(297 days)
GammaTile is indicated as a treatments with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms
GammaTile is a device intended for the treatment of intracranial neoplasms which uses cesium-131 radioactive sources embedded in a collagen matrix. GammaTile™ is designed to provide "adjuvant" radiation therapy - therapy to eliminate any remaining neoplastic cells - to patients who require surgical resection of brain neoplasms. GammaTile is positioned within the resection cavity immediately after surgical excision of the brain neoplasm to deliver radiation therapy to any neoplastic cells that remain in proximity of the resection cavity.
The provided text is a 510(k) summary for the GammaTile™ device. It outlines the regulatory clearance process for an expanded indication for use. However, it explicitly states:
"No additional testing was completed. The data obtained from the case studies suggest that GammaTile therapy adds no additional risk to the proposed patient population."
This means that a new study demonstrating the device meets acceptance criteria for the expanded indication was not performed. Instead, the submission relies on the technological equivalence to a previously cleared device (K190296) and an assessment of existing dosimetry data.
Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such new study was conducted for this specific 510(k) submission (K190839).
The document clarifies that the "technological characteristics of the proposed device, GammaTile, are identical to those of the predicate, GammaTile as described in 510(k) K190296." The submission is for an expanded indication for use, not for a change in the device or its fundamental performance.
The only "assessment" mentioned for the expanded indication is: "An assessment of dosimetry to organs at risk using GammaTile in recurrent intracranial neoplasms has been completed. The assessment resulted in a determination the cumulative radiation dose delivered to the OARs was within ranges acceptable in clinical practice." This is an assessment, not a new clinical study with defined acceptance criteria for device performance as an AI/software device would undergo.
In summary, none of the requested information regarding a study proving the device meets acceptance criteria can be extracted from the provided text because no new study of this nature was conducted or submitted for this cleared 510(k). The clearance was based on substantial equivalence and a dosimetric assessment, not a performance study against specific acceptance criteria for the expanded indication.
§ 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.