(48 days)
Not Found
No
The document describes a standard ultrasound system and its components. There is no mention of AI, ML, deep learning, or any related terms in the provided text. The focus is on the hardware, software for image display, and communication protocols.
No
The device is described as a "diagnostic imaging" system, used to "acquire and display high-resolution, real-time ultrasound data," and its intended use is for "diagnostic ultrasound imaging." This indicates its purpose is to aid in diagnosis, not directly treat conditions.
Yes
The text explicitly states: "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..."
No
The device description explicitly states that the system comprises wireless transducers, batteries, chargers, and optional docks and fans, in addition to the software. These are hardware components essential for the device's function.
Based on the provided text, the Clarius Ultrasound Scanner is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed in vitro (outside the body).
- Clarius Ultrasound Scanner Function: The description clearly states that the Clarius Ultrasound Scanner uses sound waves to create images of internal structures within the body. This is an in vivo (within the body) diagnostic imaging technique.
- Intended Use: The intended use describes diagnostic imaging and fluid flow analysis within various anatomical sites of the patient. It does not mention the analysis of specimens.
Therefore, the Clarius Ultrasound Scanner falls under the category of medical imaging devices used for in vivo diagnosis, not in vitro diagnosis.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
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:
- Battery Pack (Li-ion);
- Battery Charger;
- Clarius Dock (Optional; charging station); and
- Clarius Fan (Optional).
b. OEM/Off-the-Shelf Product(s):
- Medical Power Supply (Off-the-shelf power adaptor from SL Power Electronics; Model Number ME20A1203B02; approved in the US); and
- Medical Power Supply (Optional for use with Clarius Dock; off-the-shelf power 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ (Thyroid, Prostate, Scrotum, Breast), 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.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained healthcare professionals in professional healthcare facilities, Emergency Medical Service, ambulance, or rotary aircraft environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical performance tests show compliance to the following standards:
AAMI/ANSI ES60601-1 (2012)
AAMI ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) (General II (ES/EMC))
IEC 60601-1-2 (2007 & 2014)
IEC 60601-1-6 (2013)
IEC 60601-1-12 (2014)
IEC 60601-2-37 (2004)
IEC 62133 (2012)
IEC 62366 (2014)
ISO 10993-1 (2009)
ISO 10993-5 (2014)
ISO 10993-10 (2014)
ISO 10993-11 (2017)
ISO-10993-12 (2014)
ISO 62304 (2006)
ISO 15223-1 (2012)
ISO 14971 (2007)
NEMA UD 2 (2009)
The Clarius Ultrasound Scanner did not require clinical testing to establish substantial equivalence to the predicate devices indicated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
Indications for Use
510(k) Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use Tables
Clarius Ultrasound Scanner
Clinical Application | Mode of Operation | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track 1 Only) | Specific | |||||||
(Tracks 1 & 3) | B | M | Color | |||||
Doppler | Power | |||||||
Doppler | PW | |||||||
Doppler | 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 (Abdominal | ||||||||
organs & 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 | ||||||||
Peripheral | ||||||||
Vessel | 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:
4
System: Clarius Ultrasound Scanner Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
5
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:
6
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 | | | | | | |
| Peripheral
Vessel | 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. | | | | | | | |
7
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:
8
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 | | | | | | | |
| Peripheral
Vessel | 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. | | | | | | | | |
9
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:
10
Device Name: L7 Linear Scanner
| Peripheral
Vessel | 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 K172385
Note 1: Needle Enhancement in B-Mode. | | | | | | | | |
11
EC7 Scanner
Device Name: EC7 Scanner
Clinical Application | Mode of Operation | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track 1 Only) | Specific | |||||||
(Tracks 1 & 3) | B | M | Color | |||||
Doppler | Power | |||||||
Doppler | PW | |||||||
Doppler | 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 |
12
Device Name: EC7 Scanner
Cardiac | Cardiac Adult | ||||
---|---|---|---|---|---|
Cardiac Pediatric | |||||
Intravascular (Cardiac) | |||||
Trans-esophageal (Cardiac) | |||||
Intra-cardiac | |||||
Other | |||||
Peripheral | |||||
Vessel | Peripheral Vessel | ||||
Other (Carotid) |
13
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 Seward
QA/RA Manager
Clarius Mobile Health Corp.
350 – 3605 Gilmore Way, Burnaby, B.C., Canada, V5G 4X5
Email: brendan.seward@clarius.me
Tel: (+1) 778-800-9975
Fax: N/A |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | February 20, 2018 |
-
- 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
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.
14
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
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).
15
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.
-
- 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.
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 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 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:
16
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, S1000
Ultrasound 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) |
17
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/ANSI | ||
ES60601-1 | 2012 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential |
Performance | ||
AAMI ANSI | ||
ES60601-1 | 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 Safety | ||
and 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 essential | |
performance - Collateral Standard: Electromagnetic Capability - Requirements and tests. (4th | ||
Edition) | ||
IEC 60601-1-6 | 2013 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential |
performance -Collateral standard: Usability | ||
IEC 60601-1-12 | 2014 | Medical Electrical Equipment - Part 1-12: General requirements for basic safety and essential |
performance - Collateral Standard: Requirements for medical electrical equipment and medical | ||
electrical 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 essential |
performance 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 - Safety |
Requirements for Portable Sealed Secondary Cells, And for Batteries Made from Them, For Use in | ||
Portable 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 management |
process | ||
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 be |
Supplied - 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.
18
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.