(116 days)
The Solera Magnum Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts.
The Solera Magnum is a single-use, over-the-wire disposable catheter, with an integral Motor Drive Unit (MDU). The Solera Magnum has a central hollow drive shaft connected to an expanding clot maceration and removal system. The clot removal system is comprised of a Nitinol macerator and a Nitinol outer protective basket. The macerator is attached to the drive shaft and rotates within the stationary protective basket. The protective basket expands to the lumen diameter and acts to protect the graft wall from the rotating macerator. Mechanical aspiration is achieved by rotation of the drive shaft and by an applied vacuum (locking syringe). The rotation of this drive shaft in conjunction with the vacuum causes material to be pumped out of the treatment area after maceration. Aspiration is controlled (i.e., on/off) by a button on the motor drive unit, which may be activated by the physician to allow flow out of the Solera Magnum. The default position is 'off' to and is designed to minimize blood loss during the procedure.
The provided text does not contain the information required to complete the requested output regarding acceptance criteria and a study proving a device meets them.
The document is a 510(k) summary for the Solera Magnum Thrombectomy Catheter, focusing on demonstrating substantial equivalence to a predicate device (Solera Thrombectomy Catheter). It lists the intended use, device description, materials, and a general statement about testing.
Here's why the information is missing:
- No specific acceptance criteria are listed. The document states, "All components, subassemblies, and/or full devices met the required specifications for the completed tests," but it does not specify what those specifications or acceptance criteria were.
- No detailed study is described. The document mentions "The Solera Magnum Thrombectomy Catheter was tested in the same manner as the Solera Thrombectomy Catheter (K003570)," and that all components "met the required specifications for the completed tests." However, it does not provide any details about this testing, such as:
- The type of study (e.g., in-vitro, ex-vivo, clinical trial).
- Specific performance metrics measured.
- Sample sizes for anything.
- Data provenance.
- Ground truth establishment.
- Expert involvement.
- Comparative effectiveness.
- AI-related information (this device is a catheter, not an AI/software device).
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document's purpose is to show substantial equivalence through general statements about testing, not to provide detailed study results for specific performance metrics against pre-defined acceptance criteria.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).