(422 days)
No
The document explicitly states that body composition is measured using an "experimentally derived algorithm" based on BIA, and there is no mention of AI, ML, or related concepts in the description of any of the device's functions or performance studies.
No
The device is intended for measuring and displaying physiological parameters and estimating body composition, which are diagnostic and monitoring functions, not therapeutic.
Yes
This device is designed for measuring various physiological parameters such as blood pressure, SpO2, pulse rate, temperature, weight, and height, and also estimates body composition using BIA. These measurements and estimations help in assessing a patient's health status, which is characteristic of a diagnostic device.
No
The device description explicitly states it is a "device designed for measuring of the patient's physiological parameters" and describes hardware components and methods like photoelectric, oscillating, and infrared radiation energy technology, as well as BIA. It also mentions integrating an FDA-cleared device (K170047), which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Multi-parameter detector measures physiological parameters directly from the patient's body (blood pressure, SpO2, pulse rate, temperature, weight, height) and uses bio-electrical impedance analysis (BIA) to estimate body composition. These measurements are taken in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It uses sensors and electrical signals applied to the body to obtain its measurements.
Therefore, the Multi-parameter detector falls under the category of medical devices that perform in vivo measurements and analysis, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DQA, FLL, PUH
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
Adults.
Intended User / Care Setting
Hospital outpatient clinic and experience room.
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Temperature measurement accuracy: Maximum allowable error of ±0.2℃, clinical repeatability ±0.3 ℃.
Blood Pressure Measurement accuracy: Average difference within ±5.0mmHg, standard deviation not greater than 8.0mmHg.
Interface friendliness and operation response time satisfaction rate: 100.00%.
Whole device function and stability evaluation index satisfaction rate: 100.00%.
Incidence rate of adverse events: 0.00%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2770 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.
0
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.
1
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.
2
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
3
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) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
4
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, Zhongshan
City, 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 Product | |
| Codes | DQA, FLL, PUH |
| Regulation No. | 21 CFR 870.1130 |
5
Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. Multi-parameter detector
3. Primary Predicate Device
| Trade Name | Microlife Upper Arm Automatic Digital Blood Pressure
Monitor |
|----------------|-----------------------------------------------------------------|
| 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 Product | |
| Codes | 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.
6
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 Digital | ||
| Blood Pressure Monitor | Vitals360® Multi-Vitals Mobile Monitor | N/A | ||
| Classification | II | II | II | Same |
| Product Code | DXN | DXN | MWI | |
| Subsequent | ||||
| Product | ||||
| Codes | DQA, FLL, PUH | N/A | DQA, DSH DXN, FLL | Similar |
| Intended | ||||
| use/Indications | ||||
| for 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 | ||||
| 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. | The Upper Arm Blood Pressure Monitor, | |||
| Model BP3KV1-5W is a device intended | ||||
| to measure the systolic and diastolic | ||||
| blood pressure and pulse rate of an adult | ||||
| individual by using a non-invasive | ||||
| oscillometric technique in which an | ||||
| inflatable cuff is wrapped around the | ||||
| upper arm for a circumference range | ||||
| from 22 to 52cm. The device is suitable | ||||
| for use by adults, including adults with | ||||
| conditions of diabetes, pregnancy, or | ||||
| pre-eclampsia. The device detects the | ||||
| appearance of irregular heartbeat during | ||||
| measurement and gives a warning signal | ||||
| with the reading once the irregular | ||||
| heartbeat is detected. The device can be | ||||
| used in connection with a smart phone | ||||
| via Bluetooth or with a personal | ||||
| computer (PC) via USB. The | ||||
| measurement data can be transferred to | ||||
| a smart phone running the Microlife | ||||
| Connected Health+ mobile software | ||||
| (App) or a PC running the Microlife BP | ||||
| Analyzer+ (BPA+) software. | Vitals360® device is intended to be used for | |||
| measuring, displaying, reviewing and storing | ||||
| of non-invasive blood pressure (NIBP), | ||||
| non-invasive monitoring of functional oxygen | ||||
| saturation of arterial hemoglobin (SpO2), | ||||
| pulse rate (PR), forehead temperature | ||||
| (TEMP), ECG, weight and height in adults no | ||||
| less than 18 years of age. | ||||
| This VITALS360® device is intended for use | ||||
| by trained adults only who can use | ||||
| smartphones proficiently. | ||||
| This VITALS360® device is intended for use | ||||
| in a clinical or home environment. | ||||
| This VITALS360® device is a reusable device | ||||
| following thorough cleaning between uses. | Different | |||
| Environment of | ||||
| Use | Hospital outpatient clinic and | |||
| experience room. | Home | Clinical or home environment | Same | |
| OTC or Rx | Rx | OTC | Rx | Identical to the |
| secondary | ||||
| Patient | ||||
| Population | Adult | Adult | No less than 18 years of age. | Similar |
| Power Source | 100V-240V~50Hz/60Hz 1.0A | 4 AA batteries, Or | ||
| AC adapter 6 V DC 600 mA | (100-240) VAC, 50/60Hz, 0.5A | Identical to the | ||
| secondary |
7
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 |
| Pressure | ||||
| measurement | ||||
| range - | ||||
| Systolic | 60mmHg-260mmHg | 60 mmHg-255 mmHg | 60 mmHg-230mmHg | |
| Pressure | ||||
| measurement | ||||
| range - | ||||
| Diastolic | 30mmHg-200mmHg | 40mmHg-200mmHg | 40 mmHg-130mmHg | Similar |
| Accuracy or | ||||
| pressure | ||||
| indicator | ±3mmHg | Pressure within ± 3 mmHg or | ||
| 2% of reading >200mmHg | Mean deviation values: ±5 mmHg. | |||
| Standard deviation ≤ 8 mmHg. | ||||
| Cuff pressure | ||||
| range | 0~300mmHg | 0~299mmHg | 0~300mmHg | Identical to the |
| secondary |
| SpO2 | ||||
|---|---|---|---|---|
| Code: DQA | ||||
| Features | Proposed Device | Primary Predicate Device (K072325) | Secondary Predicate Device (K210086) | Comments |
| Measuring | ||||
| range | 70%~100% | N/A | 70%~100% | Identical to the |
| secondary | ||||
| Accuracy | $\pm$ 3% | N/A | $\pm$ 2% (during 90~100%), | |
| $\pm$ 4% (during 70~89%) | Different |
8
Version: A/0
| TEMP | ||||
|---|---|---|---|---|
| Code: FLL | ||||
| Features | Proposed Device | Primary Predicate Device (K072325) | Secondary Predicate Device (K210086) | Comments |
| Fundamental | ||||
| scientific | ||||
| technology | Infrared technology | N/A | Infrared technology | Identical to the |
| secondary | ||||
| Unit of | ||||
| measure | °C/°F | N/A | °C/°F | Identical to the |
| secondary | ||||
| Measurement | ||||
| site | Forehead | N/A | Forehead | Identical to the |
| secondary | ||||
| Temperature | ||||
| measurement | ||||
| range | 22.0°C | N/A | 34.0°C | Different |
| Temperature | ||||
| measurement | ||||
| accuracy | 22°C~42.9°C ±0.3°C | N/A | ±0.3°C | Identical to the |
| secondary |
| Body composition | ||||
|---|---|---|---|---|
| Code: PUH | ||||
| Features | Proposed Device | Primary Predicate Device (K072325) | Secondary Predicate Device (K210086) | Comments |
| Technology | BIA (bioelectrical impedance | |||
| analysis) | ||||
| Operating frequency range | 50kHz/250kHz | |||
| Electrode type | Tactile | |||
| Number/Place | ||||
| ment of | ||||
| Electrodes | 8 electrodes Placed on Hands and | |||
| feet (Tetra-polar Electrode method) | N/A | N/A | Different | |
| Patient | ||||
| Position | Upright | |||
| Impedance | ||||
| measurement | ||||
| range | 200Ω~800Ω |
9
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.
10
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.
11
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.
12
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.