Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional and Superficial, Urology (including prostate), Transvaginal, and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
The GE LOGIQ 9 is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 64 cm wide, 90 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 display. This modification will provide users with additional probe options, improved user interface and productivity.
GE LOGIQ 9 Ultrasound System with BT04 Modification
1. Table of Acceptance Criteria and Reported Device Performance
This document primarily focuses on the substantial equivalence of the GE LOGIQ 9 BT04 to existing predicate devices and the expansion of its indicated uses with new transducers. The "acceptance criteria" here are implicitly defined by the FDA's criteria for substantial equivalence, which primarily revolve around demonstrating that the modified device is as safe and as effective as legally marketed predicate devices. The "reported device performance" is essentially the claim of substantial equivalence and the expansion of indications.
| Acceptance Criteria Category | Specific Criteria/Requirement | Reported Device Performance | Evidence/Justification |
|---|---|---|---|
| Technological Characteristics | "Same technological characteristics" as predicate device. | The GE LOGIQ 9 BT04 has "the same technological characteristics" as the current GE LOGIQ 9 and GE Voluson. | Stated in Section b) 6. Comparison with Predicate Device. |
| Safety and Effectiveness | "Key safety and effectiveness features" are same as predicate. | The GE LOGIQ 9 BT04 has "key safety and effectiveness features" as the current GE LOGIQ 9 and GE Voluson. | Stated in Section b) 6. Comparison with Predicate Device. |
| Physical Design, Construction, Materials | "Same physical design, construction, and materials" as predicate device. | The GE LOGIQ 9 BT04 has "the same physical design, construction, and materials" as the current GE LOGIQ 9 and GE Voluson. | Stated in Section b) 6. Comparison with Predicate Device. |
| Intended Uses/Basic Operating Modes | "Same intended uses and basic operating modes" as predicate device. | The GE LOGIQ 9 BT04 has "the same intended uses and basic operating modes" as the current GE LOGIQ 9 and GE Voluson, with new indications for specific transducers. | Stated in Section b) 6. Comparison with Predicate Device, and detailed in the Intended Use tables for each transducer. |
| Non-clinical Safety Conformity | Conforms to applicable medical device safety standards for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, and mechanical safety. | The device has been evaluated and found to conform with applicable medical device safety standards in these areas. | Stated in Section b) 1. Non-clinical Tests. |
| Quality Systems | Manufacturer conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems. | The manufacturer's design and development process conforms to these quality systems. | Stated in Section b) 3. Conclusion. |
| Clinical Practice Consistency | Intended uses and key features are consistent with traditional clinical practice and FDA guidelines. | Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. | Stated in Section b) 3. Conclusion. |
| Post-market Requirements (for new transducers) | Submission of a post-clearance special report containing complete information, including acoustic output measurements based on production line devices. | Condition for market clearance for new transducers (4D3C, 4D10L, 4DE7C, P8D). | Stated in the FDA 510(k) clearance letter. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set data is provided in this submission, as the device was deemed to not require clinical tests for its 510(k) clearance.
- Data Provenance: Not applicable, as no clinical test data was submitted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. No clinical test data was submitted.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test data was submitted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The submission explicitly states, "Clinical Tests: None required." The clearance is based on substantial equivalence to predicate devices and non-clinical testing.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
- Not applicable. This document describes an ultrasound imaging system, not an AI or algorithm-only device requiring standalone performance evaluation. The "device" is the ultrasound machine itself, intended for use by a qualified physician.
7. Type of Ground Truth Used
- Not applicable. No clinical data with ground truth was used for this 510(k) submission, as clinical tests were not required. The "ground truth" for demonstrating safety and effectiveness relied on comparison to established predicate devices and non-clinical engineering evaluations against safety standards.
8. Sample Size for the Training Set
- Not applicable. This submission does not pertain to an AI/ML algorithm or device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This submission does not pertain to an AI/ML algorithm or device that would require a 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.