Blood Pressure Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size. January 26, 2021 Bioland Technology Ltd. Yiging Feng. RA No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Shenzhen, Guangdong 518116 China Re: K202934 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: December 24, 2020 Received: December 28, 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K202934 Device Name Blood Pressure Monitor, 2008, A221-2 #### 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 heatbeats 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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, 518116Shenzhen, Guangdong PEOPLE'S REPUBLIC OF CHINA Tel: +86 755 3690 0999 Fax: +86755 3329 6299 Contact person: Yiging Feng E-mail: regulator-a@bioland.com.cn #### B. Subject device Trade name: Blood Pressure Monitor Model: 2008, A221-2 Classification name: System, Measurement, Blood-Pressure, Non-Invasive Regulation Medical Specialty: Cardiovascular Product Code: DXN Regulation number: 830.1130 Device class: Class II Code of Federal Regulations: 21CFR 870.1130 ### C. Predicate Device Device name: Blood Pressure Monitor K number: K201467 Manufacturer: Bioland Technology Ltd. #### 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 2008, A221-2 blood pressure monitor contains shell, button, display screen, air tube, cuff and battery. The systolic, diastolic 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. #### F. Substantial Equivalence table {4}------------------------------------------------ | Device | Subject Device | Predicate Device | Remarks | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Manufacturer | Bioland Technology Ltd | Bioland Technology Ltd | N/A | | Model | 2008, A221-2 | 2005 | N/A | | Classification | II | II | Same | | Product code | DXN | DXN | Same | | Classification | System, Measurement, | System, Measurement, | Same | | name | Blood-Pressure, Non-Invasive | Blood-Pressure, Non-Invasive | Same | | Regulation No. | 870.1130 | 870.1130 | Same | | 510(K) number | N/A | K201467 | N/A | | Intended Use | The device is a digital monitor intended<br>for use in measuring blood pressure<br>and pulse rate in adult patient<br>population. The device detects the<br>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>Site | Upper arm | Upper arm | Same | | Measurement<br>method | Oscillometric method | Oscillometric method | Same | | Measurement<br>range | Pressure: 0 to 300 mmHg<br>Pulse Rate: 40 to 195 beats/min | Pressure: 0 to 300 mmHg<br>Pulse Rate: 40 to 195 beats/min | Same | | Pressure sensor | Semiconductor pressure sensor | Semiconductor pressure sensor | Same | | Measuring<br>accuracy | Pressure: Within $ ± $ 3mmHg<br>Pulse Rate: Within $ ± $ 5% | Pressure: Within $ ± $ 3mmHg<br>Pulse Rate: Within $ ± $ 5% | Same | | Cuff | 22-32cm | 22-32cm | Same | | Inflation method | Automatic by electric pump | Automatic by electric pump | Same | | Deflation<br>method | Automatic pressure release valve | Automatic pressure release valve | Same | | Power Source | 4*AA batteries | 4*AA batteries | Same | | Display | LCD Display | LCD Display | Same | | Operating<br>Environment<br>Condition | 5~40°C (41°F ~104°F), 15%~85% RH<br>(non-condense) | 15°C~40°C(59°F ~104°F), RH≤85%<br>(non-condense) | Similar | | Storage<br>Environment<br>Condition | -20~55°C(-4°F~131°F), RH≤93%<br>(non-condense) | -20~55°C(-4°F~131°F), RH≤93%<br>(non-condense) | Same | | Device | Subject Device | Predicate Device | Remarks | | Memory | 2*50 sets (2008)<br>50 sets (A221-2) | 128 sets | Different<br>Note 1 | | Auto power off time | Within 3min | Within 3min | Same | | Weight | Approx 208g (Not including battery) | Approx. 313g ( Including battery) | Different<br>Note 2 | | Dimension<br>(L*D*H) | 135mm*100mm*53mm | 130mm*95mm*53mm | Different<br>Note 3 | | Irregular Heart beat Feature | Yes | Yes | Same | | Low battery indication | Yes | Yes | Same | | Classify blood pressure level bar | Yes | No | Different<br>Note 4 | | Patient contact materials | Surface contact Skin<br>Limited duration of use<24 hours | Surface contact Skin<br>Limited duration of use<24 hours | 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 | | Biocompatibility | ISO 10993-5: 2009<br>ISO 10993-10: 2010 | ISO 10993-5: 2009<br>ISO 10993-10: 2010 | Same | | Clinical | ISO 81060-2 | ISO 81060-2 | Same | {5}------------------------------------------------ Note 1: The memory size of subject device and predicate device are different. But the difference is very slight, it will not affect the main function and the intended use of the subject device. At the same time memory size of subject device is clearly indicated in user manual and gift-box. Therefore, the difference will not result in safety and effectiveness issue of the subject device. Note 2 and Note 3: The weight and dimension between the subject device and predicate device is a little different, but the difference will not affect the main function and the intended use of the subject device, furthermore the weight and dimension is indicated in the user manual and gift-box. Thus, the difference will not result in safety and effectiveness issue of the subject device. Note 4: The subject device has the "Classify blood pressure level bar" function and the predicate device is not. The "Classify blood pressure level bar" function will not affect the main function and the intended use of the subject device, meanwhile the "Classify blood pressure level bar" function of subject device is clearly indicated in user manual. So the difference will not result in safety and {6}------------------------------------------------ effectiveness issue of the subject device. ## G. Predicate Device Comparison The subject device and the predicate device have the same intended use, same measuring range, measuring accuracy and the other similar technical parameters, they both use cuff oscillometric method to detect blood pressure and pulse rate. Thus, the subject device is substantially equivalent to the predicate device. | Testing name | Referenced standard | Summary result | Verdict | |----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------| | Electric safety<br>testing | IEC 60601-1: 2005/A1;:2012 Medical<br>electrical equipment Part 1: General<br>requirements for basic safety and essential<br>performance<br>FDA Recognition number: 19-4 | The subject complies with the<br>applicable requirements set<br>forth in the referenced electric<br>safety standard. | Pass | | EMC testing | IEC 60601-1-2:2014Medical 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 60601-1-11:2015Medical 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.<br>FDA Recognition number: 19-14 | 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 2-30: Particular requirements<br>for the basic safety and essential performance<br>of automated non-invasive<br>sphygmomanometers<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 10993-1:2018Biological evaluation of<br>medical devices -- Part 1: Evaluation and<br>testing within a risk management process | The subject complies with the<br>applicable requirements set<br>forth in the referenced | Pass | | Testing name | Referenced standard | Summary result | Verdict | | | FDA Recognition number: 2-258 | biological evaluation standard. | | | | ISO 10993-5:2009Biological evaluation of | | | | | medical devices -- Part 5: Tests for In Vitro<br>cytotoxicity | | | | | FDA Recognition number: 2-245 | | | | | ISO 10993-10:2010Biological evaluation of | | | | | medical devices -- Part 10: Tests for irritation<br>and delayed-type hypersensitivity | | | | | FDA Recognition number: 2-174 | | | ## H. Non-clinical test {7}------------------------------------------------ ## I. Clinical Testing Due to the subject device and predicate device (K number: K201467) having the same software algorithm, key components and cuff, the clinical report of blood pressure monitor (model: 2005,K number: K201467) can be applied to the traditional 510(k) as the clinical report of the subject device. Thus, the clinical data of the subject device came from the predicate device, and the clinical test information of the predicate device is as follows: | Name of clinical<br>testing | Referenced standard | Summary of testing | Patient population<br>(number of<br>subjects) | Verdict | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|---------| | Clinical accuracy<br>and repeatability<br>testing | ISO 81060-2:2018<br>Non-Invasive<br>sphygmomanometers –<br>Part 2: Clinical validation<br>of automated<br>measurement type.<br>FDA Recognition number:<br>3-160 | The methods and<br>criteria of clinical<br>accuracy and<br>repeatability testing had<br>been clinically assessed<br>to meet the<br>requirements of clinical<br>accuracy per the<br>referenced standards. | 86 subjects | Pass | ## J. Conclusion Non-clinical performance was conducted on the subject device and all tests met specified criteria. Based on the information provided in this submission, the subject device, 2008, A221-2 blood pressure monitor is substantially equivalent to the predicate device, Blood Pressure Monitor 2005.