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The Intracavitary/Interstitial System is intended for cancer treatment of the uterus, cervix, and vagina using HDR or PDR brachytherapy.

The Intracavitary/Interstitial System is a device with two (2), hollow, open-ended catheters which connect to applicator sets with ovoids, ring caps or templates on the distal end. The guide tubes extend outside of the patient. An interstitial needle is guided through the guide tube from outside the patient to an interstitial hole in the applicator. The proximal end of the guide tube contains a fixation mechanism for fixing the needle insertion depth between needle insertion and removal of the implant. The Intracavitary/Interstitial System is intended to be used with the following required accessories: Plastic Needles (K120341) and Leak Stop Channel Markers (K152018).

The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vaqina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy. The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization. The intended patient population includes adult female patients whose cancer can be treated using HDR brachytherapy, as determined by the prescribing physician. The subject device is intended to be used in a healthcare or treatment facility by trained and qualified personnel. The key performance characteristics of this applicator set are as follows: - . The ability to customize the relative depth of the tandem and ovoids, as well as adapt to different anatomies with three tandem angles (15°, 30°, 45°) and a movable cervical stop. - 3.5 mm diameter intrauterine tandems allow for easy insertion into the cervical channel helping provide maximum patient comfort. - The tandems and the pivot assembly are made from strong, lightweight titanium. - Four different ovoid sizes to allow for varying anatomy. - . Channel marking on the intrauterine tandems and colpostat tandems for easy identification. - . Ability to image the patient using CT imaging. - Ability to image the patient using MR imaging. - Optional interstitial ovoids for more complex cases with guide tubes to allow for the needles to be preloaded outside of the patient and locked into place. - . Compatible with cervical sleeves to allow easy multiple fraction and help provide maximum patient comfort and eliminate the risk of perforation. - Can be manually or machine cleaned, disinfected and steam sterilizable. - Can be securely connected to the BRAVOS Afterloader System and GammaMedeplus iX series afterloader. - Suitable for patient contact for a period of less than 30 days

The Mould Probe MR Safe is intended for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy. IORT = Intraoperative Radiation Therapy.

The Mould Probe MR Safe is a Brachytherapy applicator. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment. The Mould Probe MR Safe is intended for HDR or PDR brachytherapy and the key performance characteristics are as follows: - Suitable for intraoperative, intraluminal, and interstitial brachytherapy. - Can be used for surface treatments in combination with the suitable Varian flap. - Equipped with stabilizing mandrins for easy insertion. - MR Safe, if used without mandrins. - CT compatible, if used without mandrins. - Elastomer material construction provides increased flexibility for easy placement as well as luminal rigidity, which prevents kinks. - Steam sterilizable. - Suitable for patient contact for up to 24 hours. The stainless steel mandrins are not intended to have patient contact.

The Intraluminal Applicator Set is intended for intraluminal brachytherapy treatments including endobronchial treatments and treatments on body sites such as the bile duct using HDR brachytherapy.

The Intraluminal Applicator Set is intended for intrapy treatments including endobronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy. The Intraluminal Applicator Set acts to guide the radioactive source to the correct location for treatment. Key performance characteristics are as follows: - . Suitable for treating body sites allowing insertion of a catheter. - CT compatible. ● - MR Compatibility: Safe. ● - Fits a 2 mm diameter bronchoscope biopsy channel allowing for easy insertion. - Elastomer construction provides increased flexibility for easy placement and luminal rigidity to avoid kinks. ● - Nylon monofil adds luminal stability during catheter insertion and manipulation. ● - Comes with 2.8 mm spacing tubes, which minimize surface dose. . - . Spacing tubes enable secure placement during treatment. - The bronchial catheter and monofil are supplied sterile, and for single use. - . The guide tubes, the bronchial catheter, the bite catheters are intended for continuous use for less than 24 hours of contact with patients.

The Esophageal Brachytherapy Applicator is intended for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to the esophagus. This device is sterile, disposable and single-use.

[BKMI2001] The device has 6 independently balloons. Each balloon corresponds to a specified needle free connector (valve). The #1 valve is connected to the most distal balloon and the #6 valve corresponds with the proximal balloon. There is an indication balloon on each valve unit, which can indicate the inflated balloon. The distance between first marker printed on the main catheter and the distal tip is 19.8 cm. This device is disposable and designed for sterile and single use. [BKMI2002] The device has 8 independently balloons. Each balloon corresponds to a specified needle free connector (valve). The #1 valve is connected to the most distal balloon and the #8 valve corresponds with the proximal balloon. The distance between first marker printed on the main catheter and the distal tip is 40 cm. This device is disposable and designed for sterile and single use.

The Titanium Fletcher-style Applicator Set - Defined Geometry is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina using HDR or PDR brachytherapy. The Smit Cervical Sleeves are indicated for use where any intrauterine tandem is used for HDR or PDR brachytherapy.

The Titanium Fletcher-style Applicator Set – Defined Geometry is intended for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina when performing HDR or PDR brachytherapy. The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization. The Titanium Fletcher-Style Applicator Set Defined Geometry includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Titanium Fletcher-Style Applicator Set Defined Geometry is intended to be used in a healthcare or treatment facility by trained and qualified personnel. This 510(k) submission is also inclusive of the Smit Cervical Sleeve which is an optional component that may be used with the Titanium Fletcher Style Applicator Set Defined Geometry but is not required to successfully perform the intended use.

The Catheter Surface Flap Applicator Set is intended for use for skin cancer treatment using HDR or PDR brachytherapy.

The Catheter Surface Flap Applicator Set is an applicator for Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment. The key performance characteristics of this applicator set are as follows: - Surface applicator intended for the treatment of skin cancers. - A 10mm thick flap allowing for up to 38 channels spaced at 5 mm allows for a large uniform treatment. - Hollow pattern design and semi translucent material provides good visibility of the treatment area. - The material high flexibility allows the applicator to conform closely to complex patient anatomies such as when treating nose or ear lesions. - Silicone material gives excellent biocompatibility and durability. - Single patient multiple use. - The Catheter Surface Flap is MR and CT compatible. - Patient-contacting parts constructed of silicone and Polyvinylchloride; suitably for patient contact for a period up to 24 hours. The fixation buttons are used for locking the mould probes in place after insertion in the catheter surface flap. Some of these are supplied in the fixation button kits but they are also available to be purchased separately as spares. As spares, they are packed in sterile pouches, with 10 pieces per pouch and sold as pack of 10 pouches respectively.

The Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.

The Heyman Packing Applicator Set consists of various sized Heyman-capsules which may be connected to compatible brachytherapy afterloaders via guide tubes. The set also includes a number of associated accessories for sterilization (Cleaning Cap, Leak Stop Button, and Leak Stop Channel Marker Sets). The Heyman Packing Applicator Set is an applicator for intracavitary Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment. The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization. The Heyman Packing Applicator Set includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

AOS Interstitial Templates, Needles, and Accessories are indicated for use in adults where Brachytherapy of the cervix or prostate is an accepted clinical practice.

AOS Interstitial Templates, Needles, and Accessories are designed for interstitial Brachytherapy treatments of the cervix and prostate. The Templates are designed to be sutured to the perineal area in order to fix the geometry of the Template Need into the cervix or prostate. AOS Templates are made of silicone, with holes in a circular pattern, typically spaced 1 cm (Center-to center). AOS Templates are supplied in two configurations to accommodate a prostate or GYN treatment. The Template is sutured in place and Template Needles are inserted into the Template. The number and type of Template Needles is dependent on the model of Afterloader. Additional accessories are required in vaginal cases. The AOS GYN Templates have a large hole with a quide strip. The matching AOS Vaginal Guide Tube is inserted in this hole, lining up the guide groove. The Vaginal Guide is pushed to the desired depth and the large O-Ring is slipped over the Vaginal Guide. The AOS Collar is then used to push the Vaginal Guide until it can be slipped over and on to the Template. The O-Ring's elasticity tightens down and provides sufficient tension to hold the Vaqinal Guide in place. Each Vaginal Guide has six (6) Needle grooves for the insertion of additional Template Needles as required. Where an Afterloader is used, the Template Needles are connected to the Afterloader via an appropriate connector. If the Template Needle has a female Luer Adaptor on the proximal end, connection to the AOS Universal Connecting Guide Tube, P/N SGJ0007, provides an unobstructed pathway for the source wire or cable from the Afterloader to the appropriate distance as determined by the Afterloader. Some Afterloaders provide a transfer tube, which is connected to the other end slips over the plain end of the Template Needle and is tightened down to hold and connect the Template Needle.