(12 days)
The G20 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The G20 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. lts function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, a combination of modes, 3D imaging or Harmonic Imaging on a CRT display.
The provided document is a 510(K) summary for the Siemens SONOLINE G20 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness, rather than establishing performance against specific, quantitative acceptance criteria through new clinical efficacy studies.
Therefore, the document does not contain the following information:
- A table of acceptance criteria and the reported device performance: This submission relies on demonstrating equivalence to predicate devices, not on a new set of performance metrics.
- Sample size used for the test set and the data provenance: Clinical performance studies with test sets are not described.
- Number of experts used to establish the ground truth for the test set and their qualifications: As no specific test set is described, this information is absent.
- Adjudication method for the test set: Not applicable as there is no described test set requiring adjudication.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No such study is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a diagnostic ultrasound system, not an AI algorithm.
- The type of ground truth used: No ground truth establishment for a new performance study is described.
- The sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on:
- Intended Use: The G20 ultrasound imaging system is intended for numerous applications including General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular. It also provides measurement of anatomical structures and analysis packages for clinical diagnosis.
- Technological Comparison to Predicate Device: The device is deemed substantially equivalent to the SONOLINE Adara (K946179) and other SONOLINE G20/G50/G60 S systems (K042833, K040502, K020353). The basis for this equivalence is that "All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations."
- Compliance with Safety Standards: The device has been designed to meet several product safety standards, including UL 60601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, IEC 61157, and ISO 10993. This compliance demonstrates that the device functions safely and effectively within established industry benchmarks, which serves as a form of acceptance criteria for the safety aspects of the device.
In summary, this 510(k) submission establishes the safety and effectiveness of the G20 Diagnostic Ultrasound System by demonstrating its substantial equivalence to previously cleared predicate devices and its adherence to relevant safety and performance standards. It does not present new clinical study data with specific acceptance criteria and performance metrics for an AI/ML-based device.
§ 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.