(125 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor using well-established techniques and components, with no mention of AI or ML. The irregular heartbeat detection is based on comparing time intervals, not complex pattern recognition typically associated with AI/ML.
No
The device is intended to measure blood pressure and pulse rate, providing information for diagnosis, but not directly treating a condition.
No
The "Intended Use / Indications for Use" section explicitly states, "The Subject device is not intended to be diagnostic device."
No
The device description explicitly lists hardware components such as a main unit, cuff unit, microprocessor, pressure sensor, pump, electromagnetic deflation control valve, and LCD. This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "not intended to be diagnostic device." Its purpose is to measure blood pressure and pulse rate, which are physiological parameters, not to diagnose a disease or condition based on in vitro examination of specimens.
- Device Description: The device description details a non-invasive method using a cuff and electronic pressure sensor to measure blood pressure and pulse rate. This is a physical measurement technique, not an in vitro test.
- Lack of In Vitro Testing: There is no mention of the device being used to test biological specimens (like blood, urine, or tissue) outside of the body. IVD devices are specifically designed for such testing.
Therefore, while this is a medical device used for monitoring health parameters, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adult
Intended User / Care Setting
hospitals, hospital-type facilities and home environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical validation was performed according to ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. 85 patients (52 males and 33 females) participated. Same arm sequential method was adopted. The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Pressure: ±3mmHg; Pulse: ±5%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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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 | 220mm420mm | 220mm340m
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).