(23 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; 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 image enhancement.
The GE LOGIQ 9 Diagnostic Ultrasound System (K030934) is a general-purpose ultrasound system. The provided document does not contain acceptance criteria or a study proving the device meets said criteria. Instead, it is a 510(k) premarket notification for a predicate device.
The document indicates that no clinical tests were required for this submission. The basis for clearance is substantial equivalence to a previously cleared device (GE LOGIQ 9 K011188). This means the device is considered safe and effective because its technological characteristics, safety features, physical design, construction, intended uses, and basic operating modes are comparable to a device already on the market.
Therefore, the following information outlines the lack of specific acceptance criteria or a dedicated study within this document, as per the 510(k) process for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
Rationale: The 510(k) submission for the GE LOGIQ 9 BT03 is based on substantial equivalence to an already marketed device (GE LOGIQ 9, K011188) and not on meeting specific, pre-defined performance acceptance criteria through a clinical study. The submission states, "The GE LOGIQ 9 BT03 is of a comparable type and substantially equivalent to the current GE LOGIQ 9. It has the same technological characteristics, key safety and effectiveness features, physical design, construction, and has the same intended uses and basic operating modes as the predicate device."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. No dedicated clinical test set was used for this submission.
- Data Provenance: Not applicable. No clinical data was generated for this specific submission to prove effectiveness. The claim is based on the known performance and safety of the predicate device and the general understanding of diagnostic ultrasound.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. No clinical test set requiring expert ground truth was established for this submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No.
- Effect Size of Human Readers with AI vs. without AI Assistance: Not applicable, as this is an ultrasound system and not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study Done: No. This is not an algorithm-only device. Its performance is intrinsically tied to human operation and interpretation.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- Type of Ground Truth: Not applicable. The submission relies on the established safety and effectiveness of the predicate device and scientific literature regarding diagnostic ultrasound in general. The document explicitly states: "Diagnostic ultrasound has accumulated a long history of safe and effective performance."
8. Sample Size for the Training Set:
- Sample Size: Not applicable. As this device is not an AI/ML algorithm requiring a training set, this information is irrelevant.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable. No training set was used.
Summary of the Study (or lack thereof) that Proves the Device Meets Acceptance Criteria:
The GE LOGIQ 9 BT03 Diagnostic Ultrasound System's acceptance for marketing clearance (K030934) by the FDA was based on a premarket notification (510(k)) asserting substantial equivalence to a predicate device (GE LOGIQ 9, K011188).
The submission explicitly states: "Clinical Tests: None required."
The manufacturer, GE Medical Systems, argued that the GE LOGIQ 9 BT03 is substantially equivalent to the current GE LOGIQ 9 because it has:
- The same technological characteristics.
- The same key safety and effectiveness features.
- The same physical design and construction.
- The same intended uses and basic operating modes.
In lieu of specific clinical performance data, the submission emphasizes that:
- The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, conforming to applicable medical device safety standards.
- Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines.
- The manufacturer's design and development process conforms with 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems.
- Diagnostic ultrasound, as a modality, has a long history of safe and effective performance.
Therefore, the "study" that proves this device meets "acceptance criteria" (in the context of a 510(k)) is the demonstration of its substantial equivalence to a legally marketed predicate device, rather than a clinical trial with specific performance endpoints. The FDA's clearance indicates their agreement that the new device does not raise new questions of safety or effectiveness compared to the predicate.
§ 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.