(199 days)
Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5 cm~19.5 cm.
Automatic Wrist Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
The provided document is a 510(k) summary for an Automatic Wrist Blood Pressure Monitor (K193628). It addresses the safety and effectiveness of the device by establishing substantial equivalence to a predicate device (K151281).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the subject device (Automatic Wrist Blood Pressure Monitor, K193628) has the same performance specifications as the predicate device (AGE Automatic Wrist Blood Pressure Monitor, K151281). The acceptance criteria are implicit in the predicate device's performance, as the subject device claims "substantial equivalence" based on these matching specifications.
| Acceptance Criteria (Based on Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|
| Pressure Measuring Range: 0~294 mmHg | Pressure: 0~294 mmHg |
| Pulse Measuring Range: 40~199 beats/minute | Pulse: 40~199 beats/minute |
| Pressure Resolution: 1 mmHg or 0.1kPa | 1 mmHg or 0.1kPa |
| Pressure Measuring Accuracy: ± 3mmHg | ± 3mmHg |
| Pulse Measuring Accuracy: ±5% | ±5% |
| Cuff Circumference: 13.5~19.5cm | 13.5~19.5cm |
2. Sample size used for the test set and the data provenance:
The document mentions validation against standard AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type. This standard outlines clinical validation requirements for non-invasive sphygmomanometers. While the document does not explicitly state the sample size used for this specific validation for the subject device, it implies that this standard was followed.
It also notes that the predicate device similarly conformed to this standard. For blood pressure monitors, clinical validation studies typically involve a specific number of subjects (e.g., at least 85 subjects as per ISO 81060-2:2018 requirements), with measurements taken by trained observers against a reference standard.
The data provenance is not explicitly stated as retrospective or prospective for the subject device's validation, but adherence to a clinical validation standard like ISO 81060-2 usually implies prospective data collection for the clinical study. The country of origin of the data is not specified for the clinical validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not directly state the number of experts or their qualifications for establishing the ground truth specifically for the subject device. However, compliance with ISO 81060-2 dictates the methodology for obtaining reference blood pressure measurements for clinical validation. This standard typically requires:
- A minimum of two trained observers (experts) to simultaneously obtain reference measurements using a calibrated auscultatory method.
- These observers need to meet specific training and accuracy criteria as outlined in the standard. While "radiologist with 10 years of experience" is not the relevant qualification here, the experts would be trained clinical professionals (e.g., physicians, nurses, or technicians) skilled in auscultatory blood pressure measurement.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not explicitly state the adjudication method. However, for clinical validation studies adhering to ISO 81060-2, the standard typically requires simultaneous auscultatory measurements by two trained observers. Discrepancies between the two observers that exceed a certain threshold usually necessitate a third observer, or the exclusion of that measurement. This is a form of 2+1 adjudication, or a similar method for ensuring accuracy of the reference standard.
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:
Not applicable. This device is an Automatic Wrist Blood Pressure Monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that would involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, implicitly. The device is an "Automatic Wrist Blood Pressure Monitor." Its core function is to automatically measure blood pressure and pulse rate without human intervention beyond placing the cuff and initiating the measurement. The validation against ISO 81060-2 is a clinical validation of the device's accuracy in a standalone capacity (i.e., comparing its automated readings to a reference standard).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for validating blood pressure monitors in accordance with ISO 81060-2 is expert auscultatory measurements (manual auscultatory method performed by trained observers) taken simultaneously or in quick succession with the device's measurements. This serves as the reference standard against which the automated device's readings are compared.
8. The sample size for the training set:
The document does not explicitly mention a "training set" or its sample size. For traditional medical devices like blood pressure monitors, while there is internal development and calibration, the term "training set" in the context of machine learning algorithms (as often seen with AI devices) is not typically used or disclosed in this type of regulatory submission. The focus is on the clinical validation of the final product.
9. How the ground truth for the training set was established:
As no explicit "training set" is discussed in the context of the device's regulatory submission in the provided text, the method for establishing its ground truth is not detailed. The primary regulatory focus for substantial equivalence is the clinical validation (test set) against established standards using expert auscultatory measurements as ground truth.
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July 12, 2020
Dongguan E-Test Technology Co., Ltd % Cassie Lee, Manager Dongguan E-Test Technology Co., Ltd Room 201,301. Building 1, Changping Section No.1, Dongshen Road Dongguan City, Guangdong, China 523588
Re: K193628
Trade/Device Name: Automatic Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: December 24, 2019 Received: December 26, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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) K193628
Device Name Automatic Wrist Blood Pressure Monitor
Indications for Use (Describe)
Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5 cm~19.5 cm.
Type of Use (Select one or both, as applicable)
| ☐ Production Use: For 505, 506, or 510(k) Clearance | ☑ Same Use: Corresponding to 505, 506, or 510(k) Clearance |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------ |
| | 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: Ms. 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 Wrist Blood Pressure Monitor Model Name: BW-601, BW-602, BW-603, BW-605, BW-611, BW-612, BW-613 Review Panel: Cardiovascular Product Code: DXN Regulation Number: 870.1130 Requlatory Class: 2
3. Predicate Device Information
| Sponsor | Dongguan Ageless Health Industrial Co., Ltd |
|---|---|
| Device Name and Model | AGE Automatic Wrist Blood Pressure MonitorModels: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613 |
| 510(k) Number | K151281 |
| Product Code | DXN |
| Regulation Number | 870.1130 |
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| Regulation Class | II |
|---|---|
| ------------------ | ---- |
4. Device Description
Automatic Wrist Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. lt can automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the batterv is low.
5. Intended Use / Indications for Use
Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a noninvasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5 cm.
6. Test Summarv
6.1 The whole product and manufacturing used for the Automatic Upper Wrist 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)
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6.2 Summary of new tests on subject device
- IEC 60601-1-2: 2014, Medical electrical equipment Part 1-2: General requirements for basic safety A and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and tests
- Mechanical test according to ANSI/AAMI ES60601-1 (2005/(R)2012 + A 1:2012, C1:2009/(R)2012 + A A2:2010/(R)2012) - Amendment 1 - Revision Date 2012/08/21 and IEC 60601-1-11:2015
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Automatic Wrist 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 ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | DONGGUAN E-TESTTECHNOLOGY CO., LTD | Dongguan Ageless HealthIndustrial Co., Ltd | -- |
| Product Name | Automatic Wrist Blood PressureMonitor | AGE Automatic Wrist BloodPressure Monitor | -- |
| Model Name | BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612,BW-613 | BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612,BW-613 | -- |
| ClassificationName | System, Measurement, Blood-Pressure, Non-Invasive | System, Measurement, Blood-Pressure, Non-Invasive | SE |
| 510(k) Number | Applying | K151281 | -- |
| Product Code | DXN | DXN | SE |
| Intended Use /Indications forUse | Automatic Wrist Blood PressureMonitor is for use by medicalprofessionals or athome and is a non-invasiveblood pressure measurementsystem intended to measure thediastolic and systolic bloodpressures and pulse rate of anadult individual by using anon-invasive technique in whichan inflatable cuff is wrappedaround the wrist. The cuffcircumference is limited to 13.5cm~19.5 cm. | AGE Automatic Wrist BloodPressure Monitor is for use bymedical professionals or athome and is a non-invasiveblood pressure measurementsystem intended to measure thediastolic and systolic bloodpressures and pulse rate of anadult individual by using anon-invasive technique in whichan inflatable cuff is wrappedaround the wrist. The cuffcircumference is limited to 13.5cm~19.5 cm. | SE |
| Energy source | 3Vdc (2 "AAA" batteries) | 3Vdc (2 "AAA" batteries) | SE |
| Software | Same version software | SE | |
| hardware | Same version hardware | SE | |
| Material | ABS plastic, Nylon, Latex | ABS plastic, Nylon, Latex | SE |
| MeasurementSite | Wrist | Wrist | SE |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| Measuringrange | 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 |
| CuffCircumference | 13.5~19.5cm | 13.5~19.5cm | 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,Heart Icon, Memory RecordNumber | Blood Pressure (Systolic andDiastolic), Pulse, Date, Time,WHO BP ClassificationIndicating Bar, Low Battery Icon,Heart Icon, Memory RecordNumber | SE |
| SoftwareVersion | V01 | V01 | SE |
| Size andWeight ofmodel BW-601 | 73.5mm(L)73.2mm(W)30.9mm(H)270g | 73.5mm(L)73.2mm(W)30.9mm(H)270g | SE |
| Size andWeight ofmodel BW-602 | 72.69mm(L)64.0mm(W)28.0mm(H)150g | 73.5mm(L)73.2mm(W)30.9mm(H)270g | SE |
| Size andWeight ofmodel BW-603 | 76.0mm(L)60.5mm(W)27.1mm(H)260g | 87mm(L)67.9mm(W)31mm(H)262g | SE |
| Size andWeight ofmodel BW-605 | 73.5mm(L)60.5mm(W)30.9mm(H)270g | 87mm(L)64mm(W)31mm(H)265g | SENote 1 |
| Size andWeight ofmodel BW-606 | 75.0mm(L)70.0mm(W)32.6mm(H)280g | 87mm(L)63.4mm(W)31mm(H)265g | SE |
| Size andWeight ofmodel BW-611 | 75.0mm(L)70.0mm(W)32.6mm(H)280g | 87mm(L)62mm(W)30mm(H)245g | SENote 1 |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| Size andWeight ofmodel BW-612 | 73.5mm(L)73.2mm(W)30.9mm(H)270g | 78mm(L)72mm(W)29mm(H)255g | SENote 1 |
| Size andWeight ofmodel BW-613 | 76.0mm(L)60.5mm(W)27.1mm(H)260g | 78mm(L)72mm(W)29.6mm(H)260g | SENote 1 |
| Operationcondition | Temperature: 5°C ~ 40°CHumidity: 15 | Temperature: 5°C ~ 40°CHumidity: 15 | SE |
| Transport/storage environment | Temperature: -20°C ~ +65°CHumidity: 15 | Temperature: -20°C ~ +65°CHumidity: 15 | 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 | All the patient contractingmaterials are evaluated by thebiocompatibility standard ISO10993-5, -10. | All the patient contractingmaterials are evaluated by thebiocompatibility standard ISO10993-5, -10. | SE |
Comparison table:
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Comparison in Detail(s):
Note 1:
Although there is a little difference for "appearance", "Physical Dimensions" and "Weight" from the predicate devices, but it will not affect the main function and the intended use of the device.
Final Conclusion:
The subject device noninvasive sphygmomanometer (Automatic Upper Wrist Blood Pressure Monitor) (Model: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613) 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.
Except for new tests mentioned in section 6.2 above, all hardware and software of the subject device are based on that of the predicate device K151281.
8. Date of the summary prepared: July 7, 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).