(199 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, diastolic 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 a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Automatic Upper Arm Blood Pressure Monitor (Models: BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard from AAMI / ANSI / ISO 81060-2) | Reported Device Performance |
|---|---|
| Pressure Measurement Accuracy: ± 3 mmHg | Pressure: ± 3mmHg |
| Pulse Measurement Accuracy: ± 5% | Pulse: ±5% |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document states: "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: ... AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers Part 2: Clinical Validation of Automated Measurement Type. (Cardiovascular)."
However, the document does not directly provide the sample size or data provenance (e.g., country of origin, retrospective/prospective) for the clinical validation of the subject device itself. Instead, it refers to prior validation of the predicate devices. To get this information, one would need to consult the 510(k) submissions for predicate devices K153552 and K172895, as the subject device is deemed "substantially equivalent" to them based on these prior validations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document refers to the AAMI / ANSI / ISO 81060-2 standard for clinical validation. This standard typically involves trained observers (often medical professionals) to perform auscultatory blood pressure measurements, which serve as the ground truth.
However, the specific number of experts and their qualifications for the predicate device studies (which this device relies upon) are not explicitly stated in this 510(k) summary. The standard implicitly dictates the methodology for such experts to ensure accuracy.
4. Adjudication Method for the Test Set:
The document refers to the AAMI / ANSI / ISO 81060-2 standard. This standard specifies a rigorous methodology for obtaining reference blood pressure measurements, often including:
- Utilizing trained observers.
- Taking multiple consecutive measurements.
- Calculating the average of these measurements as the reference.
- Potentially discarding outlying measurements.
However, the specific adjudication method (e.g., 2+1, 3+1, none) used in the predicate device studies is not detailed in this 510(k) summary. One would need to refer to the original validation reports for the predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size of how much human readers improve with AI vs without AI assistance:
This device is an Automatic Upper Arm Blood Pressure Monitor and does not involve AI assistance for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not performed. The device takes direct measurements.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the device is an "Automatic Upper Arm Blood Pressure Monitor," indicating it operates in a standalone manner to measure blood pressure and pulse rate without continuous human interpretation or input during the measurement process. The clinical validation, by referring to AAMI / ANSI / ISO 81060-2, assesses the device's accuracy in autonomously taking these measurements against a reference standard.
7. The Type of Ground Truth Used:
The ground truth for blood pressure measurement, as stipulated by standards like AAMI / ANSI / ISO 81060-2, is typically established by trained observers using a validated reference method, such as auscultatory blood pressure measurement performed by healthcare professionals. This involves a mercury sphygmomanometer or an equivalent calibrated non-invasive device, with readings taken by at least two independent observers.
8. The Sample Size for the Training Set:
The document states: "All hardware and software of the subject device are based on that of the predicate device K153552 and K172895 since no new testing is presented in the submission." This implies that no new training set was explicitly created or used for the subject device beyond what was used for the predicate devices.
The text does not provide details on the training set or its size for the development of the oscillometric algorithm in either the subject device or its predicates. Blood pressure monitors using the oscillometric method are typically developed and calibrated by engineering teams using various physiological data and signal processing techniques. The "training" here refers more to the engineering development and calibration process rather than a machine learning training set with annotated data.
9. How the Ground Truth for the Training Set was Established:
As mentioned above, the development of an oscillometric blood pressure monitor involves engineering development and calibration. The "ground truth" during this development phase would typically involve:
- Reference blood pressure measurements: Using highly accurate, invasive (e.g., intra-arterial) or highly precise non-invasive (e.g., mercury sphygmomanometer with trained observers) methods during the development and calibration of the oscillometric algorithm.
- Physiological models and simulations: To refine the algorithm's ability to interpret oscillometric waveforms.
- Extensive testing against a range of patient populations: To ensure the algorithm performs robustly across different physiological conditions.
However, specific details on the ground truth establishment for the training set (developmental calibration) are not provided in this 510(k) summary. Such details would typically be part of the manufacturer's internal design and development files. The 510(k) summary primarily focuses on the clinical validation against established standards for regulatory approval.
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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: K193627
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: 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) K193627
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: 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
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Email: requlatory @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-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X,
BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819
Review Panel: Cardiovascular
Product Code: DXN
Regulation Number: 870.1130
Regulatory Class: 2
3. Predicate Device Information
| Sponsor | Dongguan Ageless Health Industrial Co., LtdDongguan Ageless Health Industrial Co., Ltd |
|---|---|
| Device Nameand Model | AGE Automatic Upper Arm Blood Pressure MonitorModels: BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826XAGE Automatic Upper Arm Blood Pressure MonitorModels: BA-815, BA-816, BA-818, BA-819 |
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| 510(k) Number | K153552 | K172895 |
|---|---|---|
| Product Code | DXN | DXN |
| RegulationNumber | 870.1130 | 870.1130 |
| RegulationClass | II | 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, diastolic 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.
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6. Test Summary
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
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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.
| Elements ofComparison | Subject Device | Predicate Device1 | Predicate Device2 | Verdict | |
|---|---|---|---|---|---|
| Company | DONGGUAN E-TESTTECHNOLOGY CO.,LTD | Dongguan Ageless HealthIndustrial Co., Ltd | Dongguan Ageless HealthIndustrial Co., Ltd | -- | |
| Product Name | Automatic Upper ArmBlood Pressure Monitor | AGE Automatic UpperArm Blood PressureMonitor | AGE Automatic UpperArm Blood PressureMonitor | -- | |
| Model Name | BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X, BA-818,BA-819 | BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X | BA-815, BA-816, BA-818,BA-819 | -- | |
| ClassificationName | System, Measurement,Blood-Pressure, Non-Invasive | System, Measurement,Blood-Pressure, Non-Invasive | System, Measurement,Blood-Pressure, Non-Invasive | SE | |
| 510(k) Number | K193627 | K153552 | K172895 | -- | |
| Product Code | DXN | DXN | DXN | SE | |
| Elements ofComparison | Subject Device | Predicate Device1 | Predicate Device2 | Verdict | |
| Intended Use /Indications forUse | Automatic Upper ArmBlood Pressure Monitoris intended for use bymedical professionals orat home to monitor anddisplay diastolic, systolicblood pressure and pulserate on adult each time,with an air cuff buckledaround one's armaccording to theinstruction in the user'sguide manual. | AGE Automatic UpperArm Blood PressureMonitor is intended foruse by medicalprofessionals or at hometo monitor and displaydiastolic, systolic bloodpressure and pulse rateon adult each time, withan air cuff buckled aroundone's arm according tothe instruction in theuser's guide manual. | AGE Automatic UpperArm Blood PressureMonitor is intended foruse by medicalprofessionals or at hometo monitor and displaydiastolic, systolic bloodpressure and pulse rateon adult each time, withan air cuff buckled aroundone's arm according tothe instruction in theuser's guide manual. | SE | |
| Energy source | DC 6V (4 X AA1.5V alkaline batteries) | DC 6V (4 X AA1.5V alkaline batteries) | DC 6V (4 X AA1.5V alkaline batteries) | SE | |
| Design | Software | Same version software | SE | ||
| hardware | Same version hardware | ||||
| Material | ABS plastic, Nylon, Latex | ABS plastic, Nylon, Latex | ABS plastic, Nylon, Latex | SE | |
| MeasurementSite | Upper Arm | Upper Arm | Upper Arm | SE | |
| Measuringrange | Pressure: 0 | Pressure: 0 | Pressure: 0 | SE | |
| Pressureresolution | 1 mmHg or 0.1kPa | 1 mmHg or 0.1kPa | 1 mmHg or 0.1kPa | SE | |
| Measuringaccuracy | Pressure: ± 3mmHg | Pressure: ± 3mmHg | Pressure: ± 3mmHg | SE | |
| Elements ofComparison | Subject Device | Predicate Device1 | Predicate Device2 | Verdict | |
| Pulse: ±5% | Pulse: ±5% | Pulse: ±5% | |||
| CuffCircumference | There are 6 size:size A: 17cm--22cm(SMALL ADULT CUFF)size B: 22cm--30cm(ADULT CUFF-1)size C: 24cm--34cm(ADULT CUFF-2)size D: 22cm--42cm (L-LARGE ADULT CUFF)size E: 30cm--42cm(LARGE ADULT CUFF)size F: 42cm--50cm(EXTRA LARGE ADULTCUFF) | size A: 17cm--22cm(SMALL ADULT CUFF)size B: 22cm--30cm(ADULT CUFF-1)size C: 24cm--34cm(ADULT CUFF-2)size D: 22cm--42cm (L-LARGE ADULT CUFF)size E: 30cm--42cm(LARGE ADULT CUFF)size F: 42cm--50cm(EXTRA LARGE ADULTCUFF) | For BA-815: 22-34 cm;For BA-816: 28-42 cm;For BA-818 and BA-819,there are 6 size:size A: 17cm--22cm(SMALL ADULT CUFF)size B: 22cm--30cm(ADULT CUFF-1)size C: 24cm--34cm(ADULT CUFF-2)size D: 22cm--42cm (L-LARGE ADULT CUFF)size E: 30cm--42cm(LARGE ADULT CUFF)size F: 42cm--50cm(EXTRA LARGE ADULTCUFF) | SE | |
| Size andWeight ofmodel BA-801X | About 460g (not includebattery);(L)115.0mm X(D)103.0mm X (H)67.5mm | About 460g (not includebattery);(L)115.0mm X(D)103.0mm X (H)67.5mm | / | SE | |
| Size andWeight ofmodel BA-802X | About 460g (not includebattery);(L)115.0mm X(D)103.0mm X (H)67.5mm | About 460g (not includebattery);(L)115.0mm X(D)103.0mm X (H)67.5mm | / | SE | |
| Elements of | Subject Device | Predicate Device1 | Predicate Device2 | Verdict | |
| Comparison | |||||
| Size andWeight ofmodel BA-803X | About 460g (not includebattery)(L)119.0mmX(D)100.0mm X(H)63.2mm | About 460g (not includebattery)(L)119.0mmX(D)100.0mm X(H)63.2mm | / | SE | |
| Size andWeight ofmodel BA-805X | About 460g (not includebattery)(L) 118.3mm X(D)100.0mm X(H)62.9mm | About 460g (not includebattery)(L) 118.3mm X(D)100.0mm X(H)62.9mm | / | SE | |
| Size andWeight ofmodel BA-806X | About 460g (not includebattery)(L) 146.0mm X(D)113.0mm X(H)66.0mm | About 460g (not includebattery)(L) 146.0mm X(D)113.0mm X(H)66.0mm | / | SE | |
| Size andWeight ofmodel BA-811X | About 460g (not includebattery)(L) 144.0mm X(D)113.0mm X(H)67.0mm | About 460g (not includebattery)(L) 144.0mm X(D)113.0mm X(H)67.0mm | / | SE | |
| Size andWeight ofmodel BA-812X | About 460g (not includebattery)(L) 113.5mm X(D)92.0mm X (H)48.0mm | About 460g (not includebattery)(L) 113.5mm X(D)92.0mm X (H)48.0mm | / | SE | |
| Size andWeight ofmodel BA-813X | About 460g (not includebattery)(L) 115.3mm X(D)92.0mm X (H)48.0mm | About 460g (not includebattery)(L) 115.3mm X(D)92.0mm X (H)48.0mm | / | SE | |
| Elements ofComparison | Subject Device | Predicate Device1 | Predicate Device2 | Verdict | |
| Size andWeight ofmodel BA-821X | About 610g (not includebattery)(L) 150.0mm X(D)100.0mm X(H)60.0mm | About 610g (not includebattery)(L) 150.0mm X(D)100.0mm X(H)60.0mm | / | SE | |
| Size andWeight ofmodel BA-822X | About 380g (not includebattery)(L) 135.0mm X(D)90.0mm X(H)47.65mm | About 380g (not includebattery)(L) 135.0mm X(D)90.0mm X(H)47.65mm | / | SE | |
| Size andWeight ofmodel BA-823X | About 460g (not includebattery)138.0mm X(D)95.0mmX (H)67.0mm | About 460g (not includebattery)138.0mm X (D)95.0mm X(H)67.0mm | / | SE | |
| Size andWeight ofmodel BA-826X | About 420g (not includebattery)143.0mm X(D)115.0mmX (H)57.0mm | About 420g (not includebattery)143.0mm X (D)115.0mmX (H)57.0mm | / | SE | |
| Size andWeight ofmodel BA-818 | About 465g (not includebattery)(L) 103.0mm X(D)129.0mm X(H)161.0mm | / | About 465g (not includebattery)(L) 103.0mm X(D)129.0mm X(H)161.0mm | SE | |
| Size andWeight ofmodel BA-819 | About 438g (not includebattery)(L) 160.0mm X(D)98.0mm X (H)55.0mm | / | About 438g (not includebattery)(L) 160.0mm X(D)98.0mm X (H)55.0mm | SE | |
| Elements of | Subject Device | Predicate Device1 | Predicate Device2 | Verdict | |
| Comparison | |||||
| Inflation andDeflation | Automatic | Automatic | Automatic | SE | |
| MeasuringMethod | Oscillometry | Oscillometry | Oscillometry | SE | |
| PatientPopulation | Adult | Adult | Adult | SE | |
| Display | Blood Pressure (Systolicand Diastolic), Pulse,Date, Time, WHO BPClassification IndicatingBar, Low Battery Icon,Heart Icon, MemoryRecord Number | Blood Pressure (Systolicand Diastolic), Pulse,Date, Time, WHO BPClassification IndicatingBar, Low Battery Icon,Heart Icon, MemoryRecord Number | Blood Pressure (Systolicand Diastolic), Pulse,Date, Time, WHO BPClassification IndicatingBar, Low Battery Icon,Heart Icon, MemoryRecord Number | SE | |
| SoftwareVersion | V01 | V01 | V01 | SE | |
| Operationcondition | Temperature: 5°C | Temperature: 5°C ~ 40°CHumidity: 15 | Temperature: 5°C ~ 40°CHumidity: 15 | SE | |
| Transport/storage environment | Temperature: -20°C | Temperature: -20°C | Temperature: -20°C | SE | |
| Safety | IEC 60601-1IEC 60601-1-11 | IEC 60601-1IEC 60601-1-11 | IEC 60601-1IEC 60601-1-11 | SE | |
| Elements of | Subject Device | Predicate Device1 | Predicate Device2 | Verdict | |
| Comparison | |||||
| IEC 80601-2-30 | IEC 80601-2-30 | IEC 80601-2-30 | |||
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | SE | |
| Biocompatibility | ISO 10993 series | 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-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819) 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 K 153552 and K 172895 since no new testing is presented in the submission.
- 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).