(221 days)
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 Upper Arm Blood Pressure Monitor, including ZK-B869, ZK-B869, ZK-B872 and ZK-B876, can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with arm circumference ranging from 22 cm to 32cm by the oscillometric technique. 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 arm cuff. The ZK-B868 is powered by 4 AA dry batteries (DC 6V), other models are powered by 4 AAA dry batteries (DC 6V). The device has a memory function that automatically stores some 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 four models have the same intended use, working principle, measuring range, accuracy, cuff, conformance standard; only in appearance and power supply have some difference.
This document describes the 510(k) summary for the "Upper Arm Blood Pressure Monitor" (Models: ZK-B868, ZK-B869, ZK-B872, ZK-B876) by ShenZhen ZhengKang Technology Co., Ltd. The information provided focuses on demonstrating substantial equivalence to a predicate device, primarily through performance data related to blood pressure measurement accuracy.
Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document mentions compliance with the standard ISO 81060-2 (Non-Invasive Sphygmomanometers -- Part 2: Clinical Validation of Automated Measurement Type). This standard sets widely accepted accuracy criteria for blood pressure monitors.
While the document doesn't explicitly present a table of acceptance criteria and reported performance in a single table, it states the device "passed" the performance testing according to ISO 81060-2.
The Accuracy section within the comparison table (page 5) lists the following for the targeted device, which are the inherent performance characteristics the device aims to meet:
| Parameter | Targeted Device (Claimed Accuracy) |
|---|---|
| Pressure | ±3mmHg (±0.4kPa) |
| Pulse Rate | ±5% |
These values are consistent with the requirements of ISO 81060-2. The statement that the performance testing was "performed to, and passed" these standards implies that the device achieved these accuracies within the limits defined by ISO 81060-2.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size used for the clinical validation according to ISO 81060-2. It also does not specify the country of origin of the data, nor whether the study was retrospective or prospective.
ISO 81060-2 typically requires a prospective study with a specific number of subjects (usually 85 subjects with specific blood pressure ranges) for clinical validation. However, these specific details are not present in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
For a blood pressure monitor, the "ground truth" (or reference measurement) is typically established by trained observers (often physicians or nurses) using a standardized auscultatory method, with the accuracy verified against a mercury sphygmomanometer or highly accurate validated electronic device.
The document does not specify the number of experts or their specific qualifications used to establish the ground truth for the clinical validation. ISO 81060-2 mandates specific procedures for reference measurements, involving two trained observers, but these details are not stated here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the test set. For clinical validation of blood pressure monitors, the ISO 81060-2 standard outlines a specific methodology for collecting simultaneous reference measurements from two trained observers, and if there are significant discrepancies, a third observer might be involved. However, this level of detail is not present in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable to this device. The device is an automated blood pressure monitor, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is inherently a "standalone" automated measurement system. Its performance, as validated against ISO 81060-2, represents its algorithm-only performance in measuring blood pressure and pulse rate. The study is a standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for blood pressure measurement is established through:
- Simultaneous auscultatory measurements by trained observers using a reference sphygmomanometer (mercury or a highly accurate validated electronic device). This is the standard method prescribed by ISO 81060-2.
While the document doesn't explicitly state "auscultatory measurements," the reference to ISO 81060-2 implies this methodology for ground truth establishment.
8. The sample size for the training set
This device is a hardware product with embedded software/firmware for an established measurement principle (oscillometric). It is not an AI/ML device that undergoes "training" in the typical sense of a deep learning model. Therefore, the concept of a "training set" as it applies to AI/ML is not relevant here, and no information on a training set size is provided.
9. How the ground truth for the training set was established
As explained above, there is no "training set" in the AI/ML context for this type of device. The accuracy of the device is assessed through clinical validation against established ground truth measurements from human observers, as per ISO 81060-2, not "trained" on a dataset.
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February 21, 2020
ShenZhen ZhengKang Technology Co., Ltd. % Becky Chen Registered Engineer Feiying Drug & Medical Consulting Technical Service Group B-3F 3005, Bldg.1, Southward Ruifeng Business Center No 22 Guimiao Rd. ShenZhen City, 518100 CHINA
Re: K191894
Trade/Device Name: Upper Arm Blood Pressure Monitor, Models: ZK-B868, ZK-B872, ZK-B876 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 16, 2020 Received: January 22, 2020
Dear Becky Chen:
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 (OS) 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.
for
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
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Indications for Use
510(k) Number (if known) K191894
Device Name
Upper Arm Blood Pressure Monitor (Model: ZK-B868, ZK-B869, ZK-B872, ZK-B876)
Indications for Use (Describe)
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.
| 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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510 (k) Summary
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: | ShenZhen ZhengKang Technology Co., Ltd. |
|---|---|
| Address: | 3/F, Building A, No. 3 FuXing Yi Lane, HeHuaCommunity, PingHu Street, LongGang District, ShenZhenCity, GuangDong, China |
| Contact person: | Huayong Yang |
| Phone number: | +86 755 8326 0864 |
| Fax number: | +86 755 8326 0864 |
| Email: | 893488645@qq.com |
| Date of summary prepared: | July 11, 2019 |
| Reason for the submission: | New device, there were no prior submissions for the device. |
(2) Proprietary name of the device
| Trade name/model: | Upper Arm Blood Pressure Monitor /Model: ZK-B868, ZK-B869, ZK-B872, ZK-B876 |
|---|---|
| Common name: | Noninvasive blood pressure measurement system |
| Regulation number: | 21CFR 870.1130 |
| Product code: | DXN |
| Review panel: | Cardiovascular |
| Regulation class: | Class II |
(3) Predicate device
| Sponsor | Shenzhen Jamr Medical Technology CO., Limited |
|---|---|
| Device Name and Model | Digital Blood Pressure Monitor Models: B01, B02, B05 &B06T |
| 510(k) Number | K172171 |
| Product Code | DXN |
| Regulation Number | 21CFR 870.1130 |
| Regulation Class | Class II |
(4) Description/ Design of device:
The Upper Arm Blood Pressure Monitor, including ZK-B869, ZK-B869, ZK-B872 and ZK-B876, can automatically complete the inflation and measurement, which can
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measure systolic and diastolic blood pressure as well as the pulse rate of adult person with arm circumference ranging from 22 cm to 32cm by the oscillometric technique. 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 arm cuff. The ZK-B868 is powered by 4 AA dry batteries (DC 6V), other models are powered by 4 AAA dry batteries (DC 6V).
The device has a memory function that automatically stores some 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 four models have the same intended use, working principle, measuring range, accuracy, cuff, conformance standard; only in appearance and power supply have some difference.
(5) Intended use / indications:
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.
(6) Materials
| Component name | Material ofComponent | Body ContactCategory | Contact Duration |
|---|---|---|---|
| Arm cuff | 420D polyester | Surface skin contact | Less than 24 hours |
We have directly purchased arm cuff from qualified supplier which has obtained Biocompatibility test reports. For details, please refer to "Biocompatibility Discussion".
| Item | Targeted device | Predicate device | Remark |
|---|---|---|---|
| Trade name | Upper Arm Blood PressureMonitor (Models:ZK-B868, ZK-B869,ZK-B872, ZK-B876) | Digital Blood PressureMonitor (Models: B01, B02,B05 & B06T) | / |
| 510 (k) number | Pending | K172171 | / |
| Regulationnumber | 21CFR 870.1130 | 21 CFR 870.1130 | Same |
| Regulationdescription | Noninvasive blood pressuremeasurement system | Noninvasive blood pressuremeasurement system | Same |
| Product code | DXN | DXN | Same |
| Class | II | II | Same |
| Indications for | This Upper Arm Blood | Digital blood pressure | Same |
| Item | Targeted device | Predicate device | Remark |
| Intended use | 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. | 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. | |
| Intended patient | Adult | Adult | Same |
| Location for use | OTC | OTC | Same |
| Environment of use | Medical facilities or home | Medical facilities or home | Same |
| Operation principle | Oscillometric | Oscillometric | Same |
| Measurement range | Pressure: 0-295mmHgPulse Rate: 40-195bpm | Pressure: 0-280mmHgPulse Rate: 40-199bpm | SimilarNote 1 |
| Accuracy | Pressure:$±3mmHg(±0.4kPa)$Pulse Rate: ±5% | Pressure:$±3mmHg(±0.4kPa)$Pulse Rate: ±5% | Same |
| Display screen | LCD | LCD | Same |
| Scale selection | mmHg/KPa | mmHg/KPa | Same |
| Cuff circumference | 22cm~32cm | 22cm~40 cm | Similar -Within thescope ofpredicatedevice |
| Memory | 2*99 sets | 2120 sets (B01/02/05)199 sets (B06T) | Similar -Within thescope ofpredicatedevice |
| Irregular pulse detection | Yes | Yes (B01/02/05)No (B06T) | Same |
| Power supply | Battery:4 AA batteries(DC6V)-(ZK-B868)4 AAA batteries(DC6V)-(ZK-B869 | 4 AAA batteries (6V DC)-(B01/02/05)Built-in high capacity lithium battery 3.7V 800 mAh-B06T | SimilarNote 2 |
| Item | Targeted device | Predicate device | Remark |
| /ZK-B872 /ZK-B876) | |||
| OR optional adapter with | |||
| USB cable (DV5V/500mA) | |||
| OperatingEnvironment | Temperature:+5°C~+40°C;Humidity:15~80%RH | Temperature:+5°C~+40°C;Humidity:10~93%RH | Similar |
| StorageEnvironment | Temperature:-20°C~+55°C;Humidity:10~93%RH | Temperature:-25°C~+70°C;Humidity:10~93%RH | Similar |
| Type oftransmission | Non-transmission | Transmission by Bluetooth(B06T)non-Transmission(B01/02/05) | Same |
| Compliancewith voluntarystandards | IEC 60601-1;IEC 60601-1-2;IEC 60601-1-11;IEC 80601-2-30;ISO 10993-1,-5,-10ISO 81060-2 | IEC 60601-1;IEC 60601-1-2;IEC 60601-1-11;IEC 80601-2-30;ISO 10993-1,-5,-10ISO 81060-2 | Same |
(7) Technological characteristics and substantial equivalence:
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ShenZhen ZhengKang Technology Co., Ltd. 510(k)s - Section 7. 510 (k) Summary
Comparison in details:
Note 1:
Although the pressure measurement range is a little different between the targeted and predicate device, the difference is insignificant and do not affect safety and effectiveness. And the targeted device have been validated all the full claimed range.
Note 2:
Although power supply is different between the targeted and predicate device, the difference is insignificant and do not affect safety and effectiveness.
Conclusion:
Upper Arm Blood Pressure Monitor is substantial equivalent to the predicate device.
(8) Performance Data:
The following performance data have been conducted to verify that the Upper Arm Blood Pressure Monitor meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the targeted device complies with the following standards:
Biocompatibility Testing:
The biocompatibility evaluation for the body-contacting component (arm cuff) of this
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device was conducted in accordance with the "Use of International Standard ISO 10993-1, 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 A InVitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Electrical and EMC Safety:
The electrical safety and EMC safety testing was performed to, and passed. the following standards:
- A IEC 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- A 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
-
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
Performance:
The performance testing was performed to, and passed, the following standards:
- IEC 80601-2-30, Medical Electrical Equipment -- Part 2-30: Particular A 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
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".
Summary:
Based on the above performance as documented in this application, the Upper Arm Blood Pressure Monitor was found to have a safety and effectiveness profile that is similar to the predicate device.
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(9) Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the Upper Arm Blood Pressure Monitor is to be concluded substantial equivalent to its predicate devices.
§ 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).