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510(k) Data Aggregation
(135 days)
Vave Wireless Ultrasound System
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.
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).
The provided text describes the Vave Wireless Ultrasound System, its intended use, and a comparison to predicate devices, along with non-clinical testing conducted. However, it explicitly states that no clinical testing was done because the device introduces "no new indications for use, modes, features or technologies relative to the predicate device that require clinical testing."
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of clinical performance, as such a study was not conducted or reported for this submission. The information provided is primarily focused on demonstrating substantial equivalence through non-clinical testing and comparison to existing devices.
To address the prompt as much as possible with the provided information, I will focus on what was done (non-clinical testing) and explicitly state what was not done (clinical study to prove acceptance criteria).
Based on the provided FDA 510(k) summary (K241051), there was no clinical study conducted to prove the device meets acceptance criteria. The submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of intended use, technological characteristics, and non-clinical testing.
The summary explicitly states: "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."
Therefore, many of the requested details regarding a clinical study (e.g., sample size, ground truth establishment, expert qualifications, MRMC study, effect size) are not applicable or provided in this document.
Below, I will outline what is available regarding non-clinical acceptance criteria and testing, and explicitly mention where clinical information is not provided.
Acceptance Criteria and Device Performance (Non-Clinical)
The acceptance criteria for this device, as implied by the non-clinical testing section, are based on compliance with various international and national standards related to medical electrical equipment, electromagnetic compatibility, usability, battery safety, software life cycle, and biocompatibility. The "reported device performance" in this context is the successful demonstration of compliance with these standards.
Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Compliance)
| Acceptance Criteria Category | Specific Standards / Requirements | Reported Device Performance |
|---|---|---|
| Electrical Safety & Essential Performance | - 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) | "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." (Implies successful compliance with these standards.) |
| Electromagnetic Compatibility (EMC) | - 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 | "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." (Implies successful compliance with these standards.) |
| Home Healthcare Environment Use | - 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. | "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." (Implies successful compliance with these standards.) |
| Emergency Medical Services (EMS) Use | - 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. | "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." (Implies successful compliance with these standards.) |
| Ultrasonic Performance | - 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 | "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." (Implies successful compliance with this standard for ultrasonic imaging specific performance.) |
| Usability Engineering | - IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices | "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." (Implies successful completion of usability engineering processes and associated tests.) |
| Battery Safety | - 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 | "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." (Implies successful compliance with this standard for the Li-ion battery.) |
| Software Life Cycle Processes | - ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software - Software Life Cycle Processes [Including Amendment 1 (2016)] | "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." (Implies successful application of defined software life cycle processes.) |
| Biocompatibility | - ISO 10993-1 Fifth Edition 2018-08 Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process | "All materials with patient contact are biocompatible and can be disinfected." (Explicitly stated in the comparison table, confirmed via ISO 10993-1 testing, as per the Non-Clinical Testing section listing this standard.) |
| Quality Assurance Measures | - Risk Analysis, Product Specifications, Design Reviews, Verification and Validation | Quality assurance measures applied to the system design and development, confirming the processes were followed, contributing to meeting specifications. (No specific performance metrics are given, but implies internal acceptance criteria were met through these processes.) |
Information Not Available (Due to No Clinical Study Conducted)
- Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set was used for performance evaluation (only non-clinical compliance testing).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is an ultrasound system, and the submission does not mention any AI assistance features or human-in-the-loop performance studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is not an algorithm for performance evaluation.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable, as no clinical training set was mentioned or implied for performance evaluation of a clinical algorithm.
- How the ground truth for the training set was established: Not applicable.
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