(173 days)
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure of adult person and adolescents age 18 through 21 years of age. It can be used at home. It is contraindicated in pregnant women, including those with preeclampsia.
The Electronic Sphygmomanometers, including ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24, is suitable for measurement of systolic blood pressure and diastolic blood pressure 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.
The provided FDA 510(k) clearance letter and synopsis for the Electronic Sphygmomanometers (K250185) primarily focus on demonstrating substantial equivalence to a predicate device, rather than detailing a specific clinical study with granular acceptance criteria for an AI-powered diagnostic device. The application is for a standard medical device (blood pressure monitor), not an AI/ML-driven diagnostic tool. Therefore, many of the requested points for an AI study (e.g., number of experts for ground truth, adjudication methods, MRMC studies, effect size of AI assistance, training set details) are not applicable or provided in this document.
However, I can extract and infer information relevant to the device's accuracy and performance validation using the provided text, particularly concerning the mentioned standards and the comparative clinical study.
Here's an attempt to describe the acceptance criteria and study as best as possible given the provided non-AI-specific document:
Device: Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)
Study Type: Comparative Clinical Study (for substantial equivalence to a predicate device and mercury sphygmomanometer) and Non-Clinical Performance Testing.
Regulation/Standard for Accuracy: IEC 80601-2-30, ISO 81060-2 (including Amendment 1(2020)), and FDA Guidance No-Invasive Blood Pressure (NIBP) Monitor Guidance.
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for non-invasive blood pressure monitors, as per ISO 81060-2 (which is explicitly listed as a standard the device complies with), relies on statistical analysis of difference between the device's readings and a reference standard (usually mercury sphygmomanometer readings or an established method). The key metrics are:
- Mean Difference (Bias): The average difference between the device reading and the reference reading.
- Standard Deviation of the Differences: A measure of the spread of these differences.
The ISO 81060-2 standard (for clinical validation of automated measurement type) typically requires:
- Mean difference between the test device and reference measurement: $\leq \pm 5$ mmHg
- Standard deviation of the differences (SD): $\leq 8$ mmHg
| Acceptance Criteria (Based on ISO 81060-2) | Reported Device Performance (from "Accuracy" section) |
|---|---|
| Mean difference $\leq \pm 5$ mmHg | Pressure: $\pm 3$ mmHg ($\pm 0.4$ kPa) or 2% of the reading |
| Standard deviation $\leq 8$ mmHg | (Not explicitly stated, but implied compliance with ISO 81060-2) |
| Pulse Rate Accuracy: $\leq \pm 5$% | Pulse Rate: $\pm 5$% |
Note: The reported accuracy of $\pm 3$ mmHg or 2% of the reading for pressure is a general accuracy specification, not necessarily the mean difference and standard deviation from the clinical validation as per ISO 81060-2. However, achieving $\pm 3$ mmHg as a general accuracy implies that the device is likely to meet or exceed the ISO 81060-2 criteria. The document states compliance with ISO 81060-2, meaning it passed these criteria.
2. Sample Size and Data Provenance
- Test Set (Clinical Study): The document states, "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."
- Sample Size: ISO 81060-2 typically requires a minimum of 85 subjects for clinical validation. The document does not explicitly state the exact sample size used in their study, but implies it met the requirements of the standard it followed.
- Data Provenance: Not specified (e.g., country of origin). The study is described as a "comparative clinical study," which generally implies a prospective data collection for the purpose of the validation.
3. Number/Qualifications of Experts for Ground Truth
- Not Applicable / Not Specified: For a blood pressure monitor, the "ground truth" for blood pressure measurements is typically established using a reference standard like a mercury sphygmomanometer or an auscultatory method performed by trained observers, as outlined in ISO 81060-2. This is a measurement comparison, not an expert-based image interpretation or diagnosis that would require multiple reading experts in the AI sense.
4. Adjudication Method
- Not Applicable / Not Specified: Since this is a direct physiological measurement comparison, adjudication methods commonly seen in AI/image interpretation studies (e.g., 2+1, 3+1 consensus) are not relevant here. The ISO 81060-2 standard defines precise measurement protocols by trained observers for comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable: This type of study is relevant for AI-assisted diagnostic aids where human readers' performance (e.g., accuracy, efficiency) is evaluated with and without AI. This device is a standalone measurement tool, not an AI diagnostic aid for human readers.
6. Standalone (Algorithm Only) Performance
- Implicitly Done: The "Performance Data" section explicitly states compliance with "IEC 80601-2-30" and "ISO 81060-2." These standards define the requirements for the automated (standalone) measurement of non-invasive blood pressure, requiring the device algorithm (oscillometric technique) to provide accurate pressure readings independently. The clinical study compares the device's automated readings against a reference standard.
7. Type of Ground Truth Used
- Reference Standard Measurement: The ground truth for blood pressure measurements was established using a mercury sphygmomanometer (or an equivalent valid reference method) during the comparative clinical study, as per the ISO 81060-2 standard. This is a direct, objective physiological measurement.
8. Sample Size for the Training Set
- Not Applicable: This is a traditional medical device (blood pressure monitor) that utilizes a deterministic oscillometric algorithm, not a machine learning or AI model that requires a "training set" in the context of deep learning. Its algorithm is based on established engineering principles for detecting pressure oscillations.
9. How Ground Truth for Training Set Was Established
- Not Applicable: As there is no "training set" for a machine learning model, this point is not relevant for this device.
FDA 510(k) Clearance Letter - Electronic Sphygmomanometers
Page 1
July 14, 2025
Jiangxi AICARE Medical Technology Co., Ltd.
Xiao Lizhu
Quality Regulations Department Manager
No. 6, South Side of Nanhuan Road
Qianping Industrial Park, Le'an County
Fuzhou, Jiangxi 344300
China
Re: K250185
Trade/Device Name: Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)
Regulation Number: 21 CFR 870.1130
Regulation Name: Noninvasive Blood Pressure Measurement System
Regulatory Class: Class II
Product Code: DXN
Dated: January 22, 2025
Received: January 22, 2025
Dear Xiao Lizhu:
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 (the 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 available 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
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K250185 - Xiao Lizhu Page 2
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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K250185 - Xiao Lizhu Page 3
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-devices/device-advice-comprehensive-regulatory-assistance/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,
Stephen C. Browning -S
LCDR 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K250185
Device Name: Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)
Indications for Use (Describe):
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure of adult person and adolescents age 18 through 21 years of age. It can be used at home. It is contraindicated in pregnant women, including those with preeclampsia.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510 (k) Summary
Jiangxi AICARE Medical Technology Co., Ltd.
K250185 Page 1 of 8
This "510(k) 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: July 11, 2025
(2) Proprietary name of the device
Trade name/model: Electronic Sphygmomanometers
ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24
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 Medical Equipment& Supply Co., Ltd |
|---|---|---|
| Device Name and Model | Arm-type Fully Automatic Electronic Blood Pressure | Digital Blood Pressure Monitor |
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| Device Name and Model | 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 | Monitor : YE620B, YE620D, 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 ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24, is suitable for measurement of systolic blood pressure and diastolic blood pressure 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.
(5) Intended use / indications:
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure of adult person and adolescents age 18 through 21 years of age. It can be used at home. It is contraindicated in pregnant women, including those with preeclampsia.
(6) Materials
| Component name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| Cuff | Nylon polyester | Surface skin contact | Less than 24 hours |
We have directly purchased cuff from qualified supplier which has obtained Biocompatibility test reports. For details, please refer to "Biocompatibility Discussion".
(7) Technological characteristics and substantial equivalence:
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| Item | Proposed device | Predicate device | Reference device1 | Reference device2 | Remark |
|---|---|---|---|---|---|
| Trade name | Electronic Sphygmomanometers (Model:ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) | 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 and YE680B | / |
| 510 (k) number | K250185 | K191894 | K200649 | K200939 | / |
| Manufacturer | 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 |
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| Item | Proposed device | Predicate device | Reference device1 | Reference device2 | Remark |
|---|---|---|---|---|---|
| Indications for use/ Intended use | Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure of adult person and adolescents age 18 through 21 years of age . It can be used at home. It is contraindicated in pregnant women, including those with preeclampsia. | 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 |
| Environment of use | Medical facilities or home | Medical facilities or home | / | household or medical facilities | Same |
| Operation principle | Oscillometric | Oscillometric | Oscillometric | Oscillometric | Same |
| Measurement range | Pressure: 0～295mmHg, Pulse Rate: 40～195 bpm | Pressure:0～295mmHg | 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: ± 3mmHg( ± 0.4kPa), or 2% of the reading | Pressure: ± 3mmHg( ± 0.4kPa) Pulse Rate:±5% | Static Pressure: ±3mmHg Pulse:±5% | Pressure: ± 3mmHg( ± 0.4kPa) Pulse Rate:±5% of reading value | Same |
| Display screen | LCD | LCD | LCD | LCD | Same |
| Scale selection | mmHg/kPa | mmHg/kPa | mmHg | mmHg/kPa | Same |
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| Item | Proposed device | Predicate device | Reference device1 | Reference device2 | Remark |
|---|---|---|---|---|---|
| Cuff circumference | 22cm-42cm | 22cm-32cm | 22-36cm | Type A(22cm-32cm, 22cm-45cm optional) Type B A(22cm-32cm, 22cm-45cm optional) | Similar Note 2 |
| Memory | 2*99sets | 2*99 sets | / | Up to 99x2 sets of data | Same |
| Power supply | Battery:4AAA batteries(DC 6V) or optional adapter with USB cable(DV5V/500mA) | Battery:4AA batteries (DC6V)-(ZK-B868) 4AAA batteries (DC6V)-(ZK-869/ZK-872/ZK-B876) or optional adapter with USB cable(DV5V/500mA) | For models DBP-1318b, DBP-1257b, DBP-1358b,DBP-1359b:4×1.5V AAA battery or Medical AC adapter (DC 6V,600mA)(recommended, not Provided); For other models:4 × 1.5V AA battery or Medical AC adapter (DC 6V,600mA)(recommended | 4 AA batteries or 6V/600mA AC adater | Same |
| Operating Environment | Temperature:+5 ℃～+40℃； Humidity:15 ～80%RH Atmospheric pressure: 80 kpa ~ 105 kpa | Temperature:+5 ℃～+40℃； Humidity:15 ～80%RH | Temp.: +10 ℃ ～+40℃ Humidity:15 ～93%RH Atmospheric:700hPa～1060hPa | Temperature:+5 ℃～+40℃； Humidity:15 ～90%RH | Similar |
| Storage Environment | Temperature:-20 ℃～+55℃； Humidity:10 ～93%RH | Temperature:-20 ℃～+55℃； Humidity:10 ～93%RH | Temp.: -25 ℃ ～+55℃ Humidity: ≤90%RH | Temperature:-20 ℃～+55℃； Humidity:15 ～90%RH(no condensation) | Same |
| Type of transmission | Non-transmission/ Bluetooth | Non-transmission | Bluetooth | / | Similar Note 3 |
| Compliance with voluntary standards | ANSI AAMI ES 60601-1; IEC 60601-1; IEC 60601-1-2; IEC 60601-1-11; IEC 80601-2-30; ISO 10993-1,-5,10; ISO 81060-2 | AAMI/ANSI ES 60601-1 IEC 60601-1; IEC60601-1-2; 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 | Same |
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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.
Note 3: Although the Type of transmission 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.
Conclusion:
Electronic Sphygmomanometers is substantially equivalent to the predicate device.
(8) Testing 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
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and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11, 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
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 non-invasive 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 In Vitro Cytotoxicity
- ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization.
- ISO 10993-23, Biological Evaluation of Medical Devices - Part 23：Tests for irritation
FCC Test:
- FCC Part15 Subpart C
- RF Exposure Evaluation
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
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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.
(9) 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.
§ 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).