(146 days)
No
The description details a standard oscillometric blood pressure monitor with a microprocessor, pressure sensor, pump, valve, LCD, and memory. There is no mention of AI/ML algorithms for data analysis, interpretation, or prediction. The performance study is a comparative clinical study against predicate and mercury devices, not an AI/ML model validation.
No
The device is used for measurement and monitoring of blood pressure and pulse rate, not for treating a condition.
No
The device measures blood pressure and pulse rate, which are physiological parameters. While these measurements can be used by a healthcare professional to assist in diagnosis, the device itself simply provides data and does not interpret that data to identify a disease, condition, or state of health or to determine a prognosis.
No
The device description explicitly lists hardware components such as a microprocessor, pressure sensor, operation keys, pump, deflation control valve, LCD screen, and cuff. It also mentions being powered by batteries. This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Electronic Sphygmomanometer measures blood pressure and pulse rate directly from the human body (specifically, the arm) using a cuff and oscillometric technique. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate, not to analyze biological samples for diagnostic purposes.
Therefore, this device falls under the category of a non-invasive medical device used for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Electronic Sphygmomanometers is intended to measure the systolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Electronic Sphygmomanometers, including X1, X2, X5, X6, X7, X8, X11, is suitable for measurement of systolic blood pressure, diastolic blood pressure and the pulse rate of adult person and adolescents 18 to 21 years old with arm circumference ranging from 22 cm to 42 cm by the oscillometric technique. The error is controlled within the range specified in IEC 80601-2-30 Non-invasive automated monitor. User can select the blood pressure unit mmHg or kPa. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated.
The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve, LCD screen and cuff. And all models are powered by 4 AAA dry batteries (DC 6V).
The device has a memory function that automatically stores 2*99 sets data of the latest measurements. It can also display the latest measurement result. Additionally, the device also can read the data through voice broadcast function.
The seven models have the same intended use, working principle, measuring range, accuracy, cuff, and conformance standard; only appearance have some difference.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm
Indicated Patient Age Range
adult person and adolescents age 18 through 21 years of age
Intended User / Care Setting
It can be used at 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)
Non-Clinical Study: Non-clinical tests were conducted to verify that the proposed device meets the same design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the proposed device complies with the following standards: ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30, ISO 81060-2.
Software: Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices".
Biocompatibility Testing: The biocompatibility evaluating for the body-contacting component (arm cuff) of this device was conducted in accordance with the "Use of International Standard ISO 10933-1, Biological Evaluation of Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process", as recongnized by FDA. The arm cuff has performed and passed the Biocompatibility test. The arm cuff complies with the following standards: ISO 10993-5, ISO 10993-10.
Clinical Study: A comparative clinical study was conducted to verify the performance of the proposed device and predicate device as well as a mercury sphygmomanometer according to ISO 81060-2. The study demonstrated a significant correlation in the performance of proposed device and predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Pressure: ± 3mmHg( ± 0.4kPa), or 2% of the reading Pulse Rate: ± 5%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image 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.
August 31, 2022
Jiangxi AICARE Medical Technology Co., Ltd % Bing Huang Registration engineer Feiying Drug and Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K221040
Trade/Device Name: Electronic Sphygmomanometers, (Model: X1, X2, X5, X6, X7, X8, X11) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 15, 2022 Received: June 22, 2022
Dear Bing Huang:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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.
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221040
Device Name
Electronic Sphygmomanometers (Model: X1,X2,X5,X6,X7,X8,X11)
Indications for Use (Describe)
Electronic Sphygmomanometers is intended to measure the systolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used 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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3
510 (k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
1) Applicant information:
| 510(k) owner's name: | Jiangxi AICARE Medical Technology Co., Ltd. |
|---|---|
| Address: | No.6, South Side of Nanhuan Road Qianping Industrial Park, Le'an |
| County, Fuzhou City, 344300 Jiangxi Province, China | |
| Contact person: | Lizhu Xiao |
| Phone number: | +86 794 6577516 |
| Fax number: | +86 794 6577516 |
| Email: | xiaolizhu@spt-tek.com |
| Date of summary prepared: | August 4, 2022 |
2) Proprietary name of the device
| Trade name/model: | Electronic Sphygmomanometers
/X1, X2, X5, X6, X7, X8, X11 |
|--------------------|--------------------------------------------------------------|
| Common name: | Noninvasive blood pressure measurement system |
| Regulation number: | 21 CFR 870.1130 |
| Product code: | DXN |
| Review panel: | Cardiovascular |
| Regulation class: | Class II |
3) Predicate and reference device
> Predicate device
| Sponsor | ShenZhen ZhengKang Technology Co., Ltd |
|---|---|
| Device Name and Model | Upper Arm Blood Pressure Monitor Model: ZK-B868, ZK-B869, ZK-B872, ZK-B876 |
| 510(k) Number | K191894 |
| Product Code | DXN |
| Regulation Number | 21CFR870.1130. |
| Regulation Class | II |
> Reference device
| Sponsor | JOYTECH Healthcare Co., Ltd | Jiangsu | Yuyue | Mecical | ||
|---|---|---|---|---|---|---|
| Equipment& Supply Co., Ltd | ||||||
| Device Name and Model | Arm-type | Fully | Automatic | Electronic | Blood | Pressure |
| Digital Blood Pressure Monitor | Monitor : YE620B, YE620D, |
4
| Model: | |||
|---|---|---|---|
| DBP-1305b, | |||
| DBP-1319b, | |||
| DBP-1333b, | |||
| DBP-1257b, | |||
| DBP-1359b | DBP-1307b, | ||
| DBP-1318b, | |||
| DBP-1332b, | |||
| DBP-1307b, | |||
| DBP-1358b | YE660E, YE660F and YE680B | ||
| 510(k) Number | K200649 | K200939 | |
| Product Code | DXN | DXN | |
| Regulation Number | 21CFR870.1130 | 21CFR870.1130 | |
| Regulation Class | II | II |
4) Description/ Design of device:
The Electronic Sphygmomanometers, including X1, X2, X5, X6, X7, X8, X11, is suitable for measurement of systolic blood pressure, diastolic blood pressure and the pulse rate of adult person and adolescents 18 to 21 years old with arm circumference ranging from 22 cm to 42 cm by the oscillometric technique. The error is controlled within the range specified in IEC 80601-2-30 Non-invasive automated monitor. User can select the blood pressure unit mmHg or kPa. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated.
The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve, LCD screen and cuff. And all models are powered by 4 AAA dry batteries (DC 6V).
The device has a memory function that automatically stores 2*99 sets data of the latest measurements. It can also display the latest measurement result. Additionally, the device also can read the data through voice broadcast function.
The seven models have the same intended use, working principle, measuring range, accuracy, cuff, and conformance standard; only appearance have some difference.
| Component
| name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| Cuff | Nylon polyester | Surface skin contact | Less than 24 hours |
Materials
We have directly purchased cuff from qualified supplier which has obtained Biocompatibility test reports. For details, please refer to "Biocompatibility Discussion".
5) Intended use / indications:
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.
6) Technological characteristics and substantial equivalence:
5
| Item | Proposed device | Predicate device | Reference device1 | Reference device2 | Remark |
|---|---|---|---|---|---|
| Trade name | Electronic | ||||
| Sphygmomanomete | |||||
| rs | |||||
| (Model:X1,X2,X5, | |||||
| X6,X7,X8,X11) | Upper Arm Blood | ||||
| Pressure Monitor | |||||
| (Model:ZK-B868, | |||||
| ZK-B869, | |||||
| ZK-B872, | |||||
| ZK-B876) | Arm-type | ||||
| Fully | |||||
| Automatic | |||||
| Digital | |||||
| Blood | |||||
| Pressure | |||||
| Monitor | |||||
| (Model: | |||||
| DBP-1307b, | |||||
| DBP-1305b, | |||||
| DBP-1318b, | |||||
| DBP-1319b, | |||||
| DBP-1332b, | |||||
| DBP-1333b, | |||||
| DBP-1307b, | |||||
| DBP-1257b, | |||||
| DBP-1358b, | |||||
| DBP-1359b) | Electronic | ||||
| Blood / | |||||
| Pressure Monitor : | |||||
| YE620B, YE620D, | |||||
| YE660E, YE660F | |||||
| andYE680B | / | ||||
| 510 | |||||
| (k) | |||||
| number | K221040 | K191894 | K200649 | K200939 | / |
| Manufactur | |||||
| er | Jiangxi AICARE | ||||
| Medical | |||||
| Technology | |||||
| Co., | |||||
| Ltd. | ShenZhen | ||||
| ZhengKang | |||||
| Technology | |||||
| Co., | |||||
| Ltd. | JOYTECH | ||||
| Healthcare | |||||
| Co., | |||||
| Ltd. | Jiangsu Yuyue | ||||
| Medical | |||||
| Equipment& | |||||
| Supply Co., Ltd | / | ||||
| Regulation | |||||
| number | 21 CFR 870.1130 | 21 CFR 870.1130 | 21 CFR 870.1130 | 21 CFR 870.1130 | Same |
| Regulation | |||||
| description | Noninvasive blood | ||||
| pressure | |||||
| measurement | |||||
| system | Noninvasive blood | ||||
| pressure | |||||
| measurement | |||||
| system | Noninvasive blood | ||||
| pressure | |||||
| measurement | |||||
| system | Noninvasive blood | ||||
| pressure | |||||
| measurement | |||||
| system | Same | ||||
| Product | |||||
| code | DXN | DXN | DXN | DXN | Same |
| Class | II | II | II | II | Same |
| Indications | |||||
| for use/ | |||||
| Intended | |||||
| use | Electronic | ||||
| Sphygmomanomete | |||||
| rs is intended to | |||||
| measure the | |||||
| systolic and | |||||
| diastolic blood | |||||
| pressure as well as | |||||
| the pulse rate of | |||||
| adult person and | |||||
| adolescents age 18 | |||||
| through 21 years of | |||||
| age .It can be used | |||||
| at medical facilities | |||||
| or at home. | This Upper Arm | ||||
| Blood Pressure | |||||
| Monitor is intended | |||||
| to measure the | |||||
| systolic and | |||||
| diastolic blood | |||||
| pressure as well as | |||||
| the pulse rate of | |||||
| adult person. It can | |||||
| be used at medical | |||||
| facilities or at | |||||
| home. | The Full Automatic | ||||
| Blood Pressure | |||||
| Monitors are | |||||
| intended to | |||||
| measure blood | |||||
| pressure (systolic | |||||
| and diastolic) and | |||||
| pulse rate of adults | |||||
| and adolescents age | |||||
| 12 through 21 years | |||||
| of age. | Electronic blood | ||||
| pressure monitor is | |||||
| intended to | |||||
| measure the blood | |||||
| pressure and pulse | |||||
| rate adult in | |||||
| household or | |||||
| medical facilities. | |||||
| (Not suitable for | |||||
| neonate, pregnancy | |||||
| or pre-eclampsia) | Similar | ||||
| Note 1 | |||||
| Patient | |||||
| population | Adult and 18 | ||||
| through 21 years of | |||||
| age | Adult | Adult and 12 | |||
| through 21 years of | |||||
| age | Adult | Similar | |||
| Note 1 | |||||
| Location | |||||
| for use | OTC | OTC | OTC | OTC | Same |
| Environme | |||||
| nt of use | Medical facilities | ||||
| or home | Medical facilities | ||||
| or home | / | household or | |||
| medical facilities | Same | ||||
| Operation | |||||
| principle | Oscillometric | Oscillometric | Oscillometric | Oscillometric | Same |
| Measureme | |||||
| nt rane | Pressure: 0 ~ | ||||
| 295mmHg, Pulse | |||||
| Rate: | |||||
| (40 ~ 160) times | |||||
| per minute | Pressure: 0 ~ | ||||
| 295mmHg Pulse | |||||
| Rate: 40~195 | |||||
| bpm | Systolic | ||||
| Pressure:60mmHg | |||||
| ~280 mmHg | |||||
| Diastolic Pressure: | |||||
| 30 mmHg ~ 200 | |||||
| mmHg | |||||
| Pulse:30 ~ 180 | |||||
| Beats/Minute | Pressure:0 ~ 300 | ||||
| mmHg | |||||
| Pules:40 ~ | |||||
| 200beats/min | Similar | ||||
| Accuracy | Pressure: | ||||
| $\pm$ 3mmHg( $\pm$ | |||||
| 0.4kPa), or 2% of | |||||
| the reading | |||||
| Pulse Rate: $\pm$ 5% | Pressure: | ||||
| $\pm$ 3mmHg( $\pm$ | |||||
| 0.4kPa) | |||||
| Pulse Rate: $\pm$ 5% | Static Pressure: | ||||
| $\pm$ 3mmHg | |||||
| Pulse: $\pm$ 5% | Pressure: | ||||
| $\pm$ 3mmHg( $\pm$ | |||||
| 0.4kPa) | |||||
| Pulse Rate: $\pm$ 5% of | |||||
| reading value | Same | ||||
| Display | |||||
| screen | LCD | LCD | LCD | LCD | Same |
| Scale | |||||
| selection | mmHg/kPa | mmHg/kPa | mmHg | mmHg/kPa | Same |
| Cuff | |||||
| circumference | 22cm-42cm | 22cm-32cm | 22-36cm | Type | Similar |
| Note 2 | |||||
| Type A(22cm-32cm, | |||||
| 22cm-45cm | |||||
| optional) | |||||
| Type B | |||||
| A(22cm-32cm, | |||||
| 22cm-45cm | |||||
| optional) | |||||
| Memory | 2*99sets | 2*99 sets | / | Up to 99x2 sets of | |
| data | Same | ||||
| Power | |||||
| supply | Battery:4AAA | ||||
| batteries(DC 6V) | |||||
| or optional | |||||
| adapt | |||||
| er with | |||||
| USB | |||||
| cable(DV5V/500 | |||||
| m A) | Battery:4AA | ||||
| batteries | |||||
| (DC6V)-(ZK-B868 | |||||
| ) | |||||
| 4AAA batteries | |||||
| (DC6V)-(ZK-869/Z | |||||
| K-872/ZK-B876) | |||||
| or optional adapter | |||||
| with | |||||
| USB | |||||
| cable(DV5V/500m | |||||
| A) | For models | ||||
| DBP-1318b, | |||||
| DBP-1257b, | |||||
| DBP-1358b,DBP-1 | |||||
| 359b:4×1.5V AAA | |||||
| battery or Medical | |||||
| AC adapter (DC | |||||
| 6V,600mA)(recom | |||||
| mended, not | |||||
| Provided); For | |||||
| other models:4 × | |||||
| 1.5V AA battery or | |||||
| Medical AC | |||||
| adapter (DC | |||||
| 6V,600mA)(recom | |||||
| mended | 4 AA batteries or | ||||
| 6V/600mA AC | |||||
| adater | Same | ||||
| Operating | |||||
| Environment | Temperature:+5 ℃ | ||||
| ~+40 ℃; | |||||
| Humidity:15 | |||||
| ~ 90%RH | |||||
| Atmospheric | |||||
| pressure: 70 kpa ~ | |||||
| 106 kpa | Temperature:+5 ℃ | ||||
| ~+40 ℃; | |||||
| Humidity:15 | |||||
| 80%RH | Temp.: +10 ℃~ | ||||
| +40 ℃ | |||||
| Humidity:15 ~ | |||||
| 93%RH | |||||
| Atmospheric:700hPa | |||||
| a~1060hPa | Temperature:+5 ℃ | ||||
| ~+40 ℃; | |||||
| Humidity:15 | |||||
| 90%RH | Similar | ||||
| Storage | |||||
| Environment | Temperature:-25 ℃ | ||||
| ~+55 ℃; | |||||
| Humidity:10 | |||||
| ~ 95%RH | Temperature:-20 ℃ | ||||
| ~+55 ℃; | |||||
| Humidity:10 | |||||
| 93%RH | Temp.: -25 ℃ ~ | ||||
| +55 ℃ | |||||
| Humidity: | |||||
| 90%RH | Temperature:-20 ℃ | ||||
| ~+55 ℃; | |||||
| Humidity:15 | |||||
| 90% RH(no | |||||
| condensation) | Similar | ||||
| Type of | |||||
| transmission | Non-transmission | Non-transmission | Bluetooth | / | Same |
| Compliance | |||||
| with | ANSI AAMI | ||||
| ES | IEC 60601-1; | ||||
| IEC 60601-1-2; | AAMI/ANSI | ||||
| 60601-1 | IEC 60601-1; | ||||
| IEC60601-1-2; | Same | ||||
| 60601-1; | |||||
| voluntary | |||||
| standards | IEC 60601-1-2; | ||||
| IEC 60601-1-11; | |||||
| IEC 80601-2-30; | |||||
| ISO 10993-1,-5,10; | |||||
| ISO 81060-2 | IEC 60601-1-11; | ||||
| IEC 80601-2-30; | |||||
| ISO 10993-1,-5,10; | |||||
| ISO 81060-2 | IEC 80601-2-30:2009 | ||||
| IEC 60601-1-11 | |||||
| IEC 60601-1-2 | |||||
| EN 300328 | |||||
| EISI EN 301489-1 | |||||
| EISI EN 301489-17 | IEC60601-1-6; | ||||
| IEC60601-1-11; | |||||
| ANSI AAM | |||||
| IEC80601-2-30; | |||||
| ISO 81060-2 |
6
7
8
Comparison in details:
Note 1: Although the patient population is a little different between the proposed and predicate device, but it's within the scope of Reference device 1, the difference is insignificant and do not affect safety and effectiveness. And the proposed device has been validated to be in conformity with its claimed range.
Note 2: Although the Cuff circumference is a little different between the proposed and predicate device, but it's within the scope of Reference device 2, the difference is insignificant and do not affect safety and effectiveness. And the proposed device has been validated to be in conformity with its claimed range
Conclusion:
Electronic Sphygmomanometers is substantially equivalent to the predicate device.
7) Test summary:
The following performance data is provided in support of the substantial equivalence determination.
Non-Clinical Study:
Non-clinical tests were conducted to verify that the proposed device meets the same design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device.. The testing results demonstrate that the proposed device complies with the following standards:
Electrical and EMC Safety:
The electrical safety and EMC safety testing was performed as per the following standards and passed:
- . ANSI AAMI ES 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2, 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, Medical electrical equipment -- Part 1-11: General requirements Page 6 of 8
9
for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Performance Data:
The performance testing was performed as per the following standards and passed:
- . IEC 80601-2-30, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
- . ISO 81060-2, Non-invasive sphygmomanometers - Part 2: clinical validation of automated measurement type [Including: Amendment 1(2020)]
- FDA Guidance No-Invasive Blood Pressure (NIBP) Monitor Guidance .
Software:
We have also conducted Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices".
Biocompatibility Testing:
The biocompatibility evaluating for the body-contacting component (arm cuff) of this device was conducted in accordance with the "Use of International Standard ISO 10933-1, Biological Evaluation of Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process", as recongnized by FDA. The arm cuff has performed and passed the Biocompatibility test. So we have reason to believe that the arm cuff is safe for the users. The arm cuff complies with the following standards:
- . ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity
- . ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
Clinical Study:
We conducted a comparative clinical study to verify the performance of the proposed device and predicate device as well as a mercury sphygmomanometer according to ISO 81060-2. The study demonstrated a significant correlation in the performance of proposed device and predicate device. The design of the proposed device specifications is substantially the same as the predicate.
All the labeling and characteristics of the Electronic Sphygmomanometers are the same as the predicate device, and most normal blood pressure monitors currently on the market. The proposed device and predicate device both use similar measuring methodologies and components to achieve the measurements.
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8) Conclusion
Based on the above analysis and non-clinical/clinical tests performed, it can be concluded that the proposed device Electronic Sphygmomanometers is as safe, as effective, and performs as well as the legally marketed predicate device, K191894, Upper Arm Blood Pressure Monitor Model: ZK-B868, ZK-B869, ZK-B872, ZK-B876.