(21 days)
Not Found
No
The document describes a standard ultrasound system and does not mention any AI or ML capabilities.
No
The device is described as a "diagnostic ultrasound system" intended for "Point-of-Care Imaging of Medical Conditions". It is used to acquire and display high-resolution, real-time ultrasound data for various diagnostic applications and procedure guidance, rather than for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "Other targeted diagnostic and measurement applications." Additionally, the "Device Description" refers to it as a "diagnostic ultrasound system."
No
The device description explicitly states that the system comprises wireless transducers, battery packs, and chargers, which are hardware components essential for acquiring and transmitting ultrasound data. While software is a key part of the system, it is not the sole component.
Based on the provided text, the Clarus Ultrasound System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Clarus Ultrasound System Function: The Clarus Ultrasound System uses sound waves to create images of internal structures within the body. It does not analyze specimens taken from the body.
The intended use and device description clearly indicate that the system is for in vivo imaging and diagnostic purposes, not in vitro testing.
N/A
Intended Use / Indications for Use
The Clarius Ultrasound System is a software-based ultrasound imaging system and accessories intended for use in Pointof-Care Imaging of Medical Conditions on the general public.
Point-of-Care clinical applications include:
-Emergency triage exam to look at trauma conditions
-Procedure guidance to guide needles into the body; and
-Other targeted diagnostic and measurement applications: fetal, fetal echo, abdominal, small organ, musculo-sketal (conventional), musculo-skeletal (superficial), urology, cardiac adult, cardiac pediatric, peripheral vessel, pediatric, carotid
-The Clarius Ultrasound System is intended for use in environments where is provided by trained medical professionals. The device is not intended for use in emergency medical service, ambulance, or aircraft.
Users will be trained medical professionals (e.g., doctors, nurses, technicians).
Product codes
IYN, IYO, ITX
Device Description
The Clarius Ultrasound System is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial off-theshelf (COTS) iOS or Android device. The Clarius Ultrasound System 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 to electronic signals in order to construct an image of the internal structures of an anatomical field. This image is sent wirelessly to an external (COTS) 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 will be via Wi-Fi Direct® (Ad-Hoc mode with security) for easy pairing.
The Clarius Ultrasound System includes:
Product/Package Components:
-
- Software:
- The Ultrasound App (Clarius App) for iOS; OR
- The Ultrasound App (Clarius App) for Android
-
- Transducers/Scanners:
- Clarius Scanner C3 (C3 Convex Transducer); OR
- . Clarius Scanner L7 (L7 Linear Transducer)
-
- Accessories:
- a. Clarius-Built:
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
fetal, abdominal, small organ (thyroid, scrotum, prostate, breast), musculo-skeletal (conventional), musculo-skeletal (superficial), urology, cardiac adult, cardiac pediatric, peripheral vessel, pediatric, carotid
Indicated Patient Age Range
general public
Intended User / Care Setting
trained medical professionals (e.g., doctors, nurses, technicians) in professional healthcare facilities. Not intended for use in emergency medical service, ambulance, or 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)
Non-clinical performance tests relied on this premarket notification for a determination of substantial equivalence include rests which show compliance to the following standards:
- IEC 60601-1 (2012) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. (Edition 3.1)
- IEC 60601-1-2 (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 60601-2-37 (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)
- ISO 10993-1 (2009) Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 30, 2016
Clarius Mobile Health Corp. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313
Re: K163138
Trade/Device Name: Clarius Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 7, 2016 Received: November 8, 2016
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
For
Enclosure
2
Indications for Use
510(k) Number (if known) K163138
Device Name Clarius Ultrasound System
Indications for Use (Describe)
The Clarus Ultrasound System is a software-based ultrasound imaging system and accessories intended for use in Pointof-Care Imaging of Medical Conditions on the general public.
Point-of-Care clinical applications include:
- · Emergency triage exam to look at trauma conditions
- · Procedure guidance to guide needles into the body; and
· Other targeted diagnostic and measurement applications: fetal, fetal echo, abdominal, small organ, musculo-sketal (conventional), musculo-skeletal (superficial), urology, cardiac adult, cardiac pediatric, peripheral vessel, pediatric, carotid
· The Clarius Ultrasound System is intended for use in environments where is provided by trained medical professionals. The device is not intended for use in emergency medical service, ambulance, or aircraft.
Users will be trained medical professionals (e.g., doctors, nurses, technicians).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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
Diagnostic Ultrasound Indication for Use Form
510(k) Number: NA
Device Name: Clarius Ultrasound System
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (specify) | Other* | |||||||
| General | ||||||||
| (Track 1 Only) | Ophthalmic | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | N | ||||||
| Abdominal | N | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | |||||||
| Small organ (thyroid, | ||||||||
| scrotum, prostate, | ||||||||
| breast) | N | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. | ||||||||
| (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | N | |||||||
| Musculo-skeletal | ||||||||
| (Superficial) | N | |||||||
| Intravascular | ||||||||
| Other (Urology, | ||||||||
| Gynecology) | N | |||||||
| Cardiac | Cardiac Adult | N | ||||||
| Cardiac Pediatric | N | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Fetal Echo) | N | |||||||
| Peripheral | ||||||||
| Vessel | Peripheral Vessel | N | ||||||
| Other (Carotid) | N |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging.
Additional Comments: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for nerve block procedures.
4
Diagnostic Ultrasound Indication for Use Form
510(k) Number: NA
Device Name: C3: convex scanner
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (specify) | Other* | |||||||
| General | ||||||||
| (Track 1 Only) | Ophthalmic | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | N | ||||||
| Abdominal | N | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | |||||||
| Small organ (thyroid, | ||||||||
| scrotum, prostate, | ||||||||
| breast) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. | ||||||||
| (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | N | |||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Urology, | ||||||||
| Gynecology) | N | |||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Fetal Echo) | N | |||||||
| Peripheral | ||||||||
| Vessel | Peripheral Vessel | N | ||||||
| Other (Carotid) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging.
Additional Comments: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for nerve block procedures.
5
Diagnostic Ultrasound Indication for Use Form
510(k) Number: NA
Device Name: L7: linear scanner
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Specific | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|---|
| (Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Combined (specify) | Other* | |
| General | ||||||||
| (Track 1 Only) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal | N | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | |||||||
| Small organ (thyroid, | ||||||||
| scrotum, prostate, | ||||||||
| breast) | N | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. | ||||||||
| (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | N | |||||||
| Musculo-skeletal | ||||||||
| (Superficial) | N | |||||||
| Intravascular | ||||||||
| Other (Urology, | ||||||||
| Gynecology) | ||||||||
| Cardiac | Cardiac Adult | N | ||||||
| Cardiac Pediatric | N | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Fetal Echo) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral Vessel | N | ||||||
| Other (Carotid) | N |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging.
Additional Comments: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for nerve block procedures.
6
Image /page/6/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" shape.
Summary
- Submitter's name, address, telephone number; Contact person
Submitter: Abhijit Ahir, Director of QA/RA Clarius Mobile Health Corp. #350 – 3605 Gilmore Way Burnaby, B.C. V5G 4X5 Canada Email: abhijit.ahir@clarius.me Tel: (+1) 778-800-9975 Fax: (+1) 778-800-9974
Contact Person: Emergo Global Representative, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 USA Tel: (+1) 512-327-9997
Date Prepared: November 28, 2016
- Name of the device, including the trade or proprietary name, if applicable, the common or usual name, and the classification, if known
Clarius Ultrasound System Device Name:
Common Name: Diagnostic Ultrasound System and Accessories
Classification: Class II
| 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 |
-
- Substantially Equivalent Devices:
| Device Name | 510(k) Number |
|---|---|
| SONON Ultrasound Imaging System (Model: SONON 300C) | K151339 |
| Philips Lumify Diagnostic Ultrasound System | K152899 |
| FUJIFILM SonoSite Edge II Ultrasound System. | K153626 |
7
Image /page/7/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange symbol that looks like three curved lines forming a stylized "C", followed by the word "clarius" in a dark blue, sans-serif font. The logo is simple and modern.
1. Device Description
The Clarius Ultrasound System is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial off-theshelf (COTS) iOS or Android device. The Clarius Ultrasound System 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.
Image /page/7/Picture/3 description: The image shows a Clarius Ultrasound device wirelessly connected to a compatible viewing device, which appears to be a tablet. The ultrasound device is a handheld scanner, and the tablet displays the ultrasound image. The text labels "Clarius Ultrasound" and "Compatible Viewing Device" are present in the image. The wireless connection is indicated by a blue wifi symbol.
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 to electronic signals in order to construct an image of the internal structures of an anatomical field. This image is sent wirelessly to an external (COTS) 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 will be via Wi-Fi Direct® (Ad-Hoc mode with security) for easy pairing.
The Clarius Ultrasound System includes:
Product/Package Components:
-
- Software:
- The Ultrasound App (Clarius App) for iOS; OR
- The Ultrasound App (Clarius App) for Android ●
-
- Transducers/Scanners:
- Clarius Scanner C3 (C3 Convex Transducer); OR ●
- . Clarius Scanner L7 (L7 Linear Transducer)
-
- Accessories:
- a. Clarius-Built:
8
Image /page/8/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" shape.
- Battery Pack (Li-ion) O
- Battery Charger O
OEM/Off-The-Shelf Product(s):
Medical Power Supply (Off-the-shelf power adaptor from SL Power Electronics, USA; Model Number ME20A1203B02; Approved in the US.
Aquasonic 100 Ultrasound Transmission Gel (Off-the-shelf ultrasound gel from Parker Laboratories Inc., USA; Approved in the US.
Image /page/8/Figure/6 description: The image shows a diagram of an ultrasound system. On the left side of the image, there is a diagram of an ultrasound probe, which includes components such as a battery, Wi-Fi, power circuitry, ultrasound system-on-chip, transmit/receive analog interface, and transducer stack. On the right side of the image, there is a diagram of a Wi-Fi enabled smartphone or tablet, which displays an ultrasound image and a user interface.
Ultrasound Probe
User Interface / Display
The concept of the Clarius Ultrasound System 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 System is intended for use in professional healthcare facilities where healthcare is provided by trained medical professionals. The device is not intended for use in Emergency Medical Service, ambulance, or aircraft environments.
9
Image /page/9/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" shape.
2. Indication for Use
The Clarius Ultrasound System is a software-based ultrasound imaging system and accessories intended for use in Point-of-Care Imaging of Medical Conditions on the general public.
Point-of-Care clinical applications include:
- Emergency triage exam to look at trauma conditions ●
- Procedure guidance to guide needles into the body; and
- Other targeted diagnostic and measurement applications: fetal echo, abdominal, small organ, musculo-skeletal (conventional), musculo-skeletal (superficial), urology, gynecology, cardiac adult, cardiac pediatric, peripheral vessel, pediatric, carotid
- The Clarius Ultrasound System is intended for use in environments where healthcare is provided by trained medical professionals. The device is not intended for use in emergency medical service, ambulance, or aircraft.
Users will be trained medical professionals (e.g., doctors, nurses, technicians).
10
Image /page/10/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange symbol that looks like three curved lines forming a "C" shape, followed by the word "clarius" in a dark blue, sans-serif font. The logo is clean and modern, with a focus on simplicity and readability.
2.1 Contraindications
Do not use the Clarius Ultrasound System in the following situations. Doing so may produce images with inaccurate results:
- Patients who have had surgery, which may have changed the composition of the examining tissue (for example, a mastectomy), as this could skew or alter the measured density.
- Patients whose bodies contain foreign artifacts (for example, implants). ●
- Ophthalmic use or any use causing the acoustic beam to pass through the eye. ●
- Intra-operative use (e.g., defined as introducing a scanner into a surgical incision or burr hole). ●
- Endocavitary use (i.e., defined as introducing a scanner within a (body) cavity or organ. E.g. an atrium, esophagus, rectum, or vagina).
- . Imaging an open wound.
- During transportation of a patient to a professional healthcare facility, or between professional healthcare facilities.
- At the scene of an emergency outside of a professional healthcare facility.
In terms of equivalent devices, we will refer to FDA's standard terminology for comparable devices: "predicate devices". The predicate devices selected to demonstrate equivalence are;
| 1. Device Name
SONON Ultrasound Imaging System. (Model 300C) | FDA 510(k) Number
(K151339) |
|-----------------------------------------------------------------|--------------------------------|
| 2. Device Name
Lumify Diagnostic Ultrasound System. | FDA 510(k) Number
(K152899) |
| 3. Device Name
FUJIFILM SonoSite Edge II Ultrasound System. | FDA 510(k) Number
(K153626) |
3. Determination of Substantial Equivalence
They Clarius Ultrasound system is a Track 3 system that employs the same fundamental scientific technology as that cleared with K151339, K153626. All indications for use introduced by Clarius are indications used by one of the predicate devices. The K152899) and (K153626) do not connect with the display wirelessly. The Clarius ultrasound system is equivalent to the K151339in this respect.
Non-Clinical Performance Data
Non-clinical performance tests relied on this premarket notification for a determination of substantial equivalence include rests which show compliance to the following standards:
| Reference No. | Year | Title |
|---|---|---|
| IEC 60601-1 | 2012 | Medical electrical equipment – Part 1: General requirements for basic safety |
| and essential performance. (Edition 3.1) |
11
Image /page/11/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange symbol that looks like three concentric arcs, with a small gap in each arc. To the right of the symbol is the word "clarius" in a dark blue, sans-serif font. The logo is clean and modern, and the colors are bright and eye-catching.
| IEC 60601-1-2 | 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 60601-2-
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) |
| ISO 10993-1 | 2009 | Biological evaluation of medical devices - Part 1: Evaluation and testing
within a risk management process |
4. Quality Assurance measures
Quality assurance measures applied to the system design and development include, but were not limited to: risk analysis, product specifications, design reviews, and verification and validation.
5. Conclusion
The Clarius Ultrasound System is essentially the same as it's predicate devices. These are prescription devices. This statement appears in the labeling. Sterilization is not applicable.
This is a Class II Device.