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510(k) Data Aggregation
(26 days)
B-400 CEILING MOUNTED POSSITIONER, MODEL B-400
To support the Diagnostic Source Assembly & Image Receptor used in performing general-purpose diagnostic fluoroscopic procedures.
The B-400 Ceiling Mounted C-Positioner is a device intended to hold an X-Ray tube and an image intensifier 180° apart in a "C" configuration for the purpose of verforming general purpose diagnostic fluoroscopic procedures. The C-Positioner allows variable positioning of the X-Ray tube/Image Intensifier from +145 degrees Left Anterior Oblique (LAO) to 55 degrees Left Posterior Oblique (LPO). The device will maintain isocenter throughout its full range of motorized movement. The entire assembly is mounted to a set of ceiling rails.
The provided text is a 510(k) summary for the OMEGA MEDICAL IMAGING, INC. B-400 Isocentric Ceiling Mounted C-Positioner, a device intended to hold an X-Ray tube and an image intensifier for general purpose diagnostic fluoroscopic procedures. The document establishes substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered because the document details a regulatory submission based on substantial equivalence, not a performance study as would be typical for an AI/ML device.
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state acceptance criteria in the typical sense of a performance study with numerical targets for metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are based on demonstrating substantial equivalence to existing legally marketed predicate devices. The "reported device performance" is essentially a comparison of its technological characteristics and intended use to these predicate devices.
Here's a table based on the substantial equivalence comparison:
| Characteristic/Criteria Category | Predicate Devices (Representative Range/Values) | B-400 Performance (Claimed) | Assessment against "Criteria" (Substantial Equivalence) |
|---|---|---|---|
| Intended Use | To support X-Ray Diagnostic Source Assembly & Image Receptor for Fluoroscopy (Common to all listed predicates) | To support X-Ray Diagnostic Source Assembly & Image Receptor for Fluoroscopy | Meets: Identical intended use, which is a primary criterion for substantial equivalence. The document explicitly states: "All of the devices listed above have the same intended use." |
| Device Description/Type | Ceiling Mounted 'C' Positioner / Cardiac Positioner / Fluoroscopy C-Arm (All predicates are ceiling-mounted C-arms) | Ceiling Mounted 'C' Positioner | Meets: Categorized as a ceiling-mounted C-Arm, consistent with predicates. The summary states: "The above devices are essentially all ceiling suspended C-Arms with some variations." |
| Technological Characteristics | Meets: The document repeatedly asserts: "The B-400 and the predicate devices all have the same intended use: to support the X-Ray tube (Diagnostic Source Assembly) and the Image Intensifier (Image Receptor) directly opposite each other with some variation in the distance from the X-Ray tube to the Image Receptor (SID), for diagnostic fluoroscopic procedures." The differences are described as "market driven variables." | ||
| Source to Image Distance (SID) | Variable (e.g., 32"-42" for B350, 34"-50" for Pegasus, 86.5-116.6 cm for Philips, Not available for Ariel) | Variable 46" to 56" | Meets: Range is within the variability seen across predicate devices and considered a "market driven variable", not a fundamental difference in safety or effectiveness. |
| Rotation about Vertical Axis | Fixed at lateral center (B350), +45°/-90° (Pegasus), +90°/-90° (Ariel, Integras) | +/- 180° | Meets: While the range is different, it's presented as a variation in capability (a "market driven variable") rather than a fundamental difference in technology or safety/effectiveness that would preclude substantial equivalence for the core function of a fluoroscopic C-arm. |
| Arc Rotation | +60°/-30° (B350), +30°/-90° (Pegasus), +45°/-45° (Ariel), +70°/-90° LAO/RAO (Integras) | +145°/-55° | Meets: Again, a different range, but considered a "market driven variable" or user preference. |
| C-Arm Radius (Throat) | 43" (B350), 46½" (Pegasus), 36" (Integras), Not available (Ariel) | 36" | Meets: Falls within the range or is comparable to predicate devices. |
| C-Arm Width O.D. Dimension | 89" (B350), 91" (Pegasus), Not available (Ariel, Integras) | 78" | Meets: Falls within the range or is comparable to predicate devices. Smaller width may even be seen as advantageous in some contexts. |
| Safety and Effectiveness | Implied to be safe and effective due to prior marketing and regulatory clearance of predicate devices when used for general diagnostic fluoroscopic procedures. | Implied to be safe and effective based on substantial equivalence to predicate devices for its intended use and technological characteristics. | Met implicitly: The fundamental 'acceptance criterion' is that the device is as safe and effective as the predicate devices. The discussion explicitly states: "The Omega B-400 Ceiling Mounted C-Positioner (C-Arm) has the same intended use & technological characteristics as the above listed devices as well as any number of other Ceiling Mounted C-Arms that have been legally marketed in the U.S. for many years." |
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