(30 days)
The LOGIQ 500 with Harmonic Imaging is a general purpose utrasound imaging system intended for use in the evaluation of soft tissue and vascular disease in the head, neck, chest, abdomen, pelvis, male and female reproductive organs, limbs and pregnant uterus. Specific indications are: fetal, abdominal, pediatric, small organ, cephalic, cardiac, transesophageal, transvaginal, peripheral vascular, intra-operative, neurological, and musculo-skeletal.
The LOGIQ 500 with Harmonic Imaging is a mobile console approximately 53 cm wide, 94 cm deep and 130 cm high equipped with a keyboard control panel, small A/N display panel, color video display monitor, assorted transducers and optional image storage or hard-copy devices. Harmonic imaging enhances or highlights the imaging of nonlinear tissue characteristics and contrast media.
Here’s an analysis of the acceptance criteria and study information based on the provided text, using the specified format.
GE LOGIQ 500 with Harmonic Imaging Modification
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety: | The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. A postclearance special report containing complete information, including acoustic output measurements based on production line devices, is required to be submitted to the FDA. |
| Effectiveness: | Harmonic imaging is implemented with conventional digital image processing technology. Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The device is considered substantially equivalent to the currently marketed GE LOGIQ 500 (predicate device) in terms of technological characteristics, key safety and effectiveness features, design, construction, materials, intended uses, operating modes, and transducers. The indications for use for the LOGIQ 500 with Harmonic Imaging are consistent with those previously cleared for the LOGIQ 500, with specific additions for certain transducers (S222, S317, and C358) across various clinical applications and modes of operation (e.g., Abdominal, Adult Cephalic, Cardiac, Other for S222; Abdominal, Cardiac for S317). |
| Quality System: | The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 9001 & EN 46001 quality system standards. |
| **Substantial ** | The GE LOGIQ 500 with Harmonic Imaging is of a comparable type and substantially equivalent to the currently marketed GE LOGIQ 500. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same design, construction, and materials, and has the same intended uses, operating modes and transducers as the predicate device. Diagnostic ultrasound has accumulated a long history of safe and effective performance. The FDA reviewed the 510(k) and determined the device is substantially equivalent for the indications for use stated to legally marketed predicate devices. Key transducers (C358, S317, S222) were also determined to be substantially equivalent for their described uses. |
| Equivalence: |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The submission states "Clinical Tests: None required." The assessment for this device was based on non-clinical tests (acoustic output, biocompatibility, thermal, electrical, and mechanical safety) and a comparison to a predicate device.
- Data Provenance: Not applicable, as no clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication method for the test set:
- Not applicable, as no clinical test set was used.
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:
- No MRMC comparative effectiveness study was done. This device is an ultrasound system with a "Harmonic Imaging" modification, not an AI-assisted diagnostic tool.
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 an algorithm, and its performance inherently involves a human operator for image acquisition and interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable, as no clinical ground truth was established or used for performance evaluation in this 510(k) submission. The primary ground for acceptance was substantial equivalence to a predicate device and compliance with safety standards.
8. The sample size for the training set:
- Not applicable, as this is an ultrasound system and not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable, as no training set was used.
§ 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.