Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B

K201467 · Bioland Technology, Ltd. · DXN · Sep 21, 2020 · Cardiovascular

Device Facts

• Record ID: K201467
• Device Name: Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B
• Applicant: Bioland Technology, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Device Story

Digital blood pressure monitor; uses oscillometric method to measure systolic/diastolic pressure and pulse rate. Input: air pressure signals from inflated cuff; processed via semiconductor pressure sensor. Output: blood pressure and pulse rate values on LCD; irregular heartbeat warning signal. Used in home environment by adult patients. Model 2006-2B includes Bluetooth for data transmission to mobile application for user management. Device consists of shell, buttons, display, air tube, cuff, and battery. Deflation controlled by preset mechanical valve. Benefits include home-based monitoring of cardiovascular metrics and irregular heartbeat detection.

Clinical Evidence

Clinical validation performed per ISO 81060-2. Study included 86 adult subjects to assess clinical accuracy and repeatability. Results met all specified criteria for non-invasive sphygmomanometers.

Technological Characteristics

Oscillometric measurement via semiconductor pressure sensor. Powered by 4xAA batteries. LCD display. Bluetooth connectivity (model 2006-2B). Biocompatibility per ISO 10993-5/10. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2; Home healthcare environment safety per IEC 60601-1-11. Performance per IEC 80601-2-30.

Indications for Use

Indicated for adult patients for the measurement of blood pressure and pulse rate. Detects irregular heartbeats during measurement.

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

• HEM-9210T (K163235)

Submission Summary (Full Text)

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September 21, 2020

Bioland Technology Ltd. Yiging Feng, R.A No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Shenzhen, Guangdong 518116 China

Re: K201467

Trade/Device Name: Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 18, 2020 Received: August 25, 2020

Dear Yiqing Feng:

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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# Indications for Use

510(k) Number (if known) K201467

Device Name

Blood Pressure Monitor, 2005, 2006, 2006-2, 2006-2B

Indications for Use (Describe)

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

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

#### A. Applicant

Name: Bioland Technology Ltd. Adress: No. A6B7 (Block G) Shangrong Industrial.Zone, No.5 Baolong Road, Baolong Community Longgang District, 518116 Shenzhen, Guangdong PEOPLE'S REPUBLIC OF CHINA Tel: [phone] Fax: [phone] Contact person: Yiqing Feng E-mail: [e-mail]

#### B. Subject device

Trade name: Blood Pressure Monitor Model: 2005, 2006, 2006-2, 2006-2B Classification name: System, Measurement, Blood-Pressure, Non-Invasive Regulation Medical Specialty: Cardiovascular Product Code: DXN Regulation number: 830.1130 Device class: Class 2 Code of Federal Regulations: 21CFR 870.1130

#### C. Predicate Device

Device name: HEM-9210T K number: K163235 Manufacturer: Omron Healthcare, Inc.

#### D. Indication for use

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

#### E. Device Description

The 2006-2B, 2006, 2006, 2005 blood pressure monitor contains shell, button, display screen, air tube, cuff and battery. The systolic blood pressures and heart beats are transmitted via air pressure in the inflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by air pump. The deflation rate is controlled and released by a preset mechanical valve at a constant rate beginning at the pressure peak during the measurement. The measurement results including diastolic, systolic pressures and heart pulse rate are displayed on the LCD. The proposed device equipped with Bluetooth transmission function, which enable user to transmit the measurement results from the device to a mobile phone through Bluetooth. Users can manage the measurement results by the mobile application.

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| Device | Subject Device | Predicate Device | Remarks |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Manufacturer | Bioland Technology Ltd | Omron Healthcare, Inc | N/A |
| Model | 2005, 2006, 2006-2, 2006-2B | HEM-9210T | N/A |
| Classification | II | II | Same |
| Product code | DXN | DXN | Same |
| Classification | System, Measurement, | System, Measurement, Blood-Pressure, | |
| name | Blood-Pressure, Non-Invasive | Non-Invasive | Same |
| Regulation No. | 870.1130 | 870.1130 | Same |
| 510(K) number | N/A | K163235 | N/A |
| Intended Use | The device is a digital monitor<br>intended for use in measuring blood<br>pressure and pulse rate in adult<br>patient population. The device detects<br>the appearance of irregular heartbeats<br>during measurement and gives a<br>warning signal with readings. | The device is a digital monitor intended<br>for use in measuring blood pressure and<br>pulse rate in adult patient population.<br>The device detects the appearance of<br>irregular heartbeats during measurement<br>and gives a warning signal with readings. | Same |
| Environmental<br>of use | Home | Home | Same |
| Patient<br>Population | Adult | Adult | Same |
| Measurement<br>method | Cuff oscillometric method | Cuff oscillometric method | Same |
| Measurement | Pressure: 0 to 300 mmHg | Pressure: 0 to 299 mmHg | Similar |
| range | Pulse Rate: 40 to 195 beats/min | Pulse Rate: 40 to 180 beats/min | Similar |
| Pressure sensor | Semiconductor pressure sensor | Semiconductor pressure sensor | Same |
| Measuring<br>accuracy | Pressure: Within ±3mmHg<br>Pulse Rate: Within ±5% | Pressure: Within ±3mmHg or 2% of<br>reading<br>Pulse Rate: Within ±5% of reading | Similar |
| Cuff | 22-32cm | 22-42cm | similar |
| Inflation method | Automatic by electric pump | Automatic by electric pump | Same |
| Deflation<br>method | Automatic pressure release valve | Automatic pressure release valve | Same |
| Display | LCD digital display | LCD digital display | Same |
| Power Source | 4*AA batteries | 4*AA batteries or AC adapter | Similar |
| Display | LCD Display | LCD Display | Same |
| Operating<br>Environment<br>Condition | 15~40°C, RH≤85% (non-condense) | 10 °C~40 °C, 15 to 90% RH | Similar |
| Storage<br>Environment | -20~55°C, RH≤93% (non-condense) | -20~60°C, 10 to 95% RH | Similar |
| Device | Subject Device | Predicate Device | Remarks |
| Condition | | | |
| Dimension<br>mm(L*D*H) | 130*95*53 (2005) | | Different |
| | 140*109*60 (2006) | 107*141*79 | Note 1 |
| | 157*96*64(2006-2&2006-2B) | | |
| Weight | Approx.313g (2005) | | |
| | Approx.350g (2006) | | |
| | Approx.495g (2006-2) | Approx. 290g (10oz)<br>(Not including battery) | Different<br>Note 1 |
| | Approx.496g (2006-2B) | | |
| | (Including battery) | | |
| Irregular Heart<br>beat Feature | Yes | Yes | Same |
| Bluetooth | Yes (only 2006-2B applied) | Yes | Similar |
| Low battery<br>indication | Yes | Yes | Same |
| Patient contact<br>materials | Surface contact | Surface contact | |
| | Skin | Skin | Same |
| | Limited duration of use<24 hours | Limited duration of use<24 hours | |
| Biocompatibility | ISO 10993-5: 2009 | ISO 10993-5: 2009 | Same |
| | ISO 10993-10: 2010 | ISO 10993-10: 2010 | Same |
| EMC | IEC 60601-1-2: 2014 | IEC 60601-1-2: 2014 | Same |
| Electrical Safety | IEC 60601-1: 2005/A1; 2012 | IEC 60601-1: 2005/A1; 2012 | Same |
| Performance | IEC 80601-2-30 | IEC 80601-2-30 | Same |
| Clinical | ISO 81060-2 | ISO 81060-2 | Same |

# F. Substantial Equivalence table

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Note 1: Although the appearance and weight of subject device and predicate device exits the difference, the difference is not a factor in function of the device; therefore, the difference of the appearance and weight has no influence on safety and effectiveness of product.

# G. Predicate Device Comparison

The subject device and the predicate device have the same intended use and the similar technical parameters, they both use cuff oscillometric method to detect human body blood pressure and pulse rate. They have similar measuring range and measuring accuracy, only the appearance size and weight are different. Thus, the subject device is substantially equivalent to the predicate devices.

### H. Non-clinical test

| Testing name | Referenced standard | Summary result | Verdict |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------|
| Electric safety | IEC 60601-1: 2005/A1: 2012 Medical electrical | The subject complies with the | Pass |
| testing | equipment Part 1: General requirements for<br>basic safety and essential performance<br>FDA Recognition number: 19-4 | applicable requirements set<br>forth in the referenced electric<br>safety standard. | |
| EMC testing | IEC 60601-1-2:2014 Medical electrical<br>equipment - Part 1-2: General requirements for<br>basic safety and essential performance -<br>Collateral standard: Electromagnetic<br>compatibility - Requirements and tests<br>FDA Recognition number: 19-8 | The subject complies with the<br>applicable requirements set<br>forth in the referenced EMC | Pass |
| Electric safety for<br>medical device<br>used in the home<br>healthcare<br>environment | IEC 60601-1-11:2015 Medical electrical<br>equipment - General requirements for basic<br>safety and essential performance - Part 1-11:<br>Collateral Standard: Requirements for medical<br>electrical equipment and medical electrical<br>systems used in the home healthcare<br>environment. | The subject complies with the<br>applicable requirements set<br>forth in the referenced IEC<br>60601-1-11:2015 | Pass |
| Performance<br>testing | IEC 80601-2-30: 2018 Medical electrical<br>equipment -- Part 2-56: Particular<br>requirements for basic safety and essential<br>performance of automated non-invasive<br>sphygmomanometers standards for<br>performance effectiveness.<br>FDA Recognition number: 3-123 | The subject complies with the<br>applicable requirements set<br>forth in the referenced<br>performance standard. | Pass |
| Biocompatibility<br>testing | ISO 10993-1:2018 Biological evaluation of<br>medical devices -- Part 1: Evaluation and<br>testing within a risk management process<br>FDA Recognition number: 2-258<br>ISO 10993-5: 2009 Biological evaluation of<br>medical devices -- Part 5: Tests for In Vitro<br>cytotoxicity<br>FDA Recognition number: 2-245<br>ISO 10993-10: 2010 Biological evaluation of<br>medical devices -- Part 10: Tests for irritation<br>and delayed-type hypersensitivity<br>FDA Recognition number: 2-174 | The subject complies with the<br>applicable requirements set<br>forth in the referenced<br>biological evaluation standard. | Pass |
| QoS testing | 47 CFR PART 15 Subpart C, Radio frequency<br>devices subpart C - Intentional radiators | The subject complies with the<br>applicable requirements set<br>forth in the referenced | Pass |
| | | standard. | |

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# I. Clinical Testing

| Name of<br>clinical<br>testing | Referenced standard | Summary of testing | Patient population<br>(number of subjects) | Verdict |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|---------|
| Clinical<br>accuracy and<br>repeatability<br>testing | ISO 81060-2 Non-Invasive<br>sphygmomanometers – Part<br>2: Clinical validation of<br>automated measurement<br>type.<br>FDA Recognition number:<br>3-160 | The methods and criteria<br>of clinical accuracy and<br>repeatability testing had<br>been clinically assessed<br>to meet the requirements<br>of clinical accuracy per<br>the referenced standards. | 86 subjects | Pass |

## J. Conclusion

Non-clinical performance and clinical tests were conducted on the subject device and all tests met specified criteria. Base on the information provided in this submission the subject device, 2005, 2006, 2006-2 and 2006-2B blood pressure monitor are substantially equivalent to the predicate device, Noninvasive Blood Pressure Measurement System, HEM-9210T.