(282 days)
It is a device intended to measure the systolic, diastolic blood pressure, 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.
Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff uses the air pump to inflate, and 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, diastolic blood pressure and pulse rate.
The provided document is a 510(k) summary for the Shenzhen Pump Medical System Co., Ltd.'s Arm Automatic Blood Pressure Monitor, Models BE6034 and BE6134. It details the device's substantial equivalence to a predicate device but does not contain a standalone clinical study on the subject device (BE6034, BE6134) for blood pressure measurement accuracy with defined acceptance criteria and reported performance.
Instead, the document states: "The subject device, Model BE6034, BE6134 is from the technical point of view, identical to the predicate blood pressure monitor. Model BF1112, BF1113 and BF1115. 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 IEC 80601-2-30:2009 & A1:2013... is unnecessary."
The acceptance criteria and reported device performance for blood pressure measurement accuracy are inferred from the predicate device's specifications, as no new clinical study was conducted for the subject devices on this aspect.
Here's a breakdown of the requested information based on the provided text, with the understanding that clinical accuracy data is based on the predicate and not a new study of the subject device in isolation:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Based on Predicate Device Specifications) | Reported Device Performance (Implied, as no new clinical study was required for the subject device for this metric) |
|---|---|---|
| Pressure Accuracy | ±3mmHg (±0.4kPa) | Meets ±3mmHg (±0.4kPa) (Implied, as subject device uses identical blood pressure measurement technology to the predicate which meets this) |
| Pulse Accuracy | ±5% | Meets ±5% (Implied, as subject device uses identical blood pressure measurement technology to the predicate which meets this) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable for a new clinical test on the subject device's blood pressure accuracy, as none was performed. The determination of device accuracy for blood pressure measurement was based on the predicate device's performance.
- Data Provenance: Not applicable for a new clinical test on the subject device's blood pressure accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no new clinical study was performed for the subject device's blood pressure accuracy. The ground truth for the predicate device's original clinical validation would have been established according to the relevant standard (IEC 80601-2-30:2009 & A1:2013, which substituted ANSI/AAMI SP10). These standards typically involve simultaneous readings by trained observers (experts) using a reference sphygmomanometer.
4. Adjudication method for the test set
- Not applicable, as no new clinical study was performed for the subject device's blood pressure accuracy.
5. 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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automatic blood pressure monitor and does not involve human readers interpreting results in the context of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- A standalone performance assessment for the subject devices (BE6034, BE6134) explicitly demonstrating blood pressure accuracy was not done or required by the FDA. The justification provided is that the "subject device... is from the technical point of view, identical to the predicate blood pressure monitor... 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, the clinical performance of the subject device is considered equivalent to the predicate device.
7. The type of ground truth used
- For blood pressure monitors, the ground truth for clinical validation (as would have been applied to the predicate device) is typically established by simultaneous measurements by trained observers using a reference method (e.g., auscultation with a mercury or aneroid sphygmomanometer). This is a common requirement for validating blood pressure measurement accuracy according to standards like IEC 80601-2-30 (which substituted ANSI/AAMI SP10).
8. The sample size for the training set
- Not applicable to this device, as it is a medical device for vital signs measurement, not an AI model that requires a training set in the conventional sense of machine learning for image analysis or diagnostics. The software calculates blood pressure based on a pressure vibration method and an algorithm, but it's not described as an adaptive learning system.
9. How the ground truth for the training set was established
- Not applicable (see point 8).
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 18, 2016
Shenzhen Pump Medical System Co., Ltd. Migo Yang Clinical Registration Specialist 2/F West, M-7 Sinosteel Building, Maqueling Estate Hi-Tech Industrial Park, Nanshan District Shenzhen, Guangdong, 518057 CN
Re: K151258
Trade/Device Name: Arm Automatic Blood Pressure Monitor, Model: BE6034, BE6134 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 5. 2016 Received: January 19, 2016
Dear 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 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
{1}------------------------------------------------
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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K151258
Device Name
Arm automatic blood pressure monitor, Model: BE6034, BE6134, Noninvasive blood pressure measurement system.
Indications for Use (Describe)
It is a device intended to measure the systolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summarv
This summary of 510(k) safety and effectiveness information is being submitted inaccordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K151258
1. Submitter's Identification
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
2/F, M-7 Sinosteel Building, Maqueling Estate,Hi-Tech Industrial Park,
Nanshan District,
518057 Shenzhen,
PEOPLE'S REPUBLIC OF CHINA
Contact: Xie Qiongyu Tel:86-0755-26710795 Fax:86-0755-26498210 E-mail:xieqy@bpump.com.cn
Date Prepared: 2016-2-12
2. Name of the Device
Trade Name: Arm automaticblood pressure monitor Model No.: BE6034, BE6134 Regulation Description: Noninvasive 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: BF1110, BF1112, BF1113 and BF1115, K130325, 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 uses the air pump to inflate, and then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital
{4}------------------------------------------------
signal to the CPU. Then the software calculates the systolic, diastolic blood pressure and pulse rate.
The arm automatic blood pressure monitor, Model: BE6034. BE6134 has the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.
5. Intended Use
It is intended for measuring systolic, diastolic blood pressure and pulse rate of an adult over the counter.
6. Indications for Use
It is a device intended to measure the systolic, diastolic blood pressure, 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. Comparisonto the 510(k) Cleared Device (Predicate device)
The subject devicemodel BE 6034, BE6134 and the predicate devicemodel BF1110, BF1112, BF1113, BF1115 use the same oscillometric method within the software algorithm to determine the systolic, diastolic blood pressure and pulse rate. Upper arm cuff is inflated automatically by air pump and the pressure is transferred via tube into a sensor in these two units.
They differ by the appearance and the way of energy supply. The appearance of subject device is little different from predicate device; The only way of energy supply of subject device is battery while both battery and DC energy are available for predicate device. But those differences either affect the accuracy or the normal use of subject device because they use the same fundamental scientific technology based on clinical declaration of identity.
The subject devices, model BE 6034, BE6134 use the same oscillometricmethod as the predicate device BF1110, BF1112, BF1113 and BF1115 to determinate the systolic, 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.
{5}------------------------------------------------
| Items | Arm automatic blood pressuremonitor | Arm automatic blood pressuremonitor | |
|---|---|---|---|
| Manufacturer | SHENZHEN PUMP MEDICALSYSTEM CO.,LTD. | SHENZHEN PUMP MEDICALSYSTEM CO.,LTD. | |
| ModelSpecification | BE6034 | BE6134 | BF1112 |
| Intended Use | It is intended for measuring adultblood pressure and pulse rate | It is intended for measuring adult bloodpressure and pulse rate | |
| Indications forUse | It is a device intended to measure thesystolic, diastolic blood pressure,pulse rate of an adult individual byusing a non invasive oscillometrictechnique in which an inflatable cuff(available sizes: 22cm to 44cm (8.7into 17.3in)) is wrapped around thesingle upper arm. | It is a device intended to measure thesystolic, diastolic blood pressure, pulserate of an adult individual by using a noninvasive oscillometric technique in whichan inflatable cuff (available sizes: 22cm to44cm (8.7in to 17.3in)) is wrapped aroundthe single upper arm. | |
| Patientpopulation | Adult | Adult | |
| Environmentof use | Home | Home | |
| MeasuringPrinciple | Oscillometric Method | Oscillometric Method | |
| MeasurementRange | Pressure: 0mmHg | Pressure: 0mmHg-280mmHg(0kPa-37.3kPa)Pulse Rate: 40bpm-80bpm | |
| Accuracy | Pressure: ±3mmHg(±0.4kPa)Pulse: ±5% | Pressure: ±3mmHg (±0.4kPa)Pulse Rate: ±5% | |
| Display | TN-LCD Digital Display | TN-LCD Digital Display | |
| Screen Size | 99mm×86mm | 85mm×57mm | |
| Memory | 2 Memory sets, 60 reading each set. | 1 Memory set, 90 reading each set. | |
| BroadcastFunction | Yes | No | No |
| Power Source | 4 AA Alkaline battery | 4 AA Alkaline battery orAC Adaptor (AC 100-240 V) | |
| OperatingEnvironment | Temperature: +5℃ | Temperature: +5℃~+40℃;Humidity: ≤93%RH | |
| Storage andTransportEnvironment | Temperature: -25℃~+70℃;Humidity: 10% | Temperature: -25℃~+70℃;Humidity: 10%~95% | |
| Weight | 360g(Without batteries) | 294g(Without batteries) | |
| Size | 140 mm×116mm×81 mm | 140mm×110mm×70mm |
The subject device is Substantially Equivalent (SE) to the predicate device which is US legal.
{6}------------------------------------------------
8. Discussion of Non Clinical tests Performed for Determination of Substantial
Equivalence: are as follows:
Testing information demonstrates substantial equivalence to the predicate device and safety and effectiveness of the Arm automatic blood pressure monitor. Model:BE6034. BE6134 in the intended environment of use is supported by testing conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", which outlines Electrical, Mechanical and Environmental Performance requirements.
The following testing was conducted: a. IEC 60601-1 Test b. IEC 60601-1-2 & IEC 80601-2-30 Clause 202 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: BE6034, BE6134 tested met all relevant requirements of the aforementioned tests.
9. Discussion of Clinical Tests Performed:
The subject device, Model BE6034, BE6134 is from the technical point of view, identical to the predicate blood pressure monitor. Model BF1112, BF1113 and BF1115. 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 IEC 80601-2-30:2009 & A1:2013(The standard IEC 80601-2-30:2009 & A1:2013has substituted the clinical requirements of ANSI/AAMI SP10) 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 is no significant differences between the Arm automatic blood pressure monitor (Model: BE6034, BE6134), and the predicate device: Arm automatic blood pressure monitor (Model: BF1110, BF1112, BF1113 and BF1115), in terms of safety and effectiveness based on electrical, mechanical and environmental test results.And they are substantially equivalent to the earlier identified predicate device.
§ 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).