(146 days)
The CT/MRI Compatible HDR Fletcher Type Applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus is accepted by up-to-date clinical guidelines.
The CT/MRI Compatible HDR Henschke Type Applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus is accepted by up-to-date clinical guidelines.
- The CT/MRI Compatible HDR Fletcher Type Applicator Set™ design is based on the conventional modified Fletcher GYN applicator with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation boost to the cervix and parametrical tissues in conjunction with external beam radiation therapy. The set consists of precision manufactured intrauterine tandems and a pair of interlocking colpostats with Fletcher type unshielded ovoids ranging in size from 1cm to 3cm. All components are designed to allow for customization of the treated geometry. The distance between the ovoids is adjustable with a lock knob. Four different tandems are provided: one straight, one with a slight curvature of 15 degrees, one with medium curvature of 30 degrees, and one with a maximal curvature of 45 degrees.
- The CT/MRI Compatible HDR Henschke Type Applicator Set™ design is based on the conventional modified Henschke GYN applicator with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation boost to the cervix and parametrical tissues in conjunction with external beam radiation therapy. The set consists of precision manufactured intrauterine tandems and a pair of interlocking colpostats with Henschke type unshielded ovoids ranging in size from 2cm to 3cm. All components are designed to allow for customization of the treated geometry. The distance between the ovoids is adjustable with a lock knob. Four different tandems are provided: one straight, one with a slight curvature of 15 degrees, one with medium curvature of 30 degrees, and one with a maximal curvature of 45 degrees.
The provided 510(k) summary for the "Kobold Applicator Kits" does not contain information typically found in a study proving a device meets acceptance criteria for AI/ML-based medical devices. The document concerns a physical medical device (applicators for radiation treatment) and focuses on demonstrating substantial equivalence to a predicate device rather than performance against specific analytical or clinical metrics.
Therefore, many of the requested categories for AI/ML device studies, such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable or not present in this document.
However, based on the provided text, I can infer the "acceptance criteria" and how the device "meets" them within the context of a 510(k) submission for a physical device.
Acceptance Criteria and Device Performance (Inferred from 510(k) context):
The primary "acceptance criterion" for this 510(k) submission is Substantial Equivalence to a legally marketed predicate device (Mick® Ring Type GYN Applicator Set with K-011657). The "study" demonstrating this involves a comparison of various device characteristics.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Intended Use: For HDR radiation treatment of cervix and uterus accepted by clinical guidelines. | Substantially equivalent to predicate. Explicitly states this for both Fletcher and Henschke type applicators. (Page 2, 4) |
| Technology/Design: Similar design, fundamental technology, and sterilization procedures. | Substantially equivalent. Numerous design and material similarities are listed in the table. (Page 2, 3) |
| Performance Characteristics: As a physical medical device, general mechanical performance and compatibility. | Substantially equivalent. "Extensive testing in accordance with known standards is documented by the manufacturer. The standard is a specification for the materials used in surgical implant applications, predicate brachytherapy devices and manufacturer's acceptance procedures are detailed in Appendix A. Mechanical testing of the finished devices is additionally described in Appendix A." (Page 4) |
| Safety - Biocompatibility: Safe for human contact. | Documented (for both Kobold devices). The predicate device's biocompatibility was "Not Documented" in the comparison table, but the conclusion states "Safe as Predicate Device" for biocompatibility, implying sufficient safety. (Page 3, 4) |
Explanation of Non-Applicable/Missing Information for AI/ML Context:
- A table of acceptance criteria and the reported device performance: Provided above, inferred from the substantial equivalence claim.
- Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI/ML algorithm requiring a test set of data. The "testing" mentioned is mechanical bench testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in the AI/ML sense for this physical device.
- Adjudication method: Not applicable. No AI/ML performance to adjudicate.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI-assisted diagnostic or therapeutic device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable. This is a physical medical device.
- The type of ground truth used: Not applicable in the AI/ML sense. The "ground truth" for a physical device might refer to engineering specifications or validated material properties against known standards, which are mentioned as referenced in "Appendix A."
- The sample size for the training set: Not applicable. No AI/ML model.
- How the ground truth for the training set was established: Not applicable. No AI/ML model.
§ 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.