Clarius Ultrasound Scanner
Device Facts
| Record ID | K232704 |
|---|---|
| Device Name | Clarius Ultrasound Scanner |
| Applicant | Clarius Mobile Health Corp. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 5, 2023 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for 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
Clarius Ultrasound Scanner (PAL HD3) is a portable, wireless, software-controlled diagnostic ultrasound system. It utilizes a dual-array transducer (phased and linear arrays side-by-side) to acquire real-time ultrasound data. The device transmits high-frequency, non-ionizing sound waves via piezoelectric ceramics; echoes are converted to electronic signals and sent wirelessly via Wi-Fi/Bluetooth to an off-the-shelf iOS or Android tablet/smartphone. The Clarius App displays the images. Used by physicians, nurses, and sonographers in hospitals, clinics, and EMS settings. The PAL HD3 allows clinicians to switch between phased and linear array modes (1-15 MHz range) without changing scanners. Output supports B-mode, M-mode, Color Doppler, and Power Doppler. Clinicians use the displayed images for diagnostic assessment and procedural guidance, facilitating rapid clinical decision-making in point-of-care environments.
Clinical Evidence
No clinical data was required or provided. Substantial equivalence is supported by non-clinical bench testing, including verification of software life cycle processes (IEC 62304), risk management (ISO 14971), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and acoustic output measurements (AIUM/NEMA UD 2/UD 3).
Technological Characteristics
Dual-array transducer (phased and linear) with 1-15 MHz frequency range. Piezoelectric sensing principle. Wireless connectivity (Wi-Fi/Bluetooth) to iOS/Android devices. Powered by internal non-removable lithium-ion battery. Complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-12, 60601-2-37, and ISO 10993-1. Software-controlled via Clarius App.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in ophthalmic, fetal, abdominal, intra-operative, pediatric, small organ, cephalic, trans-rectal, trans-vaginal, musculo-skeletal, urology, gynecology, cardiac, peripheral vessel, and carotid applications, and for procedural needle guidance. Intended 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 (K213436)
Submission Summary (Full Text)
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October 5, 2023
Image /page/0/Picture/1 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Clarius Mobile Health Corp. c/o Agatha Szeliga Director, Regulatory Affairs 205-2980 Virtual Way Vancouver, British Columbia V5M 4X3 CANADA
### Re: K232704
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, IYO, ITX Dated: September 1, 2023 Received: September 5, 2023
### Dear Agatha 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
# Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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### Indications for Use
510(k) Number (if known)
#### K232704
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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Image /page/3/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange icon on the left, followed by the word "clarius" in dark teal, and the words "ultrasound anywhere" in a smaller font size and the same dark teal color. The icon is a stylized "C" made up of three concentric arcs.
### 510(k) Summary
## K232704
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 Number: | PAL 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>205-2980 Virtual Way<br>Vancouver, BC V5M 4X3 Canada |
| Contact Name: | Agatha Szeliga<br>Director, Regulatory Affairs<br>agatha.szeliga@clarius.com |
| Date 510(k) Summary Prepared: | October 2, 2023 |
### Predicate Device Information:
| Device Trade Name: | Clarius Ultrasound Scanner |
|---------------------------------|---------------------------------------------------------|
| 510(k) Reference: | K213436 |
| 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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Image /page/4/Picture/0 description: The image is a logo for Clarius Ultrasound Anywhere. The logo consists of an orange symbol that looks like three curved lines forming a C shape. To the right of the symbol is the word "clarius" in dark teal, followed by "ultrasound anywhere" stacked on top of each other in a smaller font, also in dark teal.
### 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 Clarius Ultrasound Scanner system is a transportable ultrasound system intended for use in environments where healthcare 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.
The Clarius Scanner PAL HD3 ("PAL HD3") (subject device of this 510(k) premarket notification) is a multipurpose dual-array transducer that incorporates high-frequency linear array (equivalent to the L15 HD3 transducer cleared under K213436)) and low-frequency phased array (equivalent to the PA HD3 transducer cleared under K213436) ultrasound functionalities where the two separate transducer ceramics are arranged side-by-side within the same transducer model (PAL HD3). The Clarius Scanner PAL HD3 is a new Clarius HD3 transducer variant introduced into the HD3 product line of the Clarius Ultrasound Scanner device family and represents a design modification to the existing PA HD3 transducer of the Clarius Ultrasound Scanner system, which was most recently 510(k)-cleared under K213436.
The Clarius Scanner PAL HD3 has two separate transducer ceramics positioned side-by-side which consist of the linear array and the phased array. The Clarius Scanner PAL HD3 offers a wide frequency range of 1 – 15 MHz within a single transducer. The body and electronics of the PAL HD3 scanner are identical to the currently released HD3 scanner models (the PA HD3 and the L15 HD3) of the Clarius Ultrasound Scanner device family (cleared under K213436); the main difference is in the scanner head. The Clarius Scanner PAL HD3 will allow clinicians to switch between the phased array and the linear array without having to use two separate scanners during exams and procedures.
The Clarius Ultrasound Scanner, subject of this 510(k) premarket notification, comprises the following:
| Transducer/ Scanner | PAL HD3 |
|---------------------|---------------------------------------------------------------------------------------------------|
| Software | Clarius Ultrasound App (Clarius App) for iOS;<br>Clarius Ultrasound App (Clarius App) for Android |
| Accessories | Clarius Charger HD3<br>Clarius Power Fan HD3 |
### 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),
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Image /page/5/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange icon on the left and the word "clarius" in dark blue on the right. To the right of "clarius" is the text "ultrasound anywhere" in a smaller font, also in dark blue. The icon is a stylized "C" made up of three curved lines.
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 | K213436 | |
| 510(k) Track | Track 3 | Track 3 | |
| Product Codes | IYN1, IYO2, ITX3 | IYN1, IYO2, ITX3 | |
| 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<br>Model(s) | PAL HD3 | PA HD3, L15 HD3 | |
| Transducer Types | Phased Array and Linear Array<br>(the phased array and linear array are<br>arranged side-by-side within the same<br>transducer model) | Phased Array, Linear Array<br>(the phased array and linear array are<br>represented in two separate transducer<br>models) | |
| Intended Use | Diagnostic ultrasound imaging or fluid flow<br>analysis of the human body | Diagnostic ultrasound imaging or fluid flow<br>analysis of the human body | |
| Indications for | The Clarius Ultrasound Scanner is a software- | 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. | |
| Criteria | SUBJECT DEVICE | PREDICATE DEVICE | |
| | Clarius Ultrasound Scanner | Clarius Ultrasound Scanner | |
| | Phased Array (PAL HD3): | Phased Array (PA HD3): | |
| | Fetal Abdominal Intraoperative Pediatric Cardiac (adult, pediatric) | Fetal Abdominal Intraoperative (abdominal organs and vascular) Pediatric Cephalic (adult) Cardiac (adult, pediatric) | |
| | Linear Array (PAL HD3): | | |
| | Ophthalmic Abdominal Intraoperative Pediatric Small Organ (thyroid, prostate, scrotum, breast) Musculoskeletal (conventional, superficial) Peripheral vessel Carotid Needle enhance in B-Mode | Linear Array (L15 HD3): | |
| | | Ophthalmic Abdominal Intraoperative (abdominal organs and vascular) Pediatric Small Organ (thyroid, prostate, scrotum, breast) Musculoskeletal (conventional, superficial) Peripheral vessel Carotid Needle enhance in B-Mode | |
| 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 | Internal integrated built-in (non-removable)<br>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 | Transducer/scanner<br>Software (Clarius App)<br>Accessories (Charger and Power Fan) | Transducers/scanners<br>Software (Clarius App)<br>Accessories (Charger and Power Fan) | |
| Frequency | 1-5 MHz (Phased Array) and 5-15 MHz (Linear<br>Array) | 1-5 MHz (Phased Array-PA HD3) and 5-15<br>MHz (Linear Array-L15 HD3) | |
| Modes of<br>Operation | B-mode<br>M-mode<br>Color Doppler<br>Power Doppler | B-mode<br>M-mode<br>Color Doppler<br>Power Doppler | |
| Criteria | SUBJECT DEVICE | PREDICATE DEVICE | |
| | Clarius Ultrasound Scanner | Clarius Ultrasound Scanner | |
| Safety Standards | Pulse-Wave Doppler (PWD)<br>Combined (B+M; B+CD; B+PD; B+PWD) | Pulse-Wave Doppler (PWD)<br>Combined (B+M; B+CD; B+PD; B+PWD) | |
| | The Clarius Ultrasound Scanner complies with<br>the following safety standards: | The Clarius Ultrasound Scanner complies with<br>the following safety standards: | |
| | 60601-1 | 60601-1 | |
| | 60601-1-2 | 60601-1-2 | |
| | 60601-1-6<br>60601-1-12<br>60601-2-37 | 60601-1-6<br>60601-1-12<br>60601-2-37 | |
| Intended Users | Licensed healthcare professionals (e.g.,<br>doctors, nurses, sonographers) trained in<br>ultrasound use. | Licensed healthcare professionals (e.g.,<br>doctors, nurses, sonographers) trained in<br>ultrasound use. | |
| | Environment of<br>Use | Hospital, clinic, ambulatory setting | Hospital, clinic, ambulatory setting |
### Comparison of the Subject Device and Predicate Device for Demonstration of Substantial Equivalence
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Image /page/6/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange symbol that looks like three curved lines forming a C shape, followed by the word "clarius" in a dark teal color. To the right of "clarius" are the words "ultrasound anywhere" stacked on top of each other, also in dark teal.
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Image /page/7/Picture/0 description: The image shows the Clarius ultrasound logo. On the left is an orange icon that looks like three curved lines. To the right of the icon is the word "clarius" in a dark teal color. To the right of "clarius" are the words "ultrasound anywhere" stacked on top of each other, also in dark teal.
### Non-Clinical Performance Testing of the Clarius Ultrasound Scanner
The PAL HD3 scanner of the Clarius Ultrasound Scanner device family was designed by Clarius Mobile Health Corp. in accordance with the applicable requirements and standards to establish performance and safety of the device. The device's safety and performance were verified by tests conducted by Clarius and accredited third-party laboratories. Validation testing was performed to ensure that the final product is capable of meeting the requirements for the specified clinical applications and performs as intended to meet users' needs, while demonstrating substantial equivalence to the predicate device.
Non-clinical performance testing of the PAL HD3 subject device, which is part of the Clarius Ultrasound Scanner device family, demonstrates compliance to the following standards:
| Standard Designation No.<br>and Date | Title of Standard |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 62304:2006 + A1:2015 | Medical device software - Software life cycle processes |
| ISO 14971:2019 | Medical Devices - Application of risk management to medical devices |
| IEC 60601-1:2005 + A1:<br>2012 | Medical electrical equipment - Part 1: General requirements for basic safety and<br>essential performance |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and<br>essential performance - Collateral Standard: Electromagnetic Capability -<br>Requirements and tests |
| IEC 60601-1-6:2010 +<br>A1:2013 | Medical electrical equipment - Part 1-6: General requirements for basic safety and<br>essential performance - Collateral standard: Usability |
| IEC 60601-2-37:2015 | Medical Electrical Equipment - Part 2-37: Particular Requirements For the basic<br>safety and essential performance of ultrasonic medical diagnostic and monitoring<br>equipment |
| IEC 60601-1-12:2014 | Medical Electrical Equipment - Part 1-12: General requirements for basic safety<br>and essential performance - Collateral Standard: Requirements for medical<br>electrical equipment and medical electrical systems intended for use in the<br>emergency medical services environment |
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Image /page/8/Picture/0 description: The image shows the Clarius logo. On the left is an orange symbol that looks like three curved lines that are stacked on top of each other. To the right of the symbol is the word "clarius" in dark teal. To the right of that word are the words "ultrasound anywhere" stacked on top of each other, also in dark teal.
| IEC 62133:2012 | Secondary cells and batteries containing alkaline or other non-acid electrolytes -<br>Safety requirements for portable sealed secondary cells, and for batteries made<br>from them, for use in portable applications |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1:2018 | Biological evaluation of medical devices – Part 1: Evaluation and testing within a<br>risk management process |
| ISO 15223-1:2021 | Medical devices - Symbols to be used with information to be supplied by the<br>manufacturer - Part 1: General requirements |
| AIUM/NEMA UD 2-2004<br>(R2009) | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment<br>Revision 3 |
| IEC 62366-1:2015 | Medical devices – Part 1: Application of usability engineering to medical devices |
| AIUM/NEMA UD 3-2004 | NEMA Standards Publication UD 3-2004 (R2009) Standard for Real-Time Display of<br>Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound<br>Equipment |
| IEC 60529:2013 | Degrees of protection provided by enclosures (IP Code) |
| IEC 61157:2013 | IEC 61157: Standard means for the reporting of the acoustic output of medical<br>diagnostic ultrasonic equipment |
### Summary of Clinical Testing of the Clarius Ultrasound Scanner
The Clarius Ultrasound Scanner (PAL HD3 transducer model) did not require clinical studies to support the determination of substantial equivalence.
### Conclusion & Summary of Substantial Equivalence
Based on the information presented in this Special 510(k) premarket notification, and based on the fundamental scientific technology, technological characteristics, principle of operation, intended use, environment of use, and indications for use, the modified Clarius Ultrasound Scanner has been determined to be substantially equivalent in terms of safety and effectiveness to the predicate device, the Clarius Ultrasound Scanner (510(k)-cleared in K213436).
The differences in design between the subject device (PAL HD3 scanner of the Clarius Ultrasound Scanner device family) and the predicate device (PA HD3 scanners of the Clarius Ultrasound Scanner device family 510(k)-cleared in K213436) do not raise any issues related to safety or effectiveness.
