(139 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 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.
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).
The document is a 510(k) Pre-market Notification for a Digital Blood Pressure Monitor. It describes the device's characteristics, intended use, and comparison to a predicate device. The clinical validation data provided is specifically for demonstrating the accuracy of the blood pressure monitor.
Here's an analysis of the provided text to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for accuracy are based on ISO 81060-2:2013, which specifies the requirements for clinical validation of automated non-invasive sphygmomanometers. The document states that the device's accuracy is "within acceptable scope specified in ISO 81060-2."
While ISO 81060-2 provides specific statistical criteria (mean difference and standard deviation of differences between the device and reference measurements), the document does not explicitly list these numerical criteria or the exact calculated performance metrics but rather makes a summary statement of compliance.
However, a "Substantial Equivalence Comparison" table (Table 1) provides the following for the subject device and predicate device:
| Characteristic | Subject device (Digital Blood Pressure Monitor-Automatic Upper Arm Style) | Predicate device (Arm Blood Pressure Monitor - K150430) |
|---|---|---|
| Accuracy | Pressure: ±3mmHg; Pulse: ±5% | Pressure: ±5mmHg; Pulse ±5%. |
Note: The accuracy characteristic listed as "Pressure: ±3mmHg; Pulse: ±5%" for the subject device seems to be a design specification or internal target, rather than reported clinical performance data resulting from the ISO 81060-2 study. The ISO standard specifies a statistical method to declare accuracy, not a simple range. The statement under section 9 "Brief discussions of clinical tests" that "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2" is the key clinical performance outcome. Without the specific numerical results (mean difference and standard deviation) from the ISO 81060-2 test, a precise performance table cannot be constructed from this document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Eighty-seven (87) patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical investigation," which implies prospective data collection for this purpose.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- For blood pressure accuracy studies following ISO 81060-2, "experts" in the traditional sense of image interpretation for AI are not typically involved in establishing ground truth.
- Ground Truth: The ground truth for blood pressure measurements is established by a manual Mercury Sphygmomanometer as the reference device, with measurements performed by trained personnel according to the standard. The document states: "The manual Mercury Sphygmomanometer was used as a reference device."
4. Adjudication Method for the Test Set
- Adjudication Method: The document describes a "Same arm sequential method" for the clinical testing. This is a specific protocol for comparing automated blood pressure readings to a reference standard, not an adjudication method in the context of multiple human readers for AI. It implies direct comparison of measurements taken immediately after each other.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This study is for the clinical validation of a blood pressure monitor's accuracy against a standard, not an AI-assisted diagnostic device where human reader improvement would be measured.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, in essence. The validation described is for the device (the automated blood pressure monitor) itself, which functions as a standalone algorithm (oscillometric technique) to measure blood pressure without human interpretation of complex data (like medical images). It's comparing the device's automated readings to a reference standard.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established using a manual Mercury Sphygmomanometer as the reference device. This falls under the category of a reference standard method (a gold/silver standard where applicable) for physiological measurements.
8. The Sample Size for the Training Set
- Not Applicable/Not Provided: This document describes the clinical validation of a physical medical device (blood pressure monitor), not an AI/machine learning model where a distinct "training set" would be used for algorithm development. The device's underlying oscillometric algorithm is presumably developed and optimized by the manufacturer using internal methods, but this document does not detail that process or any "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable/Not Provided: As mentioned above, this document does not refer to a training set for an AI model. The "ground truth" for the device's function is inherent in its design and the physical principles of oscillometry, calibrated and validated against established standards.
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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.
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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
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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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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.,LtdAddress: Floor 5, Block B, Building G, Jinxiongda SciencePark, South Huanguan Road, Guanlan,Longhua New District, Shenzhen, 518110,Guangdong, ChinaContact person: Huaguang.MengTEL: 0755-29588956FAX: 0755-28588961E-Mail: huaguangmeng@combei.com.cn |
| Submission Correspondent | Image: Logo of "卓远天成"Contact person: Miss Migo. YangE-Mail: migo@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 |
| 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-
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Product: NIBP
Version: A/0
| device | 3A, BP800A, BPCB0A-2A, BP866A, BP105A, BP106A, BP108A, BP116A, BP118A, BP880A, BP168A, BP126A, BP156A;Classification panel: Cardiovascular |
|---|---|
| Classificationinformation | Classification name: System, Measurement, Blood-Pressure, Non-InvasiveRegulation Number: 870.1130Device Class: IIProduct 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
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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.
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7 SE Comparison
| Characteristics | Subject device | Predicate device (K150430) | Remark |
|---|---|---|---|
| Device Name | Digital Blood Pressure Monitor-AutomaticUpper 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 forUse | The Subject device is non-invasive bloodmeasurement system intended to measurethe diastolic, systolic blood pressures andpulse rate of an adult individual in hospitals,hospital-type facilities and homeenvironments.The Subject device is not intended to bediagnostic device.NA | Fudakang Arm Blood PressureMonitor and Wrist Blood PressureMonitor are non-invasive bloodmeasurement system intended tomeasure the diastolic, systolicblood pressures and pulse rate ofan adult individual in hospitals,hospital-type facilities and homeenvironments.Fudakang Arm Blood PressureMonitor and Wrist Blood PressureMonitor are not intended to bediagnostic deviceThe Fudakang BT series BloodPressure Monitors are of Bluetoothtransmission function, which enableuser to transfer the measurementrecord from the device to a mobilephone or PC through Bluetooth. | same |
| IntendedPopulation | adult | same | |
| IntendedAnatomicalsite | upper arm | ||
| Prescription &OTC | OTC | ||
| WorkingPrinciple | Oscillometric method | ||
| Internal Powersupply | 4- size "AA" alkaline Batteries | 4- size "AA" alkaline Batteries | same |
| Characteristics | Subject device | Predicate device (K150430) | Remark |
| WorkingCurrent | <30mV | same | |
| ContactMaterial | ABS, PMMA | same | |
| MemoryFunction | 2×120 memory | 1×60 memory | SE |
| Cuff Size | 22cm | Same | |
| Measuringrange | Pressure: 30 to 280 mmHg (in 1 mmHgincrement); | Pressure: (40mmHg~280mmHg); | Similar |
| Pulse: 40 to 200 beat/minute | Pulse rate range(40-160)hypo/minute | Note01 | |
| Accuracy | Pressure: ±3mmHg; Pulse: ±5% | Pressure: ±5mmHg; Pulse ±5%. | SE |
| OperatingEnvironment | 5~40°C, | same | |
| 15%~85%RH | same | ||
| Storage &TransportEnvironment | -10~55°C | same | |
| 10%~95%RH | same |
Table 1. Substantial Equivalence Comparison
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Product: NIBP
Version: A/0
Note01: 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.
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 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 quidances and standards:
- Non-Invasive Blood Pressure (NIBP) Monitor Guidance や
- ゃ IEC 60601-1:2005+A1:2012: Medical Electrical Equipment - Part 1: General 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 や
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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:
- ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for や 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;
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
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The subject device: 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 Fudakang Industrial CO.,LTD(K150430).
§ 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).