(94 days)
RP Brachytherapy Needles are intended to be used for the placement of radionuclide seeds, and/or gold markers and/or Brachytherapy spacer/sleeve accessories during Brachytherapy or IMRT procedures.
The RP Sleeve is intended to be used to facilitate the placement and containment of radioactive seeds and gold markers with or without spacers into the body during Brachytherapy or IMRT procedures.
The RP Spacer is intended to be used during Brachytherapy or IMRT procedures to facilitate the implant of radionuclide seeds or gold markers at predetermined intervals within the body tissue. Spacers are indicated for use in soft tissues or organ tissue, but not to be used during cardiovascular or neurological procedures.
RP Gold Markers are intended to provide localization information during Brachytherapy, IMRT, or other procedures involving radiation treatments.
Riverpoint Medical Brachytherapy Needles and accessories are devices which are used together or independent of each other during Brachytherapy or other IMRT procedures. Intended uses and material information is included below.
Brachytherapy Needles are used to deliver a separately obtained radionuclide source and/or accessory into the patient at the desired location. Intended uses and material information is included below.
RP Sleeves are composed of an extruded polymer material with known biocompatibility which can be used with or without RP Spacers to facilitate the placement of radionuclide seeds into the patient during Brachytherapy or IMRT procedures.
Gold Markers consist of ≥99.99% which can be implanted in order to provide increased visibility at the location of implant. Markers are to be available in a variety of sizes and configurations as desired by customers.
All devices within this submission are provided sterile for one-time use or non-sterile for further processing, and are sterilized via Ethylene Oxide when applicable.
This submission (K103449) is for various brachytherapy accessories (needles, sleeves, spacers, and gold markers), not a device that relies on performance criteria based on empirical study data like accuracy, sensitivity, or specificity. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through material properties, intended uses, and manufacturing processes. Therefore, the typical structure for describing acceptance criteria and study results related to performance metrics is not applicable here.
The document describes safety and effectiveness based on substantial equivalence to existing devices, adhering to special controls and guidance for brachytherapy sources.
Here's a breakdown of the relevant information from the provided text, framed in the context of substantial equivalence rather than performance metrics:
1. Table of Acceptance Criteria and Reported Device Performance (as applicable to substantial equivalence):
| Acceptance Criteria Category | Description (as inferred from the document) | Reported Device "Performance" / Justification |
|---|---|---|
| Intended Use | Must be substantially equivalent to predicate devices. | The stated intended uses for the Brachytherapy Needles, RP Sleeve, RP Spacer, and Gold Markers align with the general uses of brachytherapy accessories. |
| Material Composition | Materials must be biocompatible and consistent with predicate devices. | RP Sleeves are composed of an "extruded polymer material with known biocompatibility." Gold Markers consist of "≥99.99% gold." (Implicitly, other components of needles, etc. are also consistent with predicates). |
| Sterilization | Must be sterilized via an appropriate and validated method. | "All devices within this submission are provided sterile for one-time use or non-sterile for further processing, and are sterilized via Ethylene Oxide when applicable." |
| Design/Functionality | Basic functional principles (e.g., placing seeds, providing localization) must be comparable to predicate devices. | The functional descriptions (e.g., "facilitate the placement of radionuclide seeds," "provide localization information") are consistent with the function of the predicate devices. |
| Absence of Radioactive Material | The devices do not contain radioactive material. | "Although the majority of the product classifications selected for the devices within this submission list radionuclide sources, none of the devices within this submission contain any amount of radioactive material." This distinguishes them from the radioactive sources themselves, which have separate regulatory considerations. |
| Regulatory Compliance | Adherence to relevant FDA guidance and regulations. | "FDA Guidance 'Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources' was followed (as applicable) during the preparation of this submission..." |
2. Sample size used for the test set and the data provenance:
- This information is not provided in the document. For these types of devices (accessories for brachytherapy, where the focus is on material safety, sterilization, and mechanical function), the "test set" would typically refer to materials testing, biocompatibility studies, and sterilization validation, rather than a clinical performance study with patient data. The document does not detail specific studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. "Ground truth" established by experts is relevant for diagnostic or AI-driven devices where accuracy against a gold standard is being assessed. For brachytherapy accessories, the "ground truth" relates more to material properties meeting specifications, sterility, and mechanical integrity, which are validated through engineering tests and accepted standards rather than expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set:
- This information is not applicable and not provided. Adjudication methods are used in scenarios where multiple readers interpret data (e.g., medical images) to resolve discrepancies for establishing ground truth, which is not the type of assessment described or implied for these devices.
5. 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:
- This information is not applicable and not provided. An MRMC study is relevant for diagnostic devices, particularly those involving AI, to assess the impact of the device on human reader performance. This submission is for brachytherapy accessories, not a diagnostic or AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable and not provided. "Standalone performance" refers to the performance of an algorithm without human intervention, again relevant for AI or automated diagnostic devices. This submission is for physical medical accessories.
7. The type of ground truth used:
- The "ground truth" for this submission would primarily be established through material specifications, biocompatibility standards, mechanical testing results, and sterilization validation reports. The document does not explicitly detail these, but they are implied as the basis for demonstrating safety and effectiveness for such devices. The "safety and effectiveness" section broadly states that the devices "have been designed and manufactured to be substantially equivalent to the predicate devices listed in this submission for all aspects of safety and effectiveness," implying that the underlying evidence for this claim comes from technical and non-clinical testing.
8. The sample size for the training set:
- This information is not applicable and not provided. "Training set" is relevant for machine learning or AI algorithms. This is a submission for physical medical devices.
9. How the ground truth for the training set was established:
- This information is not applicable and not provided. (See point 8).
In summary, this 510(k) submission (K103449) is a premarket notification for brachytherapy accessories that relies on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with acceptance criteria based on metrics like accuracy, sensitivity, or specificity. The "study" here refers to the compilation of evidence (e.g., material data, design specifications, manufacturing processes, sterilization validation) that demonstrates the new devices are as safe and effective as their legally marketed predecessors.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.