(86 days)
The VariSource Reusable Transfer Guide Tubes are intended to connect between the VariSource Remote HDR Afterloader system and its range of applicators. This connection creates a conduit for the source wire to travel through and allows radioisotopes to be positioned within the patient's tumour site.
Transfer Guide Tubes are designed to provide a secure connection between the VarlSource afterloader and applicators, needles or catheters along which the source wire travels during Brachytherapy. Each Transfer Guide Tube has an appropriate connection at one end for the Varisource Afterloader and at the other end a connection for an applicator, needle or catheter.
The provided text describes a 510(k) premarket notification for "VariSource Transfer Guide Tube Sets." This document focuses on demonstrating substantial equivalence to a predicate device and details the modifications made. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is not a performance study for an AI/ML device.
The submission is for a physical medical device (transfer guide tubes for brachytherapy), not an AI/ML device. Therefore, the requested information regarding AI/ML performance, ground truth, expert consensus, sample sizes for training/test sets, MRMC studies, or standalone performance is not applicable to this document.
The document mainly includes:
- Device Description: What the VariSource Transfer Guide Tube Sets are and their function.
- Predicate Device: K952913 Applicators for Varian VariSource Remote HDR afterloader.
- Detailed Comparison Table: Highlighting features/specifications of the new/modified device versus the cleared predicate device. This table covers:
- Intended Use/Indications for Use
- Material
- Number of Uses
- Sterilization
- Fitting
- Closed or opened ended when not attached
- Other technical changes (manufacturing processes)
- Indications for Use: The specific medical purposes for which the device is intended.
The regulatory approval process for such a device largely relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and verification/validation testing of the physical components (which are not detailed in this specific snippet but would be part of a full submission).
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.