(131 days)
The CT/MRI Compatible Sure-guide Vaginal Cylinder Set is indicated for use in any patient case where High Dose Rate (HDR) radiation treatment of the vagina is acceptable by up-to-date clinical and practice guidelines.
The CT/MRI Compatible Sure-guide Stump Vaginal Cylinder Set is indicated for use in any patient case where High Dose Rate (HDR) radiation treatment of the vagina is acceptable by up-to-date clinical and practice guidelines.
The CT/MRI Compatible Miami HDR Set is indicated for use in any patient case where High Dose Rate (HDR) radiation treatment of the cervix, vagina, and uterus is acceptable by up-to-date clinical and practice guidelines.
- Vaginal
The CT/MRI compatible Sure-guide Vaginal Cylinder Set design is based on conventional cylindrical HDR delivery systems with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation as definitive treatment, adjuvant treatment, or as a treatment boost to the vaginal walls with or without external beam radiation therapy. The set consists of a precision manufactured Sure-guide cylinders of varied diameters for optimal radiation treatment delivery and anatomical customization.
- Stump
The CT/MRI Compatible Sure-guide Stump Vaginal Cylinder Set design is based on conventional cylindrical HDR delivery systems with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation as definitive treatment, adjuvant treatment, or as a treatment boost to the vaginal walls with or without external beam radiation therapy. The set consists of a precision-manufactured Sure-guide Stump Cylinders of varied diameters for optimal radiation treatment delivery and anatomical customization.
- Miami
The CT/MRI Compatible Sure-guide Miami HDR applicator Set is designed according to the conventional modified Miami applicator with a click fit connector interface. This applicator is particularly useful when the vaginal vault space is limited or narrow due to tumor, restricted anatomy, or fibrosis. It can also be useful to treat tumors that extend from the uterus or cervix down onto the vaginal wall. The set consists of a precision manufactured intrauterine tandems and a full set of variable diameter Miami cylinders (all components are designed to allow for customization of the treated geometry). The distance that the tandem is inserted can be customized for each case. Four differing tandems are provided: one straight, one slight curvature, one medium curvature, and one maximal curvature. These allow for maximal accommodation of the uterine flexure.
The provided text describes K123941, the Kobold Sure-guide Vaginal Cylinder Set, Kobold Sure-guide Stump Vaginal Cylinder Set, and Kobold Sure-guide Miami Cylinder Set. This is a 510(k) submission, meaning the manufacturer is claiming substantial equivalence to a predicate device, rather than proving safety and efficacy through extensive clinical studies with acceptance criteria in the same way a novel device might.
Here's a breakdown based on the information available:
Acceptance Criteria and Reported Device Performance
The submission states that "FDA has not established special controls or performance standards for this device," and "Performance Tests: Not Required." Since this is a substantial equivalence claim, the "acceptance criteria" are primarily met by demonstrating similarity to the predicate device in aspects like intended use, design, materials, and functional characteristics.
The "reported device performance" is framed in terms of substantial equivalence to the predicate device (K-033371, Intracavity BrachyTherapy Applicators).
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Claimed Similarity to Predicate) |
|---|---|
| Intended Use | Substantially equivalent to predicate device for HDR radiation treatment of the vagina, cervix, and/or uterus. |
| Technological Characteristics (Design, Materials, Afterloader Compatibility, Sterilization) | Same fundamental technology, similar nature of body contact, similar in shape and design, use the same sterilization procedures. Materials are titanium, Ultem®, silicone, high-temperature vinyl (stainless steel for Miami). Afterloader compatibility with GammaMed® and VariSource® with click-fit connector. |
| Biocompatibility | Documented and claimed "Safe as Predicate Device." |
| Environmental Compatibility (CT/MRI) | CT/MRI compatible, same as predicate device. |
| Cleaning/Sterilization Validation | Test results included (Steam 18 min at 273°F (134°C), 44psi (3 bar) Dry 15 min). |
| Mechanical Testing | Documented in Appendix A (details not provided in the summary). |
Study Information
The submission does not describe a traditional clinical study with defined acceptance criteria for a novel device. Instead, it focuses on demonstrating substantial equivalence to a predicate device. Therefore, many of the requested study details are not applicable or not provided.
- Sample size used for the test set and the data provenance: Not applicable. This submission relies on benchtop testing and comparison to a predicate device, not a clinical test set with patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a clinical test set is not established for this type of submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical applicator for brachytherapy, not an AI-powered diagnostic or treatment planning tool that would involve human readers or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical performance evaluation. The "ground truth" here is the established safety and effectiveness of the predicate device, to which the new device is compared.
- The sample size for the training set: Not applicable. There is no machine learning or AI component to this device.
- How the ground truth for the training set was established: Not applicable.
§ 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.