(27 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).
The Voluson E8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 57 cm wide, 96 cm deep and 149 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10 inch LCD touch screen and color 15 inch LCD image display. This modification will provide users with additional probe options, improved user interface and overall quality and image enhancement.
The acceptance criteria and study information for the GE Voluson E8 Diagnostic Ultrasound System are outlined below based on the provided document.
Acceptance Criteria and Device Performance
The GE Voluson E8 Diagnostic Ultrasound System is considered substantially equivalent to its predicate device, the GE Voluson 730 Pro/Expert. The primary acceptance criteria for this 510(k) submission revolve around demonstrating this substantial equivalence in terms of safety and effectiveness, particularly with additional probe options, improved user interface, and overall quality/image enhancement.
Since this is a 510(k) submission for an ultrasound system, the device performance is demonstrated by its adherence to established safety standards and its ability to perform diagnostic imaging across a range of clinical applications and operating modes, as defined by its "Indications for Use" statement. The "reported device performance" is essentially that the device meets these indications for use and safety standards.
The tables below synthesize the acceptance criteria (defined by the new and previously cleared indications for use) and the reported device performance, which is documented as fulfilling these indications. "P" indicates previously cleared indications (met by the predicate and thus an acceptance criterion for the new device), "N" indicates new indications (also met by the new device), and "E" indicates expanded indications (existing indications on the predicate with added modes, also met by the new device).
General Acceptance Criteria Table (Across all transducers)
| Acceptance Criteria (Indications for Use - Clinical Application & Modes) | Reported Device Performance (Meets Criteria) |
|---|---|
| Fetal/Obstetrics (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging Mode, Biopsy Guidance, Infertility Monitoring) | Yes |
| Abdominal (including GYN, pelvic, renal, urology) (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging Mode, Biopsy Guidance) | Yes |
| Pediatric (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging Mode, Biopsy Guidance) | Yes |
| Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients) (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging Mode, Biopsy Guidance) | Yes |
| Neonatal Cephalic (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging Mode) | Yes |
| Adult Cephalic (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse) | Yes |
| Cardiac (adult and pediatric) (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging Mode) | Yes |
| Peripheral Vascular (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging Mode, Biopsy Guidance) | Yes |
| Musculo-skeletal Conventional (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging Mode, Biopsy Guidance) | Yes |
| Musculo-skeletal Superficial (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging Mode, Biopsy Guidance) | Yes |
| Transvaginal (B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging Mode, Biopsy Guidance) | Yes |
| Transrectal (including urology/prostate) (B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging Mode, Biopsy Guidance) | Yes |
| Intraoperative (B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging Mode) | Yes |
| Intraoperative Neurological (B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging Mode) | Yes |
| Conformity with applicable medical device safety standards (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, mechanical safety) | Yes |
| Design and development process conforms with 21 CFR 820, ISO 9001, and ISO 13485 quality systems. | Yes |
Note: The detailed tables for each transducer (RAB2-5-D, RAB4-8-D, RIC5-9-D, RNA5-9-D, RRE6-10-D, AB2-7-D, 4C-D, IC5-9-D, PA6-8-D, SP10-16-D, RSP6-16-D, RIC6-12-D, RAM3-8, RSM5-14, 9L-D, M12LW, 3S-D, P2D, P6D, M6C, 11L-D) would essentially list "Yes" for all "P", "N", and "E" marks within the corresponding clinical applications and operating modes shown in the document. Due to the extensive nature of these individual transducer tables, a consolidated representation of the types of criteria and the overall performance confirmation is provided above.
Study Details
The provided document explicitly states: "2. Clinical Tests: None required."
This indicates that the submission relies on demonstrating substantial equivalence to a predicate device (GE Voluson 730 Pro/Expert) through non-clinical means and historical data regarding the safe and effective performance of diagnostic ultrasound, rather than requiring new clinical trials. Therefore, much of the requested information about test sets, ground truth, and expert evaluation for a clinical study is not applicable.
Here's a breakdown of the specific points based on the document:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No clinical test set or patient data was used as clinical tests were not required. The device's performance is extrapolated from its predicate and adherence to engineering and safety standards.
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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. No clinical test set requiring expert ground truth was utilized.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 is a submission for a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a diagnostic ultrasound system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical test set. The "ground truth" for this submission are the established safety and performance characteristics of legally marketed predicate ultrasound devices and the adherence to relevant medical device safety standards.
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The sample size for the training set: Not applicable. No training set for an algorithm was used as this is a device submission focused on substantial equivalence via engineering, safety, and performance characteristic comparison.
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How the ground truth for the training set was established: Not applicable.
§ 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.