(205 days)
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.
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).
Here's an analysis of the provided text to fulfill your request:
Acceptance Criteria and Study for the Digital Blood Pressure Monitor-Wrist Style
The provided 510(k) summary indicates that the device was evaluated against the ISO 81060-2:2013 Non-invasive sphygmomanometers Part 2: Clinical validation of automated measurement type standard. This standard defines the acceptance criteria for accuracy in automated non-invasive sphygmomanometers.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Based on ISO 81060-2:2013)
| Measurement Parameter | Acceptance Criteria (Mean difference ± Standard Deviation) | Acceptance Criteria (Standard Deviation of differences from reference) | Reported Device Performance (Mean difference ± Standard Deviation) (for test group*) | Reported Device Performance (Standard Deviation) (for test group*) |
|---|---|---|---|---|
| Sistolic Blood Pressure | Mean difference ≤ ±5 mmHg | SD ≤ 8 mmHg | Within acceptable scope specified in ISO 81060-2 (Exact numbers not provided) | Within acceptable scope specified in ISO 81060-2 (Exact numbers not provided) |
| Diastolic Blood Pressure | Mean difference ≤ ±5 mmHg | SD ≤ 8 mmHg | Within acceptable scope specified in ISO 81060-2 (Exact numbers not provided) | Within acceptable scope specified in ISO 81060-2 (Exact numbers not provided) |
*Note: The document states "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2," but it does not provide the specific mean differences or standard deviations obtained from the clinical study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Eighty-seven (87) patients. This consisted of 36 males and 51 females.
- Data Provenance: Not explicitly stated, but given the manufacturer (Shenzhen Combei Technology Co., Ltd. in China) and the submission date, it is highly likely that the data originates from China. The study is described as a prospective clinical investigation since patients participated in the study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: The document states that a "manual Mercury Sphygmomanometer was used as a reference device." This implies that the ground truth measurements were obtained by trained human operators using this reference device. However, the exact number of experts/operators and their specific qualifications (e.g., "physician with X years of experience," "trained technician") are not specified in the provided text.
4. Adjudication Method
- Adjudication Method: The document mentions a "Same arm sequential method" was adopted. This method typically involves taking measurements simultaneously or in rapid succession on the same arm by both the test device and the reference device. It does not explicitly describe an adjudication method for discrepancies between multiple readers, as the ground truth seems to be established by one or more operators using the reference manual device. Therefore, a specific adjudication method like "2+1" or "3+1" is not applicable or not specified in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This document describes a clinical validation for a blood pressure monitor, focusing on its accuracy against a reference standard.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was conducted.
6. Standalone Performance Study (Algorithm Only)
- Was a standalone performance study done? Yes, the clinical investigation described is essentially a standalone performance study of the algorithm within the device. The study directly compares the device's measurements against a reference standard (manual mercury sphygmomanometer) without human intervention in the device's measurement process, beyond initiating the measurement.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established by measurements obtained using a manual Mercury Sphygmomanometer as a reference device. This is considered an expert-derived reference standard as it relies on trained human operators properly using a calibrated, recognized reference instrument.
8. Sample Size for the Training Set
- Sample Size (Training Set): The document does not specify the sample size for any training set. Blood pressure monitors like this typically do not involve machine learning models that require explicit "training sets" in the same way AI algorithms for image analysis do. Their algorithms are usually based on established oscillometric principles and calibrated during manufacturing. Therefore, this question is likely not applicable to the device described.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Not applicable, as no specific "training set" or explicit machine learning training process is described or implied for this type of device in the document.
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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
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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
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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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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 |
|---|---|
| Manufacturerinformation | 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, China |
| Contact person: Huaguang.MengTEL: 0755-29588956FAX: 0755-28588961E-Mail: huaguangmeng@combei.com.cn | |
| SubmissionCorrespondent | 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. |
| 历大 17 | 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 |
| Establishmentregistration 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, |
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Shenzhen Combei Technology Co.,Ltd
Version: A/0
| device | BPCB0A-2F, BP850W, BP300W, BP810W, BP602W,BP608W, BP606W, BP660W, BP830W, BP866W; |
|---|---|
| Classification panel: Cardiovascular | |
| Classificationinformation | 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
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| 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.
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7 SE Comparison
| Characteristics | Subject device | Predicate device(K150430) | Remark |
|---|---|---|---|
| Device Name | Digital Blood Pressure Monitor-Wrist Style | Wrist Blood PressureMonitor | 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 TechnologyCo.,LTD | Fudakang Industrial Co.,Ltd | NA |
| Intended Use/Indication forUse | The subject device intendedto measure the diastolic,systolic blood pressures andpulse rate of an adultindividual in hospitals,hospital-type facilities andhome environments by usinga non-invasive oscillometrictechnique in which aninflatable cuff (available size:12.5 | Fudakang Arm BloodPressure Monitor and WristBlood Pressure Monitor arenon-invasive bloodmeasurement systemintended to measure thediastolic, systolic bloodpressures and pulse rate ofan adult individual inhospitals, hospital-typefacilities and homeenvironments. | same |
| The subject device intendedto measure the diastolic,systolic blood pressures andpulse rate of an adultindividual in hospitals,hospital-type facilities andhome environments by usinga non-invasive oscillometrictechnique in which aninflatable cuff (available size:12.5 | Fudakang Arm BloodPressure Monitor and WristBlood Pressure Monitor arenot intended to bediagnostic device | ||
| Characteristics | Subject device | Predicate device(K150430) | Remark |
| intended to be diagnosticdevice. | |||
| IntendedPopulation | adult | same | |
| IntendedAnatomicalsite | wrist | same | |
| Prescription &OTC | OTC | same | |
| WorkingPrinciple | Oscillometric method | same | |
| Internal Powersupply | 2- size "AAA" alkaline Batteries | same | |
| WorkingCurrent | ≤30mV | same | |
| ContactMaterial | ABS, PMMA | same | |
| MemoryFunction | 2×120 memory | 1×60 memory | SE |
| Cuff Size | 12.5cm | 135mm | Note01 |
| Measuringrange | Pressure: 30 to 280 mmHg (in 1mmHg increment); | Pressure:(40mmHg~280mmHg); | Note02 |
| Pulse: 40 to 200 beat/minute | Pulse rate range(40-160)hypo/minute | ||
| Accuracy | Pressure: ±3mmHg; Pulse: ±5% | Pressure: ±5mmHg; Pulse±5%. | SE |
| OperatingEnvironment | 5~40℃,15%~85%RH | same | |
| Storage &TransportEnvironment | -10~55℃10%~95%RH | same |
Table 1. Substantial Equivalence Comparison
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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
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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;
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| 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).
§ 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).