(221 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor with a microprocessor, pressure sensor, pump, valve, LCD, and memory function. There is no mention of AI, ML, or any advanced algorithms beyond basic signal processing for blood pressure and pulse rate calculation. The performance studies reference standard medical device testing and software validation, not AI/ML specific evaluations.
No
The device is intended to measure blood pressure and pulse rate, which are diagnostic measurements for monitoring health, not for treating or curing a disease or condition.
Yes
The device is described as an "Upper Arm Blood Pressure Monitor" intended to "measure the systolic and diastolic blood pressure as well as the pulse rate," which are diagnostic measurements for health conditions.
No
The device description explicitly lists hardware components such as a microprocessor, pressure sensor, pump, deflation control valve, LCD screen, and arm cuff, indicating it is a physical device with embedded software, not a software-only medical 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 perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The description clearly states that this device measures blood pressure and pulse rate by applying a cuff to the upper arm and using the oscillometric technique. This is a physical measurement taken on the body (in vivo).
- Intended Use: The intended use is to measure blood pressure and pulse rate, not to analyze biological samples for diagnostic purposes.
Therefore, this Upper Arm Blood Pressure Monitor falls under the category of a non-IVD medical device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
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.
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
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
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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.
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 (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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3
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, HeHua |
| Community, PingHu Street, LongGang District, ShenZhen | |
| City, 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
4
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 of
Component | Body Contact
Category | 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 Pressure | ||
| Monitor (Models: | |||
| ZK-B868, ZK-B869, | |||
| ZK-B872, ZK-B876) | Digital Blood Pressure | ||
| Monitor (Models: B01, B02, | |||
| B05 & B06T) | / | ||
| 510 (k) number | Pending | K172171 | / |
| Regulation | |||
| number | 21CFR 870.1130 | 21 CFR 870.1130 | Same |
| Regulation | |||
| description | Noninvasive blood pressure | ||
| measurement system | Noninvasive blood pressure | ||
| measurement 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: 0-295mmHg | ||
| Pulse Rate: 40-195bpm | Pressure: 0-280mmHg | ||
| Pulse Rate: 40-199bpm | Similar | ||
| Note 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 the | |||
| scope of | |||
| predicate | |||
| device | |||
| Memory | 2*99 sets | 2*120 sets (B01/02/05) | |
| 1*99 sets (B06T) | Similar - | ||
| Within the | |||
| scope of | |||
| predicate | |||
| device | |||
| 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 | Similar | ||
| Note 2 | |||
| Item | Targeted device | Predicate device | Remark |
| /ZK-B872 /ZK-B876) | |||
| OR optional adapter with | |||
| USB cable (DV5V/500mA) | |||
| Operating | |||
| Environment | Temperature: | ||
| +5°C~+40°C; | |||
| Humidity: | |||
| 15~80%RH | Temperature: | ||
| +5°C~+40°C; | |||
| Humidity: | |||
| 10~93%RH | Similar | ||
| Storage | |||
| Environment | Temperature: | ||
| -20°C~+55°C; | |||
| Humidity: | |||
| 10~93%RH | Temperature: | ||
| -25°C~+70°C; | |||
| Humidity: | |||
| 10~93%RH | Similar | ||
| Type of | |||
| transmission | Non-transmission | Transmission by Bluetooth | |
| (B06T) | |||
| non-Transmission | |||
| (B01/02/05) | Same | ||
| Compliance | |||
| with voluntary | |||
| standards | IEC 60601-1; | ||
| IEC 60601-1-2; | |||
| IEC 60601-1-11; | |||
| IEC 80601-2-30; | |||
| ISO 10993-1,-5,-10 | |||
| ISO 81060-2 | IEC 60601-1; | ||
| IEC 60601-1-2; | |||
| IEC 60601-1-11; | |||
| IEC 80601-2-30; | |||
| ISO 10993-1,-5,-10 | |||
| ISO 81060-2 | Same |
(7) Technological characteristics and substantial equivalence:
5
6
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
7
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.
8
(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.