(422 days)
The Multi-parameter detector is intended to be used for measuring and displaying of non-invasive blood pressure (NBP). non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), weight and height in adults.
The Multi-parameter detector is also intended to estimate body mass index (BMI), Body fat percentage, basal metabolism and free fat mass, bone mass and body water percentage) using the BIA (Bio-electrical Impedance Analysis) method.
The Multi-parameter detector is a device designed for measuring of the patient's physiological parameters. The Multi-parameter detector can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology.
The Multi-parameter detector are non-invasive body composition analyzers. The devices employ BIA (Bio-electrical Impedance Analysis) method and then measure body composition using an experimentally derived algorithm.
The Multi-parameter detector integrates an FDA market cleared devices, All-in-One Health Monitor (K170047) for measurement of oxygen saturation of arterial hemoqlobin (SpO2).
The provided document is a 510(k) summary for a "Multi-parameter detector." It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, along with non-clinical and clinical testing performed. However, it does not provide the detailed acceptance criteria and "study that proves the device meets the acceptance criteria" in the format requested, particularly for an AI/algorithm-based device study.
The document primarily focuses on demonstrating substantial equivalence based on performance standards for traditional medical devices (blood pressure, SpO2, temperature, body composition) rather than the rigorous evaluation of a new AI/ML-driven diagnostic or assistive technology.
Here's a breakdown of what can be extracted and what is missing based on your prompt:
Extracted Information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides performance standards and reports whether the device met them, rather than a direct "acceptance criteria" table with specific quantitative thresholds and exact results for each parameter alongside performance metrics like sensitivity/specificity for an AI.
| Parameter | Acceptance Standard (from document) | Reported Device Performance (from document) |
|---|---|---|
| NIBP (Non-Invasive Blood Pressure) | Average difference: ≤ ±5.0 mmHg; Standard deviation: ≤ 8.0 mmHg (per ISO 81060-2:2018) | Achieved: Average value of difference within ±5.0mmHg, standard deviation not greater than 8.0mmHg. (Based on 119 subjects) |
| TEMP (Forehead Temperature) | Max allowable error: ±0.2°C for 35.0-42.0°C; Clinical repeatability: ≤ ±0.3°C (per ISO 80601-2-56:2017+AMD1:2018) | Achieved: 105 subjects did not exceed max allowable error of ±0.2°C (in 35.0°C-42.0°C range); Clinical repeatability did not exceed ±0.3°C. |
| SpO2 (Pulse Oximetry) | Accuracy claim: ±3% for 70%-100% range (per ISO 80601-2-61:2017) | Verified via prior clearance (K170047, which inherited from K063641 compliant with ISO 9919:2005). ARMS of 1.49 for 70%-100%, meeting ±3% claim. |
| PR (Pulse Rate) | (Implicitly tied to SpO2, no specific criteria or performance given) | Verified via prior clearance (K170047, which inherited from K063641). |
| Height/Weight/Impedance | Internal standards applied. | "Tested... according to our internal standards." (No specific acceptance criteria or performance numbers reported in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance:
- NIBP: 119 subjects.
- TEMP: 105 subjects.
- SpO2: 10 healthy subjects (aged 22-40, Fitzpatrick 2-6), but this was for the integrated FDA cleared device (K170047), not a new test for this submission's SpO2 component.
- Data Provenance: The NIBP and TEMP clinical studies were described as "single-center, randomized, self-controlled clinical trial[s]" conducted by Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. This implies prospective data, likely from China given the company's location.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not explicitly stated in the document.
- For NIBP and TEMP, the ground truth was established by comparison with "registered mercury thermometer and desktop sphygmomanometer." This implies these are the "gold standard" reference devices, not human experts.
4. Adjudication Method for the Test Set:
- Not applicable/Not stated. The ground truth was based on direct measurements from reference devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:
- No. This type of study is typical for AI/ML diagnostic tools assisting human readers (e.g., radiologists). The device in question is a multi-parameter measurement device, not an AI diagnostic tool requiring human reader studies to demonstrate assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The performance metrics (accuracy, standard deviation) for NIBP, TEMP, and SpO2 are reported for the device itself compared to reference standards, indicating standalone performance. The document describes the device directly measuring these parameters.
7. The Type of Ground Truth Used:
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
June 15, 2024
Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. % Liz Li, Counselor Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong 518000 China
Re: K231116
Trade/Device Name: Multi-parameter detector Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DQA, FLL, PUH Dated: September 11, 2023 Received: September 20, 2023
Dear Liz Li:
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 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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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 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-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 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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about mediation-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,
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
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Indications for Use
510(k) Number (if known) K231116
Device Name Multi-parameter detector
Indications for Use (Describe)
The Multi-parameter detector is intended to be used for measuring and displaying of non-invasive blood pressure (NBP). non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), weight and height in adults.
The Multi-parameter detector is also intended to estimate body mass index (BMI), Body fat percentage, basal metabolism and free fat mass, bone mass and body water percentage) using the BIA (Bio-electrical Impedance Analysis) method.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
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Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. Multi-parameter detector
510(k) Summary
1. Contact Details
1.1 Applicant information
| Applicant Name | Zhongshan Jinli Electronic Weighing Equipment Co.,Ltd. |
|---|---|
| Address | 283rd South Min'an Road, Xiaolan Town, ZhongshanCity, Guangdong, China |
| Phone No. | +86-760-28133793 |
| Contact person | Jerry Liang |
| Contact person's e-mail | jerry@kinleehealth.com |
| Date Prepared | Dec.30.2023 |
1.2 Submission Correspondent
| Image: Logo | Shenzhen Joyantech Consulting Co., Ltd. |
|---|---|
| 1713A, 17th Floor, Block A, Zhongguan Times Square,Liuxian Avenue, Xili Town, Nanshan District, Shenzhen,Guangdong Province, China | |
| Phone No. | +86 755-86069197 |
| Contact person | Liz Li |
| Contact person's e-mail | liz@cefda.com |
| Website | http://www.cefda.com |
2. Device information
| Device Trade name | Multi-parameter detector |
|---|---|
| Device Common name | Multi-parameter detector |
| Classification | II |
| Classification name | System, Measurement, Blood-Pressure, Non-Invasive |
| Product code | DXN |
| Subsequent ProductCodes | DQA, FLL, PUH |
| Regulation No. | 21 CFR 870.1130 |
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Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. Multi-parameter detector
3. Primary Predicate Device
| Trade Name | Microlife Upper Arm Automatic Digital Blood PressureMonitor |
|---|---|
| 510(k) Number | K222979 |
| Product Code | DXN |
| Regulation No. | 21 CFR 870.1130 |
| Manufacturer | Microlife Intellectual Property GmbH |
4. Secondary Predicate Device
| Trade Name | Vitals360® Multi-Vitals Mobile Monitor |
|---|---|
| 510(k) Number | K210086 |
| Product Code | MWI |
| Subsequent ProductCodes | DQA, DSH DXN, FLL |
| Regulation No. | 21 CFR 870.2300 |
| Manufacturer | VoCare, Inc. |
5. Device Description
The Multi-parameter detector is a device designed for measuring of the patient's physiological parameters. The Multi-parameter detector can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology.
The Multi-parameter detector are non-invasive body composition analyzers. The devices employ BIA (Bio-electrical Impedance Analysis) method and then measure body composition using an experimentally derived algorithm.
The Multi-parameter detector integrates an FDA market cleared devices, All-in-One Health Monitor (K170047) for measurement of oxygen saturation of arterial hemoqlobin (SpO2).
6. Intended use
The Multi-parameter detector is intended to be used for measuring and displaying of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), weight and height in adults.
The Multi-parameter detector is also intended to estimate body mass index (BMI), Body fat percentage, visceral fat grade, basal metabolism and free fat mass (muscle mass, bone mass and body water percentage) using the BIA (Bio-electrical Impedance Analysis) method.
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7. Substantial Equivalence Comparison
| Item | Proposed Device | Primary Predicate Device (K222979) | Secondary Predicate Device (K210086) | Comments |
|---|---|---|---|---|
| Trade name | Multi-parameter detector | Microlife Upper Arm Automatic DigitalBlood Pressure Monitor | Vitals360® Multi-Vitals Mobile Monitor | N/A |
| Classification | II | II | II | Same |
| Product Code | DXN | DXN | MWI | |
| SubsequentProductCodes | DQA, FLL, PUH | N/A | DQA, DSH DXN, FLL | Similar |
| Intendeduse/Indicationsfor use | The Multi-parameter detector isintended to be used for measuringand displaying of non-invasive bloodpressure (NIBP), non-invasivemonitoring of functional oxygensaturation of arterial hemoglobin(SpO2), pulse rate (PR), foreheadtemperature (TEMP), weight andheight in adults.The Multi-parameter detector isintended to estimate body massindex (BMI), Body fat percentage,visceral fat grade, basal metabolismand free fat mass (muscle mass,bone mass and body waterpercentage) using the BIA(Bio-electrical Impedance Analysis)method. | The Upper Arm Blood Pressure Monitor,Model BP3KV1-5W is a device intendedto measure the systolic and diastolicblood pressure and pulse rate of an adultindividual by using a non-invasiveoscillometric technique in which aninflatable cuff is wrapped around theupper arm for a circumference rangefrom 22 to 52cm. The device is suitablefor use by adults, including adults withconditions of diabetes, pregnancy, orpre-eclampsia. The device detects theappearance of irregular heartbeat duringmeasurement and gives a warning signalwith the reading once the irregularheartbeat is detected. The device can beused in connection with a smart phonevia Bluetooth or with a personalcomputer (PC) via USB. Themeasurement data can be transferred toa smart phone running the MicrolifeConnected Health+ mobile software(App) or a PC running the Microlife BPAnalyzer+ (BPA+) software. | Vitals360® device is intended to be used formeasuring, displaying, reviewing and storingof non-invasive blood pressure (NIBP),non-invasive monitoring of functional oxygensaturation of arterial hemoglobin (SpO2),pulse rate (PR), forehead temperature(TEMP), ECG, weight and height in adults noless than 18 years of age.This VITALS360® device is intended for useby trained adults only who can usesmartphones proficiently.This VITALS360® device is intended for usein a clinical or home environment.This VITALS360® device is a reusable devicefollowing thorough cleaning between uses. | Different |
| Environment ofUse | Hospital outpatient clinic andexperience room. | Home | Clinical or home environment | Same |
| OTC or Rx | Rx | OTC | Rx | Identical to thesecondary |
| PatientPopulation | Adult | Adult | No less than 18 years of age. | Similar |
| Power Source | 100V-240V~50Hz/60Hz 1.0A | 4 AA batteries, OrAC adapter 6 V DC 600 mA | (100-240) VAC, 50/60Hz, 0.5A | Identical to thesecondary |
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VOL_006:001_510(k) Summary
Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
| NIBP | ||||
|---|---|---|---|---|
| Code: DXN | ||||
| Features | Proposed Device | Primary Predicate Device (K072325) | Secondary Predicate Device (K210086) | Comments |
| Method | Oscillometric method | Oscillometric method | Oscillometric method | Same |
| Pressuremeasurementrange -Systolic | 60mmHg-260mmHg | 60 mmHg-255 mmHg | 60 mmHg-230mmHg | |
| Pressuremeasurementrange -Diastolic | 30mmHg-200mmHg | 40mmHg-200mmHg | 40 mmHg-130mmHg | Similar |
| Accuracy orpressureindicator | ±3mmHg | Pressure within ± 3 mmHg or2% of reading >200mmHg | Mean deviation values: ±5 mmHg.Standard deviation ≤ 8 mmHg. | |
| Cuff pressurerange | 0~300mmHg | 0~299mmHg | 0~300mmHg | Identical to thesecondary |
| SpO2 | ||||
|---|---|---|---|---|
| Code: DQA | ||||
| Features | Proposed Device | Primary Predicate Device (K072325) | Secondary Predicate Device (K210086) | Comments |
| Measuringrange | 70%~100% | N/A | 70%~100% | Identical to thesecondary |
| Accuracy | $\pm$ 3% | N/A | $\pm$ 2% (during 90 | Different |
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Version: A/0
| TEMP | ||||
|---|---|---|---|---|
| Code: FLL | ||||
| Features | Proposed Device | Primary Predicate Device (K072325) | Secondary Predicate Device (K210086) | Comments |
| Fundamentalscientifictechnology | Infrared technology | N/A | Infrared technology | Identical to thesecondary |
| Unit ofmeasure | °C/°F | N/A | °C/°F | Identical to thesecondary |
| Measurementsite | Forehead | N/A | Forehead | Identical to thesecondary |
| Temperaturemeasurementrange | 22.0°C | N/A | 34.0°C | Different |
| Temperaturemeasurementaccuracy | 22°C~42.9°C ±0.3°C | N/A | ±0.3°C | Identical to thesecondary |
| Body composition | ||||
|---|---|---|---|---|
| Code: PUH | ||||
| Features | Proposed Device | Primary Predicate Device (K072325) | Secondary Predicate Device (K210086) | Comments |
| Technology | BIA (bioelectrical impedanceanalysis) | |||
| Operating frequency range | 50kHz/250kHz | |||
| Electrode type | Tactile | |||
| Number/Placement ofElectrodes | 8 electrodes Placed on Hands andfeet (Tetra-polar Electrode method) | N/A | N/A | Different |
| PatientPosition | Upright | |||
| Impedancemeasurementrange | 200Ω~800Ω |
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K231116
VOL_006:001_510(k) Summary
Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
Version: A/0
The subject device, Multi-parameter detector, is substantially equivalent to the predicate device K222979 and K210086. This condusion is based upon comparison on intended use and technological characteristics. Any difference between devices or concerns of safety or effectiveness.
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Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
8. Non-clinical Testing
The following data were provided in support of the substantial equivalence determination:
1) Electrical Safety, Electromagnetic Compatibility
IEC 60601-1:2005, AMDI:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11:2015 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 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
2) Performance testing
IEC 80601-2-30: 2018 Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
ISO 80601-2-61: 2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
ISO 80601-2-56: 2017 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
ASTM E 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
In addition, we tested the following items according to our internal standards.
- Height
- Weight
- Impedance
3) Biocompatibility test
Biocompatibility testing was conducted in accordance with the 2020 FDA quidance "Use of International Standard ISO 10993, Biological Evaluation of Medical Device Part 1: Evaluation and Testing."
The subject device has passed biocompatibility testing in according to following standards.
ISO 10993-5:2019 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
4) Software validation
The subject device contains an embedded software system.
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Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
Software verification and validation testing were conducted as recommended by FDA's Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
5) Human Factor Engineering and Usability Engineering Evaluation
The usability document of the subiect device was determined according to IEC 62366-1:2015 & FDA guidance of Applying Human Factors and Usability Engineering to Medical Devices
9. Clinical testing
Clinical studies were conducted to verify the accuracy of subject device. The clinical studies were conducted per following standards:
-
- ISO 81060-2: 2018 Non-invasive sphygmomanometers Part 2: Clinical investigation of intermittent automated measurement type
-
- ISO 80601-2-56: 2017+AMD1: 2018 Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
The Multi-parameter detector integrates an FDA market cleared devices, All-in-One Health Monitor (K170047) for measurement of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The SpO2 and PR cleared under K170047 were originally cleared under K063641, which is in compliance with ISO 9919: 2005.
The pulse oximeter accuracy was tested in ten healthy subjects, aged 22-40, with skin tones varying from Fitzpatrick 2-6. 3 subjects had dark skin with Fitzpatrick 5 or 6. The Arms of 70%-100% is 1.49, it meets the accuracy claims of ±3%.
Therefore, there is no test of these two parts (SpO2 and PR) in this clinical test.
Clinical testing has been performed under an approved protocol with subject informed consent. Clinical test results support device accuracy claims for the specified measurement range.
The Clinical studies was a single-center, randomized, self-controlled clinical trial for accuracy validation. Compared with registered mercury thermometer and desktop sphygmomanometer, the accuracy of body temperature and blood pressure measurement was used as the main effectiveness observation indications, and easy for use and device stability were used as the main safety observation indications to evaluate the safety and effectiveness of the Multi-parameter detector (body temperature and blood pressure) produced by Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
In the evaluation of the accuracy of temperature measurement, 105 subjects did not exceed the maximum allowable error of ±0.2℃ in the temperature display range of 35.0 ℃~ 42.0 ℃, and the clinical repeatability did not exceed the range of ±0.3 ℃, which met the temperature measurement standards.
In the evaluation of the accuracy of Blood Pressure Measurement, a total of 119 subjects completed the experiment. The average value of the difference between the blood pressure value (systolic or diastolic blood pressure) measured by the test device and the reference blood pressure measurement value is within the range of ±5.0mmHg, and the standard deviation is not greater than 8.0mmHg, which meets the standard requirements.
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Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
The interface friendliness of the device and the satisfaction rate of the operation response time were both 100.00%. The satisfaction rate of the whole device function and stability evaluation index was 100.00%. There were no adverse events and serious adverse events in the clinical trial, and the incidence rate was 0.00%, and the device has good safety.
10. Other information (such as required by FDA guidance/Test)
N/A
11.Conclusions
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate devices.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.