(197 days)
Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
Automatic Upper Arm Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable cuff is wrapped around upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but using an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic and calculating pulse rate is a well-known technique in the market so called "oscillometric method". The device also has low voltage indication, which will be triggered when the battery is low.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Automatic Upper Arm Blood Pressure Monitor:
This document is a 510(k) Summary for a medical device called "Automatic Upper Arm Blood Pressure Monitor" (Model: BA-815, BA-816) by DONGGUAN E-TEST TECHNOLOGY CO., LTD. It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Crucially, this document states: "All hardware and software of the subject device are based on that of the predicate device (K172895), since no new testing is presented in the submission." This means that the acceptance criteria and performance data presented implicitly refer to the predicate device, as the subject device is deemed identical.
Acceptance Criteria and Reported Device Performance
The device is a non-invasive blood pressure monitor. The performance criteria are defined by the standard AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type.
| Acceptance Criterion (from standards body) | Reported Device Performance (from comparison table) | Additional Details / Notes |
|---|---|---|
| Measuring Accuracy | Pressure: ± 3mmHg | This is a core accuracy requirement for blood pressure monitors, specifically for the measurement of pressure (systolic and diastolic). The device claims to meet this standard. |
| Pulse: ±5% | This is the accuracy requirement for pulse rate measurement. The device claims to meet this standard. | |
| Pressure Resolution | 1 mmHg or 0.1kPa | This indicates the smallest increment the device can display for pressure readings. This is a technical specification rather than a direct performance metric against a clinical standard, but it contributes to the overall measurement capability. |
| Measuring Range | Pressure: 0~280 mmHg | This specifies the operational range for pressure measurement. |
| Pulse: 40~199 beats/minute | This specifies the operational range for pulse rate measurement. | |
| Cuff Circumference | For BA-815: 22-34 cm; For BA-816: 28-42 cm; | While not a direct performance metric, proper cuff sizing is critical for accurate blood pressure measurement. These ranges align with standard adult and large adult arm circumferences. The predicate device also had similar cuff sizes for these models, and additional sizes for other predicate models (which are not subject devices). |
Study Details (Based on the predicate device's compliance with AAMI / ANSI / ISO 81060-2)
Since "no new testing is presented in the submission" and the subject device is identical to the predicate, the compliance is based on the predicate device's clinical validation to AAMI / ANSI / ISO 81060-2 Second Edition. This standard outlines the requirements for clinical validation studies for automated non-invasive sphygmomanometers. The details below are inferred requirements from that standard, as the specific clinical study report is not provided in this 510(k) summary.
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Sample Size used for the test set and the data provenance:
- Sample Size: The AAMI / ANSI / ISO 81060-2 standard generally recommends a minimum of 85 participants for clinical validation studies, with a balanced distribution across age groups, genders, and blood pressure ranges (normotensive, hypertensive, hypotensive) to ensure robustness. The document does not explicitly state the sample size used in the predicate's study.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Clinical validation studies according to AAMI are typically prospective in nature, conducted in a controlled clinical environment.
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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):
- The AAMI / ANSI / ISO 81060-2 standard requires at least two trained observers (experts) to perform simultaneous auscultatory measurements using a mercury sphygmomanometer as the reference standard (ground truth). These observers should be blinded to each other's readings and to the device under test.
- The standard typically requires observers to be medically trained professionals (e.g., physicians, nurses) with demonstrated proficiency in indirect blood pressure measurement. Specific years of experience are not explicitly stated in the general overview of the standard but implied through training and certification. The document does not explicitly state the number or qualifications of experts for the predicate's study.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The AAMI / ANSI / ISO 81060-2 standard outlines specific protocols for comparing the automated device readings against the auscultatory measurements. If the two observers' readings differ by more than a predefined threshold, a third observer ("2+1") or a repeat measurement might be required to establish the ground truth or resolve discrepancies.
- The document does not explicitly state the adjudication method used for the predicate's study, but a standard compliant study would have such a method.
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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, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging analysis or diagnostic aids where human interpretation is assisted by AI. This device is an automated blood pressure monitor; it does not involve human "readers" or AI assistance for interpretation in the same way an imaging system would. It provides direct numerical outputs for blood pressure and pulse rate.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone study was done. The clinical validation per AAMI / ANSI / ISO 81060-2 is fundamentally a standalone clinical performance study. The automatic blood pressure monitor operates on its own, providing measurements, and its performance is compared directly against the reference standard (auscultatory method). There is no "human-in-the-loop" for the device's measurement process itself, although human interaction is required to apply the cuff and initiate the measurement.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth used for validating the accuracy of non-invasive blood pressure monitors under AAMI / ANSI / ISO 81060-2 is simultaneous auscultatory measurement performed by trained human observers using a mercury sphygmomanometer. This is considered the clinical reference standard for indirect blood pressure measurement.
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The sample size for the training set:
- Since no new testing was performed for the subject device and it is stated that "All hardware and software of the subject device are based on that of the predicate device," there is no specific mention of a training set for the subject device or for the predicate device's original validation. Automated blood pressure monitors are often developed and calibrated using internal data, but the AAMI validation focuses on clinical performance rather than a 'training/test' split akin to machine learning models. If the device uses a machine learning algorithm, the training set details would typically be proprietary and not disclosed in a 510(k) summary (unless it directly impacts the safety and effectiveness and needs specific validation).
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How the ground truth for the training set was established:
- As there's no explicitly mentioned "training set" in the context of this 510(k) summary, the method for establishing its ground truth is not provided. For the initial development and calibration of such a device, ground truth would likely be established through a combination of simulated physiological signals and clinical data obtained using reference methods like direct intra-arterial measurements or auscultatory measurements.
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July 10, 2020
Dongguan E-Test Technology Co., Ltd % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, 510000 CHINA
Re: K193624
Trade/Device Name: Automatic Upper 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: March 25, 2020 Received: April 13, 2020
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.
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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/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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193624
Device Name
Automatic Upper Arm Blood Pressure Monitor
Indications for Use (Describe)
Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
| 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 requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: DONGGUAN E-TEST TECHNOLOGY CO., LTD
Establishment Registration Number: Applying
Address: Room 201,301, Building 1, Changping Section No.1, Dongshen Road, Changping Town, Dongguan City, Guangdong, China.
Tel: +86-0769-81158038
Contact Person (including title): Victor Wan (Vice-president)
E-mail: victor@agelh.com
Application Correspondent:
Contact Person: Cassie Lee
DONGGUAN E-TEST TECHNOLOGY CO., LTD
Address: Room 201,301, Building 1, Changping Section No.1, Dongshen Road, Changping Town, Dongguan City, Guangdong, China.
Tel: +86-0769-81158038
Email: regulatory@glomed-info.com
2. Subject Device Information
Type of 510(k): Traditional
Common Name: Noninvasive blood pressure measurement systems
Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Trade Name: Automatic Upper Arm Blood Pressure Monitor
Model Name: BA-815, BA-816
Review Panel: Cardiovascular
Product Code: DXN
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Regulation Number: 870.1130
Requlatory Class: 2
3. Predicate Device Information
| Sponsor | Dongguan Ageless Health Industrial Co., Ltd |
|---|---|
| Device Name andModel | AGE Automatic Upper Arm Blood Pressure MonitorModels: BA-815, BA-816, BA-818, BA-819 |
| 510(k) Number | K172895 |
| Product Code | DXN |
| RegulationNumber | 870.1130 |
| Regulation Class | II |
4. Device Description
Automatic Upper Arm Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable cuff is wrapped around upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but using an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic and calculating pulse rate is a well-known technique in the market so called "oscillometric method". The device also has low voltage indication, which will be triggered when the battery is low.
5. Intended Use / Indications for Use
Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
6. Test Summary
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K193624
The whole product and manufacturing used for the Automatic Upper Arm Blood Pressure Monitor are identical to those of the predicate device, which were demonstrated to conform with the following standards:
- � IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005 + A1:2012
- � IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and tests, 2014
- ◆ ◆ IEC 60601-1-11, Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment [Including: Technical Corrigendum 1 (2011)]
- � IEC 80601-2-30, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers
- � ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
- � ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010
- � AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type. (Cardiovascular)
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Automatic Upper Arm 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.
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| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
|---|---|---|---|---|
| Company | DONGGUAN E-TESTTECHNOLOGY CO., LTD | Dongguan Ageless HealthIndustrial Co., Ltd | -- | |
| Product Name | Automatic Upper Arm BloodPressure Monitor | AGE Automatic Upper Arm BloodPressure Monitor | -- | |
| Model Name | BA-815, BA-816 | BA-815, BA-816, BA-818, BA-819 | -- | |
| ClassificationName | System, Measurement, Blood-Pressure, Non-Invasive | System, Measurement, Blood-Pressure, Non-Invasive | SE | |
| 510(k) Number | Applying | K172895 | -- | |
| Product Code | DXN | DXN | SE | |
| Intended Use /Indications forUse | Automatic Upper Arm BloodPressure Monitor is intended foruse by medical professionals orat home to monitor and displaydiastolic, systolic blood pressureand pulse rate on adult eachtime, with an air cuff buckledaround one's arm according tothe instruction in the user'sguide manual. | AGE Automatic Upper Arm BloodPressure Monitor is intended foruse by medical professionals orat home to monitor and displaydiastolic, systolic blood pressureand pulse rate on adult each time,with an air cuff buckled aroundone's arm according to theinstruction in the user's guidemanual. | SE | |
| Energy source | DC 6V (4 X AA 1.5V alkalinebatteries) | DC 6V (4 X AA 1.5V alkalinebatteries) | SE | |
| DesignSoftware | Same version software | SE | ||
| ignhardware | Same version hardware | |||
| Material | ABS plastic, Nylon, Latex | ABS plastic, Nylon, Latex | SE | |
| MeasurementSite | Upper Arm | Upper Arm | SE | |
| Measuring range | Pressure: 0 | Pressure: 0 | SE | |
| Pressureresolution | 1 mmHg or 0.1kPa | 1 mmHg or 0.1kPa | SE | |
| Measuringaccuracy | Pressure: ± 3mmHgPulse: ±5% | Pressure: ± 3mmHgPulse: ±5% | SE | |
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
| CuffCircumference | For BA-815: 22-34 cm; | For BA-815: 22-34 cm; | SE | |
| For BA-816: 28-42 cm; | For BA-816: 28-42 cm; | |||
| For BA-818 and BA-819, thereare 6 size:size A: 17cm--22cm (SMALLADULT CUFF)size B: 22cm--30cm (ADULTCUFF-1)size C: 24cm--34cm (ADULTCUFF-2)size D: 22cm--42cm (L-LARGEADULT CUFF)size E: 30cm--42cm (LARGEADULT CUFF)size F: 42cm--50cm (EXTRALARGE ADULT CUFF) | ||||
| Size and Weightof model BA-815 | About 1150g (not includebattery)(L) 235mm X (D)182mm X(H)210mm | About 1150g (not include battery)(L) 235mm X (D)182mm X(H)210mm | SE | |
| Size and Weightof model BA-816 | About 1150g (not includebattery)(L) 255mm X (D)201mm X(H)228mm | About 1150g (not include battery)(L) 255mm X (D)201mm X(H)228mm | SE | |
| Inflation andDeflation | Automatic | Automatic | SE | |
| MeasuringMethod | Oscillometry | Oscillometry | SE | |
| PatientPopulation | Adult | Adult | SE | |
| Display | Blood Pressure (Systolic andDiastolic), Pulse, Date, Time,WHO BP ClassificationIndicating Bar, Low Battery Icon, | Blood Pressure (Systolic andDiastolic), Pulse, Date, Time,WHO BP Classification IndicatingBar, Low Battery Icon, Heart Icon,Memory Record Number | SE | |
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
| Heart Icon, Memory RecordNumber | ||||
| SoftwareVersion | V01 | V01 | SE | |
| Operationcondition | Temperature: 5°C ~ 40°CHumidity: 15 | Temperature: 5°C ~ 40°CHumidity: 15 | SE | |
| Transport/storage environment | Temperature: -20°C ~ +65°CHumidity: 10 | Temperature: -20°C ~ +65°CHumidity: 10 | SE | |
| Safety | IEC 60601-1IEC 60601-1-11IEC 80601-2-30 | IEC 60601-1IEC 60601-1-11IEC 80601-2-30 | SE | |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | SE | |
| Biocompatibility | ISO 10993 series | ISO 10993 series | SE |
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Comparison in Detail(s):
Final Conclusion:
The subject device noninvasive sphygmomanometer (Automatic Upper Arm Blood Pressure Monitor) (Model: BA-815, BA-816) has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.
All hardware and software of the subject device are based on that of the predicate device (K172895), since no new testing is presented in the submission.
8. Date of the summary prepared: July 8, 2020
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).