(205 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
The device is intended to measure blood pressure and pulse rate. It does not provide any treatment or therapy.
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 states it consists of a "Main Control Unit, LCD and attachments" and utilizes an "inflatable cuff," indicating it is a hardware device with integrated software, not a software-only medical 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."
- Function: The device measures physiological parameters (blood pressure and pulse rate) directly from the body using a non-invasive technique. IVD devices, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description confirms it's a non-invasive blood pressure monitor that interacts with the wrist.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The subject device is 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 in which an inflatable cuff(size: 12.5-21.5cm(4.9-8.5in) is wrapped around the single wrist.
The Subject device is not intended to be diagnostic device.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Subject device is battery driven automatic non-invasive Blood Pressure Monitor. It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique.
The wrist style utilizes an inflatable cuff that is wrapped around the single wrist; the cuff circumference is limited to: 12.521.5cm(4.98.5in).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
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, eighty seven patients (36 males and 51 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical test: In this clinical investigation, eighty seven patients (36 males and 51 females) participated in the clinical study. Same arm sequential method was adopted during the clinical testing. 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 10, 2018
Shenzhen Combei Technology Co., Ltd. % Ms. Migo Yang, Consultant Shenzhen Joyantech Consulting Co., Ltd. 1122#. International Mavor Communication Center. Baishizhong Rd 55#, Nanshan District, Shenzhen, Guangdong 518053 CHINA
Re: K171833
Trade/Device Name: Digital Blood Pressure Monitor-Wrist Style, with 14 models: BP800W, BP603W, BP880W, BP885W, BPCBOA-2F, BP850W, BP300W, BP810W, BP602W, BP608W, BP606W, BP660W, BP830W, BP866W Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 11, 2017 Received: December 5, 2017
Dear Ms. Migo Yang:
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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
M.A. Wilhelm
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) K171833
Device Name
Digital Blood Pressure Monitor: Wrist Style: BP800W, BP603W, BP885W, BPCB0A-2F, BP850W, BP300W, BP810W, BP602W, BP608W, BP600W, BP660W, BP830W, BP866W
Indications for Use (Describe)
The subject device is 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 in which an inflatable cuff(size: 12.5-21.5cm(4.9-8.5in) is wrapped around the single wrist.
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) | |
| 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 | Oct 8, 2016 |
|---|---|
| Manufacturer | |
| information | Submitter's Name: Shenzhen Combei Technology Co.,Ltd |
| Address: Floor 5, Block B, Building G, Jinxiongda Science | |
| Park, South Huanguan Road, Guanlan, | |
| Longhua New District, Shenzhen, 518110, | |
| Guangdong, China | |
| Contact person: Huaguang.Meng | |
| TEL: 0755-29588956 | |
| FAX: 0755-28588961 | |
| E-Mail: huaguangmeng@combei.com.cn | |
| Submission | |
| Correspondent | Contact person: Miss Migo. Yang |
| E-Mail: migo@cefda.com | |
| Shenzhen Joyantech Consulting Co., Ltd. | |
| 1122#,International Mayor Communication Center, | |
| Baishizhong Road 55#, Nanshan District, Shenzhen, | |
| Guangdong, P.R.China. | |
| 历大 17 | 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 | |
| Establishment | |
| registration number | NA |
2 Device Information
| Common name of the device | System, Measurement, Blood-Pressure, Non-Invasive |
|---|---|
| Trade name of the device | Digital Blood Pressure Monitor- Wrist Style; |
| Type/Model of the | Wrist Style: BP800W, BP603W, BP880W, BP885W, |
4
Shenzhen Combei Technology Co.,Ltd
Version: A/0
| device | BPCB0A-2F, BP850W, BP300W, BP810W, BP602W,
BP608W, BP606W, BP660W, BP830W, BP866W; |
|-------------------------------|---------------------------------------------------------------------------------------|
| | 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 510(k)
submission | Traditional |
3 Predicate Device Information
Fudakang Industrial Co., Ltd Sponsor: Wrist blood pressure monitor Device: K150430 510(K) Number: |
4 Device Descriptions
The Subject device is battery driven automatic non-invasive Blood Pressure Monitor. It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique.
The wrist style utilizes an inflatable cuff that is wrapped around the single wrist; the cuff circumference is limited to: 12.521.5cm(4.98.5in).
5 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
5
| VOL_005_510(k) Summary | |
|---|---|
| Shenzhen Combei Technology Co.,Ltd | 001_510(k) Summary |
| Product: NIBP | Version: A/0 |
home environments by using a non-invasive oscillometric technique in which an inflatable cuff (size: 12.521.5cm(4.98.5in) is wrapped around the single wrist. The Subject device is not intended to be diagnostic device.
6 Indications for Use
The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff (size: 12.521.5cm(4.98.5in) is wrapped around the single wrist. The Subject device is not intended to be diagnostic device.
6
7 SE Comparison
| Characteristics | Subject device | Predicate device
(K150430) | Remark |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Device Name | Digital Blood Pressure Monitor-
Wrist Style | Wrist Blood Pressure
Monitor | NA |
| Device Model | BP800W, BP603W, BP880W,
BP885W, BPCB0A-2F,
BP850W, BP300W, BP810W,
BP602W, BP608W, BP606W,
BP660W, BP830W, BP866W | FT-B11W, FT-B12W, FT-
B13W, FT-B14W, FTB21Y,
FT-B22Y, FT-B11W-V, FT-
B12W-V, FT-B13W-V, FT-
B14W-V, FT-B21Y-V, FT-
B22Y-V, FT-B13W-UR, FT-
B13W-BT | NA |
| Manufacturer | Shenzhen Combei Technology
Co.,LTD | Fudakang Industrial Co.,
Ltd | 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 in which an
inflatable cuff (available size:
12.521.5cm(4.98.5in) is
wrapped around the single
wrist.
The Subject device is not
intended to be diagnostic
device. | Fudakang Arm Blood
Pressure Monitor and Wrist
Blood Pressure Monitor are
non-invasive blood
measurement system
intended to measure the
diastolic, systolic blood
pressures and pulse rate of
an adult individual in
hospitals, hospital-type
facilities and home
environments. | same |
| | 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 in which an
inflatable cuff (available size:
12.521.5cm(4.98.5in) is
wrapped around the single
wrist.
The Subject device is not | Fudakang Arm Blood
Pressure Monitor and Wrist
Blood Pressure Monitor are
not intended to be
diagnostic device | |
| Characteristics | Subject device | Predicate device
(K150430) | Remark |
| | intended to be diagnostic
device. | | |
| Intended
Population | adult | | same |
| Intended
Anatomical
site | wrist | | same |
| Prescription &
OTC | OTC | | same |
| Working
Principle | Oscillometric method | | same |
| Internal Power
supply | 2- size "AAA" alkaline Batteries | | same |
| Working
Current | ≤30mV | | same |
| Contact
Material | ABS, PMMA | | same |
| Memory
Function | 2×120 memory | 1×60 memory | SE |
| Cuff Size | 12.5cm21.5cm (4.5n8.5in) | 135mm195mm7.7in) | Note01 |
(5.3in
| Measuring
range | Pressure: 30 to 280 mmHg (in 1
mmHg increment); | Pressure:
(40mmHg280mmHg); | Note02 |40℃,
| | Pulse: 40 to 200 beat/minute | Pulse rate range(40-160)
hypo/minute | |
| Accuracy | Pressure: ±3mmHg; Pulse: ±5% | Pressure: ±5mmHg; Pulse
±5%. | SE |
| Operating
Environment | 5
15%85%RH | | same |55℃
| Storage &
Transport
Environment | -10
10%~95%RH | | same |
Table 1. Substantial Equivalence Comparison
7
Shenzhen Combei Technology Co.,Ltd
Product: NIBP
Version: A/0
Note01 : Similar : The subject device has larger wrist circumference than predicate device; Both the subject device and predicate device have been tested by ISO81060-2 and clinical test as qualified.
Note02 : Similar : The subject device has a larger measuring range of pressure and pulse than predicate device. Both the subject device and predicate device have been tested by ISO81060-2 and clinical test as qualified.
The subject device is as same as predicate device in Working Principle, Intended use/Indications for Use, Intended patient population, Intended application site, Intended Environments, Working Current, Cuff size, Operating Environment
8
Shenzhen Combei Technology Co.,Ltd
Storage & Transport Environment. Only their Measuring range are a little bit different. However, the minor difference does not raise any safety or effectiveness issue based on tests.
Thus, the subject device is Substantially Equivalent (SE) to the predicate device which is legally marketed in US.
8 Brief discussions of the non-clinical tests
The subject device conforms to the following guidances and standards:
- Non-Invasive Blood Pressure (NIBP) Monitor Guidance や
- IEC 60601-1:2005+A1:2012: Medical Electrical Equipment Part 1: General や Requirements For Basic Safety And Essential Performance;
- ゃ 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.
- 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;
- 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
9 Brief discussions of clinical tests
- ISO 81060-2:2013 Non-invasive sphygmomanometers Part 2: Clinical や validation of automated measurement type;
9
| Shenzhen Combei Technology Co.,Ltd |
|---|
| Product: NIBP |
Version: A/0
In this clinical investigation, eighty seven patients (36 males and 51 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.
10 Other information (such as required by FDA guidance)
No other information.
11 Conclusions
The subject device: Digital Blood Pressure Monitor-Wrist Style; manufactured by Shenzhen Combei Technology Co.,Ltd is respectively substantially equivalent to the predicate device Wrist Blood Pressure Monitor manufactured by Fudakang Industrial CO.,LTD(K150430).