(21 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal: Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).
The LOGIQ S7 Expert AND LOGIQ S7 Pro is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 62 cm wide, 86 cm deep and 175 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 7-inch LCD touch screen and color 19-inch LCD image display.
The provided 510(k) summary for the GE Healthcare LOGIQ S7 Expert and LOGIQ S7 Pro Ultrasound System states that no clinical studies were required to support substantial equivalence ([3], "Summary of Clinical Tests").
Therefore, this submission does not contain information regarding objective acceptance criteria, device performance from clinical studies, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to clinical outcomes.
The submission focuses entirely on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with voluntary safety standards. The new features and transducers are considered substantially equivalent if they are the same as those cleared on predicate devices (LOGIQ S8 (K131527) and LOGIQ P6 (K101874) or are new but equivalent to existing transducers ([2]).
Summary of Device Performance (as presented in the document):
The device performance is described in terms of its ability to meet various safety and technical standards, rather than clinical efficacy metrics.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance |
|---|---|
| Acoustic Output | Demonstrated to be below applicable FDA limits ([2]). Compliance with NEMA UD 3 (Real Time Display of Thermal and Mechanical Acoustic Output Indices) and NEMA UD 2 (Acoustic Output Measurement Standard) ([2]). |
| Biocompatibility | Transducer materials and other patient contact materials are biocompatible ([3]). Compliance with ISO10993-1 (Biological Evaluation of Medical Devices) ([2]). |
| Cleaning and Disinfection Effectiveness | Evaluated and found to conform to applicable medical device safety standards ([2]). |
| Thermal, Electrical, Electromagnetic, and Mechanical Safety | Evaluated and found to conform to applicable medical device safety standards ([2]). Compliance with AAMI/ANSI ES60601-1 (Medical Electrical Equipment - General Requirements for Safety), IEC60601-1-2 (EMC Requirements), IEC60601-2-37 (Ultrasonic Medical Diagnostic and Monitoring), and ISO14971 (Risk Management) ([2]). |
| Imaging Capabilities, Technological Characteristics, Safety, and Effectiveness for Intended Use | Deemed "substantially equivalent" to predicate devices LOGIQ S7, LOGIQ S8 (K131527), and LOGIQ P6 (K101874) ([1], [2]). This includes the same fundamental scientific technology, clinical intended use (with Transesophageal being equivalent to LOGIQ S8), imaging modes, and similar capabilities for measurements, digital image capturing, reviewing, and reporting studies ([1], [2]). |
| Software Features (AutoEF, Autosweep, Breast Measure Assistant, OB Measure Assistant, Compare Assistant, Preset Manager) | These new software features are "the same features cleared on predicate LOGIQ S8 (K131527)" ([2]). |
Details of the "Study" (Demonstration of Substantial Equivalence):
As no clinical studies were performed, the "study" described in the document is a non-clinical comparison to predicate devices and adherence to recognized standards.
- 1. A table of acceptance criteria and the reported device performance: See the table above. The acceptance criterion is "compliance with standards" and "substantial equivalence" to predicate devices.
- 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set was used. The demonstration of safety and effectiveness was based on engineering testing, comparison to predicate devices, and compliance with standards.
- 3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. No clinical ground truth was established for the purpose of this 510(k) submission.
- 4. Adjudication method for the test set: Not applicable.
- 5. 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 document pertains to an ultrasound system, not an AI-assisted diagnostic tool for human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is an ultrasound imaging system, not a standalone algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical studies were required or performed.
- 8. The sample size for the training set: Not applicable. This device is an ultrasound system, not an AI/ML algorithm that undergoes training in the context of this submission.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.