Who is the manufacturer of Wrist Type Blood Pressure Monitor?

Avita Corporation filed the 510(k) submission for Wrist Type Blood Pressure Monitor (K200346).

What is the FDA product code for Wrist Type Blood Pressure Monitor?

DXN. It is classified under 21 CFR 870.1130 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Wrist Type Blood Pressure Monitor?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Wrist Type Blood Pressure Monitor?

AVITA BPM16 Wrist Type Blood Pressure Monitor (K102624); BP4350 Automatic Wrist Blood Pressure Monitor (K182166).

Who can help prepare an FDA 510(k) submission like Wrist Type Blood Pressure Monitor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Wrist Type Blood Pressure Monitor

K200346 · Avita Corporation · DXN · Dec 17, 2020 · Cardiovascular

Device Facts

Record ID	K200346
Device Name	Wrist Type Blood Pressure Monitor
Applicant	Avita Corporation
Product Code	DXN · Cardiovascular
Decision Date	Dec 17, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1130
Device Class	Class 2

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 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 Story

Wrist-worn blood pressure monitor; uses oscillometric method during cuff inflation to measure systolic/diastolic blood pressure and heart rate. Intended for home use by adults. Device features LCD panel for output display. Detects irregular heartbeats and provides visual warning symbol. Operates via battery power. Healthcare providers use readings to monitor patient blood pressure trends; aids in hypertension management and cardiovascular health assessment.

Clinical Evidence

Clinical validation performed per ISO 81060-2:2013. Results demonstrate device meets required limits for mean difference and standard deviation for automated non-invasive sphygmomanometers.

Technological Characteristics

ABS housing; oscillometric sensing; battery-powered (2x AAA); LCD display; wrist cuff (125-210mm). Standards: ISO 81060-2 (clinical validation), IEC 60601-1/1-11/1-2 (safety/EMC), IEC 80601-2-30 (sphygmomanometers), ISO 10993 (biocompatibility), IEC 62304 (software), IEC 62366 (usability), ISO 14971 (risk management).

Indications for Use

Indicated for adults aged 18+ with wrist circumference 125-210 mm for home-based automated measurement of systolic/diastolic blood pressure and heart rate via oscillometric method.

Regulatory Classification

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.

Predicate Devices

AVITA BPM16 Wrist Type Blood Pressure Monitor (K102624)
BP4350 Automatic Wrist Blood Pressure Monitor (K182166)

Related Devices

K183535 — Fully Automatic Electronic Blood Pressure Monitor · Andon Health Co, Ltd. · Jun 4, 2019
K061935 — SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR · Sensacare , Ltd. · Nov 8, 2006
K151330 — Microlife Wrist Watch Blood Pressure Monitor · Microlife Intellectual Property GmbH, Switzerland · Jul 14, 2015
K162338 — Full Automatic (NIBP) Blood Pressure Monitor · Health & Life Co., Ltd. · Sep 21, 2016
K042505 — OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N · Omron Healthcare, Inc. · Apr 5, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | | <div style="display:flex; flex-direction:row;"> <div style="margin-right: 10px;"> </div> <div style="margin-right: 10px;"> </div> </div> | | | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 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.. | | | {4}------------------------------------------------ | 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 {5}------------------------------------------------ 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.