(22 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; Musculoskeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neurological).
The GE LOGIQ P5 & A5 are full-featured, general-purpose diagnostic ultrasound systems consisting of a mobile console approximately 49 cm wide, 64 cm deep and 135-141 cm high that provide digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and color video LCD display. The modification combines features of the unmodified system with additional features from other systems currently marketed by GE Healthcare to provide users with a smaller, more convenient ultrasound system.
The GE LOGIQ P5/A5 Diagnostic Ultrasound System is a general-purpose diagnostic ultrasound system. Its acceptance criteria and proof of meeting those criteria are demonstrated through substantial equivalence to a predicate device, non-clinical tests, and indications for use.
1. Table of Acceptance Criteria and Reported Device Performance
The device (GE LOGIQ P5/A5 Diagnostic Ultrasound System) is deemed substantially equivalent to its predicate device (GE LOGIQ 5 PRO diagnostic ultrasound system). This means it meets the acceptance criteria by demonstrating similar performance and safety characteristics to a device already cleared for market.
Here's a summary of the key acceptance criteria and the device's reported performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Substantial equivalence to a legally marketed predicate device (GE LOGIQ 5 PRO), implying comparable technological characteristics, safety, effectiveness, design, construction, materials, intended uses, and basic operating modes. | The GE LOGIQ P5/A5 is substantially equivalent to the GE LOGIQ 5 PRO. It shares the same technological characteristics, comparable key safety and effectiveness features, similar design, construction, and materials, and the same intended uses and basic operating modes as the predicate device. |
| Non-clinical Performance | Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety, and conformity with applicable medical device safety standards. | The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, and mechanical safety. It was found to conform with applicable medical device safety standards. Compliance is verified through independent evaluation with ongoing factory surveillance. |
| Indications for Use (General System) | Intended for use by a qualified physician for evaluation of soft tissue and blood flow in various clinical applications, including: Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult & pediatric), Peripheral Vascular, Musculoskeletal Conventional & Superficial, Urology (including prostate), Transesophageal, Transrectal, Transvaginal, Intraoperative (abdominal, thoracic, vascular, neurological). | The GE LOGIQ P5/A5 supports all the listed clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculoskeletal Conventional and Superficial, Urology, Transesophageal, Transrectal, Transvaginal, Intraoperative (abdominal, thoracic, vascular and neurological)) and various modes of operation (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, and 4D/Realtime 3D). |
| Indications for Use (Per Transducer) | Each transducer model (e.g., 3.5C, 3.5CS, 4C, 5Cs, 8C, E8C, E8Cs, BE9C Biplane, ERB Biplane, i739 or t739, 8L, 9L, 10L, 11L, 12L, 3S, 5S, 7S, 8T, 4D3C, 2D, 6D) must support specific clinical applications and modes of operation. | The provided tables for each transducer confirm specific clinical applications and modes of operation ("P" for previously cleared, "N" for new indication). For instance, the 3.5C transducer supports Fetal/Obstetrics, Abdominal, Small Organ, Peripheral Vascular, and Other (Urology) across multiple modes. These extensive lists for each transducer demonstrate broad clinical applicability. |
| Quality Systems | Design and development process of the manufacturer conforms to 21 CFR 820, ISO 9001, and 13485 quality systems. | The design and development process conforms to 21 CFR 820, ISO 9001 and 13485 quality systems. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "2. Clinical Tests: None required."
Therefore, there were no traditional "test sets" or data provenance (e.g., country of origin, retrospective/prospective) for clinical tests to prove performance against specific metrics of diagnostic accuracy or efficacy. The clearance was based on substantial equivalence and non-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical tests were required, no experts were used to establish ground truth for a clinical test set in this 510(k) submission.
4. Adjudication Method for the Test Set
As no clinical tests were performed or required, there was no adjudication method used for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed as part of this 510(k) submission. The clearance relies on substantial equivalence to a predicate device and non-clinical safety testing, not on demonstrating an improvement over human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is a diagnostic ultrasound system, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study is not applicable. The device is intended for use by a qualified physician.
7. Type of Ground Truth Used
For this submission, the "ground truth" used for proving substantial equivalence was the established safety and effectiveness of the predicate device (GE LOGIQ 5 PRO) as well as adherence to recognized medical device safety standards for non-clinical aspects. This is not derived from specific pathology, outcomes data, or expert consensus on clinical cases for the device itself, but rather a regulatory acceptance of equivalence to an already approved device.
8. Sample Size for the Training Set
Since no clinical trials or AI algorithm development necessitating a training set were conducted or described in this submission, there is no mention of a sample size for a training set.
9. How the Ground Truth for the Training Set Was Established
As no training set was used (see point 8), there is no information on how its ground truth would have been established.
§ 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.