(242 days)
The H.A.M. Applicator is intended to be used as an accessory to highdose-rate (HDR) remote controlled radionuclide applicator systems cleared for market by the FDA. The H.A.M. Applicator may be used externally, on the surface of the patient, to treat superficial tumors or placed internally to treat the tumor or tumor bed in a procedure known as Intraoperative High-Dose-Rate Brachytherapy (IOHDR) [a subset of Intraoperative Radiation Therapy (IORT)], during the time the treatment site is exposed surgically.
The H.A.M. (Harrison-Anderson-Mick) Applicator system consists of the H.A.M. Applicator, the H.A.M. Sandwich (a clamping device) source-guide tubes, when required by certain HDR systems, and a Martin Arm/Clamp ( a preamended device manufactured by Martin Medizin-Technik) which attaches the H.A.M. Sandwich to the operating table. The H.A.M. Applicator is manufactured from liguid silicone rubber and contains between three and twenty-four embedded hollow tubes. The tubes are spaced 1 cm on center laterally and are positioned 5mm from the treatment surface.
This document (K961601) is a 510(k) summary for the H.A.M. Applicator, a medical device. It does not contain information about acceptance criteria, study designs, performance metrics, ground truth establishment, or sample sizes typically associated with demonstrating the performance and safety of a diagnostic or AI-powered device.
The H.A.M. Applicator is a physical accessory used for brachytherapy. The submission focuses on its intended use, technological characteristics, and substantial equivalence to a predicate device, rather than quantitative performance studies.
Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a physical device, not a performance study for a diagnostic or AI algorithm.
§ 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.