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The intended use for the microSelectron HDR version 2 is identical to the predicate device as described in 21CFR § 892.5700 as; "intended.to angly.a radionuclide source into the body or to the surface of the body for radiation therapy". This device is classified as a prescription device and will be operated only under the direct supervision of a physician in the course of the practice of medicine. There no additional Safety and Effectiveness issues raised in the intended use or indications for use of the microSelectron HDR version 2.

The microSelectron HDR version 2 is an improvement over its predicate device, primarily in the areas of eronomics and user interface. The Control Box and PC Console are designed to work with both the existing treatment unit and the new treatment unit (described below). 4.1 Control Box: The Treatment Control Unit of the predicate device has been redesigned to remove the user programmable functions from this electronics interface unit. This new control box retains only the key switches, Start, interrupt, and Print push buttons from the predicate design and includes additional visual indicators of device operation. The CPU board in the Control Box was redesigned to support higher processor speeds and a processor chosen which supports the larger program size. 4.2 Treatment Console The user programmable functions removed from the Control Box as deacribed in 4.1 above, have been functionally relocated to the treatment console. This console consists of a PC based graphics terminal utilizing a commercially available window management program. All device programming functions are carried out at the treatment console, including default setup parameters for the treatment unit and the data entry for radioactive source specification. The design goal of the treatment console was to present device specific information to the user in a graphical environment consistent with the current technology in personal computers. All functions and outputs of its predicate device have been retained and more extensive (plain language) explanation for device status codes are incorporated into the software functions of the treatment console. Data structures necessary to initiate and complete a programmed treatment are stored in both the Control Box and the Treatment Unit: the treatment console merely echoes the functions being performed by the treatment unit itself. 4.3 Treatment Unit The mechanics have been modified to create a more stable, movable, platform for precise positioning of the Treatment Unit adjacent to the patient. The center of gravity and stability of the shielded safe has been improved by relocating the largest mass (shielded safe) closer to the center line of the Treatment Unit . Structural nigidity between the treatment safe, the optical coupler, and the indexer is enhanced by using an annular structure rather than a linear (backbone) design. The source drive mechanism remains very similar to its predicate, with some minor improvements in the yaw angle of the source cable trajectory. The enclosure and covers for the Treatment Unit have been upgraded to a more contemporary design, in keeping with company's exterior design and esthetics philosophy. 4.4 Radioactive Source The radioactive source designed for the microSelectron HDR version 2 treatment unit is functionally identical to the source contained in the predicate device. The exemplary track record of over 10,000 correct source assembly operations with the predicate source showed that minor dimensional changes to the source to enhance its suitability for clinical use would not decrease the safety of the source. To this end, the diameter of the source and its driving cable have been reduced from 1.1 mm outer additionally qualified as Special Form Radioactive Material in accordance with ISO 2855. 4.5 Optional Accessories Optional accessories have been included in the design of this modified device including the provision of a radiation detector.