(347 days)
The CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Fletcher type applicator is accepted by up-to-date clinical guidelines. The Kobold® Fletcher-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Henschke-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Henschke type applicator is accepted by up-to-date clinical guidelines. The Kobold® Henschke-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Vaginal Cylinder Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the vagina is accepted by up-to-date clinical guidelines. The Kobold® Vaginal Cylinder Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Miami Cylinder Applicator Set is indicated for use in any patient case where high dose rate (HDR) radiation treatment of the cervix, vagina, and uterus with a Miami type applicator is acceptable by up-to-date clinical guidelines. The Kobold® Miami Cylinder Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid Applicator Set design is based on the conventional modified Fletcher GYN applicator. Kobold manufactures versions compatible with HDR afterloaders. This applicator is mainly utilized for HDR radiation boosts to the cervix and parametrial tissues in conjunction with external beam radiation therapy. This GYN set consists of precision manufactured intrauterine tandems and a pair of interlocking vaginal colpostats with Fletcher type unshielded barrel or cylinder ovoids (all components are designed to allow for customization of the treated geometry). The distance between the two lateral ovoids is adjustable with a lock knob. Four differing tandem geometries are provided in the set: one straight, one with slight curvature, one with medium curvature, and one with maximal curvature. These allow for maximal accommodation of the uterine shape and flexure.
The CT Compatible / MR Unsafe HDR Kobold® Henschke-model Tandem and Ovoid Applicator Set design is based on the conventional modified Henschke GYN applicator. Kobold manufactures versions compatible with HDR afterloaders. This applicator is mainly utilized for HDR radiation boosts to the cervix and parametrial tissues in conjunction with external beam radiation therapy. This GYN set consists of precision manufactured intrauterine tandems and a pair of interlocking vaginal colpostats with Henschke type unshielded ovoids (all components are designed to allow for customization of the treated geometry). The distance between the ovoids is adjustable with a lock knob. Four differing tandem geometries are provided in the set: one straight, one with slight curvature, one with medium curvature, and one with maximal curvature. These allow for maximal accommodation of the uterine shape and flexure.
The CT Compatible / MR Unsafe HDR Kobold® Vaginal Cylinder Applicator Set design is based on conventional cylindrical HDR delivery systems with a connector interface compatible with major manufacturers' afterloaders. 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 precision manufactured vaginal cylinders of varied diameters for optimal radiation treatment delivery and anatomical customization.
The CT Compatible / MR Unsafe HDR Kobold® Miami Cylinder Applicator Set design is based on conventional modified Miami applicators with a connector interface compatible with major manufacturers' afterloaders. This applicator set 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. Various tandems are provided: straight. slight curvature. medium curvature, and maximal curvature. These allow for maximal accommodation of the uterine flexure.
This document is a 510(k) summary for several medical devices: Kobold® Fletcher-model Tandem and Ovoid Applicator Set, Kobold® Henschke-model Tandem and Ovoid Applicator Set, Kobold® Vaginal Cylinder Applicator Set, and Kobold® Miami Cylinder Applicator Set.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria with specific quantitative performance metrics. The stated "acceptance criteria" are effectively the characteristics of the predicate devices. The "reported device performance" is essentially that the new devices match these characteristics or exhibit similar performance where differences exist (e.g., sterilization methods, which are tested for efficacy independently).
| Acceptance Criteria (Based on Predicate Devices) | Reported Device Performance (New Devices) |
|---|---|
| Indications for Use: |
- For HDR radiation treatment of cervix and uterus (Fletcher/Henschke models)
- For HDR radiation treatment of vagina (Vaginal Cylinder model)
- For HDR radiation treatment of cervix, vagina, and uterus (Miami Cylinder model) | Substantially equivalent to predicate. |
| Afterloader Compatibility: - GammaMed®, VariSource® (predicate) | Elekta: microSelectron®, Flexitron®; Varian: GammaMed®, VariSource® (with click-fit connector). (Expanded compatibility) |
| Design Geometry: Flexible | Flexible |
| Materials: Titanium, Ultem®, Stainless Steel, Silicone, High Temperature Vinyl | Titanium, Ultem®, Stainless Steel, Silicone, High Temperature Vinyl |
| Packing: Tray | Tray |
| Sterility: Provided Non-Sterile | Provided Non-Sterile |
| Sterilization Methods, Sterilization Conditions: - Steam 18 min at 273°F (134°C), 44psi (3 bar) Dry 15 min; no Sterrad® compatibility documented (predicate) | Steam 4 min at 270°F (132°C), 44psi (3 bar) Dry 15 min. (Different sterilization cycle parameters) |
| Biocompatibility: Documented | Documented |
| Anatomical Sites: Uterus, Cervix (Fletcher/Henschke); Vagina (Vaginal Cylinder); Cervix, Vagina, Uterus (Miami Cylinder) | Uterus, Cervix (Fletcher/Henschke); Vagina (Vaginal Cylinder); Cervix, Vagina, Uterus (Miami Cylinder) |
| Environmental Compatibility: CT/MRI Compatible (predicate) | CT Compatible / MR Unsafe (A key difference, noted in the device name and description). |
| Performance Characteristics (overall) | Substantially equivalent |
| Bench Testing: Documented in accordance with known standards | Documented by manufacturer for predicate device. (Implying the new device meets similar standards) |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not describe a clinical study or a test set of patient data with a specific sample size. The testing appears to be primarily bench testing of the devices themselves, as indicated in section 7: "Extensive testing in accordance with known standards is documented by the manufacturer for predicate device in K-123912 and K-123941." This implies the current submission relies on the established performance of the predicate devices and specific engineering tests for the new devices (e.g., material testing, sterilization efficacy). There is no mention of data provenance (e.g., country of origin, retrospective/prospective) because no patient data study is described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. This submission does not involve a "test set" requiring expert ground truth, as it is a device substantial equivalence submission based on engineering and performance characteristics compared to predicate devices, not a clinical diagnostic or AI-driven aid.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The devices are physical medical tools (applicators for radiation treatment), not diagnostic imaging aids or AI algorithms that would involve human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
Not applicable. The devices are physical medical tools, not software algorithms.
7. The Type of Ground Truth Used:
Not applicable in the context of clinical "ground truth" (e.g., pathology, outcomes data). The "ground truth" for this submission are the established performance characteristics, safety profiles, and indications for use of the predicate medical devices, as well as engineering standards for materials and sterilization.
8. The Sample Size for the Training Set:
Not applicable. There is no AI component or "training set" mentioned in this document.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no AI component or "training set" described.
§ 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.