(127 days)
CivaDerm™ Pd103 indicated for treatment of temporary intraoperative or surface application to treat selected localized tumors. It can be used either as primary treatment for residual disease after excision of primary or recurrent tumors. This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy.
The CivaDerm utilizes biocompatible materials and bioabsorbable polymers to encapsulate Pd-103, a radionuclide with a long history in radiotherapy. CivaDerm is a planar unidirectional source intended to deliver x-ray radiation for surface brachytherapy procedures. By utilizing gold backing with the radionuclide. CivaDerm provides radiation in one direction. This allows it to target radiation dose to a contoured exterior surface without irradiating surrounding healthy tissue.
I apologize, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter and summary for a brachytherapy device called CivaDerm™.
It primarily focuses on:
- The FDA's determination of substantial equivalence to a predicate device.
- General device description and intended use.
- Confirmation of manufacturing and regulatory compliance (e.g., GMP, labeling).
- A statement that "All required non-clinical testing has been successfully performed according to published industry standards" and "CivaDerm finished devices are tested and meet acceptance criteria determined by product design specifications to verify each device is safe and effective."
However, it does not provide any specific details about:
- A table of acceptance criteria and reported device performance metrics.
- Sample sizes used for a test set or training set.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Whether MRMC studies were done or any effect sizes.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes, etc.).
- How ground truth for training data was established.
This type of detailed performance study information is not typically included in an FDA 510(k) summary, which focuses on demonstrating substantial equivalence rather than a detailed report of clinical study results for a novel AI/software device.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.