Clarius Ultrasound Scanner

• K Number: K192107
• Device Name: Clarius Ultrasound Scanner
• Manufacturer: Clarius Mobile Health Corp.
• Date Cleared: 2019-08-29 ( 24 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Abbreviated
• Panel: Radiology
• Reference & Predicate Devices: K180799
• Predicate For: K201971 , K202074 , K211232 , K211665 , K211746 , K212400 , K213436 , K220490

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 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 (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.

AI/ML Overview

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system with various transducers. The acceptance criteria and the study proving the device meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance:

Criteria for Comparison	Predicate Device (K180799) Performance	Subject Device (Clarius Ultrasound Scanner) Performance
Portability	Portable ultrasound system	Portable ultrasound system
Power Source	Removable battery (Li-ion)	Removable battery (Li-ion)
Display	iOS or Android mobile device	iOS or Android mobile device
Wireless Capability	Communicates wirelessly via Wi-Fi and Bluetooth	Communicates wirelessly via Wi-Fi and Bluetooth
510(k) Track	Track 3	Track 3
Transducer Types	Convex Array, Linear Array, Phased Array, Intracavity	Convex Array, Linear Array, Phased Array, Intracavity
Intended Use	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-skeletal (Conv.), Musculo-skeletal (Superfic.), Urology, Gynecology, Cardiac adult, Cardiac pediatric, Peripheral vessel, Carotid, Needle guidance	Ophthalmic, Fetal, Abdominal, Intraoperative (Ab/Vasc), Pediatric, Small organ, Adult cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conv.), Musculo-skel. (Superfic.), Urology, Gynecology, Cardiac adult, Cardiac pediatric, Peripheral vessel, Carotid, Needle guidance
Modes of Operation	B-mode, M-mode, Color Doppler, Power Doppler, PWD, Combined (B+M; B+CD; B+PD; B+PWD)	B-mode, M-mode, Color Doppler, Power Doppler, PWD, Combined (B+M; B+CD; B+PD; B+PWD)

The reported performance of the subject device (Clarius Ultrasound Scanner) is identical to the predicate device (Clarius Ultrasound Scanner, K180799) across all listed criteria, indicating substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

The provided document does not mention a specific "test set" or its sample size for evaluating the performance of the new transducer models. The study primarily relies on demonstrating substantial equivalence to a previously cleared predicate device.

• Data Provenance: Not explicitly stated for a dedicated test set. The submission focuses on nonclinical performance data related to compliance with various international standards, rather than direct human subject testing for the new transducer models.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The document states that "The Clarius Ultrasound Scanner did not require clinical testing to establish substantial equivalence." Therefore, no experts were used to establish ground truth for a clinical test set. The substantial equivalence argument is based on technical specifications and adherence to recognized standards.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring expert adjudication was conducted or described in the provided information.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned or performed as per the provided document. The submission focuses on comparing the new device models to a predicate device based on technical and functional equivalence.

6. Standalone Performance Study (Algorithm Only):

The document does not describe a standalone algorithm-only performance study. The "Clarius Ultrasound Scanner" is described as a comprehensive ultrasound imaging system, not a device primarily driven by an AI algorithm requiring standalone performance evaluation in the context of this submission. The device is software-based but its performance evaluation within this 510(k) submission is related to hardware compliance and functional equivalence, not AI-driven diagnostic performance that would necessitate standalone algorithm studies.

7. Type of Ground Truth Used:

Not applicable. As clinical testing was not required for substantial equivalence, no clinical ground truth (e.g., expert consensus, pathology, outcomes data) was established or used for the evaluation of the subject device in this submission. The "ground truth" for the device's capabilities is implicitly established by its adherence to recognized industry standards for medical electrical equipment and its equivalence to the predicate device’s established performance.

8. Sample Size for the Training Set:

Not applicable. The provided information relates to a 510(k) submission for new transducer models, demonstrating substantial equivalence to a predicate device. It does not mention machine learning or AI models requiring a training set for diagnostic or analytical performance.

9. How Ground Truth for the Training Set Was Established:

Not applicable, as no training set for a machine learning or AI model was mentioned in the provided text.

Summary

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Clarius Mobile Health Corp. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k SAINT PAUL MN 55114

August 29, 2019

Re: K192107

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: August 2, 2019 Received: August 5, 2019

Dear Prithul Bom:

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

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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 ([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)

K192107

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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Clarius Ultrasound Scanner

System: Clarius Ultrasound Scanner

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

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	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Abdominal	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Intra-operative(Abdominal organs & vascular)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Laparoscopic
	Pediatric	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Small Organ(Thyroid, Prostate, Scrotum, Breast)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Trans-rectal	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Trans-vaginal	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Trans-urethral
	Trans-esophageal (non-Cardiac)
	Musculo-skeletal (Conventional)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Musculo-skeletal (Superficial)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Intravascular
	Other (Urology, Gynecology)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
Cardiac	Cardiac Adult	P	P	P	N	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Cardiac Pediatric	P	P	P	N	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Intravascular (Cardiac)
	Trans-esophageal (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral Vessel	Peripheral Vessel	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Other (Carotid)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	N = new indication; P = previously cleared by K180799
	Note 1: Needle Enhancement in B-Mode.

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Clarius Scanner C3 HD

DEVICE NAME: CLARIUS SCANNER C3 HD

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

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(Abdominal organs & vascular)	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD
	Laparoscopic
	Pediatric	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD
	Small Organ(Thyroid, Prostate, Scrotum, Breast)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esophageal (non-Cardiac)
	Musculo-skeletal (Conventional)	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Urology, Gynecology)	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD
Cardiac	Cardiac Adult	N	N	N		N	B+M; B+CD; B+PWD
	Cardiac Pediatric	N	N	N		N	B+M; B+CD; B+PWD
	Intravascular (Cardiac)
	Trans-esophageal (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral Vessel	Peripheral Vessel	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD
	Other (Carotid)

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Clarius Scanner C7 HD

DEVICE NAME: CLARIUS SCANNER C7 HD

Intended Use: Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows:

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(Abdominal organs & vascular)	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD
	Laparoscopic
	Pediatric	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD
	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
	Trans-vaginal
	Trans-urethral
	Trans-esophageal (non-Cardiac)
	Musculo-skeletal (Conventional)	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Urology, Gynecology)	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD
Cardiac	Cardiac Adult	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD
	Cardiac Pediatric	N	N	N		N	B+M; B+CD; B+PWD
	Intravascular (Cardiac)
	Trans-esophageal (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral Vessel	Peripheral Vessel	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD
	Other (Carotid)
	N = new indication; P = previously cleared by K180799
	Note 1: Needle Enhancement in B-Mode.

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Clarius Scanner EC7 HD

Device Name: Clarius Scanner EC7 HD

	Clinical ApplicationMode 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(Abdominal organs & 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
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esophageal (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral Vessel	Peripheral Vessel
	Other (Carotid)
	N = new indication; P = previously cleared by K180799
	Note 1: Needle Enhancement in B-Mode.

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Clarius Scanner L7 HD

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

N | N | N

DEVICE NAME: CLARIUS SCANNER L7 HD INTENDED USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS:

Other (Carotid) N = new indication; P = previously cleared by K180799 Note 1: Needle Enhancement in B-Mode.

N

B+M; B+CD; B+PD; B+PWD

Note 1

N

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Clarius Scanner L15 HD

Device Name: Clarius Scanner L15 HD

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
	Abdominal	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD	Note 1
	Intra-operative(Abdominal organs & vascular)	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD	Note 1
	Laparoscopic
	Pediatric	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD	Note 1
	Small Organ(Thyroid, Prostate, Scrotum, Breast)	N	N	N	N	N	B+CD; B+PD; B+PWD	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esophageal (non-Cardiac)
	Musculo-skeletal (Conventional)	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD	Note 1
	Musculo-skeletal (Superficial)	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD	Note 1
	Intravascular
	Other (Urology, Gynecology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esophageal (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral Vessel	Peripheral Vessel	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD	Note 1
	Other (Carotid)	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD	Note 1

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Clarius Scanner PA HD

DEVICE NAME: CLARIUS SCANNER PA HD

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	Note 1
	Abdominal	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD	Note 1
	Intra-operative(Abdominal organs & vascular)	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD	Note 1
	Laparoscopic
	Pediatric	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD	Note 1
	Small Organ(Thyroid, Prostate, Scrotum, Breast)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD	Note 1
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esophageal (non-Cardiac)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Urology, Gynecology)
Cardiac	Cardiac Adult	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD	Note 1
	Cardiac Pediatric	N	N	N	N	N	B+M; B+CD; B+PD; B+PWD	Note 1
	Intravascular (Cardiac)
	Trans-esophageal (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral Vessel	Peripheral Vessel
	Other (Carotid)
	N = new indication; P = previously cleared by K180799
	Note 1: Needle Enhancement in B-Mode.

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Clarius Scanner C3

Device Name: Clarius Scanner C3

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

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	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Abdominal	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
Other	Intra-operative(Abdominal organs & vascular)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Laparoscopic
	Pediatric	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Small Organ(Thyroid, Prostate, Scrotum, Breast)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esophageal (non-Cardiac)
	Musculo-skeletal (Conventional)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Urology, Gynecology)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
Cardiac	Cardiac Adult	P	P	P		P	B+M; B+CD; B+PWD
	Cardiac Pediatric	P	P	P		P	B+M; B+CD; B+PWD
	Intravascular (Cardiac)
	Trans-esophageal (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral Vessel	Peripheral Vessel	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Other (Carotid)
	N = new indication; P = previously cleared by K180799Note 1: Needle Enhancement in B-Mode.

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Clarius Scanner C7

DEVICE NAME: CLARIUS SCANNER C7

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	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Abdominal	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Intra-operative(Abdominal organs & vascular)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Laparoscopic
	Pediatric	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Small Organ(Thyroid, Prostate, Scrotum, Breast)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esophageal (non-Cardiac)
	Musculo-skeletal (Conventional)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Urology, Gynecology)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
Cardiac	Cardiac Adult	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Cardiac Pediatric	P	P	P		P	B+M; B+CD; B+PWD
	Intravascular (Cardiac)
	Trans-esophageal (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral Vessel	Peripheral Vessel	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Other (Carotid)
	N = new indication; P = previously cleared by K180799
	Note 1: Needle Enhancement in B-Mode.

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Clarius Scanner EC7

Device Name: Clarius Scanner EC7

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	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Abdominal	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Intra-operative(Abdominal organs & vascular)
	Laparoscopic
	Pediatric
	Small Organ(Thyroid, Prostate, Scrotum, Breast)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Trans-vaginal	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
	Trans-urethral
	Trans-esophageal (non-Cardiac)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Urology, Gynecology)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esophageal (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral Vessel	Peripheral Vessel
	Other (Carotid)
N = new indication; P = previously cleared by K180799Note 1: Needle Enhancement in B-Mode.

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Clarius Scanner L7

Device Name: Clarius Scanner L7

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
	Abdominal	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Intra-operative(Abdominal organs & vascular)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Laparoscopic
	Pediatric	P	P	P	P	P	B+M; B+CD; B+PD	Note 1
	Small Organ(Thyroid, Prostate, Scrotum, Breast)	P	P	P	P	P	B+CD; B+PD; B+PWD	Note 1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esophageal (non-Cardiac)
	Musculo-skeletal (Conventional)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Musculo-skeletal (Superficial)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Intravascular
	Other (Urology, Gynecology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esophageal (Cardiac)
	Intra-cardiac
	Other (specify)
Peripheral Vessel	Peripheral Vessel	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	Other (Carotid)	P	P	P	P	P	B+M; B+CD; B+PD; B+PWD	Note 1
	N = new indication; P = previously cleared by K180799Note 1: Needle Enhancement in B-Mode.

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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 letter C's nested inside each other. To the right of the symbol is the word "clarius" in dark teal, followed by the words "ultrasound anywhere" stacked on top of each other in the same color.

K192107

510(k) Summary

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

Submitter:	Brendan Seward
	QA/RA Manager
	Clarius Mobile Health Corp.
	350 – 3605 Gilmore Way, Burnaby, B.C., V5G 4X5, Canada
	Email: [e-mail]
	Tel: [phone]
	Fax: N/A
Date Prepared:	May 13, 2019

• 2. 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 Device:

Device Name: Clarius Ultrasound Scanner 510(k) Number: K180799

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 (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.

Users will be trained medical professionals (e.g., doctors, nurses, technicians) with previous training in ultrasound.

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Image /page/15/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. Next to the symbol is the word "clarius" in dark teal, followed by the words "ultrasound anywhere" stacked on top of each other, also in dark teal.

The Clarius Ultrasound Scanner product/package components include:

Non-HD Packages

• 1. Software:
  • The Clarius Ultrasound App (Clarius App) for iOS; and
  • . The Clarius Ultrasound App (Clarius App) for Android.
• 2. Transducers/Scanners:
  • Clarius Scanner C3;
  • Clarius Scanner EC7; ●
  • . Clarius Scanner C7; and
  • Clarius Scanner L7;
• 3. Accessories:
  • Clarius-Built: ●
    • o Battery Pack (Li-ion);
    • Battery Charger; and o
    • O Clarius Fan.
  • OEM/Off-the-Shelf Product(s): ●
    • Medical Power Supply (Off-the-shelf power adaptor from SL Power Electronics; Model o Number ME20A1203B02; approved in the US).

HD Packages

• 1. Software:
  • The Clarius Ultrasound App (Clarius App) for iOS; and
  • . The Clarius Ultrasound App (Clarius App) for Android.
• 2. Transducers/Scanners:
  • Clarius Scanner C3 HD
  • . Clarius Scanner L7 HD;
  • Clarius Scanner C7 HD;
  • Clarius Scanner EC7 HD; ●
  • Clarius Scanner L15 HD; and
  • Clarius Scanner PA HD. ●
• Accessories: 4.
  • . Clarius-Built:
    • Clarius Battery HD; o
    • Clarius Charger HD; and O
    • Clarius Fan HD. O
  • OEM/Off-the-Shelf Product(s): ●
    • Medical Power Supply (Off-the-shelf power adaptor from GlobTek, Inc.; Model Number o WR9QA3200USBNMEDR6B; approved in the US).

The concept of the Clarius Ultrasound Scanner transducers and software is primarily to provide an easy to use, high-performance, low-cost, ultrasound platform for teaching and clinical applications. The Clarius Ultrasound Scanner is intended for use in professional healthcare environments where is provided by trained medical professionals.

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Image /page/16/Picture/0 description: The image shows the Clarius logo. On the left is an orange icon that looks like a stylized letter C made of three curved lines. To the right of the icon is the word "clarius" in dark teal, followed by the words "ultrasound anywhere" stacked on top of each other, also in dark teal. The logo is simple and modern, with a focus on the company name and its association with ultrasound technology.

Changes Implemented

The subject change of this 510(k) is the addition of a new set of transducer models to the Clarius Ultrasound Scanner family. The new set of scanners comprises the Clarius Scanner L7 HD (L7 HD), Clarius Scanner C3 HD (C3 HD), Clarius Scanner C7 HD (C7 HD), Clarius Scanner EC7 HD (EC7 HD), Clarius Scanner L15 HD (L15 HD), and Clarius Scanner PA HD (PA HD). An overview of the changes implemented are provided below:

Changed Specification	Clarius Ultrasound Scanner (Subject 510(k))	Clarius Ultrasound Scanner (K180799)
Models	C3, C7, L7, EC7, C3 HD, L7 HD, C7 HD, EC7 HD, L15 HD, PA HD	C3, C7, L7, EC7
Accessories	Non-HD Scanners:Battery Pack (Li-ion); Battery Charger; Clarius Dock (optional); Clarius Fan; and Medical Power Supply. HD Scanners: Clarius Battery HD Clarius Charger HD Clarius Fan HD	Battery Pack (Li-ion);Battery Charger;Clarius Dock (optional);Clarius Fan (optional);Medical Power Supply; andMedical Power Supply for Clarius Dock
Biocompatibility Testing	All models utilize identical materials to the predicate Clarius models.	ISO 10993-5, ISO 10993-10, and ISO 10993-11 for the Clarius Scanner EC7. All other models utilize identical materials to the predicate Clarius models.

Intended Use

Diagnostic ultrasound imaging and fluid flow analysis.

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.

Predicate Device

Equivalent devices are referred to as predicate devices in alignment with the FDA's standard terminology for comparable devices. The predicate device selected to demonstrate is the Clarius Ultrasound Scanner (K180799).

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Image /page/17/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange symbol resembling a stylized letter C, followed by the word "clarius" in dark teal. To the right of "clarius" are the words "ultrasound anywhere" stacked on top of each other, also in dark teal.

Determination of Substantial Equivalence

The Clarius Ultrasound system is a Track 3 system that employs the same fundamental scientific technology as that cleared with K180799. All indications for use introduced by the Clarius Ultrasound Scanner are identical to the predicate device. A comparison table is provided below:

Criteria forComparison	Clarius Ultrasound Scanner (Subject Device)	Clarius Ultrasound Scanner (K180799)
Portability	Portable ultrasound system	Portable ultrasound system
Power Source	Removable battery (Li-ion)	Removable battery (Li-ion)
Display	iOS or Android mobile device	iOS or Android mobile device
Wireless Capability	Communicates wirelessly via Wi-Fi andBluetooth	Communicates wirelessly via Wi-Fi andBluetooth
510(k) Track	Track 3	Track 3
Transducer Types	— Convex Array— Linear Array— Phased Array— Intracavity	— Convex Array— Linear Array— Phased Array— Intracavity
Intended Use	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— Trans-rectal— Trans-vaginal— Musculo-skel. (Conv.)— Musculo-skel. (Superfic.)— Urology— Gynecology— Cardiac adult— Cardiac pediatric— Peripheral vessel— Carotid— Needle guidance
Modes of Operation	— B-mode— M-mode— Color Doppler— Power Doppler— PWD— Combined (B+M; B+CD; B+PD; B+PWD)	— B-mode— M-mode— Color Doppler— Power Doppler— PWD— Combined (B+M; B+CD; B+PD; B+PWD)

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Image /page/18/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 dark teal. To the right of "clarius" are the words "ultrasound anywhere" stacked on top of each other, also in dark teal.

Nonclinical Performance Data

Nonclinical performance tests show compliance to the following standards:

Standard	Title of Standard
ANSI/AAMI ES60601-1:2005/(R)2012 andA1:2012	C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005,MOD)
IEC 60601-1-12 Edition1.0 2014-06	Medical Electrical Equipment - Part 1-12: General Requirements for Basic Safety and EssentialPerformance - Collateral Standard: Requirements for Medical Electrical Equipment andMedical Electrical Systems Intended for Use in the Emergency Medical Services Environment
IEC 60601-1-2 Edition4.0 2014-02	Medical Electrical Equipment -- Part 1-2: General Requirements for Basic Safety and EssentialPerformance -- Collateral Standard: Electromagnetic Disturbances -- Requirements and Tests
IEC 60601-1-6 Edition3.1 2013-10	Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and EssentialPerformance - Collateral Standard: Usability
IEC 60601-2-37 Edition2.1 2015	Medical Electrical Equipment - Part 2-37: Particular Requirements for the Basic Safety andEssential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
IEC 62133 Edition 2.02012-12	Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes - SafetyRequirements for Portable Sealed Secondary Cells, and for Batteries Made from Them, forUse in Portable Applications [Including: Corrigendum 1 (2013)]
IEC 62304:2006	Medical Device Software - Software Life Cycle Processes
ISO 10993-10 ThirdEdition 2010-08-01	Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
ISO 10993-11 ThirdEdition 2017-09	Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
ISO 10993-5 ThirdEdition 2009-06-01	Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
ISO 14971 SecondEdition 2007-03-01	Medical Devices - Application of Risk Management to Medical Devices
ISO 15223-1:2012	Medical Devices - Symbols to be Used with Medical Devices Labels, Labeling, and Informationto be Supplied - Part 1: General Requirements
UD 2-2004 (R2009)	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.

Quality Assurance Measures

Quality assurance measures applied to the system design and development were conformant with FDA Quality System Requirements (QSR) 21 CFR 820.

Conclusion

This device is a modification of an existing licensed device using technologies that exist on the market as of the date of this submission. 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 device is substantially equivalent in safety and effectiveness to the predicate device.

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.