(14 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal conventional, Transrectal; and Transvaginal.
The GE LOGIQ Twin is a compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.
The GE LOGIQ Twin Diagnostic Ultrasound System is a compact and portable diagnostic ultrasound system. Device performance and acceptance criteria are defined by substantial equivalence to a predicate device, the GE LOGIQ Book Diagnostic Ultrasound System (K014206 and K032477).
1. Table of Acceptance Criteria & Reported Device Performance
| Acceptance Criteria (Set by Substantial Equivalence to Predicate Device) | Reported Device Performance (GE LOGIQ Twin) |
|---|---|
| Same technological characteristics of design, construction, and materials as predicate device (GE LOGIQ Book K014206, K032477) | Confirmed. Device is a compact and portable unit having the same technological characteristics of design, construction, and materials as the predicate device. |
| Comparable in key safety features to predicate device | Confirmed. Evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical and mechanical safety. Found to conform with applicable medical device safety standards. |
| Comparable in key effectiveness features to predicate device | Confirmed. Key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. |
| Same intended uses as predicate device | Confirmed. Intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal conventional, Transrectal; and Transvaginal. |
| Conformance with 21 CFR Part 820 (Quality System Regulation) | Confirmed. Design and development process conforms with 21 CFR 820. |
| Conformance with ISO 9001 and ISO 13485 quality systems | Confirmed. Design and development process conforms with ISO 9001 and ISO 13485. |
| Conforms to applicable medical device safety standards | Confirmed. Compliance verified through independent evaluation with ongoing factory surveillance. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is specified in the provided document for the substantial equivalence claim. The performance is assessed by comparison to the predicate device and adherence to industry standards, rather than direct performance metrics against a defined dataset.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The study is based on substantial equivalence to a predicate device and conformance to safety and quality standards, not on expert-adjudicated test sets for performance metrics.
4. Adjudication Method for the Test Set
Not applicable. No specific test set adjudication method is mentioned as a clinical study on a defined test set was not performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission explicitly states "Clinical Tests: None required."
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (ultrasound system), not an algorithm or AI. Performance is assessed on its capabilities comparable to existing cleared devices and adherence to safety standards, not standalone algorithm performance.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by the safety and effectiveness of the legally marketed predicate device (GE LOGIQ Book Diagnostic Ultrasound System, K014206 and K032477) and conformance to recognized safety and quality standards (e.g., medical device safety standards, 21 CFR 820, ISO 9001, ISO 13485). It is not based on a specific clinical ground truth from patient data like pathology or outcomes.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set for an algorithm was used.
§ 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.