinical performance as documented in the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.

#### 9. Conclusion:

Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the BSX Arm-type Electronic Blood Pressure Monitor is substantially equivalent to the predicate devices.