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IsoSphere is indicated for implantation after tumor resection in the breast to deliver the prescribed radiation dose to the tumor bed and any residual tumor in the remaining margins.

The IsoSphere is a modification to the Advantage Strand™/Advantage Load™/Secure Strand Brachytherapy Kit cleared in 510(k) K113210 on August 10, 2012. Whereas the predicate device delivers radioactive brachytherapy seeds and spacers via numerous needles, one at a time in a linear design, the IsoSphere delivers multiple radioactive brachytherapy seeds and spacers within a Secure Strand sleeve to an excision site in the breast in one sphere-shaped configuration. The IsoSphere is a 4 cm, spherical shaped device with hollow channels that contain radioactive brachytherapy seeds and spacers, depending on physician prescription. The device is composed of bioabsorbable copolymer (PLA) material, which is identical to the Secure Strand material. The IsoSphere is supplied with either Advantage I-125® seeds or Advantage Pd-103® seeds and spacers which are identical to those cleared in K113210. IsoSphere is supplied sterile for single use. A sterile, single-use, non-radioactive 4cm Sizing Sphere is included in each package to assure a proper fit in the excision site. The package also contains one pair of sterile, radiation attenuating gloves.

The IsoAid RSLN is a device intended for the localization of suscipcious tissues (non-palpable lesions) for excision with the use of radioactive seeds.

The IsoAid I-125 Radioactive Seed Localization Needle [IA-RSLN] is a pre-sterilized 18 gauge needle containing a low-activity I-125 Iodine Seed [K011205]. The needle tip is occluded with bone wax to contain the contents prior to implant. The iodine seed is loaded loose or stranded and is provided with or without trailing spacers. The stainless steel needles are provided in lengths: 5cm, 7cm, and 12cm. The device is used to facilitate the introduction of the radionuclide seed into the suspicious tissue. The seed is used singly as a point-source for localization rather than for therapeutic use as in brachytherapy. The device is packaged and labeled and EtO sterilized.

The IsoAid Brachytherapy Kit is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy. The IsoAid Brachytherapy Kit is indicated for tumors that are localized, unresectable, or have low to moderate radiosensitivity.

The IsoAid Brachytherapy Kit is a pre-sterilized kit containing brachytherapy needle and a custom-loaded strand (K013975 or K103449 or Secure Strand) of seeds spaced at a precise distance within absorbable suture. The strand is optional, when no strand is requested the seeds and spacers are custom-loaded directly into the needle. A maximum total of 20 seeds and spacers can be loaded into a needle. The spacers (K010621 or K103449) are made from the same material as the sutures. The stranded Pd-103 (K033770) and I-125 (K011205) implants are placed inside the needle. Bone Wax (K024372 or Ethicon, Inc. Bone Wax) is used at the tip of the need to keep the implants from falling out. The needle is made from 18-gauge stainless steel.

The IsoAid Brachytherapy Kit is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy. The IsoAid Brachytherapy Kit is indicated for tumors that are localized, unresectable, or have low to moderate radiosensitivity.

The IsoAid Brachytherapy Kit is a pre-sterilized kit containing brachytherapy needle and a custom-loaded strand (K013975) of seeds spaced at a precise distance within absorbable suture. The strand is optional, when no strand is requested the seeds and spacers are custom-loaded directly into the needle. A maximum total of 20 seeds and spacers can be loaded into a needle. The spacers (K010621) are made from the same material as the sutures. The stranded Pd-103 (K033770) and I-125 (K011205) implants are placed inside the needle. Bone Wax (K024372) is used at the tip of the need to keep the implants from falling out. The needle is made from 18-gauge stainless steel.

The ISOAID Palladium Brachytherapy Seeds is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.

The IsoAid palladium-103 seeds are spherical sealed sources of palladium-103. The outer capsule of the source is sealed titanium. The specifications for the IsoAid device are the same as for the predicate.