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510(k) Data Aggregation
(21 days)
BRIVO NM 615
The GE Brivo NM 615 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.
The GE Brivo NM 615 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.
The GE Brivo NM 615 system may include signal analysis and display equipment. patient and equipment supports, components and accessories. The system may be used for patients of all ages.
The BrivoNM615 is an all-purpose single detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Brivo NM 615 system are: NM Gantry with Single detector head, patient table, Remote Control Unit and NM operation console. The Brivo NM 615 is a modification of its predicate device Discovery NM 630 using only single head detector instead of Dual Head detector like in the Discovery NM 630
The GE Healthcare Brivo NM 615 is a modification of its predicate device, the Discovery NM 630. The Brivo NM 615 uses a single head detector instead of a dual-head detector.
1. Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria or detailed reported device performance in the format of a table. Instead, it relies on a declaration of substantial equivalence to its predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate device Discovery NM 630 (K111445) in terms of safety, effectiveness, and performance. | "GE Healthcare considers the Brivo Nm 615 to be as safe, as effective, and performance is substantially equivalent to the predicate device Discovery NM 630 (K111445)." |
| Compliance with voluntary standards. | "The Brivo NM615 and its applications comply with voluntary standards as detailed in Section 9, of this premarket submission." |
| No new safety questions or risks identified due to modifications. | "Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or identify any new risks." |
2. Sample Size for Test Set and Data Provenance
The submission states that no clinical studies were required to support substantial equivalence for the Brivo NM 615. Therefore, there is no specific "test set" in the context of a clinical performance study. The evaluation was based on non-clinical engineering and standards compliance testing.
3. Number of Experts and Qualifications for Ground Truth
Not applicable, as no clinical studies were performed. The determination of "ground truth" was based on established engineering principles and compliance with voluntary standards.
4. Adjudication Method for Test Set
Not applicable, as no clinical studies were performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. The submission specifically states: "The subject of this premarket submission. Brivo NM 615. did not require clinical studies to support substantial equivalence."
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Brivo NM 615 is a hardware device (a SPECT system), not an algorithm or AI solution. The evaluation was for the entire system's performance, not just an algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" in the clinical sense is not directly applicable here since no clinical studies were performed. The "ground truth" for the non-clinical evaluation was based on:
- Engineering design specifications.
- Performance metrics defined by voluntary standards.
- The established safety and effectiveness profile of the predicate device (Discovery NM 630).
8. Sample Size for Training Set
Not applicable, as this is a hardware device submission, not an AI/algorithm submission requiring a training set for model development.
9. How Ground Truth for Training Set was Established
Not applicable.
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