(139 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and does not mention AI or ML.
No
The device is described as a blood pressure monitor intended to measure blood pressure and pulse rate, not to treat or cure any 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 states it consists of a "Main Control Unit, LCD and attachments" and utilizes an "inflatable cuff," indicating it includes hardware components beyond just software.
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 description details a non-invasive blood pressure monitor that uses an inflatable cuff on the upper arm. This is a physical measurement technique, not an in vitro test.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Using reagents or assays
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro testing.
Therefore, this device falls under the category of a non-invasive physiological measurement device, not 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 in which an inflatable cuff (size: 2232cm(8.712.6in) is wrapped around the single upper arm. 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 Automatic Upper Arm style utilizes an inflatable cuff that is wrapped around the upper arm; the cuff circumference is limited to: 22cm32cm (8.7in12.6in).
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Investigation:
Study Type: Clinical validation of automated measurement type
Sample Size: eighty seven patients (36 males and 51 females)
Method: Same arm sequential method was adopted during the clinical testing.
Reference Device: The manual Mercury Sphygmomanometer was used as a reference device.
Results: 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 for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in public health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 09, 2017
Shenzhen Combei Technology Co., Ltd % Migo Yang Consultant Shenzhen Joyantech Consulting Co, Ltd. 1122#, International Mayor Communication Center, Baishizhong Nanshan District, Shenzhen, 518000 TW
Re: K163606
Trade/Device Name: Digital Blood Pressure Monitor-automatic Upper Arm Style: BP100A, BP200A, BPCB0A 3A, BP800A, BPCB0A-2A, BP866A, BP105A, BP106A, BP108A, BP116A, BP118A, BP880A, BP168A, BP126A, BP156A; Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN
Dated: April 1, 2017
Received: April 10, 2017
Dear 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
M.A. Hillebrand
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163606
Device Name
Digital Blood Pressure Monitor: Automatic Upper Arm Style: BP100A, BPCB0A-3A, BP800A, BPCB0A-2A, BP866A, BP105A, BP106A, BP108A, BP116A, BP118A, BP880A, BP168A, BP126A, BP156A;
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 in which an inflatable cuff (size: 2232cm(8.712.6in) is wrapped around the single upper arm. 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
Product: NIBP
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 | Image: Logo of "卓远天成"
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.
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 System, Measurement, Blood-Pressure, Non-Invasive the device Trade name of the Digital Blood Pressure Monitor- Automatic Upper Arm Style; device Type/Model of the Automatic Upper Arm Style: BP100A, BP200A, BPCB0A-
4
Product: NIBP
Version: A/0
| device | 3A, BP800A, BPCB0A-2A, BP866A, BP105A, BP106A, BP108A, BP116A, BP118A, BP880A, BP168A, BP126A, BP156A;
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: Arm blood pressure monitor Device: 510(K) Number: | K150430
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 Automatic Upper Arm style utilizes an inflatable cuff that is wrapped around the upper arm; the cuff circumference is limited to: 22cm32cm (8.7in12.6in).
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 home environments by using a non-invasive oscillometric
5
technique in which an inflatable cuff (size: 2232cm(8.712.6in) is wrapped around the single upper arm. 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 hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff (size: 2232cm(8.712.6in) is wrapped around the single upper arm.
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-Automatic | ||
| Upper Arm Style | Arm Blood Pressure Monitor | NA | |
| Device Model | BP100A, BP200A, BPCB0A-3A, BP800A, | ||
| BPCB0A-2A, BP866A, BP105A, BP106A, | |||
| BP108A, BP116A, BP118A, BP880A, | |||
| BP168A, BP126A, BP156A; | FT-C21Y, FT-C22Y, FT-C23Y, FT- | ||
| C24Y, FT-C11B, FT-C12B, FT- | |||
| C21Y-V, FT-C22Y-V, FTC-23Y-V, | |||
| FT-C24Y-V, FT-C11B-V, FT-C12B- | |||
| V, FT-C11B-UR, FT-C11B-BT | NA | ||
| Manufacturer | Shenzhen Combei Technology Co.,LTD | Fudakang Industrial Co., Ltd | NA |
| Intended Use/ | |||
| Indication for | |||
| Use | The Subject device is 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. | |||
| The Subject device is not intended to be | |||
| diagnostic device. | |||
| NA | 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. | |||
| Fudakang Arm Blood Pressure | |||
| Monitor and Wrist Blood Pressure | |||
| Monitor are not intended to be | |||
| diagnostic device | |||
| The Fudakang BT series Blood | |||
| Pressure Monitors are of Bluetooth | |||
| transmission function, which enable | |||
| user to transfer the measurement | |||
| record from the device to a mobile | |||
| phone or PC through Bluetooth. | same | ||
| Intended | |||
| Population | adult | same | |
| Intended | |||
| Anatomical | |||
| site | upper arm | ||
| Prescription & | |||
| OTC | OTC | ||
| Working | |||
| Principle | Oscillometric method | ||
| Internal Power | |||
| supply | 4- size "AA" alkaline Batteries | 4- size "AA" alkaline Batteries | same |
| Characteristics | Subject device | Predicate device (K150430) | Remark |
| Working | |||
| Current |