(98 days)
The LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 are general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability and clinical applications including: Abdominal, Obstetrical, Gynecological, Small parts, Vascular, Adult Cephalic, Pediatric, Musculoskeletal, Transcranial, Neonatal Cephalic, Transvaginal, Cardiac, Transrectal, and Tissue Biopsy/Fluid Drainage,
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
The LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 are entry level ultrasound scanners from the LOGIQ family for private clinics focusing on OB/GYN. The systems are for general purpose imaging and analysis providing real-time digital acquisition, processing and display capability intended for general radiology imaging, evaluation with some cardiology and vascular applications, and providing guidance during tissue biopsy and fluid drainage procedures. The track 3 systems consist of a mobile console with keyboard control panel; color display and optional image storage, wireless capability, and printing devices. They utilize a variety of linear, curved linear and matrix phased array transducers. The systems have the same hardware and software but may have different options available.
The document is a 510(k) premarket notification for the GE Medical Systems Ultrasound and Primary Care Diagnostics LLC LOGIQ V5 Expert, LOGIQ V5, and LOGIQ V3 ultrasound systems.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3 systems comply with several voluntary standards for safety and performance. These standards serve as the acceptance criteria for the device. The reported device performance is that the systems meet these standards.
| Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|
| AAMI/ANSI ES 60601-1 (Medical Electrical Equipment - General Requirements for Safety, 2005) | Conforms to standard |
| IEC 60601-1-2 (Medical Electrical Equipment Part 1-2: Electromagnetic Compatibility Requirements and Tests, 2007) | Conforms to standard |
| IEC 60601-2-37 (Medical Electrical Equipment Part 2-37: Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007) | Conforms to standard |
| NEMA UD 3 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, 2004) | Acoustic power levels below applicable FDA limits |
| ISO 10993-1 (Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing, 2009) | Transducer and patient contact materials are biocompatible |
| NEMA UD 2 (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, 2004) | Conforms to standard |
| ISO 14971 (Application of risk management to medical devices, 2007) | Risk analysis applied during development |
| NEMA, PS 3.1 3.20 (2011) (Digital Imaging and Communications in Medicine (DICOM) Set) | Conforms to standard |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "The subject of this premarket submission, LOGIQ V5 Expert / LOGIQ V5 / LOGIQ V3, did not require clinical studies to support substantial equivalence." This indicates that there was no specific clinical "test set" in the traditional sense, and therefore no associated sample size or data provenance from clinical testing for this specific submission. The majority of the comparisons are based on predicate devices and compliance with recognized standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
As no clinical studies were required, there were no experts used to establish ground truth for a clinical test set in this submission. The "ground truth" for demonstrating substantial equivalence relied on compliance with engineering and safety standards, and comparison to already cleared predicate devices.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. The document explicitly states that clinical studies were not required. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through technical comparisons and compliance with standards, not comparative effectiveness with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
This device is an ultrasound imaging system, which inherently involves a human operator (sonographer/clinician) to acquire and interpret the images. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable in the context of this device. The performance is tied to the integrated system and its ability to produce diagnostic quality images for human interpretation.
7. Type of Ground Truth Used:
The "ground truth" for demonstrating substantial equivalence in this submission is primarily based on:
- Compliance with recognized industry standards: (e.g., AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 3, ISO 10993-1, NEMA UD 2, ISO 14971, NEMA, PS 3.1 3.20).
- Technical comparison to predicate devices: Proving that the new device has the same or similar intended use, technology, probes, and performance as devices already cleared by the FDA.
8. Sample Size for the Training Set:
Not applicable. This is a medical imaging device, not an AI/ML algorithm that requires a "training set" in the context of data-driven learning. The development process involved traditional engineering design, testing, and verification against specifications and standards.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this type of device. The verification and validation process involved:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use Testing (Validation)
These measures aim to ensure the device performs according to its specifications and meets safety and efficacy requirements, derived from established engineering principles and regulatory standards.
§ 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.