(238 days)
The Model 1008 (44D as marketed under CNMC) is a well-type, re-entrant ionization chamber intended for measurement of source strength of both clinical HDR and LDR brachytherapy sources and intravascular brachytherapy (IVB) sources. Both types of IVB sources can be measured; those designed to deliver a gamma dose and those designed to deliver a beta dose. The chamber must be calibrated before any measurement of a clinical source takes place. Source strength calculation must be done with the accompanying calibration certificate from the calibration laboratory. The calibration must be performed by an accredited dosimetry calibration laboratory, with the same source type and isotope that is used clinically. The chamber constancy must be monitored after calibration with a proper Measurement Quality Assurance program in order to validate the chamber calibration over a period of time.
The Model 1008 / Model 44D is a well-type re-entrant ionization chamber designed for application with brachytherapy and intravascular brachyterapy source measurement. The chamber is hermetically sealed, there is no air density correction requirement. The fill gas is pure argon at an absolute pressure of 23.5 psi, which provides several distinct benefits. These include enhancing the response at low photon energies from both gamma and Bremsstahlung from beta radiation. higher ion collection efficiency and long term constancy measurements. The Model 1008/44D is fully guarded into the chamber and is equipped with a 1.5 meter low-noise triaxial signal cable terminated with a triaxial collection electrode inside the chamber. When properly connected to a dosimetry electrometer, the chamber housing will be common to the electrometer housing: the collection electrode will be floating with the guard at the chamber bias potential. Therefore, no shock hazard should exist.
This document describes Sun Nuclear Corporation's Model 1008 Re-entrant Chamber / Model 44D Re-entrant Chamber, which is an ionization chamber used for measuring the source strength of brachytherapy and intravascular brachytherapy sources.
The document is a 510(k) summary (K013689) submitted to the FDA, detailing the device's description, intended use, and its substantial equivalence to predicate devices. It does not contain a study that proves the device meets specific acceptance criteria in the format requested.
Therefore, I cannot populate the table or answer the subsequent questions about device performance against acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies.
The information provided focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for low-to-moderate risk medical devices. This pathway typically relies on showing that the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed studies against predefined performance acceptance criteria as might be seen for novel technologies or higher-risk devices requiring PMA.
The document highlights the features of the device which contribute to its safety and effectiveness:
| FEATURE | PURPOSE |
|---|---|
| Hermetically sealed chamber | No air density correction necessary |
| Positive Pressure | Long term constancy measurements |
| Floating collection electrode | Eliminate shock hazard |
However, these are design features and their intended benefits, not quantitative performance values compared to acceptance criteria. The closest to a "performance" claim is "long term constancy measurements," but no specific metrics or data are provided to quantify this.
In summary, the provided document does not contain the information required to fill out the table or answer the detailed questions about acceptance criteria, study methodology, or performance metrics. It is a regulatory submission focused on substantial equivalence rather than a detailed performance study report.
§ 892.1360 Radionuclide dose calibrator.
(a)
Identification. A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.(b)
Classification. Class II.