(57 days)
TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, pediatric , thoracic/pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, neonatal and adult cephalic, 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, Amplitude 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 devices, and probes which use wireless technology for communication.
This system is a Track 3 device that employs phased array probes.
The provided FDA 510(k) summary for the TE Air Diagnostic Ultrasound System explicitly states "Not applicable. The subject of this submission, TE Air Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." Therefore, no clinical study was conducted to prove the device meets acceptance criteria.
The submission relies on non-clinical tests to demonstrate substantial equivalence to predicate devices. These non-clinical tests include acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, conforming to applicable medical safety standards.
Below is a table summarizing what would typically be included if clinical performance data were available, based on the information provided, or indicating its absence.
Acceptance Criteria and Device Performance (Based on Non-Clinical Assessment):
| Acceptance Criterion Type | Reported Device Performance |
|---|---|
| Acoustic Output Safety | Below the limits of FDA. |
| Biocompatibility | Evaluated to conform with ISO 10993-1. |
| Cleaning and Disinfection Effective. | Evaluated for effectiveness. |
| Thermal Safety | Evaluated to conform with AAMI / ANSI ES60601-1 and IEC 60601-2-37. |
| Electrical Safety | Evaluated to conform with AAMI / ANSI ES60601-1 and IEC 60601-2-37. |
| Mechanical Safety | Evaluated to conform with AAMI / ANSI ES60601-1 and IEC 60601-2-37. |
| Electromagnetic Compatibility (EMC) | Evaluated to conform with IEC 60601-1-2. |
| Software Life Cycle Processes | Evaluated to conform with IEC 62304. |
| Risk Management | Evaluated to conform with ISO 14971. |
| Usability Engineering | Evaluated to conform with IEC 62366-1 and IEC 60601-1-6. |
| Clinical Performance (Accuracy, Sensitivity, Specificity, etc.) | Not evaluated through clinical studies for substantial equivalence. |
Absence of Clinical Study Information:
- Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used to assess performance for substantial equivalence.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set was used to establish ground truth for performance assessment.
- Adjudication method for the test set: Not applicable, as no clinical test set was used.
- 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, as no MRMC study or AI assistance performance evaluation was described. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of clinical decision support.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as no standalone algorithm performance was assessed for clinical endpoints.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth was established for performance assessment.
- The sample size for the training set: Not applicable, as no clinical training set was described for performance assessment.
- How the ground truth for the training set was established: Not applicable, as no clinical training set was described.
Summary of the FDA's Stance:
The FDA determined that the TE Air Diagnostic Ultrasound System is "substantially equivalent" to legally marketed predicate devices based on its similar technological characteristics, comparable key safety and effectiveness features (as demonstrated by non-clinical tests), and identical intended uses and basic operating modes. This determination did not require clinical studies to support substantial equivalence in this specific case.
§ 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.