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Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style

Q: Who is the manufacturer of Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style?

Shenzhen Combei Technology Co., Ltd. filed the 510(k) submission for Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style (K181104).

Q: What is the FDA product code for Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style?

DXN. It is classified under 21 CFR 870.1130 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style?

Truly Automatic Arm Blood Pressure Monitor (K091434).

K181104 · Shenzhen Combei Technology Co., Ltd. · DXN · Aug 29, 2018 · Cardiovascular

Device Facts

Record ID	K181104
Device Name	Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style
Applicant	Shenzhen Combei Technology Co., Ltd.
Product Code	DXN · Cardiovascular
Decision Date	Aug 29, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1130
Device Class	Class 2

Intended Use

The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The device detects the appearance of irregular heart beats during measurement and gives a warning signal with readings. The Subject device is not intended to be diagnostic device.

Device Story

Oscillometric blood pressure monitor; measures systolic/diastolic pressure and pulse rate; uses inflatable upper arm cuff (22-42 cm). Device consists of main unit (ABS housing), pressure sensor, pump, electromagnetic deflation valve, and LCD. Sensor converts cuff pressure fluctuations into electrical signals; microprocessor analyzes signals to calculate blood pressure and pulse rate. Detects irregular heartbeats by comparing pulse wave intervals to mean interval; triggers warning signal. Used in hospitals, hospital-type facilities, and home environments; operated by patients or clinicians. Optional Bluetooth connectivity for data transmission. Powered by 4 AA batteries or adapter. Provides non-invasive monitoring; aids in tracking blood pressure trends.

Clinical Evidence

Clinical validation performed per ISO 81060-2:2013. Study included 85 patients (52 male, 33 female) using same-arm sequential method against a manual mercury sphygmomanometer. Results confirmed accuracy within acceptable limits specified by ISO 81060-2. No adverse events reported.

Technological Characteristics

Materials: ABS (housing), nylon (cuff shell). Sensing: Electronic pressure sensor. Energy: 4 AA alkaline batteries or adapter. Connectivity: Optional Bluetooth LE. Dimensions: Cuff 22-42 cm. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-5/10, IEC 80601-2-30, ISO 81060-2. Algorithm: Oscillometric signal processing for BP/pulse calculation and irregular heartbeat detection.

Indications for Use

Indicated for adult individuals requiring measurement of systolic/diastolic blood pressure and pulse rate in hospital or home settings. Not intended for diagnostic use.

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

Truly Automatic Arm Blood Pressure Monitor (K091434)

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Submission Summary (Full Text)

{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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. August 29, 2018 Shenzhen Combei Technology Co., Ltd. % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. 1122#, International Mayor Communication Center, Baishizhong Road 55#, Nanshan District, Shenzhen, Guangdong, 518000, P.R. CHINA Re: K181104 Trade/Device Name: Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 25, 2018 Received: August 2, 2018 Dear Field Fu: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. ## Stephen C. Browning -S5 for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K181104 #### Device Name Arm type Blood Pressure Monitor Digital Blood Pressure Monitor-Automatic Upper Arm Style Indications for Use (Describe) The subject device intended to measure the diastolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The device detects the appearance of irregular heats during measurement and gives a warning signal with readings. The Subject device is not intended to be diagnostic device. | 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 This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR §807.92. ## 1 Administrative Information | Submission Date | Mar. 8, 2018 | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Submitter's Name: Shenzhen Combei Technology Co.,Ltd Address: 11-5B No.105, Huanguan South Road, Dahe Community, Guanlan, Longhua New District, Shenzhen, 518110 Guangdong, China | | Manufacturer information | Contact person: Kevin Fong TEL: 0755-29588956 FAX: 0755-28588961 E-Mail: kevin.fong@163.com | | Submission Correspondent | Contact person: Miss Lucy.Yan E-Mail: Lucy@cefda.com Shenzhen Joyantech Consulting Co., Ltd. 1122#, International Mayor Communication Center, Baishizhong Road 55#, Nanshan District, Shenzhen, Guangdong, P.R.China. | | | Contact person: Mr. Field.Fu E-Mail: cefda13485@163.com Shenzhen Joyantech Consulting Co., Ltd. 1122#, International Mayor Communication Center, Baishizhong Road 55#, Nanshan District, Shenzhen, Guangdong, P.R.China | | Image: Logo | 卓远天成 | | Establishment registration number | NA | ## 2 Device Information | Common name of the device | System, Measurement, Blood-Pressure, Non-Invasive | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade name of the device | Arm type Blood Pressure Monitor Digital Blood Pressure Monitor-Automatic Upper Arm Style | | Type/Model of the device | BP100A, BP156A , BPCB0A-2A, BP156A –A, BP163A, BP200A, BP116A, BP118A, BP106A, BP810A, BP800A, BP866A, BP660A, BPT801, BP101A, BP102A, BP103A, | {4}------------------------------------------------ Shenzhen Combei Technology Co.,Ltd Droduct: NIDD | Product: NIBP | Version: A/C | | |-------------------------------|------------------------------------------------------------------------------------------------|-------------| | | BP105A, BP108A, BP820A, BPCB0A-3H, BPCB0A-2H, BPB0A-3A, BP880A, BP168A, BP126A, BP122A, BP136A | | | | Classification panel: Cardiovascular | | | Classification information | Classification name: System, Measurement, Blood- Pressure, Non-Invasive | | | | Regulation Number: 870.1130 | | | | Device Class: II | | | | Product Code: DXN | | | type of submission | 510(k) | Traditional | #### 3 Predicate Device Information | Sponsor: | Truly Instrument Limited | |----------------|--------------------------------------------| | Device: | Truly Automatic Arm Blood Pressure Monitor | | 510(K) Number: | K091434 | ## 4 Device Descriptions Combei Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method". The main components of the Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, Bluetooth tranismiision (optional) and the LCD. The subject devices are powered by four AA alkaline batteries or adatpter. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irreqular pulse rhythm when the difference of the time intervals is over a specified range. #### 5 Intended Use/ Indications for Use {5}------------------------------------------------ The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The device detects the appearance of irregular heart beats during measurement and gives a warning signal with readings. The Subject device is not intended to be diagnostic device. ## 6 SE Comparison Product: NIBP | Characteri stics | Subject device | | Predicate device (K091434) | Remark | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | Device Name | Arm Blood Pressure Monitor | Digital Blood Pressure Monitor- Automatic Upper Arm Style | Truly Automatic Arm Blood Pressure Monitor series | NA DB | | Device Model | BP100A, BP156A, BPCB0A-2A, BP156A -A, BP163A, BP200A, BP116A, BP118A, BP106A, BP810A, BP800A, BP866A, BP660A, BPT801, BP101A, BP102A, BP103A, BP105A, BP108A, BP820A, BPCB0A-3H, BPCB0A-2H, BPCB0A-3A, BP880A, BP168A, BP126A | BP100A, BP156A, BPCB0A-2A, BP156A -A and BP163A | DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M | NA | | | BP122A, BP136A | | | | | Manufacturer | Shenzhen Combei Technology Co.,LTD | | Truly Instrument Limited | NA | | Intended Use/ Indication for Use | The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non- invasive oscillometric technique with a single upper arm cuff (22-42 cm). The device detects the appearance of irregular heart beats during measurement and gives a warning signal with readings. The Subject device is not intended to be diagnostic device. | | Truly Automatic Arm Blood Pressure Monitor DB series, Models DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual, by using a non- invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices features include irregular pulse rhythm detection during measurement, and display a warning signal with the reading once the irregular heartbeat is detected. | SE | | Intended Population | adult | adult | same | | | Intended Anatomical site | upper arm | upper arm | same | | | Prescription & OTC | OTC | OTC | same | | | Working Principle | Oscillometric method | Oscillometric method | same | | | Pressurizatio n Source | Automatic internal pump | Automatic internal pump | same | | | Internal Power supply | 4- size "AA" alkaline Batteries | 4- size "AA" alkaline Batteries | same | | | Memory Function | up to 199 memories (SYS, DIA, Pulse) | DB21: 2×60; DB22: 2×50; DB23: 4×99; DB31: 2×60; DB32: 1×99; DB61M : 4×99 ; DB62M : 4×99 ; DB63M : 4×99 ; DB71M : 4×99 | SE | | | Cuff Size | 220mm~420mm | 220mm~340m m | Similar Note01 | | | Measuring range | Pressure: 30 to 280 mmHg (in 1 mmHg increment); Pulse: 40 to 200 beat/minute | Pressure: (20mmHg~280 mmHg) Pulse rate range(40-195) beats/minute | Similar Note02 | | | Mesauring resolution | 1 mmHg | 1 mmHg | same | | | Accuracy | Pressure: ±3mmHg; Pulse: ±5% | Pressure: ±3mmHg; Pulse ±5%. | same | | | Irregular Heartbeat Detection | The subject devices have the IHB function. | DB22, DB23, DB61M, DB62M, DB63M, DB71M have the IHB function. | same | | #### Table 1. Substantial Equivalence Comparison {6}------------------------------------------------ #### Product: NIBP {7}------------------------------------------------ #### Product: NIBP Version: A/0 {8}------------------------------------------------ Shenzhen Combei Technology Co.,Ltd Product: NIBP transmission (optional) Similar Note03 Different Note04 | Operating Environment | 5~40℃, | 10~40℃, | |--------------------------|----------------------------------------------------------|-----------| | | 15%~85%RH | 15%~90%RH | | Bluetooth | Some models BP100A, BP156A , BPCB0A-2A. BP156A -A and | N | function with blutooth LE. BP163A has optinal wireless Note01: The subject devices have the larger arm circumference than predicate device, but the subject devices have been tested by ISO 81060-2. No. Note02: The subject device has a smaller measuring range of pressure and larger measuring range of pulse than predicate device, but the subject devices have been validated all the full claimed range. Note03: The subject device has a larger measuring range of temperature and smaller measuring range of humidity than predicate device, but the subject devices have been validated all the full claimed range. Note04: The subject device has optional bluetooth function but the predicated device has no wireless function. FCC and wireless coexistence about the wireless performance have been validated. The subject device is as same as predicate device in Working Principle, Intended patient population, intended application site, measuring accuracy. Only their Cuff size, measuring range and operating environment are a little bit different (refer to Note01 to Note 03) which had been validated by FCC and wireless coexistence. The subject device has a bluetooth function (Note 04) which had been validated. However, the differences would not raise any safety or effectiveness issue based on tests in this submission. Thus, the subject device is Substantially Equivalent (SE) to the predicate device which is legally marketed in US. #### 7 Brief discussions of the non-clinical tests The subject device conforms to the following guidances and standards: - ゃ Non-Invasive Blood Pressure (NIBP) Monitor Guidance - IEC 60601-1:2005+A1:2012: Medical Electrical Equipment Part 1: General や Requirements For Basic Safety And Essential Performance; - IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General ゃ Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests. - IEC 60601-1-11: 2010 Medical Electrical Equipment Part 1-11: General ゃ Requirements For Basic Safety And Essential Performance - Collateral Standard: {9}------------------------------------------------ Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment; - ISO 10993-5: 2009 /(R)2014 Biological evaluation of medical devices Part 5: ゃ Tests for In Vitro cytotoxicity: - ゃ ISO 10993-10: 2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization; - ゃ IEC 80601-2-30: 2013 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers - CFR 47 FCC PART 15. 247 Operation within the bands 902-928 MHz, 2400-ゃ 2483.5 MHz, and 5725-5850 MHz. #### 8 Brief discussions of clinical tests - ゃ ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type; In this clinical investigation, 85 patients (52 males and 33 females) participated in the clinical study. Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect. The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2. ### 9 Other information (such as required by FDA quidance) No other information. #### 11 Conclusions The subject device: Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style manufactured by Shenzhen Combei Technology Co.,Ltd is respectively substantially equivalent to the predicate device Arm Blood Pressure Monitor manufactured by Fudakanq Industrial CO.,LTD(K091434).