(142 days)
The Isoray Medical, Inc. Cs-131 Implant Devices with SiriusTM MRI Markers are indicated for the treatment of malignant prostatic disease. These devices may be used as a primary treatment or in conjunction with other modalities. The MRI Markers are used to facilitate the anatomical localization of seeds after they have been implanted.
The Isoray Medical, Inc. Cs-131 Implant Devices with Sirius™ Markers are a combination of two commercially available devices: The Isoray Medical Cs-131 Implant Devices, and the Sirius™ MRI Markers. They come in two configurations and listed below:
- Isoray Medical, Inc. Cs-131 PL-7 Preloaded Strands with Sirius™ Markers
- Isoray Medical, Inc. Cs-131 PL-8 Preloaded Strands with Sirius™ Markers in 18G Needles ●
The Sirius™ MRI Markers combined with the Isoray Cesium-131 Implant Devices will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy.
The Cs-131 Implant Devices are a small, cylindrical, sealed source that consists of a welded pure titanium capsule containing the low energy gamma (x-ray) emitting isotope, Cesium-131 (Cs-131), adsorbed onto an internal inorganic substrate. The external seed dimensions are 4.5 mm length and 0.8 mm diameter and the only patient-contacting material is commercially pure titanium.
The Sirius™ MRI markers consist of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride: N-Acetylcysteine solution. The Sirius™ MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy seeds containing one of the following isotopes: lodine-125, Palladium-103 or Cesium-131. The Sirius™ MRI Markers combined with the Isoray Cesium-131 Brachytherapy Seeds will be used to facilitate the anatomical location of seeds after they have been implanted.
The spacers are used to maintain the exact locations and separation distances between the seeds as indicated on the treatment plan prepared by the physicist. They are made of PLA/PGA copolymer and are absorbable. The spacer length is variable since it is a function of how many seeds are required by the patient treatment plan. The spacers are 0.8mm in diameter.
The Cs-131 Implant Devices with MRI Markers comes in two (2) configurations as listed in the table below.
The seeds, spacers, and Sirius™ MRI markers are arranged in a precise pattern in order to maintain the exact locations and separation distances between the seeds as indicated on the treatment plan prepared by the physician or medical physicist. There are no product specific guidance documents or product specific standards for brachytherapy seeds. The subject devices are EtO sterilized and are a single-use device.
The provided text is a 510(k) summary for the Isoray Medical, Inc. Cs-131 Implant Devices with Sirius™ Markers. This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.
However, this document explicitly states that "No performance data testing was performed as each of the components has been previously cleared for this intended use." and "No additional biocompatibility test was performed as biocompatibility evaluation was conducted for each of the components in previous regulatory clearances."
Therefore, the supplied text does not contain information about a study that proves the device meets specific acceptance criteria based on performance metrics. It indicates that the device's components (Cs-131 implant devices and Sirius™ MRI Markers) were previously cleared and have established safety and effectiveness.
As a result, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, because such a study is explicitly stated as not having been performed for this specific 510(k) submission.
The document focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Identical product code, regulation number, device classification name, and device classification.
- Similar indications for use, with the subject device's indication being a combination of the predicate and reference device, specifically limiting use to the prostate due to the MRI markers.
- Similar principle of operation.
- Identical condition of use, Rx or OTC status, materials of construction (for the core components), packaging, and sterilization method. The new combination device incorporates the MRI markers, which were previously cleared.
In summary, the provided text does not contain the information needed to answer your request about acceptance criteria and a performance study, as the filing strategy for this device was based on substantial equivalence to pre-cleared components rather than new performance testing.
§ 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.