(65 days)
The GPS-TUV device is a diagnostic ultrasound system which produces twodimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 3.0-12.5 MHZ. There is no transcranial application for this device.
The GPS-TUV Diagnostic Ultrasound System device is a PC (Computer) based and controlled real time, two-dimensional, mechancial sector and electronic array diagnostic ultrasound system which produces diagnostic ultrasonic images through a user friendly operation. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 3.0-12.5 MHZ. There are no transcranial applications for this device. User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-TUV Diagnostic Ultrasound System may be operated in M and B modes of inspection. The Perception Inc. GPS-TUV Diagnostic Ultrasound System supports M, B, M&B, Dual B and Quad B display modes. All probes currently intended for use with the Perception Inc. GPS -TUV Diagnostic Ultrasound System are either mechanical sector devices or electronic curved array, and make use of a fluid filled design.
The provided 510(k) summary for the Perception Inc. GPS-TUV Diagnostic Ultrasound System (K972973) indicates that no clinical tests were performed to establish the device's performance against acceptance criteria. The submission is a "Track 1 type submission," which relies on non-clinical tests and a comparison to predicate devices to demonstrate substantial equivalence.
Therefore, the following information is not available in the provided text:
- Acceptance criteria table and reported device performance based on clinical studies.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a test set.
- Sample size for the training set.
- How the ground truth for the training set was established.
However, the document does contain information about non-clinical tests performed to demonstrate substantial equivalence, which can be interpreted as fulfilling certain "acceptance criteria" for regulatory clearance based on NEMA and FDA guidance documents.
Summary of Non-Clinical Testing (interpreted as meeting acceptance criteria for substantial equivalence):
The device's safety and effectiveness were established through non-clinical tests and a comparison to predicate devices, rather than through direct clinical performance metrics against specific acceptance criteria in a clinical study. The relevant "acceptance criteria" for this type of submission are compliance with established standards and guidance documents.
Acceptance Criteria and Reported Device Performance (Non-Clinical Focus):
| Acceptance Criteria (based on regulatory standards/guidance) | Reported Device "Performance" (Compliance) |
|---|---|
| Acoustic Output: | |
| - NEMA 1992 (UD-2) compliance | Satisfactory testing results and compliance to applicable standards. |
| - FDA CDHR 1985 510(k) Guide compliance | Satisfactory testing results and compliance to applicable standards. |
| - Maximum Acoustic Output Information | Measured and calculated per NEMA and FDA documents. |
| - Estimated In-Situ Intensity | Measured and calculated per NEMA and FDA documents. |
| - FDA In-Situ Intensity Limits | Demonstrated compliance. |
| - Acoustic Output Information for each system/transducer/mode combination | Measured and calculated for each combination. |
| Electrical Safety & EMC: | |
| - UL-544, Third Edition compliance | Satisfactory testing results and compliance. |
| - Radiated and Conducted Emissions per CISPR 11 | Satisfactory testing results and compliance. |
| - Magnetic Field Emission per MIL-STD-482D, method RE101 | Satisfactory testing results and compliance. |
| - Electrostatic Discharge Immunity per IEC 801-2 | Satisfactory testing results and compliance. |
| - Radiated Field Immunity (3 V/m, 26 MHz to 1 GHz, 100% Square Wave Modulation) | Satisfactory testing results and compliance. |
| - Steady State Voltage Fluctuations | Satisfactory testing results and compliance. |
| - Line Voltage Dropouts | Satisfactory testing results and compliance. |
| - Slow Line Voltage Sags and Surges | Satisfactory testing results and compliance. |
| - Fast Transients Bursts per IEC 801-4 | Satisfactory testing results and compliance. |
| - Fast Line Voltage Surges | Satisfactory testing results and compliance. |
| - Conducted Energy Immunity per MIL-STD-462D, Method CS114 | Satisfactory testing results and compliance. |
| - Magnetic Field Immunity per MIL-STD-482D, Method RS101 | Satisfactory testing results and compliance. |
| - Quasi-Static Electric Field Immunity | Satisfactory testing results and compliance. |
| Overall Safety & Effectiveness: | |
| - Compliance with "FDA November 1993 Draft Reviewer Guidance for Pre-Market notification submissions, DCRND" | No design characteristics violated requirements; met all relevant testing requirements. |
Detailed breakdown of unavailable information:
- Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was mentioned. The non-clinical tests were performed on the device itself and its components.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth for a clinical test set was established. The "ground truth" for the non-clinical tests was adherence to the specified regulatory standards and guidance.
- 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. This device is an ultrasound system, not an AI-assisted diagnostic tool in the modern sense.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a clinical study. The "ground truth" for the non-clinical tests was the specified performance limits and requirements defined by NEMA, FDA, UL, CISPR, IEC, and MIL-STD standards.
- The sample size for the training set: Not applicable, as no algorithm training was described.
- How the ground truth for the training set was established: Not applicable.
Conclusion from the 510(k) Summary:
The submitter concluded that the Perception Inc. GPS-TUV Diagnostic Ultrasound System is substantially equivalent to predicate devices based on:
- Having the same intended use.
- Satisfactory results from all non-clinical testing (acoustic output, electrical safety, EMC).
- No new questions of safety or effectiveness revealed by non-clinical and biocompatibility testing.
- No significant changes in intended use, method of operation, material, or design compared to predicate devices that could affect safety or effectiveness.
- The device being a PC-based real-time 2D ultrasound system with M and B modes, supporting various display modes and covering general radiology, abdominal, cardiac, and vascular applications with specific probes (3.0-12.5 MHz).
The "study" that proves the device meets "acceptance criteria" in this context is the series of non-clinical engineering and performance tests conducted by a contract testing laboratory, which demonstrated compliance with recognized industry standards and FDA guidance for diagnostic ultrasound equipment at the time.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.