(135 days)
Clarius Ultrasound Scanner (K192107)
No
The document describes standard ultrasound technology and image processing without mentioning AI or ML capabilities.
No.
The device is intended for diagnostic ultrasound imaging, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Vave Wireless Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body." It also lists various applications for "diagnostic ultrasound imaging."
No
The device description explicitly states that the system consists of an Ultrasound Probe, Display Application, Battery, and Battery Charger, indicating the presence of hardware components beyond just software.
Based on the provided information, the Vave Wireless Ultrasound System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic 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 done outside the body (in vitro).
- Vave System Function: The Vave Wireless Ultrasound System uses ultrasound waves to create images of structures within the human body. It is a non-invasive imaging device that operates on the patient, not on specimens taken from the patient.
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes an in-vivo (within the body) diagnostic process.
- Device Description: The description details how the system acquires and processes ultrasound data from the body to create images.
Therefore, the Vave Wireless Ultrasound System falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Vave Wireless Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
The Vave Wireless Ultrasound System is intended to be used by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.
The Vave Wireless Ultrasound System is a transportable system that is intended for use in environments where healthcare is provided by trained healthcare professionals (e.g., Hospital, clinic, medical office), home environment, roadlair ambulance and other environments where is provided. The Vave Charger is to be used in a stationary setting.
It is indicated for diagnostic ultrasound imaging in the following applications: Ophthalmic, Fetall Obstetrics, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Small Organ (includes Breast, Thyroid, and Scrotum), Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel and procedural guidance of needles into the body. The operating modes are B mode, M mode, B+M, B+C, CD mode.
Product codes
IYN, IYO, ITX
Device Description
The Vave Wireless Ultrasound System is a handheld ultrasound imaging system consisting of the following components: Ultrasound Probe, Display Application, Battery, and Batterv Charger. The ultrasound probe (Model VA-0192), including its embedded software, is designed to acquire ultrasound image data and to wirelessly transmit the data to the display application software. The display application software runs on a commercial off-the-shelf mobile device. The operating system of the mobile device can be either iOS or Android. The ultrasound probe is completely wireless and is powered by a removable Li-ion battery (Model VA-0175). The battery is charged with a proprietary charging system (Model VCG).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal/Obstetrics, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Small Organ (includes Breast, Thyroid, and Scrotum), Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended User: qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. Users may also include medical students working under the supervision or authority of a physician during their education / training.
Care Setting: Hospital, clinic, medical office, home environment, road/air ambulance and other environments where healthcare is provided. The Vave Charger is to be used in a stationary setting.
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)
The nonclinical testing conducted on the Vave Wireless Ultrasound System includes:
- ANSI AAMI 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)
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION 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 intended for use in the emergency medical services environment.
- IEC 60601-2-37 Edition 2.1 2015 Medical Electrical Equipment Part 2- 37: Particular Requirements For The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment
- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices
- IEC 62133-2 Edition1.0 2017-02 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 - Part 2: Lithium Systems
- ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software -Software Life Cycle Processes [Including Amendment 1 (2016)]
- ISO 10993-1 Fifth Edition 2018-08 Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process
Key results: The collective results of the non-clinical testing demonstrate that the Vave Wireless Ultrasound System meets the established specifications necessary for consistent performance for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Vave Personal Ultrasound (K191541)
Reference Device(s)
Clarius Ultrasound Scanner (K192107)
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
August 30, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Vave Health, Inc % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K241051
Trade/Device Name: Vave Wireless Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: August 26, 2024 Received: August 26, 2024
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pm.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and
1
production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/unique-deviceidentification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-how-report-medicaldevice-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marjan Nabili-S
for
Yanna Kang Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
Vave Wireless Ultrasound System
Indications for Use (Describe)
The Vave Wireless Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
The Vave Wireless Ultrasound System is intended to be used by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.
The Vave Wireless Ultrasound System is a transportable system that is intended for use in environments where healthcare is provided by trained healthcare professionals (e.g., Hospital, clinic, medical office), home environment, roadlair ambulance and other environments where is provided. The Vave Charger is to be used in a stationary setting.
It is indicated for diagnostic ultrasound imaging in the following applications: Ophthalmic, Fetall Obstetrics, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Small Organ (includes Breast, Thyroid, and Scrotum), Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel and procedural guidance of needles into the body. The operating modes are B mode, M mode, B+M, B+C, CD mode.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
he-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
510(k) Notification K241051
GENERAL INFORMATION
Applicant:
Vave Health, Inc. 3031 Tisch Way, 110 Plaza West San Jose, CA U.S.A. 95128 Phone: 510-366-2466
Contact Person:
Sandhya Mitnala Sr. Director of Quality Assurance and Regulatory Vave Health, Inc. Phone: 510-366-2466 Email: sandhya@vavehealth.com
Date Prepared:
August 30th, 2024
DEVICE INFORMATION
Trade Name:
Vave Wireless Ultrasound System
Generic/Common Name:
Wireless Ultrasound System
Classification and Product Codes:
| 21 CFR Section | Classification Name | Product Code |
|---|---|---|
| 892.1550 | Ultrasonic pulsed Doppler imaging system. | IYN |
| 892.1560 | Ultrasonic Pulsed Echo Imaging System | IYO |
| 892.1570 | Diagnostic Ultrasound Transducer | ITX |
PREDICATE DEVICES
- Primary Predicate Device: Vave Personal Ultrasound (K191541) ●
- Reference Device: Clarius Ultrasound Scanner (K192107) ●
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Image /page/4/Picture/0 description: The image shows the logo for Vave. The logo consists of a stylized icon on the left and the word "vave" in lowercase letters on the right. The icon is a gray triangle with a white and gray design inside. The word "vave" is written in a sans-serif font and is also gray.
DEVICE DESCRIPTION
The Vave Wireless Ultrasound System is a handheld ultrasound imaging system consisting of the following components: Ultrasound Probe, Display Application, Battery, and Batterv Charger.
The ultrasound probe (Model VA-0192), including its embedded software, is designed to acquire ultrasound image data and to wirelessly transmit the data to the display application software. The display application software runs on a commercial off-the-shelf mobile device. The operating system of the mobile device can be either iOS or Android. The ultrasound probe is completely wireless and is powered by a removable Li-ion battery (Model VA-0175). The battery is charged with a proprietary charging system (Model VCG).
CHANGES IMPLEMENTED
The present submission is an expansion based on the previous clearance - K191541. The subject device changes of this new submission are the addition of a new transducer model, the Vave Linear Array probe ("Vave Linear") with upgraded hardware to the Vave Wireless Ultrasound System. The Vave Phased transducer model and the clinical indications supported were cleared under K191541. The Vave Linear transducer model supports additional clinical indications as described in the Indications for Use for the Linear array probe, which are the same as the reference device Clarius Ultrasound Scanner (K192107). Appropriate changes have been made to mitigate risks and ensure the safety and effectiveness of these new features.
INTENDED USE/INDICATIONS FOR USE
The Vave Wireless Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
The Vave Wireless Ultrasound System is intended to be used by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.
The Vave Wireless Ultrasound System is a transportable system that is intended for use in environments where healthcare is provided by trained healthcare professionals (e.g., Hospital, clinic, medical office), home environment, road/air ambulance and other environments where healthcare is provided. The Vave Charger is to be used in a stationary setting.
It is indicated for diagnostic ultrasound imaging in the following applications: Ophthalmic, Fetal/Obstetrics, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Small Organ (includes Breast, Thyroid, and Scrotum), Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel and procedural guidance of needles into the body.
The operating modes are B mode, M mode, B+M, B+C, CD mode.
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Image /page/5/Picture/0 description: The image shows the logo for Vave. The logo consists of a stylized triangle shape on the left, with three curved lines inside. To the right of the triangle is the word "vave" in lowercase letters. The logo and text are in a dark gray color, set against a white background.
PRESCRIPTION STATUS
This is a prescription device. The prescription device statement appears in the labeling.
STERILIZATION SITE(S)
Not applicable. There are no components in the Vave Wireless Ultrasound System supplied sterile.
TRACK
The Vave Wireless Ultrasound System will be following Track 3 outlined in the FDA Guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued February 21, 2023.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The intended use including all indications for use of the Vave Wireless Ultrasound System are the same as the predicate device. The fundamental technology of the Vave Wireless Ultrasound System is the same as the primary (K191541) and reference (K192107). Vave Wireless Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate device. The Vave Wireless Ultrasound System is substantially equivalent to the predicate device.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following table provides a detailed comparison of the intended use, indications for use and the device specifications between the subject device (Vave Wireless Ultrasound system) and the predicate and reference devices. All indications for use introduced by the subject device are similar to predicate and the reference device.
6
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| Comparison Parameter | Subject Device:
Vave Wireless
Ultrasound System | Primary
Predicate:
Vave Personal
Ultrasound
System (K191541) | Clarius Ultrasound
Scanner
(K192107) | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Vave Probe is
intended for
diagnostic
ultrasound imaging
or fluid flow
analysis of the
human body. | The Vave Probe is
intended for diagnostic
ultrasound imaging or
fluid flow analysis of the
human body. | Diagnostic ultrasound
imaging and fluid flow
analysis | |
| Indications for
use | Ophthalmic | Yes | No | Yes |
| | Fetal/OB | Yes | Yes | Yes |
| | Abdominal | Yes | Yes | Yes |
| | Intra-operative
(Abdominal organs
and Vascular) | No | No | Yes |
| | Pediatric | Yes | Yes | Yes |
| | Small Organ
(Thyroid, Scrotum,
Breast) | Yes | No | Yes |
| | Adult Cephalic | No | No | Yes |
| | Trans-rectal | No | No | Yes |
| | Trans-vaginal | No | No | Yes |
| | Musculo-skeletal
(Conventional) | Yes | No | Yes |
| | Musculo-skeletal
(Superficial) | Yes | No | Yes |
| | Urology | Yes | Yes | Yes |
| | Gynecology | Yes | Yes | Yes |
| | Renal | Yes | Yes | No |
| | Thoracic/Pleural | Yes | Yes | No |
| | Cardiac adult | Yes | Yes | No |
| | Cardiac pediatric | Yes | Yes | No |
| | Peripheral vessel | Yes | Yes | Yes |
| | Carotid | No | No | Yes |
| | Needle Guidance | Yes | Yes | Yes |
| Comparison Parameter | | Subject Device:
Vave Wireless
Ultrasound System | Primary
Predicate:
Vave
Personal
Ultrasound
(K191541) | Reference device:
Clarius Ultrasound
Scanner (K192107) |
| Environment
of Use | Professional | Yes | Yes | Yes |
| | Home | Yes | Yes | No |
| | Emergency Medical
Services | Yes | Yes | No |
| 510(k) Track | | Track 3 | Track 3 | Track 3 |
| Modes of
Operation | B-Mode | Yes | Yes | Yes |
| | Color Doppler | Yes | Yes | Yes |
| | M-Mode | Yes | Yes | Yes |
| | Combined (B+CD) | Yes | Yes | Yes |
| Patient-Contacting Materials | | All materials with
patient contact are
biocompatible and can
be disinfected | All materials with
patient contact are
biocompatible and can
be disinfected | All materials with patient
contact are
biocompatible and can
be disinfected |
| Principle/Method of Operation | | Piezoelectric material in
the transducer is used as
an ultrasound source to
transmit sound waves
into the body. Sound
waves are reflected
back to the transducer
and converted to
electrical signals that
are processed and
displayed as images of
anatomic
structures. | Piezoelectric material in
the transducer is used as
an ultrasound source to
transmit sound waves
into the body. Sound
waves are reflected
back to the transducer
and converted to
electrical signals that are
processed and displayed
as images
of anatomic structures. | Piezoelectric material in
the transducer is used as
an ultrasound source to
transmit sound waves
into the body. Sound
waves are reflected back
to the transducer and
converted to electrical
signals that are processed
and displayed as images
of anatomic structures. |
| Transducer Technology | | Piezoelectric | Piezoelectric | Piezoelectric |
| Transducer
Types | Phased Array | Yes | Yes | Yes |
| | Linear Array | Yes | No | Yes |
| | Convex Array | No | No | Yes |
| Probe Connection to Display | | Wireless | Wireless | Wireless |
| | Image export | Yes | Yes | Yes |
| | Measurements | Yes | Yes | Yes |
| | Annotations | Yes | Yes | Yes |
| Portability | | Portable Ultrasound
System | Portable
Ultrasound System | Portable Ultrasound
System |
| Power Source | | Removable battery (Li-
ion) | Removable battery (Li-
ion) | Removable battery (Li-
ion) |
| Display | | iOS or Android mobile
device | iOS or Android mobile
device | iOS or Android mobile
device |
| Comparison Parameter | | Subject Device:
Vave Wireless
Ultrasound System | Primary Predicate:
Vave Personal
Ultrasound
(K191541) | Reference device:
Clarius
Ultrasound
Scanner
(K192107) |
| Wireless Capability | | Communicates
wirelessly
via Wi-Fi and
Bluetooth | Communicates
wirelessly
via Wi-Fi and Bluetooth | Communicates
wirelessly via Wi-Fi and
Bluetooth |
| Cybersecurity | Data at rest | - 256-Bit AES
- HTTPS TLS 1.2 | - 256-Bit AES
- HTTPS TLS 1.2 | - RSA256
- 128-Bit AES
- HTTPS TLS 1.2 |
| | Data in transit | - WPA2 (AES) | - WPA2 (AES) | - WPA2 (AES) |
| | User security | - Authentication
services provided
by Amazon
Cognito; - Password reset
tokens follow
NIST standards. - NIST approved
one-way
cryptographic
hash with salt | - Authentication
services provided
by Amazon
Cognito; - Password reset
tokens follow NIST
standards.
NIST approved one-
way cryptographic
hash with salt | - Two-factor authentication
(Cloud only) - Passwords follow
NIST standards |
7
8
NONCLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary performance testing was conducted on the Vave Wireless Ultrasound System to support a determination of substantial equivalence to the predicate device. The nonclinical testing conducted on the Vave Wireless Ultrasound System includes:
- � ANSI AAMI 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)
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION � Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION � Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- . IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION 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 intended for use in the emergency medical services environment.
9
- IEC 60601-2-37 Edition 2.1 2015 Medical Electrical Equipment Part 2- 37: ● Particular Requirements For The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment
- o IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION
Medical devices - Part 1: Application of usability engineering to medical devices
- IEC 62133-2 Edition1.0 2017-02 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 - Part 2: Lithium Systems
- ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software -Software Life Cycle Processes [Including Amendment 1 (2016)]
- ISO 10993-1 Fifth Edition 2018-08 Biological Evaluation Of Medical ● Devices - Part 1: Evaluation And Testing Within A Risk Management Process
The collective results of the non-clinical testing demonstrate that the Vave Wireless Ultrasound System meets the established specifications necessary for consistent performance for its intended use.
SUMMARY OF CLINICAL TESTS
The Vave Wireless Ultrasound system introduces no new indications for use, modes, features or technologies relative to the predicate device that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.
QUALITY ASSURANCE MEASURES
Quality assurance measures applied to the system design and development include, but are not limited to:
- Risk Analysis -
- Product Specifications -
- -Design Reviews
- Verification and Validation -
CONCLUSION
The Vave Wireless Ultrasound System is substantially equivalent to the identified predicate device. The Vave Wireless Ultrasound system has the same intended use and fundamental technological characteristics as the identified predicate device.