(71 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/OB: Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatic); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional; Transrectal; and Transvaginal.
The GE LOGIQ Book BT03 is a compact and portable diagnostic ultrasound system with integrated keyboard, LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 35 cm wide, 28 cm deep and 8 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard with an intuitive layout of imaging controls, track-ball, color GUI display and Doppler audio.
The GE LOGIQ Book BT03 Ultrasound System, as described in K032477, is a diagnostic ultrasound system. It is important to note that this 510(k) pertains to a traditional submission for an ultrasound system, which relies on demonstrating substantial equivalence to a predicate device rather than on performance against specific acceptance criteria derived from a novel clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
For ultrasound systems cleared through a 510(k), acceptance criteria are typically met through a demonstration of substantial equivalence to a legally marketed predicate device, adherence to medical device safety standards, and verification of device specifications. "Performance" in this context refers to the device's adherence to those standards and its comparability to the predicate.
| Acceptance Criteria Category | Specific Criteria (Implicit from 510(k) and general ultrasound device requirements) | Reported Device Performance (Summary from K032477) |
|---|---|---|
| Substantial Equivalence | Comparable technological characteristics, design, construction, and materials to predicate device (GE LOGIQ Book, K014206). | The GE LOGIQ Book BT03 is "of a comparable type and substantially equivalent to the currently marketed GE LOGIQ Book. It has the same technological characteristics of design, construction, and materials; is comparable in key safety and effectiveness features." |
| Safety Standards | Conformance with applicable medical device safety standards for acoustic output, biocompatibility, thermal, electrical, and mechanical 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." |
| Quality System Compliance | Design and development process conforms with 21 CFR 820 Quality System Regulation and ISO 9001 & ISO 13485 quality system standards. | "The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 9001 & ISO 13485 quality system standards." |
| Intended Use | The device's clinical applications and modes of operation align with those previously cleared or being introduced for the first time as equivalent. | The system is a "general purpose ultrasound system" with specific clinical uses including Fetal/OB, Abdominal, Pediatric, Small Organ, Neonatal and Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal, Transrectal, and Transvaginal. The detailed "Indications for Use Forms" for the system and each transducer (3C-RS, 8C-RS, E8C-RS, 10LB-RS, 12L-RS, 8L-RS, 3S-RS) specify the modes of operation (B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse) available for each clinical application, indicating which are "P" (previously cleared) or "N" (new indication) or "E" (added under Appendix E). |
| Post-Clearance Requirement | Submission of a postclearance special report with complete information, including acoustic output measurements based on production line devices. | FDA approval is granted "on the condition that prior to shipping the first device, you submit a postclearance special report... contain complete information, including acoustic output measurements based on production line devices." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary explicitly states: "Clinical Tests: None required." This indicates that no new clinical study was conducted with a specific "test set" in the traditional sense for the purpose of demonstrating performance against acceptance criteria for this 510(k) submission. The device's performance was largely demonstrated through engineering and safety testing, and its substantial equivalence to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As no clinical tests were required or conducted as part of this 510(k) submission, there was no "test set" and consequently no experts used to establish ground truth for such a set.
4. Adjudication Method for the Test Set
Since no clinical tests were required or conducted, no adjudication method was used for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was mentioned or indicated as being performed for this 510(k) submission. Therefore, no effect size of human readers improving with or without AI assistance can be determined from this document.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This submission is for a diagnostic ultrasound system, which is an imaging device. It does not describe an AI algorithm or software intended for standalone diagnostic performance. Therefore, no standalone algorithm-only performance study was conducted.
7. The Type of Ground Truth Used
As no clinical studies were performed, there was no ground truth (expert consensus, pathology, or outcomes data) established for a test set for this 510(k). The regulatory pathway relied on demonstrating substantial equivalence to a predicate device and adherence to safety standards, rather than proving efficacy through clinical outcome measures from a new study.
8. The Sample Size for the Training Set
Since no AI algorithm's performance was being evaluated in this submission, there was no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
As there was no AI training set, no ground truth was established for it.
§ 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.