(112 days)
TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric , small organ,neonatal and adult cephalic, musculo-skeletal(Conventional and Superficial), thoracic/pleural (For detection of fluid and pleural motion/sliding,), adult and pediatric cardiac, Peripheral vessel and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PWD, Color Doppler, Power Doppler, Combined mode (Color+B, Power+B), Tissue Harmonic Imaging, and TDI.
The TE Air Diagnostic Ultrasound System is a general purpose, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode (Color+B, Power+B), Tissue Harmonic Imaging, and TDI mode.
TE Air consists of an app which can be installed on iOS or Android devices, and probes which use wireless technology for communication.
This system is a Track 3 device that employs phased array probes.
This FDA 510(k) summary does not contain information about specific acceptance criteria or a study proving the device meets those criteria. Instead, it describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence without requiring clinical studies.
Here's a breakdown of the information that is and is not available in the provided text, based on your request:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting specific performance acceptance criteria for a novel algorithm or diagnostic capability.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not available. Since no clinical studies were performed to prove the device meets acceptance criteria, there is no test set sample size or data provenance to report. The submission states, "Not applicable. The subject of this submission, TE Air Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not available. As no clinical studies were conducted, no ground truth was established by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available. No test set was used in clinical studies.
5. 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/Not available. No clinical studies, including MRMC studies, were performed. The device is a general-purpose diagnostic ultrasound system, and the submission does not mention AI assistance for human readers or report any effect sizes. The new software options listed (iNeedle, Smart Calc, iWorks, iScanHelper, iTouch+, B-Hist) are functions cleared in predicate devices, not necessarily AI-driven assistance that would typically be evaluated in an MRMC study for improved reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not available. No standalone performance study was conducted. The device is a diagnostic ultrasound system, implying human operation and interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not available. Since no clinical studies were performed, no ground truth was established or used.
8. The sample size for the training set
- Not applicable/Not available. The submission does not describe any training sets or machine learning models that would require one. The modifications primarily involve adding new intended uses and transducers, and incorporating software options already cleared in predicate devices, rather than a new AI algorithm requiring a dedicated training set.
9. How the ground truth for the training set was established
- Not applicable/Not available. As no training set is discussed, no ground truth establishment method for it is provided.
Summary of Device and Substantial Equivalence Justification:
The document is a 510(k) summary for the TE Air Diagnostic Ultrasound System (K240906). The submission aims to demonstrate substantial equivalence to a primary predicate device, the TE Air Diagnostic Ultrasound System (K231685), and several reference devices (Consona N9, MX7, Butterfly iQ).
The proposed device, K240906, introduces several modifications:
- New intended uses: Small organ, musculo-skeletal (Conventional and Superficial), and peripheral vessel exams, which have been cleared in the predicate Butterfly iQ (K202406).
- New transducers: z3P, z3Ps, z3Pt, e3P, e3Ps, e3Pt, a3Px, i5M, z5M, z5Ms, z5Mt, e5M, e5Ms, e5Mt, a5Mx.
- New software options: iNeedle, Smart Calc, iWorks, iScanHelper, iTouch+, B-Hist (Ellipse), B-Hist (Trace), B-Hist (Spline), B-Hist (Rectangle), which have been cleared in the predicate Consona N9 (K221300).
- Operating System update: Android 9 to Android 10.
The substantial equivalence is argued based on:
- Similar technological characteristics to predicate devices.
- Comparable key safety and effectiveness features.
- Same intended uses and basic operating modes (with the added intended uses cleared in another predicate).
- All systems transmit ultrasonic energy, perform post-processing, and allow for specialized measurements.
- Acoustic power levels of the subject device are below FDA limits, similar to the predicate TE Air (K231685).
- The software app and use of a mobile device screen are similar to the cleared TE Air (K231685).
- OS changes passed related bench tests with no safety risk.
Non-clinical tests were performed for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, conforming to applicable medical safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, ISO 10993-1, IEC 62366-1, IEC 60601-1-6).
No clinical studies were deemed necessary to support substantial equivalence for this device.
§ 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.