BPM64R automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's Arm. The intended use of this over-the-counter device is for adults aged 18 years and older with Arm circumference ranging 220 ~ 420 mm (approx. 9 ~ 17 inch) and for home use.

Device Description

Blood Pressure Monitor is a device intended for use in automatically measures human's Systolic, Diastolic blood pressure and heart rate. The Blood Pressure Monitor, BPM64R uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the AViTA Arm Type Blood Pressure Monitor BPM64R:

Based on the provided 510(k) summary, the device is a non-invasive blood pressure monitor, and its performance is evaluated against the ISO 81060-2 standard for clinical validation of automated measurement type.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from ISO 81060-2)	Reported Device Performance (AViTA Arm Type Blood Pressure Monitor BPM64R)
Required limits for mean difference	Fulfilled
Required limits for standard deviation	Fulfilled

Note: The document states that the "results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device." However, specific numerical values for the mean difference and standard deviation are not provided in this summary. To get these exact values, one would typically need to refer to the full study report or the detailed submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for the clinical validation. It mentions a "clinical investigation" and refers to "the subject device" fulfilling the required limits.

Regarding data provenance:

Country of Origin: Not specified in the provided text for the clinical study.
Retrospective or Prospective: Not specified. Clinical validations for devices like blood pressure monitors are typically prospective.

3. 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 document does not provide details on the number of experts or their qualifications for establishing the ground truth. For blood pressure monitors, the "ground truth" (reference measurements) is usually established by highly trained technicians or physicians using a validated reference sphygmomanometer, often with protocols like auscultatory measurements by two independent observers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not specify the adjudication method. Clinical validation studies for blood pressure monitors following ISO 81060-2 typically involve multiple observers. For example, two observers taking sequential measurements, with a third if there's a significant discrepancy.

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

This is not applicable to this device. The AViTA Arm Type Blood Pressure Monitor BPM64R is a standalone automated measurement device; it is not an AI-powered diagnostic tool requiring human readers for interpretation, nor does it provide "assistance" to human readers in the way an AI algorithm might in imaging diagnostics.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was done. The entire premise of this device is "automatically measures human's Systolic, Diastolic blood pressure and heart rate." The clinical investigation described is explicitly for the automated measurement type and demonstrates the device's ability to operate without human intervention for the measurement itself, though a human initiates the process and reads the display.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for blood pressure monitor validation studies, as per ISO 81060-2, typically involves simultaneous or near-simultaneous auscultatory measurements performed by trained observers using a calibrated mercury or an equivalent reference sphygmomanometer. This would fall under a form of expert reference measurement rather than pathology or outcomes data.

8. The sample size for the training set

This device is an automated measurement system, likely based on traditional oscillometric principles. It does not appear to employ a machine learning or AI model that requires a distinct "training set" in the conventional sense of AI development. Therefore, a sample size for a training set is not applicable in the context of this device as described.

9. How the ground truth for the training set was established

As there is no indication of a "training set" for a machine learning model, this question is not applicable. The device's underlying algorithms are likely based on established physiological models for oscillometric measurements, rather than being "trained" on a dataset in the AI sense.

Summary

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August 3, 2018

Avita Corporation % Anita Chen Advisor ZhengCheng Consulting Company NO. 19, 335 Lane, Fu-Xi Road Shulin District, New Taipei City New Taipei, Taiwan 238

Re: K180155

Trade/Device Name: AViTA Arm Type Blood Pressure Monitor BPM64R Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 13, 2018 Received: July 5, 2018

Dear Anita Chen:

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. 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 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); good

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manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

M. A. Willemann

for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180155

Device Name

AViTA Arm Type Blood Pressure Monitor BPM64R

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Research Use (Part 21 CFR 361. Subpart B) Gene Therapy Studies (21 CFR 361. Subpart C)

__ 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

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92.

The assigned 510(k) Number: K180155

1.	Submitter
	Mailing Address	AVITA Corporation
		9F, NO.78, SEC.1, Kwang-Fu Road,
		San-Chung District, New Taipei City,
		24158, Taiwan, R.O.C.
		Phone: +886-2-85121568
		Establishment Registration No.: NA (1stsubmission)
	Contact Person	Anita Chen /Steven Jhou
	Phone:	+886-939855759/ +8862-8512-1568 #5306
	Fax:	+886-2-85121347
	E-mail:	M9104303@gmail.com /steven_jhou@avita.com.tw
	Date Prepared	2018.01.05
2	Device Name
	Trade or Proprietary Name	AVITA Arm Type Blood Pressure Monitor
	Model	BPM64R
	Common or usual name	Blood Pressure Monitor
	Product Code	DXN
	Device	Blood Pressure Monitor
	CFR Classification	CFR Part 870.1130
	Device Class	II
	Classification Panel	Cardiovascular

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Predicate Device Name 3

510(k) number:

Trade or proprietary or model name: Manufacturer:

Device Description: 4

K151869

Microlife BP3NF1-2B Automatic Blood Pressure Monitor

Microlife Intellectual Property Gmbh

Indications for Use: 5.

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aged 18 years and older with Arm circumference ranging 220 ~ 420 mm (approx. 9 ~ 17 inch) and for home use. 6. Technological Characteristics A comparison of the device features, and Substantial Equivalence intended use, and other Comparison with Predicate: information demonstrates that the Product name is substantially equivalent to the predicate device as summarized in Table 1. The differences raise no new question of safety and effectiveness.

7. Performance Testing

Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device. Compliant to the standard of ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device.

8. Non-Clinical Tests Performed:

a. EMC Test: IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility -Requirements and Tests
b. Radio Frequency Wireless Test: The EUT was performed according to FCC Part 15 Subpart C Section 15.247 procedure and setup followed by ANSI C63.10.2013 requirements.
c. Safety Test:

-IEC 60601-1:2005+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance -IEC 60601-1-11:2010, Medical electrical equipment-Part 1-11: General Requirement for basic safety and essential performance- Collateral Standard: Requirements for medical electrical systems used in the home healthcare environment

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d. Biocompatibility testing

The biocompatibility evaluation and testing of the Product name was conducted in accordance with the following standards and guidance, as recognized by the FDA:

. FDA Draft Guidance - Use of International Standard ISO- 10993. "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing".
ISO 10993-5, Biological evaluation of medical devices- Part 5: Tests for in vitro . cytotoxicity
. 10993-10, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
. ISO 10993-11, Biological evaluation of medical devices- Part 11: Tests for systemic toxicity.
e. Reliability Test:

IEC 80601-2-30 Edition1.1 2013-07 Medical electrical equipment-Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

f. Software Verification and Validation: IEC 62304:2006/AC: 2008 standard and FDA Guidance for the Content of Pre-Market Submission for Software Contained in Medical Devices standard.
g. Usability Validation:

IEC 60601-1-6:2010+A1:2013 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance -Collateral Standard: Usability.

IEC 62366:2007+A1:2014 Medical Devices-Application of usability engineering to medical device.

EN ISO 14971:2012 - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01 )

9. Conclusion

Based on the intended use and/or indications for use, technological characteristics, performance testing and comparison to the predicate device, the subject device is substantially equivalent to the predicate device and raises no new questions of safety or effectiveness.

Regulation Number and Section

§ 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).