(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics, Abdominal[1], Pediatric, Small Organ[2], Neonatal Cephalic, Adult Cephalic, Cardiac[3], Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Other[4], Transesophageal, Transrectal, Transvaginal, Intraoperative[5], Intraoperative Neurological.
The GE LOGIQ 7 is a full featured general purpose diagnostic uitrasond bystem. The user interface includes a Computer Reyboard, Specialized official and a color video CRT or LCD image display & LCD touch panel. It provides digital acquisition, processing and display capability.
The provided document is a 510(k) Premarket Notification for the GE LOGIQ 7 Ultrasound System, specifically mentioning the BT05 model and a submission date of September 2, 2005.
Acceptance Criteria and Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE LOGIQ 7 Diagnostic Ultrasound System K010329, K032182, K04181) rather than establishing novel safety and effectiveness criteria or proving performance against specific acceptance metrics derived from a study.
The core "acceptance criteria" here is that the GE LOGIQ 7 BT05 system and its associated transducers are substantially equivalent to legally marketed predicate devices with respect to safety and effectiveness. This implies that the new device performs at least as well as the predicate in its intended uses and does not raise new questions of safety or effectiveness.
The reported device performance is its conformity to safety standards and its intended uses being consistent with traditional clinical practice and FDA guidelines.
Here's a table summarizing conceptual "acceptance criteria" as implicitly stated by the 510(k) process in this context, and the reported device performance. It's crucial to understand that for a 510(k), explicit quantitative acceptance criteria for clinical performance are often not required if substantial equivalence can be demonstrated through other means (e.g., comparison of technological characteristics and safety data).
| Acceptance Criteria (Implied by 510(k) for Substantial Equivalence) | Reported Device Performance (from document) |
|---|---|
| Technological Characteristics: Comparable to predicate device. | The GE LOGIQ 7 BT05 "has the same technological characteristics" as the predicate device. It is a "full featured general purpose diagnostic ultrasound system" with digital acquisition, processing, display capability, and a user interface including a computer keyboard, specialized official (presumably "control panel" or "interface"), and a color video CRT or LCD image display & LCD touch panel. |
| Safety and Effectiveness: Key safety and effectiveness features comparable to predicate device. Does not raise new questions of safety/effectiveness. | The GE LOGIQ 7 BT05 has "the same key safety and effectiveness features" as the predicate device. It has been evaluated for: |
- Acoustic output
- Biocompatibility
- Cleaning and disinfection
- Electrical and mechanical safety
It "has been found to conform with applicable medical device safety standards." The conclusion states, "Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE LOGIQ 7 BT05 is safe and effective and substantially equivalent with respect to safety and effectiveness to devices currently cleared for market." The FDA's letter concurs with the substantial equivalence finding. |
| Intended Uses: Same as predicate device. | The GE LOGIQ 7 BT05 "has the same intended uses as the predicate device." The "Indications for Use" list a broad range of clinical applications (e.g., Fetal, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, etc.) for the main system. For the new transducers (4C, 4D3C-L, 4D10L, i739/t739), the document details "new indications" (marked with 'N') or "added under Appendix E" (marked with 'E') for specific anatomical regions and modes of operation. These are additions/expansions to previously cleared uses. |
| Basic Operating Modes: Same as predicate device. | The GE LOGIQ 7 BT05 "has the same basic operating modes as the predicate device." Various modes are listed in the "Indications for Use" tables, including B-mode, M-mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Doppler, Color M-Doppler, Power Doppler, Combined Modes, Harmonic Imaging, and Coded Pulse. |
| Design, Construction, and Materials: Comparable to predicate device. | The GE LOGIQ 7 BT05 "is of a comparable type and substantially equivalent to the predicate device... It has the same ... design, construction, and materials" as the predicate. |
| Conformity to Standards: Device conforms to applicable medical device safety standards. | The device "has been found to conform with applicable medical device safety standards." Compliance is "verified through independent evaluation with ongoing factory surveillance." The device's development process follows FDA guidelines and ISO 13485 quality systems. |
| No Clinical Tests Required (for 510(k) comparison): | The document explicitly states: "Clinical Tests: None required." This is a key finding for a 510(k) submission, indicating that the device's technological characteristics and intended uses are sufficiently similar to a predicate such that new clinical data are not deemed necessary to establish substantial equivalence. |
Study Proving Acceptance Criteria:
The document explicitly states: "Clinical Tests: None required."
Therefore, no clinical study was conducted as part of this 510(k) submission to prove the device meets specific performance criteria. The basis for safety and effectiveness is substantial equivalence to a predicate device, supported by non-clinical tests.
Given the above, the following information cannot be extracted from the provided document:
- Sample size used for the test set and the data provenance: Not applicable, as no clinical tests were performed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical tests were performed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical tests were performed.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device, and no clinical studies were performed.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is an ultrasound imaging system, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical tests were performed.
- The sample size for the training set: Not applicable, as no clinical tests were performed and this is not an AI device that would typically have a "training set."
- How the ground truth for the training set was established: Not applicable.
In summary, the GE LOGIQ 7 Ultrasound System BT05 gained clearance through the 510(k) pathway by demonstrating substantial equivalence to a previously cleared predicate device, relying on non-clinical engineering and safety testing. No clinical performance studies were required for this specific submission.
§ 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.