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 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 off-the-shelf 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.

Piezoelectric material in the systems transmits high frequency, non-ionizing sound waves to the designated region of the body and converts the subsequent echoes detected into electronic signals in order to construct an image of the internal structures of an anatomical field. This image is sent wirelessly to an external iOS or Android viewing device on which the image can be displayed. The transducer houses a battery and power generator, multichannel beam former, pre-scan converter, and Wi-Fi components. The battery is removable and comes with a separate charger. Communication between the transducer and the compatible viewing device is performed via Wi-Fi Direct® (Ad-Hoc mode with security) for easy pairing.

The Clarius Ultrasound System product/package components include:

Software:
. The Clarius Ultrasound App (Clarius App) for iOS; OR
The Clarius Ultrasound App (Clarius App) for Android. ●
Transducers/Scanners:
Clarius Scanner C3 (C3 Convex Transducer);
. Clarius Scanner EC7 (EC7 Convex Endocavitary Transducer);
Clarius Scanner C7 (C7 Convex Transducer); OR ●
Clarius Scanner L7 (L7 Linear Transducer).
Accessories:
a. Clarius-Built:
o Battery Pack (Li-ion);
Battery Charger; O
Clarius Dock (Optional; charging station); and O
Clarius Fan (Optional). O
b. OEM/Off-the-Shelf Product(s):
Medical Power Supply (Off-the-shelf power adaptor from SL Power Electronics; O Model Number ME20A1203B02; approved in the US); and
Medical Power Supply (Optional for use with Clarius Dock; off-the-shelf power o adaptor from MEAN WELL Enterprises Co., Ltd.; Model Number GSM160B12-R7B; approved in the US).

The concept of the Clarius Ultrasound System transducers and software is to provide an easy to use, highperformance, low-cost, ultrasound platform for teaching and clinical applications. The Clarius Ultrasound Scanner is intended for use in professional healthcare facilities where healthcare is provided by trained medical professionals. The device is also intended for use in Emergency Medical Service, ambulance, or rotary aircraft environments.

AI/ML Overview

The Clarius Ultrasound Scanner is a diagnostic ultrasound system. The provided text, a 510(k) summary, outlines its substantial equivalence to predicate devices, thus demonstrating it meets acceptance criteria through a comparison study rather than independent performance testing against predefined metrics.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are not directly stated as quantitative performance metrics (e.g., sensitivity, specificity for a specific diagnostic task). Instead, the device's acceptance is based on demonstrating "substantial equivalence" to legally marketed predicate devices. This means the device performs at a level comparable to, or as safely and effectively as, the predicate devices for its intended use, without raising new questions of safety or effectiveness.

The "reported device performance" is implicitly demonstrated through its substantial equivalence to the predicate devices and compliance with relevant nonclinical performance standards.

The table below outlines the comparison criteria used to establish substantial equivalence, which serves as the framework for acceptance.

Criteria for Comparison	Clarius Ultrasound Scanner Performance (Subject Device)	Predicate Device Performance (Clarius Ultrasound System K172385)	Predicate Device Performance (ACCUSON S3000, S2000, S1000 K172162)
Portability	Portable ultrasound system	Portable ultrasound system	Mobile ultrasound system
Power Source	Removable battery (Li-ion)	Removable battery (Li-ion)	Battery or AC power
Display	iOS or Android mobile device	iOS or Android mobile device	Inbuilt digital display
Wireless Capability	Communicates wirelessly via Wi-Fi and Bluetooth	Communicates wirelessly via Wi-Fi and Bluetooth	Communicates via cable
510(k) Track	Track 3	Track 3	Track 3
Transducer Types	– Convex Array– Linear Array– Phased Array– Intracavity	– Convex Array– Linear Array– Phased Array	– Convex Array– Linear Array– Phased Array– Intracavity Array– Trans-esophageal
Intended Use	Diagnostic ultrasound imaging and fluid flow analysis	Diagnostic ultrasound imaging and fluid flow analysis	Diagnostic ultrasound imaging and fluid flow analysis
Indications for Use	– Ophthalmic– Fetal– Abdominal– Intraoperative (Ab/Vasc)– Pediatric– Small organ– Adult cephalic– Trans-rectal– Trans-vaginal– Musculo-skel. (Conv.)– Musculo-skel. (Superfic.)– Urology– Gynecology– Cardiac adult– Cardiac pediatric– Peripheral vessel– Carotid– Needle guidance	– Ophthalmic– Fetal– Abdominal– Intraoperative (Ab/Vasc)– Pediatric– Small organ– Adult cephalic– Musculo-skel. (Conv.)– Musculo-skel. (Superfic.)– Urology– Gynecology– Cardiac adult– Cardiac pediatric– Fetal echo– Peripheral vessel– Carotid– Needle guidance	– Fetal– Abdominal– Intraoperative (Ab/Vasc)– Intraoperative (Neuro)– Pediatric– Small organ– Neonatal cephalic– Adult cephalic– Trans-rectal– Trans-vaginal– Musculo-skel. (Conv.)– Musculo-skel. (Superfic.)– Gynecology– Cardiac adult– Cardiac pediatric– Trans-esophageal (Card.)– Peripheral vessel– Needle guidance
Modes of Operation	– B-mode– M-mode– Color Doppler– Power Doppler– PWD– CWD– Combined (B+M; B+CD; B+PD; B+PWD)	– B-mode– M-mode– Color Doppler– Power Doppler– CWD– Combined (B+M, B+CD, B+PD)	– B-Mode– M-Mode– Color Doppler– Color M Doppler– Power Doppler– PWD– CWD– Harmonic Imaging– Combined (B+M, B+PWD, B+CD, B+PD, B+CWD)

Study Proving Acceptance Criteria

The study described is a comparison study for substantial equivalence under the FDA's 510(k) pathway. It demonstrates that the Clarius Ultrasound Scanner does not introduce any new technology or indications for use that differ significantly from legally marketed predicate devices, thus concluding that it is substantially equivalent in safety and effectiveness.

Sample size used for the test set and the data provenance:
- The document states: "The Clarius Ultrasound Scanner did not require clinical testing to establish substantial equivalence to the predicate devices indicated."
- Therefore, there was no separate "test set" of clinical data for the subject device to quantify its performance against specific acceptance criteria. The equivalence is established by comparing the design, technological characteristics, intended use, and indications for use of the subject device to the previously cleared predicate devices.
- The provenance of data for the predicate devices is not detailed in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Since no clinical testing was performed for the subject device, no experts were used to establish ground truth for a test set in the context of this 510(k) summary. The "ground truth" for the predicate devices' clearance would have been established during their respective regulatory processes, not during this submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set requiring adjudication was used for this submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done, as this submission did not involve clinical performance testing of the device's diagnostic accuracy or the impact of AI assistance on human readers. The device is purely an imaging system; the provided document does not mention AI components for image analysis or interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an ultrasound imaging system, and the document focuses on establishing substantial equivalence based on hardware, software, intended use, and modes of operation, not on an algorithm's standalone diagnostic performance. No AI algorithm in a standalone capacity is mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the purposes of this 510(k) submission, the "ground truth" for acceptance is the established safety and effectiveness of the predicate devices as determined by their prior FDA clearances. The subject device is deemed safe and effective because it is substantially equivalent to these already cleared devices, not through new clinical ground truth establishment for its own performance.
The sample size for the training set:
- Not applicable. The document does not describe any machine learning components that would require a "training set" of data for this device.
How the ground truth for the training set was established:
- Not applicable. As there is no described training set, there methods for establishing ground truth for it are absent.

Summary

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May 14, 2018

Image /page/0/Picture/1 description: The image contains 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 text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.

Clarius Mobile Health Corp. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313

Re: K180799

Trade/Device Name: Clarius Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 8, 2018 Received: May 9, 2018

Dear Mr. Job:

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. 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K180799

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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Indications for Use Tables

Clarius Ultrasound Scanner

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	ColorDoppler	PowerDoppler	PWDoppler	Combined(Specify)	Other*
Ophthalmic	Ophthalmic	P
Fetal Imaging& Other	Fetal	P	P	P	P	N	B+M; B+CD;B+PD; B+PWD
	Abdominal	P	P	P	P	N	B+M; B+CD;B+PD; B+PWD	Note 1
	Intra-operative (Abdominalorgans & vascular)	P	P	P	P	N	B+M; B+CD;B+PD; B+PWD	Note 1
	Laparoscopic
	Pediatric	P	P	P	P	N	B+M; B+CD;B+PD; B+PWD	Note 1
	Small Organ (Thyroid, Prostate,Scrotum, Breast)	P	P	P	P	N	B+CD; B+PD;B+PWD	Note 1
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	N	B+M; B+CD;B+PD; B+PWD
	Trans-rectal	N	N	N	N	N	B+M; B+CD;B+PD; B+PWD
	Trans-vaginal	N	N	N	N	N	B+M; B+CD;B+PD; B+PWD
	Trans-urethral
	Trans-esophageal (non-Cardiac)
	Musculo-skeletal (Conventional)	P	P	P	P	N	B+CD; B+PD;B+PWD	Note 1
	Musculo-skeletal (Superficial)	P	P	P	P	N	B+CD; B+PDN	Note 1
	Intravascular
	Other (Urology, Gynecology)	P	P	P	P	N	B+M; B+CD;B+PD; B+PWD
Cardiac	Cardiac Adult	P	P	P		N	B+M; B+CD;B+PWD
	Cardiac Pediatric	P	P	P		N	B+M; B+CD;B+PWD
	Intravascular (Cardiac)
	Trans-esophageal (Cardiac)
	Intra-cardiac
	Other
PeripheralVessel	Peripheral Vessel	P	P	P	P	N	B+M; B+CD;B+PD; B+PWD	Note 1
	Other (Carotid)	P	P	P	P	N	B+M; B+CD;B+PD; B+PWD	Note 1

System: Clarius Ultrasound Scanner Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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System: Clarius Ultrasound Scanner Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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C3 Convex Scanner

Clinical Application Mode of Operation PW B M Power Combined Other* General Specific Color (Track 1 Only) (Tracks 1 & 3) Doppler Doppler Doppler (Specify) Ophthalmic Ophthalmic Fetal Imaging Fetal P P P P N B+M; B+CD; & Other B+PD; B+PWD P P P P Abdominal N B+M; B+CD; B+PD; B+PWD P P P Intra-operative (Abdominal P N B+M; B+CD; B+PD; B+PWD organs & vascular) Laparoscopic Pediatric P P P P N B+M; B+CD; B+PD; B+PWD Small Organ (Thyroid, Prostate, Scrotum, Breast) Neonatal Cephalic P P Adult Cephalic P P N B+M; B+CD; B+PD; B+PWD Trans-rectal Trans-vaginal Trans-urethral Trans-esophageal (non-Cardiac) P P P P Musculo-skeletal (Conventional) N B+M; B+CD; B+PD; B+PWD Musculo-skeletal (Superficial) Intravascular Other (Urology, Gynecology) P P P P N B+M; B+CD; B+PD; B+PWD

Device Name: C3 Convex Scanner Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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Device Name: C3 Convex Scanner

Cardiac	Cardiac Adult	P	P	P		N	B+M; B+CD;B+PWD
	Cardiac Pediatric	P	P	P		N	B+M; B+CD;B+PWD
	Intravascular (Cardiac)
	Trans-esophageal (Cardiac)
	Intra-cardiac
	Other
PeripheralVessel	Peripheral Vessel	P	P	P	P	N	B+M; B+CD;B+PD; B+PWD
	Other (Carotid)
N = new indication; P = previously cleared by K172385
Note 1: Needle Enhancement in B-Mode.

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C7 Convex Scanner

Clinical Application Mode of Operation M PW B Combined Other* General Specific Color Power (Track 1 Only) (Tracks 1 & 3) Doppler Doppler Doppler (Specify) Ophthalmic Ophthalmic Fetal Imaging Fetal P P P P N B+M; B+CD; & Other B+PD; B+PWD P P P P N Abdominal B+M; B+CD; B+PD; B+PWD P P Intra-operative (Abdominal P P N B+M; B+CD; B+PD; B+PWD organs & vascular) Laparoscopic Pediatric P P P P N B+M; B+CD; B+PD; B+PWD Small Organ (Thyroid, Prostate, P P P P N B+M; B+CD; Scrotum, Breast) B+PD; B+PWD Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esophaqeal (non-Cardiac) Musculo-skeletal (Conventional) P P P P N B+M; B+CD; B+PD; B+PWD Musculo-skeletal (Superficial) Intravascular Other (Urology, Gynecology) P P P P N B+M; B+CD; B+PD; B+PWD

Device Name: C7 Convex Scanner Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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Device Name: C7 Convex Scanner

Cardiac	Cardiac Adult	P	P	P	P	N	B+M; B+CD;B+PD; B+PWD
	Cardiac Pediatric	P	P	P		N	B+M; B+CD;B+PWD
	Intravascular (Cardiac)
	Trans-esophageal (Cardiac)
	Intra-cardiac
	Other
PeripheralVessel	Peripheral Vessel	P	P	P	P	N	B+M; B+CD;B+PD; B+PWD
	Other (Carotid)
N = new indication; P = previously cleared by K172385Note 1: Needle Enhancement in B-Mode.

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L7 Linear Scanner

Clinical Application Mode of Operation PW Specific B M Power Combined Other* General Color (Track 1 Only) (Tracks 1 & 3) Doppler Doppler Doppler (Specify) P Ophthalmic Ophthalmic Fetal Imaging Fetal & Other Abdominal P P P P N B+M; B+CD; Note 1 B+PD; B+PWD P P Intra-operative (Abdominal P P N B+M; B+CD; Note 1 organs & vascular) B+PD; B+PWD Laparoscopic P P Pediatric P P N B+M; B+CD; Note 1 B+PD; B+PWD Small Organ (Thyroid, Prostate, P P P N B+CD; B+PD; Note 1 Scrotum, Breast) B+PWD Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esophageal (non-Cardiac) Musculo-skeletal (Conventional) P P P P N B+M; B+CD; Note 1 B+PD; B+PWD Musculo-skeletal (Superficial) P P P P B+M; B+CD; N Note 1 B+PD; B+PWD Intravascular Other (Urology, Gynecology) Cardiac Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac Other

Device Name: L7 Linear Scanner Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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Device Name: L7 Linear Scanner

PeripheralVessel	Peripheral Vessel	P	P	P	P	N	B+M; B+CD;B+PD; B+PWD	Note 1
	Other (Carotid)	P	P	P	P	N	B+M; B+CD;B+PD; B+PWD	Note 1
N = new indication; P = previously cleared by K172385Note 1: Needle Enhancement in B-Mode.

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EC7 Scanner

Device Name: EC7 Scanner

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	ColorDoppler	PowerDoppler	PWDoppler	Combined(Specify)	Other*
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N	N	N	B+M; B+CD;B+PD; B+PWD
	Abdominal	N	N	N	N	N	B+M; B+CD;B+PD; B+PWD
	Intra-operative (Abdominalorgans & vascular)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid, Prostate,Scrotum, Breast)	N	N	N	N	N	B+M; B+CD;B+PD; B+PWD
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	B+M; B+CD;B+PD; B+PWD
	Trans-vaginal	N	N	N	N	N	B+M; B+CD;B+PD; B+PWD
	Trans-urethral
	Trans-esophageal (non-Cardiac)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Urology, Gynecology)	N	N	N	N	N	B+M; B+CD;B+PD; B+PWD

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Device Name: EC7 Scanner

Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esophageal (Cardiac)
	Intra-cardiac
	Other
PeripheralVessel	Peripheral Vessel
	Other (Carotid)

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Image /page/13/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange symbol that looks like three concentric letter C's, followed by the word "clarius" in dark blue, sans-serif font. The logo is simple and modern, with a focus on the company name.

510(k) Summary

1. Submitter's name, address, telephone number, and contact person:

Submitter:	Brendan SewardQA/RA ManagerClarius Mobile Health Corp.350 – 3605 Gilmore Way, Burnaby, B.C., Canada, V5G 4X5Email: brendan.seward@clarius.meTel: (+1) 778-800-9975Fax: N/A
Date Prepared:	February 20, 2018

1. Name of the device, including the trade or proprietary name, if applicable, the common or usual name, and the classification, if known:

Device Name:	Clarius Ultrasound Scanner
Common Name:	Diagnostic Ultrasound System and Accessories
Classification:	Class II
Classification Names:

21 CFR Section	Classification Name	Product Code
892.1550	Ultrasonic Pulsed Doppler Imaging System	90 IYN
892.1560	Ultrasonic Pulsed Echo Imaging System	90 IYO
892.1570	Diagnostic Ultrasound Transducer	90 ITX

3. Substantially Equivalent Devices:

Device Name	510(k) Number
Clarius Ultrasound Scanner	K172385
ACUSON S3000, S2000, S1000 Diagnostic Ultrasound Systems	K172162

Device Description

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Image /page/14/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange symbol that looks like three concentric letter C's. To the right of the symbol is the word "clarius" in dark blue, with the first letter in lowercase.

Image /page/14/Figure/1 description: The image shows a diagram of an ultrasound system. On the left side of the image, there is a device that is labeled with the following components: Battery, Wi-Fi, Power Circuitry, Ultrasound System-on-Chip Beamforming & Processing, Transmit/Receive Analog Interface, and Transducer Stack. The device is scanning a patient, and the ultrasound image is being displayed on a Wi-Fi enabled smartphone or tablet on the right side of the image. The smartphone or tablet also has a user interface.

Ultrasound Probe

User Interface / Display

The Clarius Ultrasound System product/package components include:

1. Software:
- . The Clarius Ultrasound App (Clarius App) for iOS; OR
- The Clarius Ultrasound App (Clarius App) for Android. ●
1. Transducers/Scanners:
- Clarius Scanner C3 (C3 Convex Transducer);
- . Clarius Scanner EC7 (EC7 Convex Endocavitary Transducer);
- Clarius Scanner C7 (C7 Convex Transducer); OR ●
- Clarius Scanner L7 (L7 Linear Transducer).

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Image /page/15/Picture/0 description: The image shows the logo for Clarius Mobile Health. The logo consists of an orange symbol on the left and the word "clarius" in dark blue on the right. The symbol is made up of three curved lines that form a stylized "C". The word "clarius" is in a sans-serif font and is all lowercase.

1. Accessories:
- a. Clarius-Built:
  - o Battery Pack (Li-ion);
  - Battery Charger; O
  - Clarius Dock (Optional; charging station); and O
  - Clarius Fan (Optional). O
- b. OEM/Off-the-Shelf Product(s):
  - Medical Power Supply (Off-the-shelf power adaptor from SL Power Electronics; O Model Number ME20A1203B02; approved in the US); and
  - Medical Power Supply (Optional for use with Clarius Dock; off-the-shelf power o adaptor from MEAN WELL Enterprises Co., Ltd.; Model Number GSM160B12-R7B; approved in the US).

Changes Implemented

The present submission is an expansion based upon a previous clearance – K172385. The subject changes of this new submission are the added mode of operation of Power Doppler and the addition of a new transducer model, Clarius Scanner EC7, which functions as an endocavitary scanner. This new scanner adds trans-rectal and trans-vaginal to the indications for use of the system. Appropriate changes have been made to mitigate risks and ensure effectiveness of these new features.

Intended Use

Diagnostic ultrasound imaging and fluid flow analysis.

Indications for Use

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

Predicate Devices

Equivalent devices are referred to as predicate devices in alignment with the FDA's standard terminology for comparable devices. The predicate devices selected to demonstrate equivalence are:

1. Device Name FDA 510(k) Number Clarius Ultrasound Scanner (K172385) FDA 510(k) Number 2. Device Name ACUSON S3000, S2000, S1000 Diagnostic Ultrasound Systems K172162

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Image /page/16/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. The icon is made up of three curved lines that form a stylized "C". The word "clarius" is written in a sans-serif font.

Determination of Substantial Equivalence

The Clarius Ultrasound system is a Track 3 system that employs the same fundamental scientific technology as that cleared with K172385 and K172162. All indications for use introduced by the Clarius Ultrasound Scanner are similar to at least one of the predicate devices. A comparison table is provided below:

Criteria for Comparison	Clarius Ultrasound Scanner	Clarius Ultrasound System(K172385)	ACCUSON S3000, S2000, S1000Ultrasound Systems(K172162)
Portability	Portable ultrasound system	Portable ultrasound system	Mobile ultrasound system
Power Source	Removable battery (Li-ion)	Removable battery (Li-ion)	Battery or AC power
Display	iOS or Android mobile device	iOS or Android mobile device	Inbuilt digital display
Wireless Capability	Communicates wirelessly via Wi-Fi and Bluetooth	Communicates wirelessly via Wi-Fi and Bluetooth	Communicates via cable
510(k) Track	Track 3	Track 3	Track 3
Transducer Types	– Convex Array– Linear Array– Phased Array– Intracavity	– Convex Array– Linear Array– Phased Array	– Convex Array– Linear Array– Phased Array– Intracavity Array– Trans-esophageal
Intended Use	Diagnostic ultrasound imaging and fluid flow analysis	Diagnostic ultrasound imaging and fluid flow analysis	Diagnostic ultrasound imaging and fluid flow analysis
Indications for Use	– Ophthalmic– Fetal– Abdominal– Intraoperative (Ab/Vasc)– Pediatric– Small organ– Adult cephalic– Trans-rectal– Trans-vaginal– Musculo-skel. (Conv.)– Musculo-skel. (Superfic.)– Urology– Gynecology– Cardiac adult– Cardiac pediatric– Peripheral vessel– Carotid– Needle guidance	– Ophthalmic– Fetal– Abdominal– Intraoperative (Ab/Vasc)– Pediatric– Small organ– Adult cephalic– Musculo-skel. (Conv.)– Musculo-skel. (Superfic.)– Urology– Gynecology– Cardiac adult– Cardiac pediatric– Fetal echo– Peripheral vessel– Carotid– Needle guidance	– Fetal– Abdominal– Intraoperative (Ab/Vasc)– Intraoperative (Neuro)– Pediatric– Small organ– Neonatal cephalic– Adult cephalic– Trans-rectal– Trans-vaginal– Musculo-skel. (Conv.)– Musculo-skel. (Superfic.)– Gynecology– Cardiac adult– Cardiac pediatric– Trans-esophageal (Card.)– Peripheral vessel– Needle guidance
Modes of Operation	– B-mode– M-mode– Color Doppler– Power Doppler– PWD– CWD– Combined (B+M; B+CD; B+PD;B+PWD)	– B-mode– M-mode– Color Doppler– Power Doppler– CWD– Combined (B+M, B+CD, B+PD)	– B-Mode– M-Mode– Color Doppler– Color M Doppler– Power Doppler– PWD– CWD– Harmonic Imaging– Combined (B+M, B+PWD,B+CD, B+PD, B+CWD)

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Image /page/17/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. The icon is made up of three concentric circles that are not fully closed, creating a stylized "C" shape.

Equivalency Conclusion

The subject device does not introduce any new technology or indications for use; therefore, the system is substantially equivalent to the predicate devices.

Nonclinical Performance Data

Nonclinical performance tests show compliance to the following standards:

Reference No.	Year	Title
AAMI/ANSIES60601-1	2012	Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and EssentialPerformance
AAMI ANSIES60601-1	2012	AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012(Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safetyand Essential Performance (IEC 60601-1:2005, Mod). (General II (ES/EMC))
IEC 60601-1-2	2007&2014	Medical electrical equipment - Part 1-2: General requirements for basic safety and essentialperformance - Collateral Standard: Electromagnetic Capability - Requirements and tests. (4thEdition)
IEC 60601-1-6	2013	Medical electrical equipment - Part 1-6: General requirements for basic safety and essentialperformance -Collateral standard: Usability
IEC 60601-1-12	2014	Medical Electrical Equipment - Part 1-12: General requirements for basic safety and essentialperformance - Collateral Standard: Requirements for medical electrical equipment and medicalelectrical systems used in the emergency medical services environment
IEC 60601-2-37	2004	Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essentialperformance of ultrasonic medical diagnostic and monitoring equipment. (3rd and 4th Edition)
IEC 62133	2012	Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes - SafetyRequirements for Portable Sealed Secondary Cells, And for Batteries Made from Them, For Use inPortable Applications [Including: Corrigendum 1 (2013)]
IEC 62366	2014	Consolidated Version Medical Devices - Application of Usability Engineering to Medical Devices
ISO 10993-1	2009	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk managementprocess
ISO 10993-5	2014	Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10	2014	Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
ISO 10993-11	2017	Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
ISO-10993-12	2014	Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
ISO 62304	2006	Medical Device Software - Software Life Cycle Processes
ISO 15223-1	2012	Medical Devices - Symbols to be Used with Medical Devices Labels, Labeling, and Information to beSupplied - Part 1: General Requirements
ISO 14971	2007	Medical Devices - Applications of Risk Management to Medical Devices
NEMA UD 2	2009	Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment - Revision 3

Clinical Testing

The Clarius Ultrasound Scanner did not require clinical testing to establish substantial equivalence to the predicate devices indicated.

Quality Assurance Measures

Quality assurance measures applied to the system design and development include, but were not limited to: risk analysis, verification and validation, product specifications, and design reviews.

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Image /page/18/Picture/0 description: The image shows the logo for Clarius. 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 a dark blue sans-serif font.

Conclusion

This device is a modification of an existing licensed device using technologies that exist on the market today. The development and testing conducted on the device ascertain that it is safe for use by physicians. The Clarius Ultrasound Scanner does not introduce indications for use, technological features, or system characteristics that are not seen in its predicate devices; the device is substantially equivalent in safety and effectiveness to these predicate devices.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.