(8 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; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
The GE LOGIQ 7 is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 60 cm wide, 100 cm deep and 140-160 cm (adjustable) high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT and LCD touch panel. This modification will provide users with improved image enhancement.
The GE LOGIQ 7 Diagnostic Ultrasound System, BT03 is a full-featured general-purpose diagnostic ultrasound system that has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety. It has been found to conform with applicable medical device safety standards.
1. Acceptance Criteria and Reported Device Performance
The device is considered substantially equivalent to the predicate device (GE LOGIQ 7 Diagnostic Ultrasound System K010329). The acceptance criteria are essentially that the modified device (BT03) maintains the same technological characteristics, key safety and effectiveness features, physical design, construction, materials, intended uses, and basic operating modes as the predicate device. The performance is reported as conforming to these standards.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Acoustic Output | Conforms with applicable medical device safety standards |
| Biocompatibility | Conforms with applicable medical device safety standards |
| Cleaning and Disinfection Effectiveness | Conforms with applicable medical device safety standards |
| Thermal Safety | Conforms with applicable medical device safety standards |
| Electrical Safety | Conforms with applicable medical device safety standards |
| Mechanical Safety | Conforms with applicable medical device safety standards |
| Intended Uses | Consistent with traditional clinical practice and FDA guidelines |
| Design and Development Process | Conforms with 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems |
| Substantial Equivalence to Predicate Device | Same technological characteristics, key safety and effectiveness features, physical design, construction, materials, and intended uses |
2. Sample Size for Test Set and Data Provenance
No clinical tests were required for this 510(k) Special Premarket Notification. The submission explicitly states: "Clinical Tests: None required." Therefore, there is no test set sample size or data provenance information (country of origin, retrospective/prospective). The assessment of substantial equivalence relies on non-clinical tests and a comparison to the predicate device.
3. Number of Experts and Qualifications for Ground Truth
Since no clinical tests were performed, there was no test set for which ground truth needed to be established by experts.
4. Adjudication Method
Not applicable, as no clinical test data requiring adjudication was generated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done, as clinical testing was not required for this submission.
6. Standalone Performance
A standalone (algorithm-only) performance study was not indicated or performed, as the device is a diagnostic ultrasound system with improved image enhancement, rather than an AI-driven algorithm with standalone diagnostic capabilities. The evaluation was based on non-clinical tests and comparison to the predicate device.
7. Type of Ground Truth Used
The ground truth for the safety and effectiveness evaluation was primarily based on adherence to medical device safety standards, established methods of patient examination, and the characteristics of the predicate device. There was no "ground truth" derived from patient outcomes or pathology that would typically be associated with clinical studies.
8. Sample Size for Training Set
Not applicable. The device is a diagnostic ultrasound system, and the submission does not mention artificial intelligence or machine learning components that would require a "training set" in the context of an algorithm.
9. How Ground Truth for Training Set Was Established
Not applicable, as there was no training set.
§ 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.