BPM16B 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 wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging 125 ~ 210 mm (approx. 4.9 ~ 8.3 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.

AI/ML Overview

This document is a 510(k) Premarket Notification for a Wrist Type Blood Pressure Monitor (BPM16B). The core of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.

The information provided does not describe an AI/ML device, nor does it detail a study proving the device meets acceptance criteria related to AI/ML or human augmentation. Instead, it focuses on the performance testing required for a non-invasive blood pressure measurement system.

Therefore, many of the requested criteria regarding AI/ML studies, expert adjudication, MRMC studies, and ground truth establishment for training sets are not applicable to this document. The document primarily focuses on compliance with established medical device standards for blood pressure accuracy and safety.

Here's a breakdown of the relevant information from the document as it pertains to acceptance criteria and performance testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to compliance with ISO 81060-2 and IEC 80601-2-30 for performance. While it states that the device "meets the performance specifications for its intended use" and "the required limits for mean difference and standard deviation are fulfilled," it does not provide a specific table with numerical acceptance criteria and reported device performance values for blood pressure accuracy.

However, in the comparison table (Table 1 predicate device) in Section 6, "Technological Characteristics and Substantial Equivalence Comparison with Predicate," it lists the following for "Accuracy":

Acceptance Criteria (from predicate AVITA BPM16 / claimed)	Reported Device Performance (from subject device)
Pressure ± 3mmHg	Pressure ± 3mmHg
Pulse ± 4%	Pulse ± 4%

Note: This table only shows that the claimed accuracy of the new device is the same as the predicate and the general industry standard for non-invasive blood pressure monitors. It does not present the specific results from the clinical validation study proving these accuracies beyond stating "the required limits for mean difference and standard deviation are fulfilled."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document mentions "clinical investigation" but does not specify the sample size used for the performance testing (test set).
Data Provenance: Not explicitly stated, but the submission is from Taiwan (Avita Corporation, New Taipei City, Taiwan). The testing would presumably be conducted in Taiwan. The study is a prospective clinical validation study, as it's testing the performance of the device against clinical standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable in the context of expert review for AI/ML ground truth. For a blood pressure monitor, the "ground truth" for blood pressure measurements is established by a reference method, typically auscultation by trained medical professionals, not by expert review of images or data in the way one might establish ground truth for an AI diagnostic algorithm. The ISO 81060-2 standard outlines the methodology for clinical validation, which involves direct comparison to a reference method. The document does not specify the number or qualifications of the individuals performing the reference measurements.

4. Adjudication Method for the Test Set:

Not Applicable for a blood pressure monitor in the context of expert adjudication. The "adjudication" for a blood pressure monitor pertains to how the reference measurements are taken and compared to the device measurements according to the ISO standard. This does not involve an adjudication panel for discordant readings in the way an AI diagnostic study might.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, this was not done. This type of study is relevant for diagnostic AI tools where human readers interpret medical images or data, and the AI assists or replaces them. This is a blood pressure monitor, not an AI diagnostic algorithm.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

Yes, in spirit. The performance testing (compliance to ISO 81060-2) is essentially a standalone performance assessment of the device's accuracy in measuring blood pressure compared to a reference method, without human intervention in the measurement process of the device itself. The device is "automated" and provides readings directly.

7. Type of Ground Truth Used:

Comparator Measurement / Clinical Reference Standard: The ground truth for blood pressure accuracy is established by a reference method (e.g., auscultation with a sphygmomanometer by trained observers) as defined by the ISO 81060-2 clinical validation standard. It is not expert consensus, pathology, or outcomes data in the traditional sense of an AI/ML study for diagnosis.

8. Sample Size for the Training Set:

Not Applicable. This is a medical device, not an AI/ML algorithm that requires a "training set." The device's measurement algorithm is based on oscillometric principles and is likely deterministic or uses fixed, non-AI algorithms, not machine learning that would require a distinct training set for model development.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 17, 2020

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

Re: K200346

Trade/Device Name: Wrist Type Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 7, 2020 Received: November 19, 2020

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. 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) K200346

Device Name

Wrist Type Blood Pressure Monitor

Indications for Use (Describe)

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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Section 5 510(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: TBD

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.: 9617543
	Contact Person	Anita Chen /Amber Dong
	Phone:	+886-939855759/ +8862-8512-1568 #5306
	Fax:	+886-2-85121347
	E-mail:	M9104303@gmail.com /Amber_dong@avita.com.tw
	Date Prepared	2018.01.05
2	Device Name
	Proprietary Name:	Wrist Type Blood Pressure Monitor
	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
3	Predicate Device Name
	510(k) number:	K102624
	Trade or proprietary ormodel name:	AVITA BPM16 Wrist Type Blood PressureMonitor
	Manufacturer:	AVITA Corporation
	510(k) number:	K182166
	Trade or proprietary ormodel name:	BP4350 Automatic Wrist Blood Pressure Monitor
	Manufacturer:	Omron Healthcare, Inc..

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4. Device Description:	Blood Pressure Monitor is a device intended for use inautomatically measures human's Systolic, Diastolic bloodpressure and heart rate.
5. Intended Use:	BPM16B automatically measures human's Systolic, Diastolicblood pressure and heart rate by using the oscillometric methodduring inflation. All values can be read out in one LCD panel.Measurement position is at human being's wrist. The intendeduse of th years and older with wrist circumference ranging 125~ 210 mm (approx. 4.9 ~ 8.3 inch) and for home use.
Special Conditions forUse Statement(s):	For patient only

Technological 6. Characteristics and Substantial Equivalence Comparison with Predicate:
A comparison of the device features, intended use, and other 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.

Table I predicate device		Predicate Devices	Predicate Devices
	Comparison tablebetween test
SEComparisons	Subject(AViTABPM16B Wrist TypeBlood PressureMonitor)	AViTA BPM16 WristType Blood PressureMonitorK102624	Predicate (BP4350Automatic WristBlood PressureMonitor)K182166	Comment
Classification	21CFR 870.1130	21CFR 870.1130	21CFR 870.1130	Same
Product Code	DXN	DXN	DXN	Same
FDA Class	II	II	II	Same
	Comparison tablebetween test	Predicate Devices	Predicate Devices	Predicate Devices
	Intended Use	BPM16B deviceautomaticallymeasures systolicand diastolic bloodpressure and pulserate by theoscillometricmethod. Themeasurementposition is at thewrist. The deviceis intended to beused by adultswith a wristcircumferenceranging from 125mm to 210 mm(approx. 4.9 ~ 8.3inches). Thedevice is intendedfor home use.When the devicedetects irregularheartbeats duringmeasurement, anirregular heartbeatsymbol willappear along withthe measuredreadings.	The AViTA BPMlx Series deviceautomaticallymeasures systolicand diastolic bloodpressure and pulserate by theoscillometricmethod. Themeasurementposition is at thewrist. The deviceis intended to beused by adultswith a wristcircumferenceranging from 125mm to 210 mm(approx. 4.9 ~ 8.3inches). Thedevice is intendedfor home use.When the devicedetects irregularheartbeats duringmeasurement, anirregular heartbeatsymbol will appearalong with themeasuredreadings.	The device is adigital monitorintended for use inmeasuring bloodpressure and pulserate in adultpatient populationwith wristcircumferenceranging from 5.3inches to 8.5inches (13.5cm to21.5cm). Thedevice detects theappearance ofirregularheartbeatsduringmeasurement andgives a warningsignal withreadings.	Same as The AViTABPM 1x Series
	Method ofmeasurement	Oscillimetric	Oscillimetric	Oscillimetric	Same
	MeasurementType	During inflation	During deflation	During inflation	Same as BP4350
	Range ofmeasurement	Rated Range of CuffPressure: 0~300mmHg,Rated Range ofDetermination:40~~255mmHg,Pulse 40~~199Beats/minute	Rated Range of CuffPressure: 0~300mmHg,Rated Range ofDetermination:30~~280mmHg,Pulse 40~~199Beats/minute	Rated Range of CuffPressure: 0~299mmHg,Rated Range ofDetermination:40~~260mmHg,Pulse 40~~180Beats/minute	Similar
	Accuracy	Pressure ± 3mmHgPulse ± 4%	Pressure ± 3mmHgPulse ± 4%	Pressure ± 3mmHgPulse ± 5%	Same as The AViTABPM 1x Series
	Inflation	Automatic	Automatic	Automatic	Same
	Comparison tablebetween test	Predicate Devices	Predicate Devices	Predicate Devices
Deflation	Automatic	Automatic	Automatic	Same
PressureChangedRate	2-5 mmHg/sec.	2-5 mmHg/sec.	2-5 mmHg/sec.	Same
Display	Liquid CrystalDigital	Liquid CrystalDigital	Liquid CrystalDigital	Same
PowerSupply	2 "AAA(LR03)(1.5V)"Alkaline Batteries	2 "AAA(LR03)(1.5V)"Alkaline Batteries	2 "AAA(LR03)(1.5V)"Alkaline Batteries	Same
Storage/TransportationEnvironment	- 20°C ~ + 50°C≤ 85% R.H.	- 20°C ~ + 50°C≤ 85% R.H.	- 20°C ~ + 60°C,15% ~ 90% R.H.	Same as The AVITABPM lx Series
OperatingEnvironment	10°C ~ 40°C≤ 85% R.H.700~1060 hPa	10°C ~ 40°C≤ 85% R.H.700~1060 hPa	10°C ~ 40°C15% ~ 90% R.H.800~1060 hPa	Same as The AVITABPM lx Series
Material	ABS housing	ABS housing	ABS housing	Same
Setsmemory	of 1*90	2*90, total 180	2*100, total 200	Similar
Number ofPush Button	2 keys	4 keys	5 keys	Similar
Storagepouch	Yes	Yes	Yes	Same
Cuff size	Wrist circumferenceapprox.125 ~ 210 mm(Approx. 4.9~8.3inches)	Wrist circumferenceapprox.125 ~ 210 mm(Approx. 4.9~8.3inches)	Wrist circumferenceapprox.135 ~ 215 mm(approx. 5.3 ~ 8.4inches)	Same as The AVITABPM lx Series
Unit Weight	approx.106g(exclude batteries)	approx.120g(exclude batteries)	Approx. 91 g	Similar

Table 1 predicate device

AViTA Corporation

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Section 5. 510(k) Summary

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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

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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: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

-IEC 60601-1-11:, 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

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.
Performance Test: e.

IEC 80601-2-30 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 standard and FDA Guidance for the Content of Pre-Market Submission for Software Contained in Medical Devices standard.
g. Usability & risk management:

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

IEC 62366: Medical Devices-Application of usability engineering to medical device.

EN ISO 14971 - Medical devices - Application of risk management to medical devices

9. Conclusion

Based on the intended use and/or indications for use, technological characteristics, performance testing and comparison to the predicate device, the Product name 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).