(37 days)
The SpineMedica Paradis Vaso Shield™ is indicated as a cover for vessels following anterior vertebral surgery.
The SpineMedica Paradis Vaso Shield™ is a flexible sheet of 30 Wt.1% polyvinyl alcohol (PVA) material with dimensions of 60 ±6 mm X 100 ±10 mm and a thickness of 1.0 ±0.2 mm. The corners of the sheet are rounded. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated in saline solution.
The provided 510(k) summary for the SpineMedica Paradís Vaso Shield™ indicates that performance standards were met and testing was performed to demonstrate substantial equivalence to predicate devices. However, the document does not describe specific acceptance criteria or a detailed study that proves the device meets those criteria with quantitative results.
Instead, the submission relies on the concept of "substantial equivalence" to previously cleared devices. This means the device is considered safe and effective because it has the same indications for use, design, function, and/or materials as legally marketed predicate devices. The 510(k) summary explicitly states: "Testing performed indicates the SpineMedica Paradis Vaso Shield™ is substantially equivalent to predicate devices."
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor can I answer questions about sample sizes, expert ground truth establishment, or specific study methodologies (like MRMC or standalone performance) because these details are not present in the provided document.
The 510(k) process for this device did not involve presenting new clinical or performance data against specific acceptance criteria in the same way a de novo or PMA submission might. The FDA's letter (K093551) confirms substantial equivalence and primarily focuses on labeling requirements and limitations regarding claims not established (e.g., reducing adhesion formation).
Summary of what can be inferred from the document:
The 510(k) submission for the "SpineMedica Paradís Vaso Shield™" demonstrates substantial equivalence to predicate devices rather than presenting a study with explicit acceptance criteria and corresponding performance data. The document does not contain the detailed information necessary to answer the questions posed regarding specific acceptance criteria, study methodology, sample sizes, expert qualifications, or ground truth establishment.
The FDA's review concluded that the device is substantially equivalent based on its stated indications for use, design, function, and materials being similar to pre-existing, legally marketed devices. The FDA's letter primarily focused on clarifying labeling requirements and limitations, especially concerning unproven claims.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).