(154 days)
It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm44cm (8.7in17.3in)) is wrapped around the single upper arm.
Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.
This document is a 510(k) Summary for a medical device called an "Arm automatic blood pressure monitor" (various models). The purpose of this summary is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information provided, extracting the requested details:
Acceptance Criteria and Device Performance
The acceptance criteria for accuracy are based on the ANSI/AAMI/ISO 81060-2:2009 standard for non-invasive sphygmomanometers. While the document mentions that a repeated clinical test for the subject devices was "unnecessary" due to technical similarity with the predicate, the predicate device's performance, which the subject devices claim substantial equivalence to, is detailed in a comparison table.
Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Predicate Device Claimed Performance) | Reported Device Performance (Subject Device Claimed Performance) | Basis for Acceptance/Performance |
|---|---|---|---|
| Accuracy - Pressure | ±3 mmHg (±0.4 kPa) | ±3 mmHg (±0.4 kPa) | Claimed identical to predicate |
| Accuracy - Pulse | ±5% | ±5% | Claimed identical to predicate |
| Measurement Range - Pressure | 0 mmHg ~ 280 mmHg (0 kPa ~ 37.3 kPa) | 0 mmHg ~ 280 mmHg (0 kPa ~ 37.3 kPa) | Claimed identical to predicate |
| Measurement Range - Pulse | 40 bpm ~ 180 bpm | 40 bpm ~ 180 bpm | Claimed identical to predicate |
| Operating Environment - Temperature | +5℃ ~ +40℃ | +5℃ ~ +40℃ | Claimed identical to predicate |
| Operating Environment - Humidity | 15% ~ 93% | 15% ~ 93% | Claimed identical to predicate |
| Operating Environment - Pressure | 70.0 kPa ~ 106.0 kPa | 70.0 kPa ~ 106.0 kPa | Claimed identical to predicate |
| Operating Environment - Altitude | ≤ 3000 m | ≤ 3000 m | Claimed identical to predicate |
| Storage/Transport Environment - Temperature | -25℃ ~ +70℃ | -25℃ ~ +70℃ | Claimed identical to predicate |
| Storage/Transport Environment - Humidity | 10% ~ 95% | 10% ~ 95% | Claimed identical to predicate |
| Storage/Transport Environment - Pressure | 50.0 kPa ~ 106.0 kPa | 50.0 kPa ~ 106.0 kPa | Claimed identical to predicate |
Study Information:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states that a repeated clinical test for the subject devices was unnecessary because the subject devices are identical to the predicate device from a technical point of view, and the differences (Power Source, Weight, Size, Broadcast Function) do not relate to blood pressure measurement technology. Therefore, no new clinical test data for the subject devices is provided in this summary.
- The provenance of the data for the predicate device's clinical validation (which established the acceptance criteria for these equivalence claims) is not detailed in this document. It is implied that the predicate device (K151258) met the ANSI/AAMI/ISO 81060-2:2009 standard, but the specific details of that study are not provided in this submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Since a new clinical test for the subject device was deemed "unnecessary," there would be no new ground truth established for the subject device in this submission. The ground truth for the predicate device's accuracy would have been established during its original clinical validation against the ANSI/AAMI/ISO 81060-2:2009 standard, which typically involves comparing automated measurements to those taken by trained observers using a reference sphygmomanometer. Details on the number or qualifications of these "experts" (trained observers) are not provided in this document.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No new clinical test was performed for the subject device, so no adjudication method is mentioned for its test set. The ANSI/AAMI/ISO 81060-2 standard outlines procedures for obtaining reference blood pressure measurements, often involving multiple observers to minimize bias, but the specific method used for the predicate device's validation is not detailed here.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable. The device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that would involve human "readers" or an MRMC study.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The core functionality of an "Arm automatic blood pressure monitor" is inherently standalone. It uses an oscillometric technique to calculate blood pressure and pulse rate without human intervention during the measurement process. The comparison tables indicate the subject device and predicate device "use the same oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate." This implies a standalone algorithm performance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For blood pressure monitors, the "ground truth" during clinical validation (following standards like ANSI/AAMI/ISO 81060-2) is typically established by simultaneous auscultatory measurements performed by trained observers using a calibrated reference sphygmomanometer. This is considered an expert comparison or reference measurement.
-
The sample size for the training set
- This document does not specify a training set as it focuses on demonstrating substantial equivalence rather than detailing the development and initial validation of the algorithm itself. The
oscillometric methodused is a well-established technique for blood pressure measurement, and any "training" (e.g., development of the algorithm's parameters) would have occurred during the initial design and validation of the predicate device's core technology, which is not described here.
- This document does not specify a training set as it focuses on demonstrating substantial equivalence rather than detailing the development and initial validation of the algorithm itself. The
-
How the ground truth for the training set was established
- As no training set is explicitly discussed in this document for the subject device, the method for establishing its ground truth is not provided. For oscillometric devices, the algorithm's parameters are typically derived and refined based on clinical data where the device's readings are compared against standard reference measurements.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2016
Shenzhen Pump Medical System Co., Ltd Ms. Migo Yang Clinical Registration Specialist 2/f. M-7 Sinosteel Building. Maqueling Estate. Hi-tech Industrial Park Nanshan District, Shenzhen, 518057 CN
Re: K161708
Trade/Device Name: Arm automatic blood pressure monitor, Model: BF3202, BF3212, BF6002, BF6102, BF1205, BF1215, BF1213, BF6051, BF6151, BF6043, BF6143, BF1204,BF1214, BF6023L, BF6123L, BF6048L, BF6148L, BF6053, BF6153, BF6055 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 23, 2016 Received: June 21, 2016
Dear Ms. Migo Yang,
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. 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
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Page 2 - Ms. Migo Yang
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mada Yellen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161708
Device Name
Arm automatic blood pressure monitor, Model: BF3202, BF3212, BF1205,BF1215, BF1213, BF6051,BF6151, BF6043,BF6143, BF1204,BF1214, BF6023L,BF6123L, BF6148L, BF6053,BF6153, BF6055;
Indications for Use (Describe)
It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable sizes: 22cm44cm (8.7in17.3in)) is wrapped around the single upper arm.
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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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: _K161708
Submitter's Identification: 1.
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. 2/F, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen, PEOPLE'S REPUBLIC OF CHINA
Contact: Xie Qiongyu Tel:86-0755-26710795 Fax:86-0755-26498210 E-mail:xieqy@bpump.com.cn
2. Name of the Device:
Trade Name: Arm automatic blood pressure monitor Model: BF3202,BF3212, BF6002,BF6102, BF1205,BF1215, BF1213, BF6051,BF6151, BF6043,BF6143, BF1204,BF1214, BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153,BF6055; Regulation Description: Non-invasive blood pressure measurement system. Regulation Number: 21 CFR 870.1130 Regulation Class: II Product Code: DXN Review Panel: Cardiovascular
3. Information for the 510(k) Cleared Device(Predicate device):
Arm automatic blood pressure monitor, Model: BE6034, BE6134, K151258, SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
4. Description of the device
Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with
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pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.
The arm automatic blood pressure monitor, Model: BF3202,BF3212, BF6002,BF6102, BF1205.BF1215. BF1213. BF6051.BF6151. BF6043.BF6143. BF1204.BF1214. BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; has the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.
5. Intended Use:
Arm automatic blood pressure monitor, model: BF3202,BF3212, BF6002,BF6102, BF1205.BF1215. BF1213. BF6051.BF6151. BF6043.BF6143. BF1204.BF1214. BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; is intended for measuring systolic, diastolic blood pressure and pulse rate of an adult over the counter.
6. Indications for Use:
Arm automatic blood pressure monitor, Model: BF3202,BF3212, BF6002,BF6102, BF1205,BF1215, BF1213, BF6051,BF6151, BF6043,BF6143, BF1204,BF1214, BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; is intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm.
7. Comparison to the 510(k) Cleared Device (Predicate device):
The subject device, Arm automatic blood pressure monitor, Model: BF3202,BF3212, BF6002.BF6102. BF1205.BF1215. BF1213. BF6051.BF6151. BF6043.BF6143. BF1204,BF1214, BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; and the predicate device: Arm automatic blood pressure monitor, Model: BE6034, BE6134 uses the same oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. Upper arm cuff is inflated automatically by air pump and the pressures are transferred via tubing to a sensor in the unit.
They differ by the appearance, the way of energy supply as well as PCB. The appearance of subject device is different from predicate device; The only way of energy supply of predicate device is battery while the way of energy supply of subject device can be both battery and adapter. The PCB of subject device has been updated. But those differences do not affect the accuracy or normal use of this device because they use the same fundamental scientific technology based on clinical declaration of identity and the declaration of clinical identity.
The subject device: Arm automatic blood pressure monitor, Model: BF3202,BF3212, BF6002,BF6102,BF1205,BF1215,BF1213,BF6051,BF6151,BF6043,BF6143, BF1204,BF1214,BF6023L,BF6123L,BF6048L,BF6148L,BF6053,BF6153,BF6055;
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uses the same oscillometric method as the predicate device: Arm automatic blood pressure monitor, Model: BE6034, BE6134 to determinate the systolic and diastolic blood pressure and pulse rate. They have the same function and intended use. Based upon the aforementioned information, these devices are substantially equivalent. Please refer to table below for comparison.
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| (Subject Devices:BE6034,BE6134,BF3202,BF3212,BF6002,BF6102,BF1213) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Model | Comparison | |||||||||
| No | Items | BE6034, BE6134 | BF3202 | BF3212 | BF6002 | BF6102 | BF1213 | Result | Note | |
| 1 | Manufacturer | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | SHENZHENPUMP MEDICALSYSTEMCO.,LTD. | SHENZHENPUMP MEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | Identical | NA | |
| 2 | Intended Use | It is a deviceintended tomeasure thesystolic, diastolicblood pressureand pulse rate ofan adult individualby using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic,diastolic bloodpressure andpulse rate of anadult individualby using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(availablesizes: 22cm to44cm (8.7in to17.3in)) iswrappedaround thesingle upperarm. | It is a deviceintended tomeasure thesystolic, diastolicblood pressureand pulse rate ofan adultindividual byusing a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic, diastolicblood pressureand pulse rate ofan adult individualby using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic, diastolicblood pressure andpulse rate of anadult individual byusing a non-invasiveoscillometrictechnique in whichan inflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic,diastolic bloodpressure andpulse rate of anadult individualby using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to17.3in)) iswrapped aroundthe single upperarm. | Identical | NA | |
| 3 | Indications forUse | It is intended formeasuringsystolic, diastolicblood pressureand pulse rate ofan adult over thecounter. | It is intendedfor measuringsystolic,diastolic bloodpressure andpulse rate of anadult over thecounter. | It is intended formeasuringsystolic, diastolicblood pressureand pulse rate ofan adult over thecounter. | It is intended formeasuringsystolic, diastolicblood pressureand pulse rate ofan adult over thecounter. | It is intended formeasuringsystolic, diastolicblood pressure andpulse rate of anadult over thecounter. | It is intendedfor measuringsystolic,diastolic bloodpressure andpulse rate of anadult over thecounter. | Identical | NA | |
| Model | Comparison | |||||||||
| No | Items | BE6034, BE6134 | BF3202 | BF3212 | BF6002 | BF6102 | BF1213 | Result | Note | |
| 4 | Patientpopulation | Adult | Adult | Adult | Adult | Adult | Adult | Identical | NA | |
| 5 | Environment ofuse | Home | Home | Home | Home | Home | Home | Identical | NA | |
| 6 | MeasuringPrinciple | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | Identical | NA | |
| 7 | MeasurementRange | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Identical | NA | |
| 8 | Accuracy | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Identical | NA | |
| 9 | Display | TN-LCD DigitalDisplay | TN-LCDDigital Display | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | TN-LCDDigital Display | Identical | NA | |
| 10 | Memory | 2 Memory sets, 60readings each set. | 2 Memory sets,60 readingseach set. | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | 2 Memory sets,60 readingseach set. | Identical | NA | |
| 11 | PowerSource | 4 AA Alkalinebattery | 4 AA Alkalinebattery orAC Adapter(Input: AC100-240 V,50/60Hz,400mA; Output :D.C. 6.0V,0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output : D.C.6.0V, 0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output : D.C.6.0V, 0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output : D.C.6.0V, 0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA; Output :D.C. 6.0V,0.5A;) | Different | NA | |
| Items | Model | Comparison | ||||||||
| No | BE6034, BE6134 | BF3202 | BF3212 | BF6002 | BF6102 | BF1213 | Result | Note | ||
| 12 | BroadcastFunction | BE6034: YES;BE6134: No | No | No | No | No | No | Different | NA | |
| 13 | OperatingEnvironment | Temperature:+5℃~+40℃;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPaAltitude: ≤ 3 000m | Temperature:+5℃ | Temperature:+5℃~+40℃;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPaAltitude: ≤ 3 000m | Temperature:+5℃~+40℃;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPaAltitude: ≤ 3 000m | Temperature:+5℃~+40℃;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPaAltitude: ≤ 3 000m | Temperature:+5℃ | Identical | NA | |
| 14 | StorageandTransportEnvironment | Temperature: -25℃~+70℃;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Temperature:-25°C ~ +70°CHumidity :10% | Temperature: -25°C ~ +70°C ;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Temperature: -25°C ~ +70°C ;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Temperature: -25℃ | Temperature: -25℃~+70℃;Humidity:10% | Identical | NA | |
| 15 | Weight | 360g (Withoutbatteries) | 275g(withoutbatteries) | 275g(withoutbatteries) | 293g(withoutbatteries) | 293g(withoutbatteries) | 314g(withoutbatteries) | Different | NA | |
| 16 | Size | 140mm×116mm×81mm | 138mm×110mm×68mm | 138mm×110mm×68mm | 140mm×110mm×70mm | 140mm×110mm×70mm | 150mm×110mm×77mm | Different | NA |
Table 1. Comparison of Product Specification (Subject Deviceses:BF3202,BF3212,BF6002,BF6102,BF1213)
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Table 2. Comparison of Product Specification (Subject Deviceses:BF1205,BF1215,BF6051,BF6151,BF6055)
| No | Items | Model | Comparison | ||||||
|---|---|---|---|---|---|---|---|---|---|
| BE6034, BE6134 | BF1205 | BF1215 | BF6051 | BF6151 | BF6055 | Result | Note | ||
| 1 | Manufacturer | SHENZHENPUMPMEDICALSYSTEM | SHENZHENPUMPMEDICALSYSTEM | SHENZHENPUMPMEDICALSYSTEM | SHENZHENPUMP MEDICALSYSTEMCO.,LTD. | SHENZHENPUMP MEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEM | Identical | NA |
| Model | Comparison | ||||||||
| No | Items | BE6034, BE6134 | BF1205 | BF1215 | BF6051 | BF6151 | BF6055 | Result | Note |
| CO.,LTD. | CO.,LTD. | CO.,LTD. | CO.,LTD. | ||||||
| 2 | Intended Use | It is a deviceintended tomeasure thesystolic, diastolicblood pressureand pulse rate ofan adult individualby using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic,diastolic bloodpressure andpulse rate of anadult individualby using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(availablesizes: 22cm to44cm (8.7in to17.3in)) iswrappedaround thesingle upperarm. | It is a deviceintended tomeasure thesystolic, diastolicblood pressureand pulse rate ofan adultindividual byusing a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic, diastolicblood pressureand pulse rate ofan adult individualby using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic, diastolicblood pressure andpulse rate of anadult individual byusing a non-invasiveoscillometrictechnique in whichan inflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic,diastolic bloodpressure andpulse rate of anadult individualby using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to17.3in)) iswrapped aroundthe single upperarm. | Identical | NA |
| 3 | Indications for Use | It is intended formeasuringsystolic, diastolicblood pressureand pulse rate ofan adult over thecounter. | It is intendedfor measuringsystolic,diastolic bloodpressure andpulse rate of anadult over thecounter. | It is intended formeasuringsystolic, diastolicblood pressureand pulse rate ofan adult over thecounter. | It is intended formeasuringsystolic, diastolicblood pressureand pulse rate ofan adult over thecounter. | It is intended formeasuringsystolic, diastolicblood pressure andpulse rate of anadult over thecounter. | It is intendedfor measuringsystolic,diastolic bloodpressure andpulse rate of anadult over thecounter. | Identical | NA |
| 4 | Patientpopulation | Adult | Adult | Adult | Adult | Adult | Adult | Identical | NA |
| 5 | Environment of | Home | Home | Home | Home | Home | Home | Identical | NA |
| Comparison | |||||||||
| No | Items | BE6034, BE6134 | BF1205 | BF1215 | BF6051 | BF6151 | BF6055 | Result | Note |
| use | |||||||||
| 6 | MeasuringPrinciple | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | Identical | NA |
| 7 | MeasurementRange | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Identical | NA |
| 8 | Accuracy | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Identical | NA |
| 9 | Display | TN-LCD DigitalDisplay | TN-LCDDigital Display | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | TN-LCDDigital Display | Identical | NA |
| 10 | Memory | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | Identical | NA |
| 11 | PowerSource | 4 AA Alkalinebattery | 4 AA Alkalinebattery orAC Adapter(Input: AC100-240 V,50/60Hz,400mA;Output : D.C.6.0V, 0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output : D.C.6.0V, 0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output : D.C.6.0V, 0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output : D.C.6.0V, 0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output : D.C.6.0V, 0.5A;) | Different | NA |
| 12 | BroadcastFunction | BE6034: YES;BE6134: No | No | No | No | No | No | Different | NA |
| Comparison | |||||||||
| No | Items | BE6034, BE6134 | BF1205 | BF1215 | BF6051 | BF6151 | BF6055 | Result | Note |
| 13 | OperatingEnvironment | Temperature:+5°C~+40℃;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPaAltitude: ≤ 3 000m | Temperature:+5°C~+40℃;Humidity:15%-93%Pressure:70.0kPa~106.0kPaAltitude: ≤ 3000 m | Temperature:+5°C~+40℃;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPaAltitude: ≤ 3 000m | Temperature:+5°C~+40℃;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPaAltitude: ≤ 3 000m | Temperature:+5°C~+40℃;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPaAltitude: ≤ 3 000m | Temperature:+5°C~+40℃;Humidity:15%-93%Pressure:70.0kPa~106.0kPaAltitude: ≤ 3000 m | Identical | NA |
| 14 | StorageandTransportEnvironment | Temperature:-25°C~+70°C;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Temperature:-25℃~+70℃;Humidity:10%~95%Pressure:50.0kPa~106.0kPa | Temperature:25°C~+70℃;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Temperature:25°C~+70℃;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Temperature:25°C~+70℃;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Temperature:25°C~+70℃;Humidity:10%~95%Pressure:50.0kPa~106.0kPa | Identical | NA |
| 15 | Weight | 360g (Withoutbatteries) | 315g(withoutbatteries) | 313g(withoutbatteries) | 297g(withoutbatteries) | 285g(withoutbatteries) | 357g(withoutbatteries) | Different | NA |
| 16 | Size | 140mm×116mm×81mm | 140mm×116mm×79mm | 140mm×116mm×79mm | 154mm×124mm×65mm | 154mm×124mm×65mm | 157mm×113mm×60mm | Different | NA |
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Table 3. Comparison of Product Specification (Subject Deviceses:BF6043,BF6143,BF1204,BF1214,BF6023L)
| No | Items | Model | Comparison | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| BE6034, BE6134 | BF6043 | BF6143 | BF1204 | BF1214 | BF6023L | Result | Note | |||
| 1 | Manufacturer | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | SHENZHENPUMP MEDICALSYSTEMCO.,LTD. | SHENZHENPUMP MEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | Identical | NA | |
| No | Items | BE6034, BE6134 | BF6043 | BF6143 | BF1204 | BF1214 | BF6023L | Comparison | ||
| 2 | Intended Use | It is a deviceintended tomeasure thesystolic, diastolicblood pressureand pulse rate ofan adult individualby using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic,diastolic bloodpressure andpulse rate of anadult individualby using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to17.3in)) iswrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic, diastolicblood pressureand pulse rate ofan adultindividual byusing a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrappedaround the singleupper arm. | It is a deviceintended tomeasure thesystolic, diastolicblood pressureand pulse rate ofan adult individualby using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic, diastolicblood pressure andpulse rate of anadult individual byusing a non-invasiveoscillometrictechnique in whichan inflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | It is a deviceintended tomeasure thesystolic, diastolicblood pressureand pulse rate ofan adultindividual byusing a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | Identical | NA | |
| 3 | Indications forUse | It is intended formeasuringsystolic, diastolicblood pressureand pulse rate ofan adult over thecounter. | It is intended formeasuringsystolic,diastolic bloodpressure andpulse rate of anadult over thecounter. | It is intended formeasuringsystolic, diastolicblood pressureand pulse rate ofan adult over thecounter. | It is intended formeasuringsystolic, diastolicblood pressureand pulse rate ofan adult over thecounter. | It is intended formeasuringsystolic, diastolicblood pressure andpulse rate of anadult over thecounter. | It is intended formeasuringsystolic, diastolicblood pressureand pulse rate ofan adult over thecounter. | Identical | NA | |
| 4 | Patientpopulation | Adult | Adult | Adult | Adult | Adult | Adult | Identical | NA | |
| 5 | Environment ofuse | Home | Home | Home | Home | Home | Home | Identical | NA | |
| 6 | MeasuringPrincipl | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | Identical | NA | |
| No | Items | Model | Comparison | |||||||
| e | BE6034, BE6134 | BF6043 | BF6143 | BF1204 | BF1214 | BF6023L | Result | Note | ||
| 7 | MeasurementRange | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Identical | NA | |
| 8 | Accuracy | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Pressure:±3mmHg(±0.4kPa)Pulse: ±5% | Identical | NA | |
| 9 | Display | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | Identical | NA | |
| 10 | Memory | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | Identical | NA | |
| 11 | PowerSource | 4 AA Alkalinebattery | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output: D.C. 6.0V,0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output: D.C. 6.0V,0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output: D.C. 6.0V,0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output: D.C. 6.0V,0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output: D.C. 6.0V,0.5A;) | Different | NA | |
| 12 | BroadcastFunction | BE6034: YES;BE6134: No | No | No | No | No | No | Different | NA | |
| 13 | OperatingEnvironment | Temperature:+5°C~+40°C;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPa | Temperature:+5°C~+40°C;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPa | Temperature:+5°C~+40°C;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPa | Temperature:+5°C~+40°C;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPa | Temperature:+5°C~+40°C;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPa | Temperature:+5°C~+40°C;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPa | Identical | NA | |
| No | Items | Model | Comparison | |||||||
| BE6034, BE6134 | BF6043 | BF6143 | BF1204 | BF1214 | BF6023L | Result | Note | |||
| Altitude: ≤ 3 000m | 106.0kPaAltitude: ≤ 3000 m | Altitude: ≤ 3 000m | Altitude: ≤ 3 000m | Altitude: ≤ 3 000m | Altitude: ≤ 3 000m | |||||
| 14 | StorageandTransportEnvironment | Temperature: -25℃~+70℃;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Temperature:25℃~+70℃;Humidity: 10% | Temperature:25℃~+70℃;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Temperature:25℃~+70℃;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Temperature: -25℃ | Temperature:25℃~+70℃;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Identical | NA | |
| 15 | Weight | 360g (Withoutbatteries) | 305g(withoutbatteries) | 305g(withoutbatteries) | 354g(withoutbatteries) | 354g(withoutbatteries) | 336g(withoutbatteries) | Different | NA | |
| 16 | Size | 140mm×116mm×81mm | 141mm×114mm×67mm | 141mm×114mm×67mm | 140mm×116mm×81mm | 140mm×116mm×81mm | 154mm×124mm×65mm | Different | NA |
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Table 4. Comparison of Product Specification (Subject Deviceses:BF6123L,BF6048L,BF6148L,BF6053,BF6153)
| No | Items | Model | Comparison | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| BE6034, BE6134 | BF6123L | BF6048L | BF6148L | BF6053 | BF6153 | Result | Note | |||
| 1 | Manufacturer | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | SHENZHENPUMP MEDICALSYSTEMCO.,LTD. | SHENZHENPUMP MEDICALSYSTEMCO.,LTD. | SHENZHENPUMPMEDICALSYSTEMCO.,LTD. | Identical | NA | |
| 2 | Intended Use | It is a deviceintended tomeasure thesystolic, diastolicblood pressureand pulse rate ofan adult individualby using a non- | It is a deviceintended tomeasure thesystolic,diastolic bloodpressure andpulse rate of anadult individual | It is a deviceintended tomeasure thesystolic, diastolicblood pressureand pulse rate ofan adultindividual by | It is a deviceintended tomeasure thesystolic, diastolicblood pressureand pulse rate ofan adult individualby using a non- | It is a deviceintended tomeasure thesystolic, diastolicblood pressure andpulse rate of anadult individual by | It is a deviceintended tomeasure thesystolic,diastolic bloodpressure andpulse rate of anadult individual | Identical | NA | |
| No | Items | Model | Comparison | |||||||
| BE6034, BE6134 | BF6123L | BF6048L | BF6148L | BF6053 | BF6153 | Result | Note | |||
| invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | by using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(availablesizes: 22cm to44cm (8.7in to17.3in)) iswrappedaround thesingle upperarm. | using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | invasiveoscillometrictechnique in whichan inflatable cuff(available sizes:22cm to 44cm(8.7in to 17.3in))is wrapped aroundthe single upperarm. | by using a non-invasiveoscillometrictechnique inwhich aninflatable cuff(available sizes:22cm to 44cm(8.7in to17.3in)) iswrapped aroundthe single upperarm. | |||||
| 3 | Indications forUse | It is intended formeasuringsystolic, diastolicblood pressureand pulse rate ofan adult over thecounter. | It is intendedfor measuringsystolic,diastolic bloodpressure andpulse rate of anadult over thecounter. | It is intended formeasuringsystolic, diastolicblood pressureand pulse rate ofan adult over thecounter. | It is intended formeasuringsystolic, diastolicblood pressureand pulse rate ofan adult over thecounter. | It is intended formeasuringsystolic, diastolicblood pressure andpulse rate of anadult over thecounter. | It is intendedfor measuringsystolic,diastolic bloodpressure andpulse rate of anadult over thecounter. | Identical | NA | |
| 4 | Patientpopulation | Adult | Adult | Adult | Adult | Adult | Adult | Identical | NA | |
| 5 | Environment ofuse | Home | Home | Home | Home | Home | Home | Identical | NA | |
| 6 | MeasuringPrinciple | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | OscillometricMethod | Identical | NA | |
| 7 | MeasurementRange | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Pressure:0mmHg | Identical | NA | |
| No | Items | Model | Comparison | |||||||
| BE6034, BE6134 | BF6123L | BF6048L | BF6148L | BF6053 | BF6153 | Result | Note | |||
| ~180 bpm | ||||||||||
| 8 | Accuracy | Pressure:$±3$ mmHg( $±0.4$ kPa)Pulse: $±5$ % | Pressure:$±3$ mmHg( $±0.4$ kPa)Pulse: $±5$ % | Pressure:$±3$ mmHg( $±0.4$ kPa)Pulse: $±5$ % | Pressure:$±3$ mmHg( $±0.4$ kPa)Pulse: $±5$ % | Pressure:$±3$ mmHg( $±0.4$ kPa)Pulse: $±5$ % | Pressure:$±3$ mmHg( $±0.4$ kPa)Pulse: $±5$ % | Identical | NA | |
| 9 | Display | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | TN-LCD DigitalDisplay | Identical | NA | |
| 10 | Memory | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | 2 Memory sets, 60readings each set. | Identical | NA | |
| 11 | PowerSource | 4 AA Alkalinebattery | 4 AA Alkalinebattery orAC Adapter(Input: AC100-240 V,50/60Hz,400mA;Output: D.C. 6.0V,0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output: D.C.6.0V, 0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output: D.C.6.0V, 0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output: D.C.6.0V, 0.5A;) | 4 AA Alkalinebattery orAC Adapter(Input: AC 100-240 V,50/60Hz,400mA;Output: D.C. 6.0V,0.5A;) | Different | NA | |
| 12 | BroadcastFunction | BE6034: YES;BE6134: No | No | No | No | No | No | Different | NA | |
| 13 | OperatingEnvironment | Temperature:+5℃~+40℃;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPaAltitude: ≤ 3 000m | Temperature:+5℃ | Temperature:+5℃~+40℃;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPaAltitude: ≤ 3 000m | Temperature:+5℃~+40℃;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPaAltitude: ≤ 3 000m | Temperature:+5℃~+40℃;Humidity: 15%-93%Pressure: 70.0kPa~106.0kPaAltitude: ≤ 3 000m | Temperature:+5℃ | Identical | NA | |
| No | Items | Model | Comparison | |||||||
| BE6034, BE6134 | BF6123L | BF6048L | BF6148L | BF6053 | BF6153 | Result | Note | |||
| 000 m | 000 m | |||||||||
| 14 | StorageandTransportEnvironment | Temperature:-25°C ~+70°C;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Temperature:-25°C~+70°C:Humidity:10% | Temperature:25°C~+70°C;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Temperature:25°C ~+70°C;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Temperature:25°C~+70°C;Humidity: 10%~95%Pressure:50.0kPa~106.0kPa | Temperature:25°C~+70°C;Humidity:10%~95%Pressure:50.0kPa~106.0kPa | Identical | NA | |
| 15 | Weight | 360g (Withoutbatteries) | 336g(withoutbatteries) | 339g(withoutbatteries) | 339g(withoutbatteries) | 358g(withoutbatteries) | 358g(withoutbatteries) | Different | NA | |
| 16 | Size | 140mm×116mm×81mm | 154mm×124mm×65mm | 141mm×114mm×67mm | 141mm×114mm×67mm | 140mm×116mm×81mm | 140mm×116mm×81mm | Different | NA |
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The product specification of subject device is identical in Intended Use, Indication for Use, Patient population, Environment of use, Measuring Principle, Measurement Range, Operating Environment, Storage and Transport Environment;
The subject device and predicate device are differing in Power Source, Weight, Size; Comparing to the predicate device, the subject device has additional power Adapter and Broadcast Finction: Besides, the subject device also has different appearance, which result in different weight and size; But the differences mentioned above do not affect the device. So, we concluded that there is no significant difference between the product device and predicate device: The product specification of subject device is substantially equivalent (SE) to predicate device which is US legally market device.
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K161708 Page 16 of 16
8. Discussion of Non Clinical tests Performed for Determination of Substantial
Equivalence: are as follows:
Testing information demonstrating substantial equivalence to the predicate device and safety and effectiveness of the Arm automatic blood pressure monitor, model: BF3202,BF3212, BF6002.BF6102. BF1205.BF1215. BF1213. BF6051.BF6151. BF6043.BF6143. BF1204,BF1214, BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; in the intended environment of use is supported by testing that was conducted in accordance with the FDA guidance "Reviewer Guidance for Premarket Notification Submissions", which outlines Electrical, Mechanical and Environmental Performance requirements. The following testing was conducted:
The following testing was conducted:
IEC 60601-1 Test
a. IEC 60601-1 Test
b. IEC 60601-1-2 Test
c. IEC 60601-1-11 Test
d. IEC 60601-2-30 Test
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Arm automatic blood pressure monitor, Model: BF3202,BF3212, BF6002,BF6102, BF1205,BF1215,BF1213,BF6051,BF6151,BF6043,BF6143,BF1204,BF1214, BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; tested met all relevant requirements of the aforementioned tests.
9. Discussion of Clinical Tests Performed
The subject device: Arm automatic blood pressure monitor, Model: BF3202,BF3212, BF6002.BF6102. BF1205.BF1215. BF1213. BF6051.BF6151. BF6043.BF6143. BF1204.BF1214.BF6023L.BF6123L. BF6048L.BF6148L. BF6053.BF6153. BF6055; are identical to the predicate device: Arm automatic blood pressure monitor, Model:BE6034, BE6134 from the technical point of view. The differences between them do not relate to blood pressure measurement technology, so the clinical accuracy in terms of blood pressure detection will not be affected. Therefore repeated clinical test in accordance with the standard ANSI/AAMI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type is unnecessary.
10. Software Information
Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
11. Conclusion
We have demonstrated that there are no significant differences between the subject device: Arm automatic blood pressure monitor (Model: BF3202,BF3212, BF6002,BF6102, BF1205,BF1215, BF1213, BF6051,BF6151, BF6043,BF6143, BF1204,BF1214, BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055;), and the predicate device: Arm automatic blood pressure monitor (Model: BE6034, BE6134), in terms of safety and effectiveness based on electrical, mechanical and environmental test results per the FDA guidance "Non-Invasive Blood Pressure (NIBP) Monitor Guidance", and the IEC 80601-2-30:2009 + A1:2013.
§ 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).