(122 days)
The Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate by using the oscillometric method during inflation. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults at medical facilities or at home. The intended upper arm circumference is 22-40cm (8.7" - 15.7"). Not suitable for neonatal and infants.
The blood pressure monitor model C02 and F01 are sphygmomanometers with electronic manometer intended to be used for the indirect (non-invasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults during inflation. The inflatable cuff is wrapped around the upper arm of an individual. The systolic and diastolic blood pressures are transmitted via air pressure and determined by the transducer integrated on the monitor with the oscillometric method. The systolic and diastolic blood pressure values and pulse rate per minute are displayed on the LED panel. The monitors C02 and F01 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device: Blood Pressure Monitor (Models C02 and F01)
Manufacturer: Shenzhen Jamr Technology Co., Ltd.
Predicate Device: Full Automatic (NIBP) Blood Pressure Monitor HL858CL (K190507)
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criteria for the clinical performance of the blood pressure monitor are derived from the ISO 81060-2 standard.
| Acceptance Criteria (from ISO 81060-2) | Reported Device Performance (Blood Pressure Monitor C02) |
|---|---|
| Mean error and standard deviation within required limits | "The results of this clinical investigation show that the required limits for mean error and standard deviation are fulfilled by the subject device C02." |
| BP Accuracy: ±3mmHg (±0.4kPa) | ±3mmHg (±0.4kPa) |
| PR Accuracy: ±5% of reading | ±5% of reading |
| BP Measurement Range: 60-255mmHg (SYS); 40-200mmHg (DIA) | 60-255mmHg (SYS); 40-200mmHg (DIA) |
| PR Measurement Range: 40-170 pulses/min | 40-170 pulses/min |
Note: The document explicitly states that the device passes various other non-clinical standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-11, IEC 80601-2-30, ISO 81060-1, IEC 62304, ISO 14971, IEC 62366-1) which imply acceptance criteria for electrical safety, EMC, performance, software, usability, and risk management, but specific quantitative acceptance values for these are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 90 patients (42 males and 48 females)
- Data Provenance: Not explicitly stated, but the submission is from a Chinese company (Shenzhen Jamr Technology Co., Ltd.) and refers to a "Clinical Test report" and "clinical investigation," implying this data was collected during a clinical study to support this particular device. It is most likely prospective data collected for the purpose of regulatory submission. The location of the actual clinical trial is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document states that the "Standard auscultation method was used as the reference blood pressure monitor measuring in the arm according to the sequence in ISO 81060-2."
- Number of Experts: Not explicitly stated. The ISO 81060-2 standard typically requires measurements by multiple trained observers (usually at least two trained observers taking simultaneous or sequential measurements) to establish the reference values using the auscultatory method. However, the specific number of experts involved in this particular study is not detailed in the provided summary.
- Qualifications of Experts: Not explicitly stated, but implies individuals trained in the auscultatory method of blood pressure measurement, as per the ISO 81060-2 standard.
4. Adjudication Method for the Test Set
The adjudication method is implicitly that of the ISO 81060-2 standard for assessing blood pressure devices using the auscultatory method. This standard typically involves comparisons between the automated device and a reference measurement obtained by trained observers using a sphygmomanometer and stethoscope. While the document doesn't explicitly state an "adjudication method" in terms of resolving discrepancies between multiple expert readings, the ISO 81060-2 protocol itself serves as the framework for establishing the reference values against which the device is compared. It generally involves the average of readings from multiple observers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study is a standalone clinical validation of the device's accuracy against a standard reference method (auscultation), not a comparison of human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone clinical validation (algorithm only) was done. The study evaluated the accuracy of the Blood Pressure Monitor (an automated device) against the reference auscultation method. This evaluates the device's inherent performance.
7. The Type of Ground Truth Used
The type of ground truth used is expert consensus/clinical reference measurement established by the standard auscultation method. This is considered the gold standard for non-invasive blood pressure measurement in such validation studies.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set. This is a clinical validation study for a medical device's accuracy, not a machine learning algorithm that typically requires a distinct training set. The device itself (Blood Pressure Monitor) is a hardware device with an embedded algorithm; the summary focuses on the validation of the device rather than the development of the algorithm.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this type of device validation, this information is not applicable.
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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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 25, 2020
Shenzhen Jamr Technology Co., Ltd. Luo Fusheng Management Representative 2nd Floor, A-building, No.2 Guiyuan Road, Guihua community, Guanlan town. Shenzhen, 518110 CHINA
Re: K200437
Trade/Device Name: Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 12, 2020 Received: May 29, 2020
Dear Luo Fusheng:
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 Blood Pressure Monitor
Indications for Use (Describe)
The Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate by using the oscillometric method during inflation. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults at medical facilities or at home. The intended upper arm circumference is 22-40cm (8.7" - 15.7"). Not suitable for neonatal and infants.
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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001 510(k) Summary Version: 1.1
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92.
The assigned 510(k) number is:____K200437
1.0 Information of Submitter and Correspondent
Submitter's information:
Shenzhen Jamr Technology Co., Ltd. Address: 2nd Floor, A-building, No.2 Guiyuan Road, Guihua community, Guanlan town, Longhua new district, Shenzhen, P.R.China Phone:+86-755-85292057 Fax: +86-755-61673107 Contact Person: Luo Fusheng E-mail: eng201@cigii.net, reanny@reanny.com
2.0 Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Blood pressure monitor |
| Model: | C02 and F01 |
| Classification name: | System, Measurement, Blood-Pressure, Non-Invasive |
| Review Panel: | Cardiovascular |
| Product Code: | DXN |
| Device Class: | II |
| Regulation Number: | 21 CFR 870.1130 |
3.0 Predicate Device Information
| Sponsor: | Health & Life Co., Ltd. |
|---|---|
| Device: | Full Automatic (NIBP) Blood Pressure Monitor HL858CL |
| 510(K) Number: | K190507 |
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001 510(k) Summary Version: 1.1
4.0 Device Description
The blood pressure monitor model C02 and F01 are sphygmomanometers with electronic manometer intended to be used for the indirect (non-invasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults during inflation. The inflatable cuff is wrapped around the upper arm of an individual. The systolic and diastolic blood pressures are transmitted via air pressure and determined by the transducer integrated on the monitor with the oscillometric method. The systolic and diastolic blood pressure values and pulse rate per minute are displayed on the LED panel.
The monitors C02 and F01 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance.
5.0 Intended Use
The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate by using the oscillometric method during inflation. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults at medical facilities or at home. The intended upper arm circumference is 22-40cm (8.7" - 15.7"). Not suitable for neonatal and infants.
6.0 Performance Summary
Clinical Test Summary
Testing to insure clinical accuracy of the device in accordance with ISO 81060-2 as documented in Clinical Test report.90 patients (42 males and 48 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2.
Non-Clinical Test Summary
The Subject Device has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests include the follows:
IEC 60601-1:2005+Am1:2012 IEC 60601-1-2:2014 IEC 60601-1-11:2015 IEC 80601-2-30:2018 IEC 81060-1:2007
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7.0 Comparison to predicate device and conclusion
The subject device is substantially equivalent to predicate devices, K190507, HL858CL. The substantial equivalence chart is provided as follows:
| Elements ofComparison | Predicate Device(K190507) | Subject Device | Judgment |
|---|---|---|---|
| Models | HL858CL | C02 and F01 | -- |
| Company | Health & Life Co., Ltd. | Shenzhen Jamr TechnologyCo., Ltd. | -- |
| Device Name | Full Automatic (NIBP) BloodPressure Monitor | Blood Pressure Monitor | -- |
| Product code | DXN | DXN | Same |
| Regulation # | 21CFR870.1130 | 21CFR870.1130 | Same |
| Intended use | HL858CL automaticallymeasures human's Systolic,Diastolic blood pressure and heartrate by using the oscillometricmethod during inflation. Allvalues can be read out in oneLCD panel. Measurementposition is at human being'supper arm. The intended use ofthis over-the-counter device is foradults aged 18 years and olderwith arm circumference rangingfrom 9 inches to 22 inches(approx.23 cm to 56 cm) and forhome use.HL858CL detects the appearanceof irregular heartbeats duringmeasurement; an indicatedsymbol will appear withmeasuring reading. And the RiskCategory Indicator will show theinformation with the readings onthe screen for the user trackingtheir blood pressure level.Besides, the device features abuilt-in "Bluetooth DataTransmission" function, which | The Blood PressureMonitor is intended tomeasure the systolic anddiastolic blood pressure aswell as the pulse rate byusing the oscillometricmethod during inflation.Measurement position is athuman being's upper arm.The intended use of thisover-the-counter device isfor adults at medicalfacilities or at home. Theintended upper armcircumference is 22-40cm(8.7" – 15.7"). | SE, referto Remark1 |
| Elements ofComparison | Predicate Device(K190507) | Subject Device | Judgment |
| Models | HL858CL | C02 and F01 | -- |
| enables the device automaticallytransmit measuring results topaired Bluetooth-enabled device.Also, users could simplysynchronize the current date andtime, and check the battery statusof blood pressure monitor bymeans of DailyChek® applicationsoftware with the pairedBluetooth-enabled device. | |||
| Measurementtype | Upper arm | Upper arm | Same |
| Patientpopulation | Adults person over 18 | Adults person | Same |
| MeasurementItem | SYS, DYS, Pulse rate | SYS, DYS, Pulse rate | Same |
| Principle | Oscillometric | Oscillometric | Same |
| Measurementtype | During inflation | During inflation | Same |
| BPmeasurementrange | 0-300mmHgRated Range of Determination:40~280mmHg | 0-295mmHgRated Range ofDetermination:SYS:60 | SE, refer toRemark 2 |
| BP accuracy | ±3mmHg (±0.4kPa) | ±3mmHg (±0.4kPa) | Same |
| PRmeasurementrange | 40-199 bpm | 40-170 pulses/min | SE, refer toRemark 3 |
| PRmeasurementaccuracy | ±5% of reading | ±5% of reading | Same |
| Power supply | 6V 1A, 4 × AA/1.5V (LR6) Alkalinebatteries, orAC Adapter (Model: SINPRO,HPU15-102 Input: 100-240V AC47-63Hz / Output: 5.99V DC 2A) | d.c. 4.5V, 3*AA batteries; orAC adapter INPUT: 100-240VAC 50/60HZ OUTPUT:5V DC 1A | SE, refer toremark 4 |
| Elements ofComparison | Predicate Device(K190507) | Subject Device | Judgment |
| Models | HL858CL | C02 and F01 | -- |
| Degree ofprotection againstelectric shock | Type BF applied part | Type BF applied part | Same |
| Type of protectionagainst electricshock | Internally powerequipment or class II | Internally power equipmentor class II | Same |
| Model of operation | Continuous operation | Continuous operation | Same |
| Cuff size suitablefor arm size | Arm circumferenceapprox.23 | cuff: 8.7" – 15.7" (22 - 40 cm) | SE, refer toRemark 5 |
| Sets of memory | 2*120, total 240 | 2*120, total 240 | Same |
| Automatic power off | unknown | Automatically turn offafter 60 seconds | Difference,Refer toRemark 6 |
| Operationenvironment | 5℃ | 5°C-40°C, 15%-93%RH,70-106kPa | Same |
| Storageenvironment | -25℃-70℃, ≤ 93% R.H. | -25°C-70°C, ≤ 93% R.H. | Same |
| Performance | Compliance withCompliance withANSI/AAMI/IEC 80601-2-30 | Compliance withCompliance with IEC80601-2-30 | Same |
| Clinical | Compliance withCompliance with ISO81060-2 | Compliance withCompliance with ISO81060-2 | Same |
| Material | ABS housing andABS keys | ABS housing andABS keys | Same |
| Biocompatibility | All the patient contactingmaterials are compliancewith ISO 10993 | All the patient contactingmaterials are compliancewith ISO 10993 | Same |
| Electrical Safety | Compliance with IEC60601-1 | Compliance with IEC60601-1 | Same |
| EMC | Compliance with IEC60601-1-2 | Compliance with IEC60601-1-2 | Same |
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001_510(k) Summary
Version: 1.1
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001_510(k) Summary
Version: 1.1
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001 510(k) Summary Version: 1.1
Remark 1 :
The indication for use of subject device is same as predicate device, only the description is different. The predicate device has irreqular heartbeats, risk category indicator function, and Bluetooth data transmission function. The subject device also has irregular heartbeats function, but not shown in this section. It has been shown in section 6 and section 8.3 of user manual. In additional, this indicator is only a caution, not a diagnostic basis. There is not risk category indicator function and Bluetooth data transmission for our subject device, therefore, this description is not shown. So the difference will not raise any safety or effectiveness issue.
Remark 2:
The blood pressure measurement range and rated range of determination is different between two devices, but they are within the range of predicate device. In additional, the subject device has been passed the testing according to IEC 80601-2-30, ISO 81060-1 and ISO 81060-2 standards. So the difference will not raise any safety or effectiveness issue.
Remark 3:
The PR measurement range of subject device and predicate device is difference, but the range of subject device is within the range of predicate device. In additional, the subject device has been evaluated according to ISO 81060-2 standard. The PR measurement range and accuracy are met the clinical requirements. So the difference will not raise any safety or effectiveness issue.
Remark 4:
The power supply of subject device is d.c. 4.5 V, 3*AA batteries or AC adapter (INPUT: 100-240VAC 50/60HZ OUTPUT: 5V DC 1A), and the predicate device is 6V 1A, 4 × AA/1.5V (LR6) Alkaline batteries, or AC Adapter (Model: SINPRO, HPU15-102 Input: 100-240V AC 47-63Hz / Output: 5.99V, DC, 2A). They are internal power supply or AC power supply. The subject devices are compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30 and ISO 81060-1 standards. So the difference will not raise any safety or effectiveness issue.
Remark 5:
The intended arm circumferences of the proposed and predicate device are different. This difference is very slight, and the cuff size is appropriate to the claimed intended arm
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001_510(k) Summary Version: 1.1
circumference per IEC 80601-2-30. Therefore, this point is considered as substantially equivalent.
Remark 6:
The time of automatic power off is 60s for subject device, but it is unknown for predicate device. This function is optional; it can be turned off by pressing "on/off' button, and the subject device is compliance with the IEC 80601-2-30 standard, so the difference will not raise any safety or effectiveness issue.
8. Discussion of Clinical Tests Performed:
Our blood pressure monitor and cuff have been conducted clinical testing to verify the accuracy according to ISO 81060-2: Third Edition 2018-11 Non-invasive sphygmomanometers- Part 2: Clinical investigation of intermittent automated measurement type. The results of this clinical investigation show that the required limits for mean error and standard deviation are fulfilled by the subject device C02 in the group of 90 subjects (42 male and 48 female, patient age between 17 to 74) with qualified distribution. There was not adverse effects ad complication during clinical testing. Thus, all the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met.
9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:
The subject device was tested to evaluate its safety and effectiveness, including the Following table:
Biocompatibility Testing:
The biocompatibility evaluation for the body-contacting component (cuff) 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 recognized by FDA. The cuff has performed and passed the Biocompatibility test. So we have reason to believe that the cuff is safe for the users. The cuff complies with the following standards:
ISO 10993-1:2018, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 10993-5: 2009, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
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001_510(k) Summary Version: 1.1
ISO 10993-10:2010, 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:
IEC 60601-1:2005, 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
Performance:
The performance testing was performed to, and passed, the following standards:
IEC 80601-2-30:2018, Medical Electrical Equipment -- Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive
Sphygmomanometers
ISO 81060-2:2018, Non-Invasive Sphygmomanometers -- Part 2: Clinical Validation of Automated Measurement Type
ISO 81060-1:2007, Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-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" and following standard:
IEC 62304:2015, Medical device software - Software life cycle processes
Other requirement:
The subject device was evaluated its usability and risks according to the following standards: ISO 14971:2007, Medical devices - Application of risk management to medical devices. (General)
IEC 62366-1:2015, Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices
Summary:
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001_510(k) Summary Version: 1.1
Based on the above performance as documented in this application, the Blood Pressure Monitor was found to have a safety and effectiveness profile that is similar to the predicate device.
8.0 Conclusions
Blood pressure monitor, Model C02 and F01 have the same intended use and similar characteristics as the predicate device. Form the above information we conclude the subject device, C02 and F01 are substantially equivalent to the predicate devices, HL858CL which is manufactured by. Health & Life Co., Ltd. These conclude that any differences in their characteristics do not raise any safety and effectiveness issues.
9.0 Summary prepared date
May 15, 2020
§ 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).