(89 days)
The EVAC is indicated to facilitate the evacuation of a chronic or subacute hematoma or hygroma in the cranium. The EVAC is intended for draining of fluid accumulated in the subdural space, including chronic or subacute hematomas and hygromas. The EVAC is also intended for removing air and fluid from the subdural space following open surgical procedures to remove subdural collections.
The Borvo EVAC System is intended for the drainage of subdural fluid accumulations. The EVAC System is designed to gradually drain fluid to an external reservoir by creating a low negative pressure in the subdural space. It consists of 3 components:
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- EVAC Port (Ergo or Classic)
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- Tubing
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- Vacuum bulb
An optional Cranial Access Kit can be purchased with the EVAC System, or a commercially available Cranial Access Kit with a 5.31mm drill bit can be used.
- Vacuum bulb
The provided text is a 510(k) premarket notification letter and summary for the Borvo EVAC System. It describes the device, its intended use, and a comparison to a predicate device. However, it does not include information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical performance or software validation reports for AI/ML-driven devices.
The document focuses on demonstrating substantial equivalence to a predicate device based on:
- Same intended use.
- Similar technological characteristics (with detailed comparisons of materials, dimensions, etc.).
- Performance data from non-clinical testing.
Therefore, I cannot provide the requested information about acceptance criteria, device performance against those criteria, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.
The "Performance Data" section (Section 1.7 on page 3 of 4) lists the types of non-clinical testing performed, such as:
- Dimensional
- Tensile
- Pull-Out Force
- Simulated Use
- Sterile Barrier/Packaging Testing
- Shelf Life
- Biocompatibility (ISO 10993-1)
These tests are typically used to demonstrate the physical and biological safety and performance of a medical device, but they are not related to an AI/ML algorithm's analytical or clinical performance requiring ground truth, expert review, or statistical performance metrics.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).