(84 days)
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Ophthalmic, Fetal / Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Other.
Exam Type, Means of Access: Transesophageal, Transrectal, Transvaginal, Transuretheral, Intraoperative, Intraoperative Neurological, Intravascular, Laparoscopic.
The subject device consists of a mobile console with keyboard. specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications. The device is a general-purpose ultrasound system.
The GE Healthcare Voluson S6, Voluson S8 Ultrasound System did not require a clinical study to support its substantial equivalence. The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, electromagnetic, and mechanical safety, and found to conform to applicable medical device safety standards. The manufacturer asserts that its performance is substantially equivalent to predicate devices.
Summary of Non-Clinical Tests and Quality Assurance Measures:
- Non-Clinical Tests: Acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety.
- Voluntary Standards Conformance: The device and its applications comply with voluntary standards detailed in Sections 9, 11, and 17 of the premarket submission.
- Quality Assurance Measures:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Unit level testing (Module verification)
- Integration testing (System verification)
- Final Acceptance Testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification)
- Biocompatibility: Transducer materials and other patient contact materials are biocompatible.
Information Not Available in the Provided Text:
- A table of acceptance criteria and reported device performance (beyond the summary that it conforms to standards).
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers with AI assistance.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How the ground truth for the training set was established.
§ 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.