(14 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; Adult 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 LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86 cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user includes a computer keyboard. specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display. This modification will provide users with additional probe options, additional software options (V Nav and Scan Assistant) leading to overall quality and image enhancement. The LOGIQ E9 Diagnostic Ultrasound System is initially released with the following 13 probes: S1-5, C1-5-D, 3CRF, 9L-D, 11L-D, IC5-9-D, M4S-D, M6C-D, ML6-15-D, RAB2-5-D, RIC5-9-D, RNA5-9-D, RSP6-16-D.
The GE LOGIQ E9 Diagnostic Ultrasound System is a general-purpose diagnostic ultrasound system. Its acceptance criteria and proof of meeting those criteria are established through a predicate device comparison rather than specific performance metrics like sensitivity or specificity.
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the GE LOGIQ E9 Diagnostic Ultrasound System is Substantial Equivalence to a legally marketed predicate device, specifically the GE LOGIQ BT08 Diagnostic Ultrasound System (K073408).
The reported device performance, which supports this acceptance criterion, is based on the claim that the GE LOGIQ E9:
- Has the same technological characteristics as the predicate device.
- Possesses key safety and effectiveness features similar to the predicate device.
- Is similar in physical design, construction, and materials to the predicate device.
- Has the same intended uses and basic operating modes as the predicate device.
- Conforms with applicable medical device safety standards (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety).
- Its design and development process conform to 21 CFR 820, ISO 9001, and ISO 13485 quality management systems.
The FDA's letter (Attachment {2}) confirms this determination of substantial equivalence.
Study Information
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Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. The document explicitly states: "Clinical Tests: None required" (Attachment {1}). The device's substantial equivalence is based on non-clinical tests and comparison to a predicate device, not on clinical performance metrics derived from a test set of patient data.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. As no clinical tests were required or performed to establish novel performance claims, there was no test set requiring ground truth established by experts for performance evaluation.
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Adjudication Method for the Test Set:
- Not Applicable. No clinical test set was utilized.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. No MRMC study was conducted. The clearance is based on substantial equivalence to a predicate device, not on demonstrating improved human reader performance with or without AI assistance.
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Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- Not Applicable. This device is an ultrasound system, not an AI algorithm. Its performance is inherent in its hardware and software for image acquisition and display, which are deemed substantially equivalent to a predicate.
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Type of Ground Truth Used:
- Not Applicable. No clinical ground truth (e.g., pathology, outcomes data) was used to assess the device's performance, as no clinical performance study was conducted. The ground truth for substantial equivalence is the safety and effectiveness profile of the predicate device, K073408.
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Sample Size for the Training Set:
- Not Applicable. This submission is for a diagnostic ultrasound system (hardware and associated software features), not a machine learning or AI model that requires a "training set" of data in the typical sense. The 'training' for this type of device would involve engineering design, component testing, and adherence to quality standards.
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How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no "training set" for an AI model, this question does not apply. The development is based on established engineering principles, regulatory standards, and the performance characteristics of the predicate device.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.