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The intended use of the MICK Valencia Applicator is to facilitate the placement of a radioactive source near the target area on intact skin for remote afterloading brachytherapy treatment.

The Mick Valencia Applicator is used for remote afterloading treatment on intact skin/surface. The applicator with associated plastic cap is placed onto the patient, locked into position, and connected to the remote afterloading equipment (via transfer tube) to facilitate the brachytherapy treatment in accordance with the physician approved treatment parameters. The radioactive source travels from the machine into the applicator and deliver the desired dose distribution to the defined treatment volume. When the treatment is completed, the source returns to the machine. The applicator is disconnected from the treatment unit and removed from the patient. The applicator does not control the treatment unit, it strictly provides a treatment path for the radioactive source. The Mick Valencia applicator is temporarily placed during the treatments designed as a closed system to prevent the radioactive source from coming in contact with bodily fluids. The device is the same as the legally marketed device cited, both in design and materials.

2/3 Endometrial Applicator Sets: A manual radionuclide applicator system, a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. Segmented Vaginal Applicator: The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modem era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors are now treated by internal exposure to radiation emitted from sealed radioactive sources. Two common modalities of this are Low Dose Rate remote afterloading (Brachytherapy). One common use of Brachytherapy is in the treatment of cancer of the vaginal process. The system described in this 510(k) has been developed to function as an applicator for the positioning of sealed sources in the intracavitary treatment of the vagina. HDR Miami Applicator: This applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K89113) which uses a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites. The Miami Applicator is placed in the vicinity of the cervix via the vagina just as described for the predicate device (Nucletron Miami Vaginal Applicator, K953946) and different diameter sleeves and intrauterine tubes, can be optimized to best meet the clinical needs of the patient along with minimization of dose to the mucosa. HDR Compatible Tandern and Ovoid Applicators: The applicators presented in this 510(k) notification have been developed to function as Applicators for the positioning of HDR Remote After-Loader sealed sources in the intra-cavitary treatment of cancer of the vagina and cervix. CT Compatible F/S/D Applicators: CT Compatible F/S/D applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice. HDR CT Compatible Split Ring Applicator: The HDR CT Compatible Split Ring type applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice. CCT HDR Tandem Ring Applicator with Rectal Retractor: The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/ Ring Applicator with Rectal Retractor is indicated for High Dose Rate irradiation of the uterus and cervix.

2/3 Channel Endometrial Applicator Sets: The 2/3 Channel Endometrial Applicator is designed for the treatment of the endometrium and cervix. The applicator set includes 3 intrauterine tubes that are available in 3 cm and 5 cm configurations. These intrauterine tubes can be assembled using only 2 or all 3 intrauterine tubes, depending on the patient requirements. The only change to the device will be the labeling that the device is now MR Conditional. Henschke Applicator Set: The Henschke Applicator is based on "Henschke style" geometry for brachytherapy of the endometrium and cervix. This applicator is similar in design to the Fletcher Applicator with the exception of semispherical ovoids. These ovoids are ideal for patients with narrow vaginas due to their small size, the ovoid tube is closer to the surface on the side of the cervix while maintaining distance within the fornices. The tandem is inserted into the endometrium at a pre-determined depth and secured in place with the cervical stop. The only change to the device will be the labeling that the device is now MR Conditional. Fletcher (FSD) Applicator Set: The Fletcher Applicators are based on "Fletcher style" geometry for brachytherapy of the endometrium and cervix. The ovoids are cylindrical to create equal spacing in the vaginal fornices for a symmetrical dose distribution in this area. The tandem is inserted to into the endometrium at a pre-determined depth and secured in place with the cervical stop. The only change to the device will be the labeling that the device is now MR Conditional. Miami Applicator Set: The Miami Applicator is designed for treatment of the vagina and cervix and includes an intrauterine tube for the treatment of the endometrium, as required. The design incorporates 7 treatment channels around the periphery of the cylinder body and includes a center channel that can accommodate an intrauterine tube. The intrauterine tubes are available with either a 30° angled tip or in a straight (0° angle) configuration. A stump plug is provided to seal the end of the applicator when an intrauterine tube is not required. Build-up caps are available for the cylinder body to provide added spacing between the mucosa and radioactive source. This applicator provides additional treatment options, with the peripheral channels, to increase the dose to the target area while limiting the dose to normal tissue. The only change to the device will be the labeling that the device is now MR Conditional. Ring & Tandem Applicator Sets: The Ring & Tandem Applicator is based on the Stockholm technique for brachytherapy of the endometrium and cervix. The applicator consists of a ring tube and intrauterine tube that, when combined, create a fixed geometry and form a 90° angle. Build up caps of different diameters are provided for the ring tube that provide additional spacing between the radioactive source and mucosa. Including the Vienna Ring and Tandem Accessory Kit. The only change to the device will be the labeling that the device is now MR Conditional. Segmented Vaginal Applicator Set: The Segmented Vaginal Applicator is designed for treatment of the vagina and cervix and includes an intrauterine tube for the treatment of the endometrium, as required. The intrauterine tubes are available in different angles and lengths to meet anatomical requirements. The four individual segment design allows the applicator length to be adjustable based on the treatment volume. Additionally, the segments are available in different diameters to match the patient's anatomy. The only change to the device will be the labeling that the device is now MR Conditional. Split Ring Applicator Sets: The Splicator's patented design combines the benefits of several other intracavitary applicators. The ring tubes can be configured as a closed/complete ring or separated/" split' into four different distances, symmetrically or asymmetrically with the spacing bracket. Build-up caps of different diameters fit over the ring tubes to provide additional tissue spacing distance between the radioactive source and the cervix. The only change to the device will be the labeling that the device is now MR Conditional. Vienna System: The Mick Radio-Nuclear Instruments, Inc. Vienna System is intended to be used as an accessory to the Mick CT HDR Tandem I Ring Applicator and is indicated for High Dose Rate irradiation of the uterus and cervix. The Vienna System consists of perforated Build-Up Caps and complementary Needle Collectors which connect to the Mick CT HDR Tandem Ring Applicator. Pre-bent interstitial needles are intended to be used with the Vienna System but they are not manufactured by Mick Radio-Nuclear Instruments. Inc. and are not part of this submission. Build-Up Caps: When used with the CT HDR Tandem/Ring Applicator, the Vienna Build-Up Caps enable the introduction of up to nine (9) interstitial needles around the circumference of the ring to enhance the standard HDR treatment. The Vienna System is not designed to be used with any Rectal Retractor due to the introduction of the interstitial needles. Needle Collectors: When used in conjunction with the Vienna Build-Up Caps, the Needle Collectors will maintain and control the positioning of an array of up to nine (9) interstitial needles. The Needle Collectors are part of the Vienna System and as such, are not designed to be used with any Rectal Retractor. The Vienna System is designed to be used as an accessory with the Applicator and this does not alter the indications for use and is MR Conditional.

The CT/MR M.A.C Interstitial GYN Template is indicated for high dose rate irradiation of vaginal, endometrial and urethral cancers. It is intended to provide a needle guidance system for the introduction of needles and a vaginal obturator into the treatment site.

The CT/MR M.A.C. GYN Interstitial Template Set includes a labeled template, a slotted channel Vaginal Obturator, a set of intrauterine tubes in different angles, locking collets to accommodate both peripheral needle channels in the Template and needle channels in the central Vaginal Obturator, an Allen wrench to lock the intrauterine tube in the Obturator and a collet wrench to securely affix the needles by way of individual collets to both the Template and the vaginal obturator. The set features an Obturator - Template design with an optional intrauterine tube enabling complete or targeted treatment of the vagina, cervix, endometrium and parmetrium.

The Nfick Radio-Nuclear Instruments, Inc. Vienna System is intended to be used as an accessory to the Nfick CT HDR Tandem / Ring Applicator and is indicated for High Dose Rate irradiation of the vierus and cervix.

The Vienna System consists of perforated Build-Up Caps and complementary Needle Collectors which connect to the Nfick CT HDR Tandem / Ring Applicator. The Vienna System is comprised of two sizes of Build-Up Caps, both 5.0mm & 7.5mm, to replicate the original Build-Up Caps in the applicator set and complementary Needle Collectors. The system is designed to utilize implanted rigid interstitial needles that are commercially available and must be purchased separately. The Vienna System is not designed to be used in conjunction with any type of Rectal Retractor. The Vienna Build-Up Caps have nine pre-drilled holes in the circumference of the Build-Up ring to accept separate interstitial needles for a wider dose distribution during treatment. One size Vienna Build- Up Cap can accommodate all three angles of Rings and Tandems. Needle Collectors are offered as part of the system and are used to "collect", stabilize and protect interstitial needles inserted through the Vienna Build-Up Cap. The Needle Collector is offered in three different angles (30°, 45° & 60°) and all have nine channels oriented to the pre-drilled hole positions in the Vienna Build-Up Cap.

The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is indicated for High Dose Rate irradiation of the uterus and cervix. The modification that precipitated this Special 510(k) does not alter the indications for use.

The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is intended for use in Brachytherapy. It is indicated for use where high dose rate (HDR) irradiation of the uterus and cervix is an accepted clinical practice. The applicator is designed to be compatible with the sealed sources found in High Dose Rate After-Loaders and do not modify or change the source, source packaging or remote source positioning mechanisms found on these after-loaders. The applicator presents a stable and flexible delivery system for the administration of high dose rate irradiation of cancers of the uterus and cervix. The applicator offers several treatment options by including three different angles of Rings (30°, 45° & 60°) and nine different Tandems. The Tandems are offered in complementary angles to the three rings and in three different Tandem lengths for each angle (2cm, 4cm & 6cm from the ring axis). In addition, there are two sizes of Build-Up Caps (5mm & 7.5mm) that affix to the Rings that offer shielding to patient tissue and a Rectal Retractor is included. The entire applicator system is housed in a specially designed Sterilization Cassette, meant for both storage and sterilization. This applicator has been cleared by FDA since 2003. The modification presented in this Special 510(k) allows for the removal of the paddle portion of the Rectal Retractor from the Rectal Retractor assembly. This facilitates easier cleaning by the user to prevent potential build-up of soil in the paddle. There are no other impacts to the applicator system in this modification. The intended use is unchanged. The modification to a two-piece Rectal Retractor design is controlled through the Mick Radio-Nuclear design controls and is manufactured onsite at Mick Radio-Nuclear Instruments, Inc. The two-piece Rectal Retractor design does not introduce any new risks or potential negative impacts to the overall performance of the applicator.

The HDR CT Compatible Split Ring type applicator is indicated for use in any case where high dose rate Brachytherapy treatment of the cervix or uterus is an accepted clinical practice.

The HDR CT Compatible Split Ring Applicator presented in this 510(k) notification has been developed to function for the positioning of HDR Remote After-Loader sealed sources in the treatment of cancer of the cervix or uterus. The design of these systems is similar to that of the predicate devices listed below. The delivery of radiation therapy via high dose rate Brachytherapy treatment of the cervix or uterus requires not only a stable system for precise dosimetry but also a reproducible and predictable geometry for positioning of the radioactive source under remote control. The HDR CT Compatible Split Ring Applicator is designed to act as such a device.

The CT Compatible F/S/D applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice.

The CT Compatible F/S/D Applicator presented in this 510(k) notification has been developed to function for the positioning of HDR Remote After-Loader sealed sources in the treatment of cancer of the cervix or uterus. The design of these systems is the similar to that of the predicate devices listed below. The delivery of radiation therapy via high dose rate Brachytherapy treatment of the cervix or uterus requires not only a stable system for precise dosimetry but also a reproducible and predictable geometry for positioning of the radioactive source under remote control. The CT Compatible F/S/D Applicator is designed to act as such a device.

The Mick HDR IORT Shielded Applicator presented in this 510(k) notification has been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader scaled sources in the superficial or interoperative treatment of cancer. The Mick HDR IORT Shielded Applicator presented in this 510(k) notification has been developed to function as accessories/applicator for the positioning of HDR Remote After-Loader sealed sources during intraoperative procedures or externally on the patient surface.

The Mick HDR IORT Shielded Applicator presented in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader scaled sources in the superficial or interoperative treatment of cancer. The design of these systems is the similar to that of the predicate devices listed below. The delivery of radiation therapy via high dose rate Brachytherapy for superficial or interoperative treatment requires not only a stable system for precise dosimetry but also a reproducible and predictable geometry for positioning of the radioactive source under remote control. The Mick HDR IORT Shielded Applicator is designed to act as such a device.

The Mick HDR Interstitial Implant Accessories (consisting of needles, catheters, and fixation buttons) presented in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader sealed sources in the interstitial treatment of cancer of the oral cavity, oropharyngeal tumors, head and neck and soft tissue sarcomas.

The Mick HDR Interstitial Implant Accessories (consisting of needles, catheters, and fixation buttons) presented in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader sealed sources in the interstitial treatment of cancer of the oral cavity, oropharyngeal tumors, head and neck and soft tissue sarcomas. The design of these systems is the similar to that of the predicate devices listed below. The delivery of radiation therapy via high dose rate Brachytherapy requires the ability to guide and position the radioactive source under remote control so that the sealed source is contained within the treatment volume providing precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick HDR Interstitial Implant Accessories are designed to act as such.

The applicators presented in this 510(k) notification have been developed to function as Remote After-Loader sealed sources in the intracavitary treatment of cancer of the vagina and cervix.

The Mick Radio-Nuclear Instruments, Inc. HDR compatible Tandem and Ovoid Applicators are intended for use in HDR Brachytherapy as described for the predicate device (Cervix Applicator, Varian Medical Systems, K033371). The design of these systems is the similar to that of the predicate devices listed below. The delivery of radiation therapy to cervix via high dose rate Brachytherapy requires the ability to properly link the applicator to the HDR unit so that the radioactive source can be remotely positioned in the applicator along with the ability to properly localize the sealed sources at the treatment volume providing precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear HDR compatible Tandem and Ovoid Applicators are designed to act as such a device and utilize the same design as previously cleared for other applicators manufactured by Mick Radio-Nuclear Instruments (Vaginal Applicator Set, Shielded, K001544, HDR Tandem/Ring Applicator with Rectal Retractor, K011657).