Electronic 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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. December 4, 2020 Shenzhen Pango Electronic Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China Re: K200716 Trade/Device Name: Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 4, 2020 Received: November 5, 2020 Dear Diana Hong: 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. {1}------------------------------------------------ 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-reporting- combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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. LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K200716 Device Name Electronic Blood Pressure Monitor Indications for Use (Describe) The Electronic Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm~32 cm and 32 cm~42 cm. 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}------------------------------------------------ # Tab #6 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: - 1. Date of Preparation: 2/20/2020 - Sponsor Identification 2. # Shenzhen Pango Electronic Co.,Ltd. No.25, 1st Industrial Park, Fenghuang Road, Xikeng, Henggang, Longgang District Shenzhen, Guangdong, 518115, China. Establishment Registration Number: 3006792041 Contact Person: Xiaoyun Yang Position: Vice General Manager Tel: +86-755-33825988 Fax: +86-755-33825989 Email: sales@pan-go.com - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person) Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 360 925-3199 Email: info@mid-link.net {4}------------------------------------------------ #### 4. Identification of Proposed Device Trade Name: Electronic Blood Pressure Monitor Common Name: Arm Blood Pressure Monitor; Models: PG-800B18, PG-800B19, PG-800B19L, PG-800B28, PG-800B29 and PG-800B51 ### Regulatory Information Classification Name: Noninvasive blood pressure measurement system Classification: II; Product Code: DXN; Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular; #### Indications for Use: The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm~32 cm and 32 cm~42 cm. #### Device Description The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the World Health Organization (WHO) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2. The proposed electronic blood pressure monitor has six models, including PG-800B18, PG-800B19, PG-800B19L. PG-800B28. PG-800B29. PG-800B51. All models follow the same software, measurement principle and NIBP algorithm. The proposed device is intended to be used in medical facilities or at home. The product is provided non-sterile, and not to be sterilized by the user prior to use. {5}------------------------------------------------ - ર . Identification of Predicate Device 510(k) Number: K170151 Product Name: Electronic Blood Pressure Monitor Model: PG-800B22, PG-800B23, PG-800B26, PG-800B27, PG-800B31, PG-800B32, PG-800B33, PG-800B35, PG-800B36, PG-800B37, PG-800B43 and PG-800B42 Manufacturer: Shenzhen Pango Electronic Co., Ltd. - 6. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - > IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment -Part 1: General requirements for basic safety, and essential performance - A IEC 60601-1-2:2014, -Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests - A IEC 80601-2-30:2009, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers - > 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. - 7. Clinical Test Conclusion No Clinical study is included in this submission, because the blood pressure measurement function including the measurement principle and NIBP algorithm of the proposed device is identical with that of the legally marketed Electronic Blood Pressure Monitor (predicat device, K170151), which is also manufactured by the sponsor. In addition, the cuff size of the proposed device is also same as that of the legally marketed Electronic Blood Pressure Monitor (predicat device, K170151). {6}------------------------------------------------ #### 8. Substantially Equivalent (SE) Comparison | Item | Proposed Device, Electronic Blood Pressure<br>Monitor | Predicate Device, K170151<br>Electronic Blood Pressure Monitor | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | DXN | DXN | | Regulation Number | 21 CFR 870.1130 | 21 CFR 870.1130 | | Class | II | II | | Indications for Use | The Electronic Blood Pressure Monitor is<br>intended to measure the systolic and diastolic<br>blood pressure as well as the pulse rate of adult<br>person via non-invasive oscillometric<br>technique in which an inflatable cuff is<br>wrapped around the upper arm. It can be used<br>at medical facilities or at home. The intended<br>arm circumference includes: 22 cm~32 cm and<br>32 cm~42 cm. | The Electronic Blood Pressure Monitor is<br>intended to measure the systolic and<br>diastolic blood pressure as well as the pulse<br>rate of adult person via non-invasive<br>oscillometric technique in which an<br>inflatable cuff is wrapped around the upper<br>arm. It can be used at medical facilities or at<br>home. The intended arm circumference<br>includes: 22 cm~32 cm and 32 cm~42 cm. | | Measurement Site | Upper arm | Upper arm | | Patient Population | Adult | Adult | | Measurement Item | Systolic Pressure, Diastolic Pressure, Pulse<br>Rate | Systolic Pressure, Diastolic Pressure, Pulse<br>Rate | | Measurement<br>Method | Oscillometric | Oscillometric | | Component | LCD / Key / Cuff / MCU / Pump / Batteries | LCD / Key / Cuff / MCU / Pump / Batteries | | Blood Pressure Range | 30~280mmHg/ | 30 ~ 280 mmHg | | Blood Pressure Accuracy | 3mmHg | 3 mmHg | | Pulse Rate Range | 40 ~ 199 bpm | 40 ~ 199 bpm | | Data storage | SYS, DIA, Pulse Rate, Measurement Time,<br>Memory Number. | SYS, DIA, Pulse Rate, Measurement Time,<br>Memory Number. | | WHO BP Classification | Model PG-800B18, PG-800B19,<br>PG-800B19L, PG-800B28, PG 800B29 has<br>WHO BP Classification Per WHO<br>Classification<br>Model PG-800B51 has not WHO BP<br>Classification | All models provide WHO Classification | | Power Supply | 4 x 1.5V Batteries (LR03 or AAA) for models<br>PG-800B18, PG-800B19,<br>PG-800B19L ,PG-800B28, PG-800B29<br>Rechargeable Li-ion Battery PL 652035HC for<br>model: PG-800B51 | 4x 1.5V Battery (AA or LR6 batteries) | | Records Quantity | Single patient records quantity:90 for E)for<br>models PG-800B18, PG-800B19, PG-800B28,<br>PG-800B29, PG-800B51 | Single patient records quantity:90 for<br>Electronic Blood Pressure Monitor<br>(PG-800B42) | | | Doulbe patient records quantity: 90/90 for r for | Doulbe patient records quantity:60/60 for | | | model :PG PG-800B19L | Electronic Blood Pressure Monitor | | | | (PG-800B22, PG-800B23, PG-800B26, | | | | PG-800B27, PG-800B31, PG-800B32, | | | | PG-800B33, PG-800B35, PG-800B36, | | | | PG-800B37, PG-800B43) | | Arm circumference | 22~32cm and 32~42cm | 22~32cm and 32~42cm | | Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | | Particular | Comply with IEC | Comply with IEC | | Performance | 80601-2-30:2009 | 80601-2-30:2009 | | Clinical study | Not conducted | Conducted according to ISO 81060-2 | | Patient Contact Material | Cuff - Nylon Brush Tricot | Cuff - Nylon | | | Enclosure - ABS | Enclosure - ABS | | | Key - ABS | Key - ABS | | Software Level Concern | Moderate | Moderate | # Table 1 Comparison of Technology Characteristics {7}------------------------------------------------ By comparisons, there are mainly four differences between proposed device and predicated device. which are power supply, voltage, record quantities and clincial study. ### SE Analysis 1-WHO BP classification Majority models of proposed device have WHO BP classification which is identical to predicated device except model PG-800B51. Yet the WHO BP classification indicating is only for reference, it cannot be used as diagnosis criteria. This difference will not affect the safety and effectiveness, therefore this item is considered as substantial equivalence. #### SE Analysis 2- Power supply The difference between proposed device and predicated device (K170151) is the batteries , the proposed device use 4 x 1.5V Batteries (for models: PG-800B18, PG-800B19, PG-800B19L PG-800B28, PG-800B29) and Rechargeable Li-ion Battery PL 652035HC for model: PG-800B51 while the predicate device use four AA or LR6 batteries, but the power supply safety of proposed device is justified by the IEC60601-1 electricity test reports, and the rechargeable battery of the proposed device meets the requirements of IEC 62133. thus This difference will not affect the safety and effectiveness, therefore this item is considered as substantial equivalence. #### SE Analysis 3 -Record quantities For single patient model, the proposed device has the same record quantities as predicate device. For double patient model, the records quantities of proposed device is 90/90 while for predicated device is 60/60 , yet the proposed device adopt same measurement principle and NIBP algorithm as predicated device, software function is justified by the software documents. This difference will not affect the safety and effectiveness, therefore this item is considered as substantial equivalence. {8}------------------------------------------------ ## SE Analysis 4- Clinical study No Clinical study is included in this submission, because the blood pressure measurement function including the measurement principle and NIBP algorithm of the proposed device is identical with that of the legally marketed Electronic Blood Pressure Monitor (predicat device, K170151), which is also manufactured by the sponsor. In addition, the cuff size of the proposed device is also same as that of the legally marketed Electronic Blood Pressure Monitor (predicat device, K170151). - 9. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.