Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard oscillometric blood pressure measurement and does not mention AI or ML.

Therapeutic

No
This device measures blood pressure and heart rate, but it does not treat any condition or provide therapy.

Diagnostic

Yes
A blood pressure monitor measures physiological parameters (blood pressure and heart rate) to provide information about a person's health status, which is a form of diagnostic information.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Blood Pressure Monitor" that uses the "oscillometric method during inflation" and has an "LCD panel," indicating it is a physical hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body. The intended use and device description clearly state that this device measures blood pressure and heart rate directly from the human wrist using the oscillometric method. It does not analyze blood, urine, tissue, or any other sample taken from the body.
The measurement is performed in vivo. The measurement is taken directly on the living human body (at the wrist), not in a laboratory setting on a sample.

Therefore, this device falls under the category of a non-invasive medical device for physiological measurement, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

DXN

Device Description

Blood Pressure Monitor is a device intended for use in automatically measures human's Systolic, Diastolic blood pressure and heart rate.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

wrist

Indicated Patient Age Range

18 years and older

Intended User / Care Setting

home use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K102624, K182166

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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

1

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)

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

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 or
model name:	AVITA BPM16 Wrist Type Blood PressureMonitor
	Manufacturer:	AVITA Corporation
	510(k) number:	K182166
	Trade or proprietary or
model 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 in
automatically measures human's Systolic, Diastolic blood
pressure and heart rate. |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5. Intended Use: | 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 th years and older with wrist circumference ranging 125
~ 210 mm (approx. 4.9 ~ 8.3 inch) and for home use. |
| Special Conditions for
Use 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 table
between test
SE
Comparisons	Subject(AViTA
BPM16B Wrist Type
Blood Pressure
Monitor)	AViTA BPM16 Wrist
Type Blood Pressure
Monitor
K102624	Predicate (BP4350
Automatic Wrist
Blood Pressure
Monitor)
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 table
between test	Predicate Devices	Predicate Devices	Predicate Devices
	Intended Use	BPM16B device
automatically
measures systolic
and diastolic blood
pressure and pulse
rate by the
oscillometric
method. The
measurement
position is at the
wrist. The device
is intended to be
used by adults
with a wrist
circumference
ranging from 125
mm to 210 mm
(approx. 4.9 ~ 8.3
inches). The
device is intended
for home use.
When the device
detects irregular
heartbeats during
measurement, an
irregular heartbeat
symbol will
appear along with
the measured
readings.	The AViTA BPM
lx Series device
automatically
measures systolic
and diastolic blood
pressure and pulse
rate by the
oscillometric
method. The
measurement
position is at the
wrist. The device
is intended to be
used by adults
with a wrist
circumference
ranging from 125
mm to 210 mm
(approx. 4.9 ~ 8.3
inches). The
device is intended
for home use.
When the device
detects irregular
heartbeats during
measurement, an
irregular heartbeat
symbol will appear
along with the
measured
readings.	The device is a
digital monitor
intended for use in
measuring blood
pressure and pulse
rate in adult
patient population
with wrist
circumference
ranging from 5.3
inches to 8.5
inches (13.5cm to
21.5cm). The
device detects the
appearance of
irregular
heartbeats
during
measurement and
gives a warning
signal with
readings.	Same as The AViTA
BPM 1x Series
	Method of
measurement	Oscillimetric	Oscillimetric	Oscillimetric	Same
	Measurement
Type	During inflation	During deflation	During inflation	Same as BP4350
	Range of
measurement	Rated Range of Cuff
Pressure: 0~
300mmHg,
Rated Range of
Determination:
40~255mmHg,
Pulse 40~199
Beats/minute	Rated Range of Cuff
Pressure: 0~
300mmHg,
Rated Range of
Determination:
30~280mmHg,
Pulse 40~199
Beats/minute	Rated Range of Cuff
Pressure: 0~
299mmHg,
Rated Range of
Determination:
40~260mmHg,
Pulse 40~180
Beats/minute	Similar
	Accuracy	Pressure ± 3mmHg
Pulse ± 4%	Pressure ± 3mmHg
Pulse ± 4%	Pressure ± 3mmHg
Pulse ± 5%	Same as The AViTA
BPM 1x Series
	Inflation	Automatic	Automatic	Automatic	Same
	Comparison table
between test	Predicate Devices	Predicate Devices	Predicate Devices
Deflation	Automatic	Automatic	Automatic	Same
Pressure
Changed
Rate	2-5 mmHg/sec.	2-5 mmHg/sec.	2-5 mmHg/sec.	Same
Display	Liquid Crystal
Digital	Liquid Crystal
Digital	Liquid Crystal
Digital	Same
Power
Supply	2 "AAA(LR03)(1.5
V)"
Alkaline Batteries	2 "AAA(LR03)(1.5
V)"
Alkaline Batteries	2 "AAA(LR03)(1.5
V)"
Alkaline Batteries	Same
Storage/
Transportatio
n
Environment	- 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 AVITA
BPM lx Series
Operating
Environment	10°C ~ 40°C
≤ 85% R.H.
700~1060 hPa	10°C ~ 40°C
≤ 85% R.H.
700~1060 hPa	10°C ~ 40°C
15% ~ 90% R.H.
800~1060 hPa	Same as The AVITA
BPM lx Series
Material	ABS housing	ABS housing	ABS housing	Same
Sets
memory	of 1*90	2*90, total 180	2*100, total 200	Similar
Number of
Push Button	2 keys	4 keys	5 keys	Similar
Storage
pouch	Yes	Yes	Yes	Same
Cuff size	Wrist circumference
approx.
125 ~ 210 mm
(Approx. 4.9~8.3
inches)	Wrist circumference
approx.
125 ~ 210 mm
(Approx. 4.9~8.3
inches)	Wrist circumference
approx.
135 ~ 215 mm
(approx. 5.3 ~ 8.4
inches)	Same as The AVITA
BPM 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

6

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

7

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.