(317 days)
Not Found
No
The description focuses on standard oscillometric methods and does not mention AI or ML. The performance studies are standard clinical accuracy tests against a reference method.
No.
The device is intended to measure blood pressure and pulse rate, not to treat or cure any medical condition. It is a diagnostic/monitoring device, not a therapeutic one.
Yes
Explanation: The device is intended to "measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique." The measurement of these physiological parameters for medical purposes constitutes a diagnostic function.
No
The device description explicitly states it is a sphygmomanometer with an electronic manometer and an inflatable cuff, indicating it is a hardware device that uses software for measurement and display.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Arm Blood Pressure Monitor measures blood pressure and pulse rate non-invasively by wrapping a cuff around the upper arm. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate directly from the patient's arm, not to perform tests on biological samples.
Therefore, based on the provided information, this device falls under the category of a non-invasive medical device used for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-32cm.Suitable for adults who over the age of 12.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The arm blood pressure monitor model AES-U171, AES-U181, AES-U131 are sphygmomanometers with electronic manometer intended to be used for the indirect (noninvasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults who over the age of 12 (not for neonatal) . 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 LCD panel.
The monitors AES-U171, AES-U181 and AES-U131 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance, and AES-U171 have print function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adults who over the age of 12
Intended User / Care Setting
It can be used at medical facilities or at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test Summary: Testing to insure clinical accuracy of the device in accordance with ISO 81060-2 as documented in Clinical Test report. Eighty-six patients (43 males and 43 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left 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 60601-1-2:2007, IEC 60601-1-11:2015, IEC 80601-2-30:2009.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1130 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).
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration written in blue text.
January 3, 2019
Alicn Medical (Shenzhen), Inc Meisong Fang Manager 4/F, B Building, Shenfubao Modern Optical Factory Kengzi Street, Pingshan District Shenzhen, 518122 CHINA
Re: K180435
Trade/Device Name: Arm Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 26, 2018 Received: November 26, 2018
Dear Meisong Fang:
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 avare 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S5
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) K180435
Device Name Arm Blood Pressure Monitor
Indications for Use (Describe)
The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-32cm.Suitable for adults who over the age of 12.
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 and 21 CFR §807.92.
The assigned 510(k) number is: _K180435
1.0 Information of Submitter and Correspondent
Submitter's information:
Alicn Medical (Shenzhen), Inc. Address: 4/F, B Building, Shenfubao Modern Optical Factory, Kengzi Street, Pingshan District, Shenzhen, Guangdong, China, 518122 Phone:+86-755-26501548 Fax: +86-755-26504849 Contact Person: Meisong Fang E-mail: hans.fang@alicn.com.hk
Submission correspondent's information:
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd Address: Room 2012#, Gebu commercial building, Hongxing community, Songgang street, Baoan district, Shenzhen 518000, China Contact Person: Reanny Wang; E-mail: cefdacfda@163.com
2.0 Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Arm blood pressure monitor |
| Model: | AES-U171, AES-U181 and AES-U131 |
| Classification name: | System, Measurement, Blood-Pressure, Non-Invasive |
| Review Panel: | Cardiovascular |
| Product Code: | DXN |
| Device Class: | II |
| Regulation Number: | 21 CFR 870.1130 |
4
3.0 Predicate Device Information
| Sponsor: | Shenzhen Urion Technology Co., Ltd. |
|---|---|
| Device: | Upper Arm Electronic Blood Pressure Monitor, U80AH |
| 510(K) Number: | K160019 |
4.0 Device Description
The arm blood pressure monitor model AES-U171, AES-U181, AES-U131 are sphygmomanometers with electronic manometer intended to be used for the indirect (noninvasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults who over the age of 12 (not for neonatal) . 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 LCD panel.
The monitors AES-U171, AES-U181 and AES-U131 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance, and AES-U171 have print function.
5.0 Intended Use
The Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-32cm.Suitable for adults who over the age of 12.
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. Eighty-six patients (43 males and 43 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left arm. Blood pressure measurements were repeated
5
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 60601-1-2:2007
□ IEC 60601-1-11:2015
□ IEC 80601-2-30:2009
7.0 Comparison to predicate device and conclusion
The subject device is substantially equivalent to predicate devices, K160019, U80AH. The substantial equivalence chart is provided as follows:
| Elements of
Comparison | Predicate Device
(K160019) | Subject Device | | | Judgment |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------|----------------------------------------------------------------------------------|
| Models | U80AH | AES-U171 | AES-U181 | AES-U131 | -- |
| Company | Shenzhen Urion Technology
Co., Ltd. | Alicn Medical (Shenzhen), Inc. | | | -- |
| Device
Name | Upper Arm Electronic Blood
Pressure Monitor | Arm Blood Pressure Monitor | | | -- |
| Product code | DXN | DXN | | | SE |
| Regulation # | 21CFR870.1130 | 21CFR870.1130 | | | SE |
| Intended use | The U80 Series Upper Arm
Electronic Blood Pressure
Monitor is intended to
measure the systolic and
diastolic blood pressure as
well as the pulse rate of
adult person via non-
invasive oscillometric
technique in which an
inflatable cuff is wrapped
around the upper arm. It can
be used at medical facilities
or at home. The intended
upper arm circumference is
22-36cm.Suitable for adults
who over the age of 12. | The Arm Blood Pressure Monitor is
intended to measure the systolic and
diastolic blood pressure as well as the
pulse rate of adult person via non-
invasive oscillometric technique in
which an inflatable cuff is wrapped
around the upper arm. It can be used
at medical facilities or at home. The
intended upper arm circumference is
22-32cm.Suitable for adults who over
the age of 12. | | | SE, only
upper arm
circumference
is difference,
refer to
Remark 3 |
| Elements of
Comparison | Predicate Device
(K160019) | Subject Device | | | Judgment |
| Models | U80AH | AES-U171 | AES-U181 | AES-U131 | -- |
| Measuremen
t type | Upper arm | Upper arm | | | SE |
| Patient
population | Adults person over 12 | Adults person over 12 | | | SE |
| Measuremen
t Item | SYS, DYS, Pulse rate | SYS, DYS, Pulse rate | | | SE |
| Principle | Oscillometric | Oscillometric | | | SE |
| BP
measuremen
t range | 0-290mmHg | 0-290mmHg (0-39kPa) | | | SE |
| BP accuracy | ±3mmHg (±0.4kPa) | ±3mmHg (±0.4kPa) | | | SE |
| PR
measuremen
t range | 40-199 bpm | 40-199 pulses/min | | | SE |
| PR
measuremen
t accuracy | ±5% of reading | ±5% of reading | | | SE |
| Power
supply | DC6.0V, 4×AA alkaline
batteries or AC adapter | DC7.4V
/850mAh
internal
polymer li-
ion battery | DC6.0V, 4×AAA
batteries | | SE, refer to
remark 1 |
| Waterproof | IP22 | IP21 | | | SE, refer to
remark 2 |
| Degree of
protection
against
electric
shock | Type BF applied part | Type BF applied part | | | SE |
| Cuff size
suitable for
arm size | About 22cm between 36cm | cuff: 22cm~32cm | | | SE, refer to
Remark 3 |
| Automatic
power off | In 3 minutes | Automatically turn off after 60 seconds | | | Difference,
Refer to
Remark 4 |
| Elements of
Comparison | Predicate Device
(K160019) | Subject Device | | | Judgment |
| Models | U80AH | AES-U171 | AES-U181 | AES-U131 | -- |
| Operation
environment | 5 °C -40°C, 15%-80%RH,
70-106kPa | 5°C-40°C, 15%-80%RH, 70-106kPa | 5°C-40°C, 15%-80%RH, 70-106kPa | 5°C-40°C, 15%-80%RH, 70-106kPa | SE |
| Storage
environment | -20 °C -55 °C , 1 0% -85% RH,
avoid crash, sun burn or rain
during transportation | -20°C-55℃, 15%-85% RH, 70-106kPa | -20°C-55℃, 15%-85% RH, 70-106kPa | -20°C-55℃, 15%-85% RH, 70-106kPa | SE, Refer to
Remark 5 |
6
Alicn Medical (Shenzhen), Inc.
7
Alicn Medical (Shenzhen), Inc.
Remark 1 :
The power supply of subject device AES-U171 is DC7.4V /850mAh internal polymer li-ion battery, and the predicate device U80AH is DC6.0V, 4×AA alkaline batteries. The subject devices are compliance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-1-11 standards. So the difference will not raise any safety or effectiveness issue.
Remark 2 :
The Arm blood pressure monitor is portable medical equipment in non-transit-operable use, according to IEC 60601-1-11 standard requirement, the enclosure ingress of water and particulate matter requirement should be IP21 at least. The subject devices are compliance with IEC 60601-1-11 standard requirement. So the difference will not raise any safety or effectiveness issue.
Remark 3:
The intended arm circumferences (22-32 cm) of the proposed and predicate device are different. This difference is very slight, and the cuff size is appropriate to the claimed intended arm circumference per IEC 80601-2-30.Therefore, this point is considered as substantially equivalent.
Remark 4:
The time of automatic power off is difference with predicate device, the time of subject devices is less than predicate device, but they are both compliance with the IEC 80601-2-30 standard, so the difference will not raise any safety or effectiveness issue.
Remark 5:
8
The Relative Humidity of storage environment of subject devices is difference with predicate device, and they are both compliance with IEC60601-1-11 standard, it will not raise any safety or effectiveness issue.
8.0 Conclusions
Arm blood pressure monitor, Model AES-U171, AES-U181 and AES-U131 have the same intended use and similar characteristics as the predicate device. Moreover, the subject device demonstrates product safety by successful completion of testing to the IEC 60601-1 standard and electromagnetic standard IEC 60601-1-2. The performance test demonstrates the monitors meet the IEC 80601-2-30 and clinical test meets the ISO 81060-2. These conclude that any differences in their characteristics do not raise any safety and effectiveness issues.
Form the above information we conclude the subject device, AES-U171, AES-U181 and AES-U131are substantially equivalent to the predicate devices, U80AH.
9.0 Summary prepared date
February 7, 2018