(178 days)
The Apollo System is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.
The Apollo System is designed to aid a physician in the removal of tissue and/or fluids during image-guided neurosurgery. The reusable components have three functions; vacuum generation, generation of vibrational energy, and saline irrigation. The disposable component, the Wand is a rigid cannula to remove tissue and/or fluid with the assistance of vibrational energy and aspiration. The disposable wand is designed to be image-guided, such as passing through the working channel of various neuro-endoscope trocars, allowing visualization of the procedure. To aid in tissue and/or fluid removal, the Apollo Generator provides the saline irrigation and vibrational energy to the Wand to ensure the Wand does not become clogged. Aspiration of the tissue and/or fluid is performed by the Apollo Vacuum Pump. Any tissue and/or fluid removed is collected in the Apollo Collection Canister. Activation of saline infusion and vibrational energy is controlled by the Apollo Foot Switch.
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device conformance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
The document is a 510(k) premarket notification decision letter from the FDA for the Apollo™ System. It primarily focuses on:
- Regulatory classification and history: K152699, Class II, Neurological Endoscope (Product Code GWG).
- Indications for Use: Controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.
- Predicate devices: K132931 (Apollo™ System) and K990572 (SONOTOME™ System).
- Device description and comparison to predicates: Outlines operating principles, system console, amplitude and frequency of vibration, irrigation flow rate, aspiration, and disposables.
- Non-clinical data summary: States a literature review was conducted to substantiate safe and effective performance and substantial equivalence, along with the appropriateness of the revised indication for use and labeling.
- Summary of Substantial Equivalence: Concludes the device has a similar safety and effectiveness profile to predicate devices.
The document does not contain details about specific performance metrics, clinical trials, or validation studies using specific datasets that would include the information you've requested.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).