(125 days)
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.
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.
The provided document contains information about the acceptance criteria and study that proves the device meets the acceptance criteria. Here's a summary of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states compliance with ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. This standard outlines the acceptance criteria for blood pressure monitor accuracy. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between the device and reference for systolic and diastolic blood pressure) are not explicitly detailed in the provided text, the document indicates that the results showed the accuracy of the blood pressure monitor is "within acceptable scope specified in ISO 81060-2."
From the "SE Comparison" table, the reported device accuracy is:
| Metric | Acceptance Criteria (per ISO 81060-2:2013) | Reported Device Performance |
|---|---|---|
| Pressure | (Not explicitly stated, but device claims compliance with ISO 81060-2) | ±3mmHg |
| Pulse | (Not explicitly stated, but device claims compliance with ISO 81060-2) | ±5% |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: 85 patients
- Data provenance: Not explicitly stated, but the study was conducted as a "clinical investigation" for regulatory submission, implying prospective data collection. The manufacturer is Shenzhen Combei Technology Co., Ltd. from China, so the study was likely conducted in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document mentions that "The manual Mercury Sphygmomanometer was used as a reference device" and that a "Same arm sequential method was adopted during the clinical testing." For non-invasive sphygmomanometer validation studies following ISO 81060-2, ground truth is typically established by trained observers using a reference manual sphygmomanometer. However, the exact number of experts/observers and their specific qualifications (e.g., radiologist with 10 years of experience) are not provided in this document.
4. Adjudication method for the test set:
The document states "Same arm sequential method was adopted during the clinical testing" using a manual Mercury Sphygmomanometer as a reference. This method involves taking simultaneous or sequential measurements by both the device under test and the reference method. For validation against ISO 81060-2, typically multiple observers take readings, and their readings are often averaged or adjudicated for the reference measurement. However, the specific adjudication method (e.g., 2+1, 3+1, none) is not explicitly detailed in the provided text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on validating the accuracy of the automated blood pressure monitor against a manual reference standard, not on comparing human readers with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone study was done. The clinical investigation described in section 8 (Brief discussions of clinical tests) evaluates the automated blood pressure monitor's performance directly against a reference device, without human interpretation of the device's output influencing the measurement. It's an algorithm-only (device-only) performance evaluation.
7. The type of ground truth used:
The type of ground truth used was measurements from a manual Mercury Sphygmomanometer, which serves as the reference standard for blood pressure measurement in accordance with ISO 81060-2.
8. The sample size for the training set:
The document does not provide information on the sample size for the training set. The clinical study mentioned (85 patients) is for validation/testing, not for training the algorithm. As a medical device that measures blood pressure using well-established oscillometric principles, it's possible that the core algorithm does not rely on a large, distinct "training set" in the same way a machine learning-based diagnostic algorithm would, or that such training data was internal to development and not disclosed in the 510(k) summary.
9. How the ground truth for the training set was established:
As no information is provided on a training set, the method for establishing its ground truth is also not mentioned.
{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.,LtdAddress: 11-5B No.105, Huanguan South Road, DaheCommunity, Guanlan, Longhua New District, Shenzhen,518110 Guangdong, China | |
| Manufacturerinformation | Contact person: Kevin FongTEL: 0755-29588956FAX: 0755-28588961E-Mail: kevin.fong@163.com |
| SubmissionCorrespondent | Contact person: Miss Lucy.YanE-Mail: Lucy@cefda.comShenzhen Joyantech Consulting Co., Ltd.1122#, International Mayor Communication Center,Baishizhong Road 55#, Nanshan District, Shenzhen,Guangdong, P.R.China. |
| Contact person: Mr. Field.FuE-Mail: cefda13485@163.comShenzhen 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 |
| Establishmentregistration 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 MonitorDigital 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 | ||
| Classificationinformation | Classification name: System, Measurement, Blood-Pressure, Non-Invasive | |
| Regulation Number: 870.1130 | ||
| Device Class: II | ||
| Product Code: DXN | ||
| type ofsubmission | 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
| Characteristics | Subject device | Predicatedevice(K091434) | Remark | |
|---|---|---|---|---|
| Device Name | ArmBloodPressureMonitor | Digital BloodPressureMonitor-AutomaticUpper ArmStyle | TrulyAutomatic ArmBloodPressureMonitorseries | NADB |
| 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 -Aand BP163A | DB21, DB22,DB23, DB31,DB32, DB61M,DB62M,DB63M,DB71M | NA |
| BP122A,BP136A | ||||
| Manufacturer | Shenzhen Combei TechnologyCo.,LTD | TrulyInstrumentLimited | NA | |
| Intended Use/Indication forUse | The subject device intended tomeasure the diastolic, systolicblood pressures and pulse rateof an adult individual inhospitals, hospital-typefacilities and homeenvironments by using a non-invasive oscillometrictechnique with a single upperarm cuff (22-42 cm).The device detects theappearance of irregular heartbeats during measurement andgives a warning signal withreadings.The Subject device is notintended to be diagnosticdevice. | TrulyAutomatic ArmBloodPressureMonitor DBseries, ModelsDB21, DB22,DB23, DB31,DB32, DB61M,DB62M,DB63M,DB71M are aseries devicesintended tomeasure thesystolic anddiastolic bloodpressure andpulse rate ofan adultindividual, byusing a non-invasivetechnique inwhich aninflatable cuffis wrappedaround theupper arm.The devicesfeaturesincludeirregular pulserhythmdetectionduringmeasurement,and display awarning signalwith thereading oncethe irregularheartbeat isdetected. | SE | |
| IntendedPopulation | adult | adult | same | |
| IntendedAnatomicalsite | upper arm | upper arm | same | |
| Prescription& OTC | OTC | OTC | same | |
| WorkingPrinciple | Oscillometric method | Oscillometricmethod | same | |
| Pressurization Source | Automatic internal pump | Automaticinternal pump | same | |
| InternalPower supply | 4- size "AA" alkaline Batteries | 4- size "AA"alkalineBatteries | same | |
| MemoryFunction | 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~340mm | SimilarNote01 | |
| Measuringrange | Pressure: 30 to 280 mmHg (in1 mmHg increment);Pulse: 40 to 200 beat/minute | Pressure:(20mmHg~280mmHg)Pulse raterange(40-195)beats/minute | SimilarNote02 | |
| Mesauringresolution | 1 mmHg | 1 mmHg | same | |
| Accuracy | Pressure: ±3mmHg; Pulse:±5% | Pressure:±3mmHg;Pulse ±5%. | same | |
| IrregularHeartbeatDetection | The subject devices have theIHB function. | DB22, DB23,DB61M,DB62M,DB63M,DB71M havethe IHBfunction. | 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
| OperatingEnvironment | 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).
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
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.(b)
Classification. Class II (performance standards).