CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor

• K Number: K202757
• Device Name: CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor
• Manufacturer: Contec Medical Systems Co., Ltd.
• Date Cleared: 2021-04-28 ( 219 days)
• Product Code: DXN
• Regulation Number: 870.1130

Intended Use

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.

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.

Predicate Devices

K191180

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard oscillometric blood pressure measurement and data storage, with no mention of AI or ML algorithms for data analysis, interpretation, or prediction.

Therapeutic

No.
The device is used for measurement and monitoring of blood pressure and pulse rate, not for treatment or therapy.

Diagnostic

Yes

Explanation: The device is intended to measure and monitor blood pressure and pulse rate. While it doesn't provide a diagnosis itself, the measurements it provides are critical for medical professionals to diagnose conditions like hypertension. The physiological over-limit prompt function further supports its role in identifying potential health concerns, making it a diagnostic aid.

SaMD (Software as a Medical Device)

No

The device description explicitly states the devices are "battery driven automatic non-invasive Blood Pressure Monitor" and describes physical components and functions like inflation, measurement, and data storage, indicating it is a hardware device with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The description clearly states that this device is an Electronic Sphygmomanometer and Automatic Blood Pressure Monitor. Its function is to measure blood pressure and pulse rate non-invasively at the upper arm using the oscillometric technique. This involves applying a cuff to the arm and detecting pressure changes, not analyzing biological samples.
• Intended Use: The intended use is to measure blood pressure and pulse rate of adult persons. This is a physiological measurement, not a diagnostic test performed on a sample.

Therefore, the device described is a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DXN

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.

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

medical facilities or at home.

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K191180

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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 ([e-mail]) or phone [phone] 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)

K202757

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

• 2. 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: [phone] Fax: [phone] Email: [e-mail]

• 3. Submission Correspondent
     Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401

Tel: [phone] Fax: [phone] Email: [e-mail]

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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
Trade
Name	Electronic
Sphygmomanometer	Electronic
Sphygmomanometer	Automatic Blood Pressure Monitor
Over limit
prompt	yes	no	yes
display	TFT LCD display	Segment code screen
display	TFT LCD display
Storage
function	Three users, each user
stores 100 groups of
data	Three users, each user
stores 99 groups of data	General single blood pressure
measurement storage 300 groups of
data , automatic blood pressure
measurement (350 groups of data)
Power
Supply	four alkaline batteries
or 5V power adapter	four alkaline batteries or
5V 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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K202757

9. Substantially Equivalent (SE) Comparison

| Item | Proposed Device
CONTEC08A/CONTEC08C/ABPM50 | | Predicate Device
AOJ-30A and AOJ-30B
K191180 | Remark | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|------------|
| Manufacture | Contec Medical Systems Co., Ltd. | | Shenzhen AOJ Medical Technology
Co., 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 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 Electronic Blood Pressure Monitor is 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. | SE | |
| Clinical Use | Medical Facilities and Home Use | | Medical Facilities and Home Use | SE | |
| Patient
Population | Adult | | Adult | SE | |
| Measurement Type | Upper arm | | Upper arm | SE | |
| Measurement
Principle | 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) | | | |
| Physical
Dimensions | CONTEC08A/CONTEC08C | 130(L)*110(W)*80(H) mm | Approx: 138 mm(Length)x120
mm(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 | 10270 mmHg | Blood Pressure | 30255 mmHg | Analysis 2 |
| Range | Pulse Rate | 40240BPM | 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 cm36 cm | | Analysis 2 |
| Patient Contact
Material | 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 |
| Biocompatibility
test | Cytotoxicity | | Cytotoxicity | | SE |
| | Skin Sensitization | | Skin Sensitization | | |
| | Skin Irritation | | Skin Irritation | | |
| Operation
Environments | +5 °C40 °C | | + 5°C+40°C, | | Analysis 1 |
| | 15 %RH85 %RH (Non-condensing) | | 15%RH90%RH | | |
| | 700 hPa1060 hPa | | 70 kPa106 kPa | | |
| Storage
Environments | -20 °C~+55 °C; | | - 20°C~+ 55°C, | | Analysis 1 |
| | Relative humidity: ≤95 %; No corrosive gas and drafty. | | 10%RH93%RH | | |
| | 700 hPa1060 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.