(89 days)
The device is a digital monitor intended to measure the diastolic, systolic blood pressures and pulse rate in adult patient population by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm of which the circumference includes 22 cm to 32 cm (8.7 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches). It can be used in hospital environment or at home.
The Automatic Arm Electronic Blood Pressure Monitor, including LBP70C and LBP70D, can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult patient with arm circumference ranging from 22 cm to 32 cm (8.7 inches to 12.6 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches) by the oscillometric technique. User can select the blood pressure unit mmHg or KPa. The device has irregular heat beat (IHB) indicator which can indicate a rhythm 25% less or 25% more than the average rhythm detected while measuring the systolic and diastolic blood pressure. The subject device consists of the PCBA, pressure sensor, operation keys, pump, control valve, LCD screen, cuff, batteries and optional accessory AC adapter. The two models have same intended use, working principle, measuring range, accuracy, cuff, component and appearance. They are only different in power supply. Model LBP70C is powered by 4 AA alkaline batteries or AC adapter, while model LBP70D is powered by rechargeable lithium-polymer battery or AC adapter. The device has a memory function that can automatically store up to 90 sets of data for each user. It can also display the latest measurement result.
The provided text describes the acceptance criteria and a clinical study conducted for the Automatic Arm Electronic Blood Pressure Monitor (K210435).
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Standard / Requirement) | Reported Device Performance (Subject Device) | Compliance |
|---|---|---|---|
| Blood Pressure Accuracy | ISO 81060-2 (Mean Difference $\pm 5$ mmHg, Standard Deviation $\leq 8$ mmHg) | Mean Difference $\pm 3$ mmHg / $\pm 0.4$ kPa | Meets |
| Pulse Rate Accuracy | Not explicitly stated in table, but generally $\pm 5$% is accepted | $\pm 5$% | Meets (implied) |
| Systolic BP Range | IEC 80601-2-30: At least 60~230 mmHg | 60~255 mmHg | Meets |
| Diastolic BP Range | IEC 80601-2-30: At least 40~130 mmHg | 30~195 mmHg | Meets |
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10 | No cytotoxicity, no sensitization, negligible irritation | Meets |
| Electrical Safety | IEC 60601-1, IEC 60601-1-11 | Meeting requirements | Meets |
| EM Compatibility | IEC 60601-1-2 | Meeting requirements | Meets |
| Software | IEC 62304, FDA Guidance for Software | Developed, documented, and validated accordingly | Meets |
| Operating Temperature | 5°C~40°C | 5°C~40°C | Meets |
| Operating Humidity | 15%RH~85%RH | 15%RH~85%RH | Meets |
| Operating Atmospheric Pressure | IEC 80601-2-30 requirements (not explicitly listed for this range in tables) | 70 kPa | Meets (after verification) |
| Storage Temperature | -20°C~55°C | -20°C~55°C | Meets |
| Storage Humidity | ≤93%RH | ≤93%RH (compared to predicate 10%RH~93%RH) | Meets (after verification) |
| Storage Atmospheric Pressure | IEC 80601-2-30 requirements (not explicitly listed for this range in tables) | 50 kPa | Meets (after verification) |
Note on Measurement Range: While the table indicates $\pm 3$ mmHg accuracy for blood pressure, the full ISO 81060-2 standard typically defines acceptance based on the mean difference and standard deviation of differences between the device and reference measurements. The text states "the results showed the accuracy of the subject device is within acceptable scope specified in ISO 81060-2," implying these statistical criteria were met.
2. Sample Size and Data Provenance for Test Set
- Sample Size: 85 patients (46 males, 39 females).
- Data Provenance: The document does not explicitly state the country of origin. The study was conducted as a "clinical study," which implies it was a prospective collection of data for the purpose of validating the device.
3. Number of Experts and Qualifications for Ground Truth
- The document implies the use of a manual Mercury Sphygmomanometer as a reference sphygmomanometer. This suggests that human operators (who would be skilled in using such a device) were involved in generating the reference measurements.
- Number of Experts: Not explicitly stated. For ISO 81060-2, a minimum of two trained observers are typically required, but the document does not specify this detail.
- Qualifications of Experts: Not explicitly stated. For a standard like ISO 81060-2, trained observers are required, typically with experience in auscultatory blood pressure measurement using a mercury sphygmomanometer.
4. Adjudication Method for Test Set
The document states, "Same arm sequential method was adopted during the clinical study." This method involves taking measurements on the same arm sequentially using both the test device and the reference device. There is no mention of an adjudication process (e.g., 2+1, 3+1) for discrepancies, as the ground truth is established by the direct measurements from the reference standard. If multiple human observers were used, the ISO standard would typically dictate an averaging or specific agreement criteria, but this is not detailed here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This study focuses on validating the accuracy of the automated blood pressure monitor against a reference standard, not on comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance
The study directly assesses the performance of the Automatic Arm Electronic Blood Pressure Monitor, which is a standalone device. While it contains "intelligent" components (Automatic Arm Electronic Blood Pressure Monitor, Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.), the intent of the clinical study is to validate the accuracy of the device itself (algorithm + hardware) in producing blood pressure measurements. Therefore, the reported performance is effectively the standalone performance of the device without explicit human-in-the-loop assistance for the measurement process (beyond the human placing the cuff).
7. Type of Ground Truth Used
The ground truth was established using measurements from a manual Mercury Sphygmomanometer. This is considered a reference standard for blood pressure measurement in clinical validation studies as per ISO 81060-2.
8. Sample Size for Training Set
The document does not provide any information regarding the training set size or how the device's algorithms were developed. The information provided pertains solely to the clinical validation (test set).
9. How Ground Truth for Training Set Was Established
As no information about a training set is provided, no details on how its ground truth was established can be given. The document focuses on the validation of the finished device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
May 12, 2021
Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. % Arthur Goddard President FDA Regulatory and Quality Systems Consultant 31853 Cedar Road Mayfield Heights, Ohio 44124-4445
Re: K210435
Trade/Device Name: Automatic Arm Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 8, 2021 Received: February 12, 2021
Dear Arthur Goddard:
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.
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
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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 (QS) 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,
LT 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Automatic Arm Electronic Blood Pressure Monitor
Indications for Use (Describe)
The device is a digital monitor intended to measure the diastolic, systolic blood pressures and pulse rate in adult patient population by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm of which the circumference includes 22 cm to 32 cm (8.7 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches). It can be used in hospital environment 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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Section 5: 510(K) Summary
This summary of 510(K) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1900 and 21 CFR 807.92.
The assigned 510(K) Number: K210435
5. 510(K) Summary
5.1. Date of Preparation: February 8th, 2021
5.2. Sponsor
Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. North side of floor 3, BLD 9 BaiWangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District 518055 Shenzhen, Guangdong, CHINA. Tel: + 86-0755-86952278 Fax: + 86-0755-86952287
Contact Person: Aaron Lin Position: General Manager Email: aaron.lin@lepu-medical.com
5.3. Official Correspondent
Mr. Arthur Goddard 31853 Cedar Road, Cleveland, Ohio, 44124-4445, U.S.A. Tel: (216) 233-5722 Email: asjgoddard@aol.com
5.4. Subject Device Identification
Subject Device Name: Automatic Arm Electronic Blood Pressure Monitor Model: LBP70C, LBP70D Common name: Noninvasive Blood Pressure Measurement System Classification Name(s): Noninvasive Blood Pressure Measurement System Product Code: DXN Regulation Number: 21 CFR 870.1130 Review Panel: Cardiovascular Classification: II
5.5. Predicate Device
510(k) Number: K183058 Device Name: Arm-type Electronic Blood Pressure Monitor Manufacturer: Shenzhen BSX Technology Electronics Co., Ltd.
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5.6. Indications for use
The device is a digital monitor intended to measure the diastolic, systolic blood pressures and pulse rate in adult patient population by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm of which the circumference includes 22 cm to 32 cm (8.7 inches to 12.6 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches). It can be used in hospital environment or at home.
5.7. Device Description
The Automatic Arm Electronic Blood Pressure Monitor, including LBP70C and LBP70D, can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult patient with arm circumference ranging from 22 cm to 32 cm (8.7 inches to 12.6 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches) by the oscillometric technique. User can select the blood pressure unit mmHg or KPa.
The device has irregular heat beat (IHB) indicator which can indicate a rhythm 25% less or 25% more than the average rhythm detected while measuring the systolic and diastolic blood pressure.
The subject device consists of the PCBA, pressure sensor, operation keys, pump, control valve, LCD screen, cuff, batteries and optional accessory AC adapter. The two models have same intended use, working principle, measuring range, accuracy, cuff, component and appearance. They are only different in power supply. Model LBP70C is powered by 4 AA alkaline batteries or AC adapter, while model LBP70D is powered by rechargeable lithium-polymer battery or AC adapter.
The device has a memory function that can automatically store up to 90 sets of data for each user. It can also display the latest measurement result.
5.8. Predicate Devices and Subject Device Comparison
| Table 5-1 Feature Comparison with Predicate Devices | |||
|---|---|---|---|
| Item | Subject Device | Predicate DeviceK183058 | Remark |
| Product Name | Automatic Arm ElectronicBlood Pressure Monitor | Arm-type Electronic BloodPressure Monitor | SE |
| Product Code | DXN | DXN | |
| RegulationNumber | 21 CFR 870.1130 | 21 CFR 870.1130 | |
| ClassificationName(s) | Noninvasive Blood PressureMeasurement System | Noninvasive Blood PressureMeasurement System | |
| Classification | II | II | |
| Indications for | The device is a digital monitor | The blood pressure monitor | Discussion 1 |
| Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. | Traditional 510(k) Premarket Notification | ||
| Item | Subject Device | Predicate DeviceK183058 | Remark |
| use | intended to measure thediastolic, systolic bloodpressures and pulse rate inadult patient population byusing a non-invasiveoscillometric technique inwhich an inflatable cuff iswrapped around the upperarm of which thecircumference includes 22 cmto 32 cm (8.7 inches to 12.6inches) or 22 cm to 42 cm(8.7 inches to 16.5 inches). Itcan be used in hospitalenvironment or at home. | is a non-invasive bloodpressure measurementsystem intended to measurethe diastolic and systolicblood pressures and pulserate of an adult individualby using a non-invasiveoscillometric technique inwhich an inflatable CUFF iswrapped around the arm ofwhich the circumferenceincludes 22 cm~32 cm. It isintended to be used inhospital environment or athome. | |
| Discussion 1:The indications for use of the subject device and predicate device are compared from thefollowing aspects: | |||
| Item | Subject Device | K183058 | Discussion |
| Intendedpatientpopulation | Adult | Adult | SE |
| Intendedapplicationsite | Upper arm | Upper arm | SE |
| Intended useenvironment | hospital or home | hospital or home | SE |
| MeasurementPrinciple | non-invasive oscillometric | non-invasive oscillometric | SE |
| ArmCircumference | 22 cm | 22 cm~32 cm | A |
| Basicfunctions | Measure the diastolic, systolicblood pressures and pulse rate | Measures the diastolic andsystolic blood pressures andpulse rate | SE |
| A. The subject device and the predicate device are different in arm circumference. The |
Table 5-1 Feature Comparison with Predicate Devi
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22-32cm of the arm circumference of subject device is substantially equivalent to the predicate device, and the 22-42cm of the arm circumference of subject device is substantially equivalent to the reference device (K192609, produced by Globalcare Medical
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| Item | Subject Device | Predicate DeviceK183058 | Remark |
|---|---|---|---|
| ------ | ---------------- | ----------------------------- | -------- |
Technology Co., Ltd). Additionally, LEPU Intelligent Medical has verified the accuracy of the measurement within 22-32cm and 22-42cm of the arm circumference accordance to the requirements of ISO 81060-2, and the results meet the requirements. Please refer to Section 20 for details. So, the difference does not raise any new issues of safety or efficacy.
Per the comparison and discussion above, the subject device and predicate device have same intended patient population, intended application site, intended use environment, measurement principle and basic functions. Arm circumference of the subject and the predicate device are substantially the same. Therefore, the noted difference in indications for use does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.
| ContactingMaterial | Enclosure-ABS+PMMACuff- PolyesterAir tube-PVC | Cuff - Polyester | Discussion 2 |
|---|---|---|---|
| ------------------------ | ------------------------------------------------------- | ------------------ | -------------- |
Discussion 2:
The cuff of the two devices are made of same materials of the enclosure of the predicate device are not mentioned. The materials used in subject device have excellent performance and safety, and can meet the requirements of the device for the material. The biological safety of all the materials has been verified, including cytotoxicity, sensitization and irritation tests. The test results meet the requirements of the ISO10993 series of standards. Please refer to Section 15 for detail. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.
| Power Source | 4x1.5V AA alkaline batteriesor AC adapter (LBP70C)3.7V 2200mAh Rechargeablelithium battery or AC adapter(LBP70D) | 4x1.5V AAA AlkalineBattery (BSX516, BSX525,BSX583, BSX593 andBSX595)3.7V 400mAh Li-ionBattery (BSX523) | Discussion 3 |
|---|---|---|---|
| -------------- | ---------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------- | -------------- |
Discussion 3:
The subject device and the predicate device are different in power source. For the alkaline battery power supply method, although the power supply battery model is different, the voltage of the two devices is both 6V. For the lithium battery power supply method, the voltage of the two devices is both 3.7V. The battery capacity of the subject device is 2200mAh, which is better than the 400mAh of the predicate device. Regardless of the power supply method, the voltage of the two devices is the same, so the difference does not raise any new issues of safety. Additionally, LEPU Intelligent Medical has verified the power source requirements of the device in accordance with the requirements in IEC 80601-2-30 and IEC 60601-1, and the results meet the requirements. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate
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| Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. | Traditional 510(k) Premarket Notification | ||
|---|---|---|---|
| Item | Subject Device | Predicate Device | Remarks |
| Item | Subject Device | Predicate Device | Remark |
| K183058 | |||
| device |
| Item | Subject Device | Predicate DeviceK183058 | Remark | |
|---|---|---|---|---|
| MeasurementRange | BloodPressure | Static pressure:0 | BloodPressure0-299mmHg | Discussion 4 |
| Pulse rate | 40 to 199 bpm | Pulse rate40 to 180 bpm |
Discussion 4:
The subject device and predicate device are different in measurement range.
The blood pressure measurement range (0280mmHg) of subject device is within that of predicate device (0299mmHg). According to the table below, the systolic and diastolic blood pressure measurement range can meet the requirement of IEC 80601-2-30.
| Item | IEC 80601-2-30 Requirement | Subject Device | Conclusion |
|---|---|---|---|
| Systolicbloodpressure | At least60~230mmHg | 60~255mmHg | Meet the requirement |
| Diastolicbloodpressure | At least40~130mmHg | 30~195mmHg | Meet the requirement |
The PR measurement range of the subject device is 40199bpm, which is greater than the 40180bpm of the predicate device. For this reason, LEPU Intelligent Medical has verified the accuracy of the measurement within the measurement range, and the results meet the requirements, please refer to Section 18 for details. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.
| Accuracy | BloodPressure | $\pm 3 mmHg$ /$\pm 0.4 kPa$ | BloodPressure | $\pm 3 mmHg$ | SE |
|---|---|---|---|---|---|
| Pulse rate | $\pm 5%$ | Pulse rate | $\pm 5%$ | ||
| OperatingTemperature | 5°C~40°C | 5°C~40°C | Discussion 5 | ||
| Operating | 15%RH~85%RH | 15%RH~85%RH |
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| Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. | Traditional 510(k) Premarket Notification |
|---|---|
| ------------------------------------------------------- | ------------------------------------------- |
| Item | Subject Device | Predicate DeviceK183058 | Remark |
|---|---|---|---|
| humidity | |||
| Operatingatmosphericpressure | 70 kPa ~106 kPa | 80 kPa~106kPa | |
| Storagetemperature | -20°C~55°C | -20°C~55°C | |
| Storage humidity | ≤93%RH | 10%RH~93%RH | |
| Storageatmospherepressure | 50 kPa ~106kPa | 70 kPa~106kPa |
Discussion 5:
The subject device and the predicate device are different in operating/storage atmospheric pressure and storage humidity. LEPU Intelligent Medical has verified the environmental requirements of the device in accordance with the requirements in IEC 80601-2-30, and the results meet the requirements. So, the difference does not raise any new issues of safety or efficacy. The subject device can be considered to be substantially equivalent to that of the predicate device.
| Table 5-3 Performance and Safety Comparison | |||
|---|---|---|---|
| Item | Subject DeviceFinger pulse oximeter | Predicate DeviceK161560Fingertip Pulse Oximeter | Remark |
| Particularrequirements forbasic safety andessentialperformance | Meeting the requirements ofIEC 80601-2-30 | Meeting the requirementsof IEC 80601-2-30 | SE |
| Electrical Safety | Meeting the requirements ofIEC 60601-1 and IEC60601-1-11 | Meeting the requirementsof IEC 60601-1 and IEC60601-1-11 | SE |
| ElectromagneticCompatibility | Meeting the requirements ofIEC 60601-1-2 | Meeting the requirementsof IEC 60601-1-2 | SE |
| Biocompatibility | Meeting the requirements ofISO 10993-1, ISO 10993-5,ISO 10993-10 | Meeting the requirementsof ISO 10993-1, ISO10993-5, ISO 10993-10 | SE |
| Clinical study | Meeting the requirements ofISO 81060-2 | Meeting the requirementsof ISO 81060-2 | SE |
Table 5-3 Performance and Safety Comparison
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5.9. Performance Tests Summary
Bench test were conducted to verify that the subject device met all design specifications, as was Substantially Equivalent (SE) to the predicate device.
A Biocompatibility Testing
The Automatic Arm Electronic Blood Pressure Monitor was assessed against the International Standard ISO 10993-1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." The subject device would be classified as a Surface Medical Device in contact with the intact skin for a Limited Duration (<24 hours). The following test were performed for any user contacting material:
| Test | Standard | Results |
|---|---|---|
| Cytotoxicity Study usingMTT Method | ISO 10993-5 | Under the conditions of this study, the MEMextracts of test article would be consideredno cytotoxicity potential. The negativecontrols, blank controls, and the positivecontrols performed as anticipated. |
| Skin Sensitization StudyGuinea Pig MaximizationTest | ISO 10993-10 | Under the condition of this study, the testarticle extracts showed no evidence ofcausing delayed dermal contact sensitizationin the guinea pig. The test article was notconsidered a sensitizer in the guinea pigmaximization test. |
| Skin Irritation Study | ISO 10993-10 | Under the conditions of this study, theirritation response category of the test articleis classified as Negligible for polar extractand Negligible for non-polar extract. |
> Non-clinical Tests
The Automatic Arm Electronic Blood Pressure Monitor is tested per the following standard, to evaluate its performance. The test results demonstrated that the proposed device comply with the standard requirements.
IEC 60601-1: 2005+AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
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.
IEC 60601-1-11 Edition 2.0:2015-01 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 80601-2-30: Edition 2.0 2018-03 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated
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Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. Traditional 510(k) Premarket Notification
non-invasive sphygmomanometers.
> Clinical data
A clinical study was conducted per the requirement of ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type to validate the accuracy of blood pressure measurements by subject device based on an oscillometric method. In this clinical study, 85 patients (46 males and 39 females) participated in the clinical study. Same arm sequential method was adopted during the clinical study. The manual Mercury Sphygmomanometer was used as a reference sphygmomanometer. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect. The results showed the accuracy of the subject device is within acceptable scope specified in ISO 81060-2.
A Software
The software embedded in Automatic Arm Electronic Blood Pressure Monitor has been developed, documented, and validated in accordance with industry standards (IEC 62304 - Medical device software - Software life cycle processes) and FDA guidance (GUIDANCE FOR THE CONTENT OF PRE-MARKET SUBMISSIONS FOR SOFTWARE CONTAINED IN DEVICES).
5.10. Substantially Equivalent Conclusion
The subject device, Automatic Arm Electronic Blood Pressure Monitor, is determined to be Substantially Equivalent (SE) to the predicate device, in respect of safety and efficacy.
§ 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).