Clarius Ultrasound Scanner

K213436 · Clarius Mobile Health Corp. · IYN · Nov 15, 2021 · Radiology

Device Facts

• Record ID: K213436
• Device Name: Clarius Ultrasound Scanner
• Applicant: Clarius Mobile Health Corp.
• Product Code: IYN · Radiology
• Decision Date: Nov 15, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body. The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

Device Story

Portable, software-controlled ultrasound system; acquires/displays high-resolution, real-time ultrasound data. Piezoelectric transducers transmit non-ionizing sound waves; convert echoes to electronic signals; construct anatomical images. Images transmitted wirelessly via Wi-Fi/Bluetooth to off-the-shelf iOS or Android devices. Used by qualified healthcare practitioners (doctors, nurses, sonographers) in clinical and EMS environments. Output viewed on mobile device screen; assists in diagnostic imaging and procedural guidance. Benefits include portability and real-time visualization for clinical decision-making.

Clinical Evidence

Bench testing only. Performance and safety verified through testing against recognized standards (IEC 60601 series, ISO 10993-1, etc.). No clinical data presented.

Technological Characteristics

Portable ultrasound system; wireless transducers (convex, linear, phased array, intracavity). Piezoelectric sensing. Internal integrated lithium-ion battery. Connectivity via Wi-Fi/Bluetooth to iOS/Android devices. Complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-12, 60601-2-37, ISO 10993-1, AIUM/NEMA UD 2/3, IEC 62304, IEC 62366-1, ISO 14971, IEC 60529, IEC 62133, IEC 61157.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculoskeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and needle guidance. For use by trained healthcare professionals in clinical and EMS environments.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Clarius Ultrasound Scanner (K192107)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

Clarius Mobile Health Corp. % Ms. Agatha Szeliga Director, Regulatory Affairs 130-2985 Virtual Way Vancouver, British Columbia V5M 4X7 CANADA

# Re: K213436

Trade/Device Name: Clarius Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN Dated: October 21, 2021 Received: October 22, 2021

November 15, 2021

Dear Ms. Szeliga:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K213436

Device Name Clarius Ultrasound Scanner

#### Indications for Use (Describe)

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body.

The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary - K213436

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.

| Subject Device Trade Name: | Clarius Ultrasound Scanner |
|-------------------------------|-----------------------------------------------------------|
| Subject Device Model Numbers: | C3 HD3, C7 HD3, EC7 HD3, L7 HD3, L15 HD3, PA HD3, L20 HD3 |
| Common Name: | Diagnostic Ultrasound System and Accessories |

#### Regulation Number, Name and Product Codes:

| Regulation Number | Regulation Name | Product Code |
|-------------------|------------------------------------------|--------------|
| 21 CFR § 892.1550 | Ultrasonic Pulsed Doppler Imaging System | IYN |
| 21 CFR § 892.1560 | Ultrasound Pulsed Echo Imaging System | IYO |
| 21 CFR § 892.1570 | Diagnostic Ultrasonic Transducer | ITX |

| FDA 510(k) Review Panel: | Radiology |
|-------------------------------|-------------------------------------------------------------------------------------|
| Classification: | Class II |
| Manufacturer: | Clarius Mobile Health Corp.<br>130-2985 Virtual Way<br>Vancouver, BC V5M 4X7 Canada |
| Contact Name: | Agatha Szeliga<br>Director, Regulatory Affairs<br>[e-mail] |
| Date 510(k) Summary Prepared: | October 20, 2021 |

# Predicate Device Information:

| Device Trade Name: | Clarius Ultrasound Scanner |
|---------------------------------|---------------------------------------------------------|
| 510(k) Reference: | K192107 |
| Submitter Name: | Clarius Mobile Health Corp. |
| Regulation Name: | Ultrasonic Pulsed Doppler Imaging System |
| Classification Product Code(s): | IYN |
| Subsequent Product Codes | IYO, ITX |
| Regulation Number: | 21 CFR § 892.1550; 21 CFR § 892.1560; 21 CFR § 892.1570 |
| Classification: | Class II |

Note: The predicate device has not been subject to a design-related recall.

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#### Device Description

The Clarius Ultrasound Scanner is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an offthe-shelf (OTS) iOS or Android device. The Clarius Ultrasound Scanner comprises a series of wireless transducers employing Bluetooth and Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range of portable personal devices.

The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals, including the emergency medical services (EMS) environment.

The Clarius Ultrasound Scanner is intended for use by qualified healthcare practitioners (e.g., doctors, nurses, sonographers) who are trained in the use of ultrasound imaging technology.

| Transducers/ Scanners (various models) | C3 HD3, C7 HD3, EC7 HD3, L7 HD3, L15 HD3, PA HD3, L20 HD3 |
|----------------------------------------|---------------------------------------------------------------------------------------------------|
| Software | Clarius Ultrasound App (Clarius App) for iOS;<br>Clarius Ultrasound App (Clarius App) for Android |
| Accessories | Clarius Charger<br>Clarius Fan |

The Clarius Ultrasound Scanner comprises the following:

#### Indications for Use for the Clarius Ultrasound Scanner

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body.

The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

| Criteria | SUBJECT DEVICE | PREDICATE DEVICE |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Clarius Ultrasound Scanner | Clarius Ultrasound Scanner |
| 510(k) Holder/<br>Manufacturer | Clarius Mobile Health Corp. | Clarius Mobile Health Corp. |
| Submission<br>Reference | Current Submission | K192107 |
| 510(k) Track | Track 3 | Track 3 |
| Product Codes | IYN1, IYO2, ITX3 | IYN1, IYO2, ITX3 |
| Criteria | SUBJECT DEVICE | PREDICATE DEVICE |
| | Clarius Ultrasound Scanner | Clarius Ultrasound Scanner |
| Regulation | 21 CFR 892.15501 | 21 CFR 892.15501 |
| Number | 21 CFR 892.15602 | 21 CFR 892.15602 |
| | 21 CFR 892.15703 | 21 CFR 892.15703 |
| Regulation Name | Ultrasonic Pulsed Doppler Imaging System1; | Ultrasonic Pulsed Doppler Imaging System1; |
| | Ultrasonic Pulsed Echo Imaging System2; | Ultrasonic Pulsed Echo Imaging System2; |
| | Diagnostic Ultrasonic Transducer3 | Diagnostic Ultrasonic Transducer3 |
| Transducer | C3 HD3, C7 HD3, EC7 HD3, L7 HD3, L15 HD3, | C3 HD, C7 HD, EC7 HD, L7 HD, L15 HD, PA HD, |
| Models | PA HD3, L20 HD3 | L20 HD |
| Transducer Types | Convex Array | Convex Array |
| | Linear Array | Linear Array |
| | Phased Array | Phased Array |
| | Intracavity | Intracavity |
| Intended Use | Diagnostic ultrasound imaging and fluid flow | Diagnostic ultrasound imaging and fluid flow |
| Indications for | analysis of the human body<br>The Clarius Ultrasound Scanner is a software- | analysis of the human body<br>The Clarius Ultrasound Scanner is a software- |
| Use and Clinical | based ultrasound imaging system and | based ultrasound imaging system and |
| Usage | accessories, intended for diagnostic imaging. | accessories, intended for diagnostic imaging. |
| | It is indicated for diagnostic ultrasound | It is indicated for diagnostic ultrasound |
| | imaging and fluid flow analysis in the | imaging and fluid flow analysis in the |
| | following applications: ophthalmic, fetal, | following applications: ophthalmic, fetal, |
| | abdominal, intra-operative (non- | abdominal, intra-operative (non- |
| | neurological), pediatric, small organ, cephalic | neurological), pediatric, small organ, cephalic |
| | (adult), trans-rectal, trans-vaginal, musculo- | (adult), trans-rectal, trans-vaginal, musculo- |
| | skeletal (conventional, superficial), urology, | skeletal (conventional, superficial), urology, |
| | gynecology, cardiac (adult, pediatric), | gynecology, cardiac (adult, pediatric), |
| | peripheral vessel, carotid, and procedural | peripheral vessel, carotid, and procedural |
| | guidance of needles into the body. | guidance of needles into the body. |
| | The system is a transportable ultrasound | The system is a transportable ultrasound |
| | system intended for use in environments | system intended for use in environments |
| | where healthcare is provided by trained | where healthcare is provided by trained |
| | healthcare professionals. | healthcare professionals. |
| | Ophthalmic Fetal Abdominal Intraoperative (Ab/Vasc) Pediatric Small Organ Adult cephalic Trans-rectal Trans-vaginal Musculoskeletal (conventional) Musculoskeletal (superficial) Urology Gynecology Cardiac adult | Ophthalmic Fetal Abdominal Intraoperative (Ab/Vasc) Pediatric Small Organ Adult cephalic Trans-rectal Trans-vaginal Musculoskeletal (conventional) Musculoskeletal (superficial) Urology Gynecology Cardiac adult |
| Criteria | SUBJECT DEVICE | PREDICATE DEVICE |
| | Clarius Ultrasound Scanner | Clarius Ultrasound Scanner |
| | Cardiac pediatric Peripheral vessel Carotid Needle guidance | Cardiac pediatric Peripheral vessel Carotid Needle guidance |
| Principle of<br>Operation | Piezoelectric material in the system's<br>transducer transmits high frequency, non-<br>ionizing sound waves to the designated<br>region of the body and converts the<br>subsequent echoes detected to electronic<br>signals in order to construct an image of the<br>internal structures of an anatomical field. The<br>image is sent wirelessly from the transducer<br>to an external iOS or Android viewing device<br>on which the image can be displayed. | Piezoelectric material in the system's<br>transducer transmits high frequency, non-<br>ionizing sound waves to the designated<br>region of the body and converts the<br>subsequent echoes detected to electronic<br>signals in order to construct an image of the<br>internal structures of an anatomical field. The<br>image is sent wirelessly from the transducer<br>to an external iOS or Android viewing device<br>on which the image can be displayed. |
| Power Source | Internal integrated built-in (non-removable)<br>lithium-ion battery | Removable lithium-ion battery |
| Display | iOS or Android mobile device | iOS or Android mobile device |
| Wireless<br>Capability | Communicates wirelessly via Wi-Fi and<br>Bluetooth | Communicates wirelessly via Wi-Fi and<br>Bluetooth |
| Portability | Portable ultrasound system | Portable ultrasound system |
| System<br>Components | Transducers/scanners<br>Software (Clarius App)<br>Accessories (Charger and Fan) | Transducers/scanners<br>Software (Clarius App)<br>Accessories (Charger and Fan) |
| Modes of<br>Operation | B-mode<br>M-mode<br>Color Doppler<br>Power Doppler<br>Pulse-Wave Doppler (PWD)<br>Combined (B+M; B+CD; B+PD; B+PWD) | B-mode<br>M-mode<br>Color Doppler<br>Power Doppler<br>Pulse-Wave Doppler (PWD)<br>Combined (B+M; B+CD; B+PD; B+PWD) |
| Safety Standards | The Clarius Ultrasound Scanner complies with<br>the following safety standards:<br>60601-1<br>60601-1-2<br>60601-1-6<br>60601-1-12<br>60601-2-37 | The Clarius Ultrasound Scanner complies with<br>the following safety standards:<br>60601-1<br>60601-1-2<br>60601-1-6<br>60601-1-12<br>60601-2-37 |
| Standard | Title of Standard | |
| IEC 60601-1:2012 | Medical electrical equipment – Part 1: General requirements for basic safety | |
| | and essential performance | |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety | |
| | and essential performance - Collateral Standard: Electromagnetic | |
| | Compatibility - Requirements and tests | |
| IEC 60601-1-6 Edition 3.1 2013- | Medical electrical equipment - Part 1-6: General Requirements for Basic Safety | |
| 10 | and Essential Performance - Collateral Standard: Usability | |
| IEC 60601-1-12 Edition 1.0 2014- | Medical electrical equipment - Part 1-12: General Requirements for Basic | |
| 06 | Safety and Essential Performance - Collateral Standard: Requirements for | |
| | Medical Electrical Equipment and Medical Electrical Systems Intended for Use | |
| | in the Emergency Medical Services Environment | |
| IEC 60601-2-37:2015 | Medical electrical equipment - Part 2-37: Particular requirements for the basic | |
| | safety and essential performance of ultrasonic medical diagnostic and | |
| | monitoring equipment | |
| ISO 10993-1:2018 | Biological evaluation of medical devices – Part 1: Evaluation and testing within | |
| | a risk management process | |
| AIUM/NEMA UD 2-2004 | NEMA Standards Publication UD 2-2004 (R2009) Acoustic Output | |
| | Measurement Standard for Diagnostic Ultrasound Equipment Revision 3. | |
| | (Radiology) | |
| AIUM/NEMA UD 3-2004 | NEMA Standards Publication UD 3-2004 (R2009) Standard for Real-Time | |
| | Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic |…