Automatic Digital Blood Pressure Monitor
Device Facts
| Record ID | K190982 |
|---|---|
| Device Name | Automatic Digital Blood Pressure Monitor |
| Applicant | Xiamen Ants Bro Technology Co., Ltd. |
| Product Code | DXN · Cardiovascular |
| Decision Date | May 29, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1130 |
| Device Class | Class 2 |
Indications for Use
Automatic Digital 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 wrist or the upper arm. It can be used at medical facilities or at home. The intended wrist circumference is 12.5~20 cm and the intended arm circumference has several models: 23~33 cm, 25~35 cm, 22~42 cm, 33~43 cm.
Device Story
Device is a non-invasive digital blood pressure monitor; utilizes oscillometric technique via inflatable cuff wrapped around wrist or upper arm. Input: pressure oscillations detected during cuff deflation. Processing: program-controlled automatic inflation/deflation; calculates systolic/diastolic blood pressure and pulse rate. Output: LCD digital display of measurements. Used in medical facilities or home by patients or clinicians. Provides objective blood pressure data to assist in monitoring cardiovascular health.
Clinical Evidence
Clinical validation performed per ISO 81060-2:2013. Study included 90 patients for arm sphygmomanometer and 90 patients for wrist sphygmomanometer. Manual mercury sphygmomanometer used as reference. Results confirmed accuracy within acceptable limits specified in ISO 81060-2. No adverse events reported.
Technological Characteristics
Non-invasive oscillometric measurement system. Powered by 1.5V batteries (AA or AAA). Features LCD digital display. Operates via program-controlled automatic inflation/deflation. Complies with IEC 60601-1, IEC 60601-1-11, IEC 80601-2-30 (electrical safety), IEC 60601-1-2 (EMC), ISO 10993-5/10 (biocompatibility), and IEC 62366 (usability).
Indications for Use
Indicated for adult patients to measure systolic/diastolic blood pressure and pulse rate via non-invasive oscillometric technique using a wrist or upper arm cuff. Intended for use in medical facilities or home environments.
Regulatory Classification
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.
Predicate Devices
- Digital Blood Pressure Monitor Wrist Style (K171833)
- AGE Automatic Upper Arm Blood Pressure Monitor (K153552)
Submission Summary (Full Text)
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May 29, 2020
Xiamen Ants Bro Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, 510000 Cn
Re: K190982
Trade/Device Name: Automatic Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 1, 2019 Received: April 15, 2019
Dear Cassie Lee:
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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# Indications for Use
510(k) Number (if known) K190982
Device Name Automatic Digital Blood Pressure Monitor
#### Indications for Use (Describe)
Automatic Digital 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 wrist or the upper arm. It can be used at medical facilities or at home. The intended wrist circumference is 12.5~20 cm and the intended arm circumference has several models: 23~33 cm, 25~35 cm, 22~42 cm, 33~43 cm .
Type of Use (*Select one or both, as applicable*)
| <span></span> Residential Use ( <i>Per 31 CFR 801.4; Primary Residence</i> ) | <span></span> One-Time Transaction ( <i>31 CFR 801.4; Subsequent Sale</i> ) |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
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AS-55G, AS-55A, AS-55M, AS-55F
# 510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
### 1. Submitter's Information
510(k) Owner's Name: Xiamen Ants Bro Technology Co., Ltd.
Establishment Registration Number: Applying
Address: 4th and 5th floor, No. 5 Building, Tech.&Innovation center, No. 289 Wengjiao Road, Haicang District, Xiamen China
Tel: +86-13459020349
Fax: +86-0592-6537633
Contact Person: Jane Xu (Manger)
Email: Sales1@asxd.com.cn
### Application Correspondent:
Contact Person: Cassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd.
Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China
Tel: +86 20 8266 2446
Email: regulatory@glomed-info.com
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Sponsor: Xiamen Ants Bro Technology Co., Ltd. Subject Device: Automatic Digital Blood Pressure Monitor, Models: BA4110/AS-35A, BA6310/AS-35E, BA4900/AS-35W, AS-35K, AS-35I, AS-35H, AS-35X, AS-35J, AS-35L, AS-35F, AS-55G, AS-55A, AS-55M, AS-55F
# 2. Subject Device Information
Type of 510(k): Traditional
Common Name:Non-invasive blood pressure measurement systems
Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Trade Name:Automatic Digital Blood Pressure Monitor
Model Name: BA4110/AS-35A, BA6310/AS-35E, BA4900/AS-35W, AS-35K, AS-35I, AS-35H,
AS-35X, AS-35J, AS-35L, AS-35F, AS-55G, AS-55A, AS-55M, AS-55F
Review Panel: Cardiovascular
Product Code: DXN
Regulation Number: 870.1130
Regulatory Class: 2
### 3. Predicate Device Information
| Sponsor | Shenzhen Combei Technology<br>Co.,Ltd. | Dongguan Ageless Health Industrial<br>Co., Ltd. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Name<br>and Model | Digital Blood Pressure Monitor Wrist<br>Style<br>Models: BP800W, BP603W, BP880W,<br>BP885W, BPCB0A-2F, BP850W,<br>BP300W, BP810W, BP602W, BP608W,<br>BP606W, BP660W, BP830W, BP866W | AGE Automatic Upper Arm Blood<br>Pressure Monitor<br>Model: BA-801X, BA-802X, BA-803X,<br>BA-805X, BA-806X, BA-811X,<br>BA-812X, BA-813X, BA-821X,<br>BA-822X, BA-823X, BA-826X (X can be<br>A, B, C, D, E, F) |
| 510(k) Number | K171833 | K153552 |
| Product Code | DXN | DXN |
| Regulation | 870.1130 | 870.1130 |
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Sponsor: Xiamen Ants Bro Technology Co., Ltd.
Subject Device:
Automatic Digital Blood Pressure Monitor, Models: BA4110/AS-35A, BA6310/AS-35E, BA4900/AS-35W, AS-35K, AS-351, AS-35H, AS-35X, AS-35J, AS-35L, AS-35F, AS-55G, AS-55A, AS-55M, AS-55F
| Number | | |
|---------------------|----|----|
| Regulation<br>Class | II | II |
# 4. Device Description
Automatic Digital Blood Pressure Monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual via non-invasive Oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm.It can be used at medical facilities or at home.
The Automatic Digital Blood Pressure Monitor main units have the operating elements of ON/OFF knob, SET key which can be user-friendly controlled.
Arm type Blood Pressure Monitor is equipped with inflatable cuff, while The wrist type Blood Pressure Monitor`s cuff is attached to the device body itself.
# 5. Intended Use / Indications for Use
Automatic Digital 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 wrist or the upper arm.It can be used at medical facilities or at home. The intended wrist circumference is 12.5~20 cm and the intended arm circumference has several models: 23~33 cm, 25~35 cm, 22~42 cm, 33~43 cm.
### 6. Test Summary
Automatic Digital Blood Pressure Monitor has been evaluated the safety and performance by lab bench testing as following:
- � Electrical safety test according to IEC 60601-1 and IEC 80601-2-30 standards
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
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| Sponsor: | Xiamen Ants Bro Technology Co., Ltd. |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device: | Automatic Digital Blood Pressure Monitor, Models: BA4110/AS-35A, BA6310/AS-35E, BA4900/AS-35W, AS-35K, AS-35I, AS-35H, AS-35X, AS-35J, AS-35L, AS-35F, AS-55G, AS-55A, AS-55M, AS-55F |
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- � Usability test according to IEC62366 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
# 7. Summary of the clinical study
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type;
In this clinical investigation, Arm sphygmomanometer had ninety patients (23-33cm: 49 males and 41 females, 25-35cm: 38 males and 52 females, 22-42cm: 48 males and 42 females, and 33-43cm: 38 males and 52 females) and Wrist sphygmomanometer also had ninety patients (43 males and 47 females) participated in the clinical study. Same simultaneous method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any adverse event or side-effect.
The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2.
# 8. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Automatic Digital Blood Pressure Monitor is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of<br>Comparison | Subject Device | Predicate Device1 | Predicate Device2 | Verdict |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | | | | t |
| Elements of<br>Comparison | Subject Device | Predicate Device1 | Predicate Device2 | Verdict |
| Company | Xiamen Ants Bro<br>Technology Co., Ltd. | Shenzhen Combei<br>Technology<br>Co., Ltd. | Dongguan Ageless<br>Health Industrial<br>Co., Ltd. | -- |
| Trade Name | Automatic Digital Blood<br>Pressure Monitor | Digital Blood<br>Pressure Monitor<br>Wrist Style | AGE Automatic<br>Upper Arm Blood<br>Pressure Monitor | -- |
| Classification<br>Name | Non-invasive blood pressure<br>measurement system | Non-invasive blood<br>pressure<br>measurement<br>system | Non-invasive blood<br>pressure<br>measurement<br>system | SE |
| 510(k)<br>Number | Applying | K171833 | K153552 | -- |
| Product Code | DXN | DXN | DXN | SE |
| Intended Use /<br>Indications for<br>Use | Automatic Digital Blood<br>Pressure Monitor is intended<br>to measure the diastolic,<br>systolic blood pressures<br>and pulse rate of an adult<br>individual in hospitals,<br>hospital-type facilities and<br>home environments by using<br>a non-invasive oscillometric<br>technique in which an<br>inflatable cuff is wrapped<br>around the wrist or the upper<br>arm. The intended wrist<br>circumference is 12.5~20 cm<br>and the intended arm<br>circumference with four<br>sizes:<br>23~33 cm, 25~35 cm, 22~42<br>cm, 33~43 cm | The subject device<br>intended to<br>measure the<br>diastolic, systolic<br>blood pressures<br>and pulse rate of an<br>adult individual in<br>hospitals,<br>hospital-type<br>facilities and home<br>environments by<br>using a<br>non-invasive<br>oscillometric<br>technique in which<br>an<br>inflatable cuff (size:<br>12.5~21.5cm(4.9~8<br>.5in) is wrapped<br>around the single | AGE Automatic<br>Upper Arm Blood<br>Pressure Monitor is<br>for use by medical<br>professionals or at<br>home and is a<br>non-invasive blood<br>pressure<br>measurement<br>system intended to<br>measure the<br>diastolic and<br>systolic blood<br>pressures and<br>pulse rate of an<br>adult individual by<br>using a<br>non-invasive<br>technique in which<br>an inflatable cuff is | SE<br>Note 1 |
| Elements of<br>Comparison | Subject Device | Predicate Device1 | Predicate Device2 | Verdict |
| | | wrist.<br>The Subject device<br>is not intended to<br>be diagnostic<br>device. | wrapped around the<br>upper arm. The cuff<br>circumference is six<br>sizes. | |
| Display | LCD Digital Display | LCD Digital Display | LCD Digital Display | SE |
| Measurement<br>Site | Wrist Upper Arm | Wrist | Upper Arm | SE |
| Cuff<br>Circumference | Wrist type:12.5~20 cm<br>Arm type:<br>23~33 cm, 25~35 cm, 22~42 cm, 33~43 cm | 12.5~21.5cm | size A: 17cm--22cm<br>size B: 22cm--30cm<br>size C: 24cm--34cm<br>size D: 22cm--42cm<br>size E: 30cm--42cm<br>size F: 42cm--50cm | SE<br>Note 1 |
| Inflation and<br>Deflation | Program-controlled and<br>automatic | Program-controlled<br>and automatic | Program-controlled<br>and automatic | SE |
| Measuring<br>Method | Non-invasive Oscillometric | Non-invasive<br>Oscillometric | Non-invasive<br>Oscillometric | SE |
| Measuring<br>scope | Pressure:<br>30mmHg~280 mmHg;<br>Pulse: 40 bpm~199 bpm | Pressure:<br>30mmHg~280<br>mmHg<br>Pulse: 40 bpm<br>~200 bpm | Pressure:<br>0mmHg~280<br>mmHg<br>Pulse: 40 bpm ~200<br>bpm | SE |
| Measuring<br>accuracy | Pressure: ±3mmHgPulse:<br>±5% | Pressure: ±<br>3mmHg<br>Pulse: ±5% | Pressure: ± 3mmHg<br>Pulse: ±5% | SE |
| Patient<br>Population | Adult | Adult | Adult | SE |
| Display | LCD Digital Display | LCD Digital Display | LCD Digital Display | SE |
| Power Supply | Wrist type: | 2x 1.5V "AAA" | 4x 1.5V "AA" | SE |
| Elements of<br>Comparison | Subject Device | Predicate Device1 | Predicate Device2 | Verdict |
| | 2x 1.5V "AAA" batteries<br>Arm type:<br>4x 1.5V "AA" batteries/<br>4x 1.5V "AAA" batteries | batteries | batteries | |
| Operation<br>condition | Temperature: +5 to +40 °C,<br>Humidity: 15 to 85%,<br>Pressure: 70.0k Pa - 106.0k<br>Pa | Temperature: +5 to<br>+40 °C,<br>Humidity: 15 to<br>85%, | Temperature: +5 to<br>+40 °C,<br>Humidity: 10 to<br>90%,<br>Pressure: 86.0k Pa<br>- 106.0k Pa | SE |
| Transport/stor<br>age<br>environment | Temperature:-25°C - +70°C,<br>Humidity:10%~95%,<br>Pressure: 70.0k Pa - 106.0k<br>Pa | Temperature:-10°C<br>- +55°C,<br>Humidity:10%~<br>95%, | Temperature:-20°C<br>- +65°C,<br>Humidity:10%~<br>95%,<br>Pressure: 86.0k Pa<br>- 106.0k Pa | SE |
| Safety | IEC 60601-1<br>IEC 60601-1-11<br>IEC 80601-2-30 | IEC 60601-1<br>IEC 60601-1-11<br>IEC 80601-2-30 | IEC 60601-1 | SE |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | SE |
| Dimensions<br>(L * D * H, unit:<br>mm) | BA4110 (AS-35A): 125 X<br>95 X 60<br>BA6310 (AS-35E):<br>140X105X65<br>A4900 (AS-35W):<br>133 X 75 X 33<br>AS-35H:<br>150 X 110 X 70<br>AS-351:<br>140 X 105 X 62<br>AS-35K: | -- | -- | SE<br>Note 2 |
| Elements of | Subject Device | Predicate Device1 | Predicate Device2 | Verdict |
| Comparison | | | | t |
| | AS-35X:<br>150 X 110 X 74 | | | |
| | AS-35J:<br>150X 110X 74 | | | |
| | AS-35L:<br>140 X 113 X 73 | | | |
| | AS-35F:<br>140X 10 X 63 | | | |
| | AS-55A:<br>78X 62 X 65 | | | |
| | AS-55G:<br>90 X 66 X26 | | | |
| | AS-55M:<br>89 X 66 X55 | | | |
| | AS-55F:<br>63 X 66 X69 | | | |
| Weight<br>(not include<br>battery) | BA4110 (AS-35A): about<br>300g | -- | -- | SE<br>Note 2 |
| | BA6310 (AS-35E): about<br>300g | | | |
| | A4900 (AS-35W): about<br>300g | | | |
| | AS-35H: about 300g AS-35I:<br>about 250g | | | |
| | AS-35K: about 250g | | | |
| | AS-35X: about 300g | | | |
| | AS-35J: about 328g | | | |
| | AS-35L: about 280g | | | |
| | AS-35F: about 281g | | | |
| | AS-55A: about 95g…
