(219 days)
The Electronic Sphygmomanometer and Automatic Blood Pressure Monitor are intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
The proposed devices, ABPM50 Automaitc Blood Pressure Monitor, CONTEC08A and CONTEC08C Electronic Sphygmomanometers are battery driven automatic non-invasive Blood Pressure Monitor. They can automatically complete the inflation and BP measurement, which can measure systolic, and diastolic blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. ABPM50 and CONTEC08A and CONTEC08C can be only used on adult individuals.
The devices have the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure and pulse rate.
ABPM50 and CONTEC08A have physiological over-limit prompt function which can be turned on or off by users. When the measurement results exceed the over-limit prompt limit, the physiological over-limit prompt function will be triggered. The over-limit can be set by users, and the low limit must be lower than the corresponding high limit.
In addition, all of the three proposed devices have technical over-limit prompt function, which will be triggered when the battery voltage is low, and this technical over-limit prompt function can not be cancelled unless being closed or the power replaced.
The provided FDA 510(k) summary (K202757) for the Electronic Sphygmomanometer, Automatic Blood Pressure Monitor CONTEC08A/CONTEC08C/ABPM50 details the non-clinical and clinical tests performed to demonstrate substantial equivalence to a predicate device.
Here's an breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device, being a non-invasive blood pressure measurement system, are primarily based on established international standards for accuracy and safety. The reported device performance is presented as compliance with these standards and specific measurement ranges.
| Category | Acceptance Criteria (Standard/Range) | Reported Device Performance/Compliance |
|---|---|---|
| Accuracy | ISO 81060-2 (Clinical Investigation of Intermittent Automated Measurement Type) | "Total 85 subjects are included in each clinical study, the results of proposed device meet the performance parameters claimed in user manual, and the proposed device complies with ISO 81060-2." (Page 6) "The clinical trial results verify that the clinical accuracy of the proposed device is not inferior to that of predicate device." (Page 6) |
| Static Pressure | ±3 mmHg | ±3 mmHg (Page 8, Table 7-1) |
| Pulse Accuracy | ±5% | ±5% (Page 8, Table 7-1) |
| Electrical Safety | IEC 60601-1, IEC 60601-1-11 | Complies with IEC 60601-1, IEC 60601-1-11 (Page 7, Table 7-1) |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 | Complies with IEC 60601-1-2:2014 (Page 6, Table 7-1) |
| Performance Test | IEC 80601-2-30 Edition 1.1 2013-07 (Particular Requirements for Basic Safety and Essential Performance of Automated Non-Invasive Sphygmomanometers) | Complies with IEC 80601-2-30 Edition 1.1 2013-07 (Page 7, Table 7-1) "the proposed device has passed the IEC8601-2-30 and ISO81069-2 test, the performance of the proposed device can be guaranted..." (Page 9, Analysis 2) |
| Biocompatibility | ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization) | Complies with ISO 10993-5 and ISO 10993-10. (Page 7, Table 7-1) "has passed the Biocompatibility test (including Cytotoxicity, Skin Sensitization, Skin Irritation)..." (Page 9, Analysis 3) |
| Measurement Range (BP) | Varies (Predicate: 30-255 mmHg) | 10-270 mmHg (Proposed device, Page 8, Table 7-1) |
| Measurement Range (Pulse) | Varies (Predicate: 40-199 bpm) | 40-240 BPM (Proposed device, Page 8, Table 7-1) |
| Operating Environment | +5 °C | "has passed the IEC 60601-1-1 test, the safety and performance of the proposed device can be guaranteed." (Page 9, Analysis 1) |
| Storage Environment | -20 °C~+55 °C, ≤95% RH, 700 hPa~1060 hPa (No corrosive gas and drafty) | "has passed the IEC 60601-1-1 test, the safety and performance of the proposed device can be guaranteed." (Page 9, Analysis 1) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Total 85 subjects are included in each clinical study." (Page 6)
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given that the manufacturer and correspondent are based in China, it is highly probable the clinical study was conducted in China. The study appears to be prospective as it describes a clinical investigation for the purpose of regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document states that the clinical study was conducted "in accordance with ISO 81060-2". ISO 81060-2 (Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type) outlines specific requirements for the observers and the comparison method to establish ground truth.
While the exact number and qualifications of experts (e.g., clinicians, trained observers) are not explicitly stated in this FDA submission summary, ISO 81060-2 typically requires:
- At least two trained observers to measure blood pressure using a reference sphygmomanometer simultaneously with the device under test.
- These observers must be trained and certified to perform auscultatory blood pressure measurements (e.g., using a mercury column or validated alternative) with high accuracy and reproducibility. The standard often specifies requirements for their training and regular performance validation to ensure inter-observer agreement.
4. Adjudication Method for the Test Set
The document does not explicitly describe an "adjudication" method in the context of expert consensus, as this is typically seen in studies where multiple readers interpret images or data and discrepancies need resolving. For blood pressure measurement, ISO 81060-2 mandates a specific comparison method where the device's measurements are compared against simultaneous auscultatory measurements obtained by trained observers. The standard defines how these measurements are to be collected and statistically analyzed (e.g., mean difference and standard deviation between the device and the reference measurements) to determine accuracy, rather than an "adjudication" of differing expert opinions on a specific diagnosis.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance
This device (Electronic Sphygmomanometer/Automatic Blood Pressure Monitor) is a medical measurement device, not an AI-based diagnostic tool that assists human readers in interpreting complex data like medical images. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which is common for AI tools in radiology or pathology, was not performed or applicable here. The study focused on demonstrating the device's accuracy and safety against established standards and a predicate device through direct measurement comparison.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the primary evaluation of this device is a standalone performance assessment. The device is designed to automatically measure and display blood pressure and pulse rate without continuous human intervention during the measurement process. The clinical study evaluated the device's direct measurement performance against a gold standard (auscultatory measurements) as per ISO 81060-2.
7. The Type of Ground Truth Used
The ground truth used for the clinical study was expert consensus/reference measurement through a standardized protocol. Specifically, it involved:
- Simultaneous blood pressure measurements taken by trained observers using a reference method (typically auscultation with a mercury sphygmomanometer or validated equivalent) alongside the device under test.
- This is the standard approach defined in ISO 81060-2 for validating automated non-invasive sphygmomanometers.
8. The Sample Size for the Training Set
The document does not mention a training set because this medical device approval is for a physical measurement device, not a machine learning or AI algorithm that requires a separate training set. The "study" described is a clinical validation study to confirm the accuracy and safety of already developed hardware and software, rather than a development and training phase for a learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of an AI/ML algorithm for this type of device, this question is not applicable. The device's underlying measurement algorithms are based on established oscillometric principles and do not "learn" from a dataset in the way a deep learning model would.
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April 28, 2020
Contec Medical Systems Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, Beijing 102401 China
Re: K202757
Trade/Device Name: Electronic Sphygmomanometer, Automatic Blood Pressure Monitor CONTEC08A/CONTEC08C/ABPM50 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 24, 2021 Received: March 29, 2021
Dear Ray Wang:
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.
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality 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)
Device Name
Trade Name: Electronic Sphygmomanometer, Automatic Blood Pressure Monitor Model: CONTEC08A/CONTEC08C/ABPM50
Indications for Use (Describe)
The Electronic Sphygmomanometer and Automatic Blood Pressure Monitor are intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
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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Tab #4 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K202757
-
Date of Preparation 1.
03/19/2021 -
- Sponsor
Contec Medical Systems Co., Ltd.
No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, 066004,China
Establishment Registration Number: 3006979678 Contact Person: Xueyong Li Position: Quality Manager Tel: +86-355-8015490 Fax: +86-355-8015490 Email: lxy1011@163.com
-
- Submission Correspondent
Mr. Ray Wang
- Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401
Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
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4. Identification of Proposed Device
Trade Name: Electronic Sphygmomanometer; Automatic Blood Pressure Monitor Common Name: system, measurement, blood-pressure, non-invasive Model(s): CONTEC08A/CONTEC08C/ABPM50
Regulatory Information: Classification Name: Noninvasive Blood Pressure Measurement System;
Classification: II: Product Code: DXN; Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular ;
Indication For Use Statement:
The Electronic Sphygmomanometer and Automatic Blood Pressure Monitor are intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
5. Device Description
The proposed devices, ABPM50 Automaitc Blood Pressure Monitor, CONTEC08A and CONTEC08C Electronic Sphygmomanometers are battery driven automatic non-invasive Blood Pressure Monitor. They can automatically complete the inflation and BP measurement, which can measure systolic, and diastolic blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. ABPM50 and CONTEC08A and CONTEC08C can be only used on adult individuals.
The devices have the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure and pulse rate.
ABPM50 and CONTEC08A have physiological over-limit prompt function which can be turned on or off by users. When the measurement results exceed the over-limit prompt limit, the physiological over-limit prompt function will be triggered. The over-limit can be set by users, and the low limit must be lower than the corresponding high limit.
In addition, all of the three proposed devices have technical over-limit prompt function, which will be triggered when the battery voltage is low, and this technical over-limit prompt function can not be cancelled unless being closed or the power replaced.
The main differences among the three (CONTEC08A / CONTEC08C / ABPM50) are as follows:
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| model | CONTEC08A | CONTEC08C | ABPM50 |
|---|---|---|---|
| TradeName | ElectronicSphygmomanometer | ElectronicSphygmomanometer | Automatic Blood Pressure Monitor |
| Over limitprompt | yes | no | yes |
| display | TFT LCD display | Segment code screendisplay | TFT LCD display |
| Storagefunction | Three users, each userstores 100 groups ofdata | Three users, each userstores 99 groups of data | General single blood pressuremeasurement storage 300 groups ofdata , automatic blood pressuremeasurement (350 groups of data) |
| PowerSupply | four alkaline batteriesor 5V power adapter | four alkaline batteries or5V power adapter | two alkaline batteries |
6. Identification of Predicate Device Predicate Device: 510(k) Number: K191180
Product Name: Electronic Blood Pressure Monitor: Models AOJ-30A and AOJ-30B Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.
7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ハ 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
-
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11 Edition 2.0 2015-01 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
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-
IEC 80601-2-30 Edition 1.1 2013-07, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- ) ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [including: Amendment 1 (2020)]
-
ISO 10993-5 Third Edition 2009-06-01. Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
-
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
- Clinical Test Conclusion 8.
Controlled human clinical studies were conducted on proposed device with predicates in accordance with ISO 81060-2, mean deviation, standard deviation has been evaluated per clinical validation. The clinical trial results verify that the clinical accuracy of the proposed device is not inferior to that of predicate device.
Total 85 subjects are included in each clinical study, the results of proposed device meet the performance parameters claimed in user manual, and the proposed device complies with ISO 81060-2.
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9. Substantially Equivalent (SE) Comparison
| Item | Proposed DeviceCONTEC08A/CONTEC08C/ABPM50 | Predicate DeviceAOJ-30A and AOJ-30BK191180 | Remark | ||
|---|---|---|---|---|---|
| Manufacture | Contec Medical Systems Co., Ltd. | Shenzhen AOJ Medical TechnologyCo., Ltd. | -- | ||
| Product Code | DXN | DXN | SE | ||
| Regulation Number | 21 CFR 870.1130 | 21 CFR 870.1130 | SE | ||
| Indication for Use | The Electronic Sphygmomanometer and Automatic Blood PressureMonitor are intended to measure the systolic and diastolic bloodpressure as well as the pulse rate of adult person via non-invasiveoscillometric technique at medical facilities or at home. | The Electronic Blood Pressure Monitor is intended tomeasure the systolic and diastolic blood pressure as wellas the pulse rate of adult person via non-invasiveoscillometric technique at medical facilities or at home. | SE | ||
| Clinical Use | Medical Facilities and Home Use | Medical Facilities and Home Use | SE | ||
| PatientPopulation | Adult | Adult | SE | ||
| Measurement Type | Upper arm | Upper arm | SE | ||
| MeasurementPrinciple | Oscillometric | Oscillometric | SE | ||
| Components | LCD / Key / Cuff / MCU / Pump / Batteries | LCD / Key / Cuff / MCU / Pump / Batteries | SE | ||
| Power Source | CONTEC08A/CONTEC08C | 4x1.5V(4 "AA" alkaline batteries);5V adapter, optional | 4x1.5V | Analysis 1 | |
| ABPM50 | 2x1.5V(2 "AA" alkaline batteries) | ||||
| PhysicalDimensions | CONTEC08A/CONTEC08C | 130(L)*110(W)*80(H) mm | Approx: 138 mm(Length)x120mm(Width)x59 mm(Height) | Analysis 1 | |
| ABPM50 | 128(L)*69(W)*36 mm(H) | ||||
| CONTEC08A/CONTEC08C | 300 gram(without batteries) | Approx: 483.8 g, excluding battery | Analysis 1 | ||
| Weight | ABPM50 | 240 gram(without batteries) | |||
| Measurement | Blood Pressure | 10~270 mmHg | Blood Pressure | 30~255 mmHg | Analysis 2 |
| Range | Pulse Rate | 40~240BPM | Pulse Rate | 40-199 bpm | |
| Accuracy | Static Pressure | ±3 mmHg | Static Pressure | ±3 mmHg | SE |
| Pulse | ±5% | Pulse | ±5% | ||
| Arm Circumference | 22-32 cm and 32-43cm | 22 cm~36 cm | Analysis 2 | ||
| Patient ContactMaterial | PVC+ Nylon+Ployester | Cuff-Terylene | Analysis 3 | ||
| Electrical safety | IEC 60601-1 | IEC 60601-1 | SE | ||
| IEC 60601-1-11 | IEC 60601-1-11 | ||||
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | SE | ||
| Performance test | IEC80601-2-30 | IEC80601-2-30 | SE | ||
| Clinical data | ISO81060-2 | ISO81060-2 | SE | ||
| Biocompatibilitytest | Cytotoxicity | Cytotoxicity | SE | ||
| Skin Sensitization | Skin Sensitization | ||||
| Skin Irritation | Skin Irritation | ||||
| OperationEnvironments | +5 °C~40 °C | + 5°C~+40°C, | Analysis 1 | ||
| 15 %RH~85 %RH (Non-condensing) | 15%RH~90%RH | ||||
| 700 hPa~1060 hPa | 70 kPa~106 kPa | ||||
| StorageEnvironments | -20 °C~+55 °C; | - 20°C~+ 55°C, | Analysis 1 | ||
| Relative humidity: ≤95 %; No corrosive gas and drafty. | 10%RH~93%RH | ||||
| 700 hPa~1060 hPa | 70 kPa~106 kPa |
Table 7-1 General Comparison
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Analysis 1
The proposed device is different in Power Source, Waight, Operation Environments and Storage Environments from the predicate device. The differences is small, and the proosed device has passed the II 200601-1-1 test, the safety and performance of the proposed device can be guaranteed. By complying with non-clinical the proposed device is determined to be substantially equivalency with predicate device.
Analysis 2
The proposed device is different in Measuremence from the predicate device. But the proposed device has passed the IEC8601-2-30 and ISO81069-2 test, the performance of the proposed device can be guaranted, by complying with not-clinical the proposed device is determined to be substantially equivalency with predicate device.
Analysis 3
The proposed device is different in Patent Contact from the predicate device has passed the Biocompatibility tost (including Cytotoxicity , Skin Sensitzation , Skin Intritation ), we believe the effect the effectiveness and safety compared with the predicate device, the proposed device is determined to be substantially equivalency with predicate device.
10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
§ 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).