(26 days)
The BioLucent Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
The BioLucent Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The BioLucent Applicator is provided sterile and is a single use device.
The provided document is a 510(k) Special submission for a medical device (BioLucent Applicator), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device requiring extensive clinical trials with specific acceptance criteria related to disease detection or diagnosis.
Therefore, the document does not contain information typically associated with acceptance criteria and a study proving a device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).
Here's why and what information is available:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of diagnostic effectiveness. For a device like the BioLucent Applicator (a remote controlled radionuclide applicator system), the "acceptance criteria" would primarily revolve around its mechanical integrity, biocompatibility, sterilization efficacy, and functional specifications that ensure it can safely and effectively deliver radiation as intended, consistent with its predicate devices.
- Reported Device Performance: The document states:
- "Performance testing was conducted on the BioLucent Applicator to demonstrate the integrity, suitability and substantial equivalence of the device."
- "The BioLucent Applicator is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics."
- This implies that the device's performance (e.g., functionality, safety features) met standards consistent with the predicate devices, but specific quantitative metrics are not provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This submission does not discuss a "test set" in the context of patient data or diagnostic performance. The "performance testing" mentioned would likely involve in vitro or engineering tests on device samples, not patient data. Therefore, this information is not applicable or available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable, as there is no "test set" for diagnostic performance described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as there is no "test set" for diagnostic performance described.
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:
- Not applicable. This device is an applicator for radiation delivery, not a diagnostic imaging device involving human readers or AI assistance in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device for radiation delivery, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable, as there is no diagnostic or interpretive element described for this device's performance. The "ground truth" for the performance testing would likely be engineering specifications, material standards, and functional requirements for an applicator.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of available information related to performance and acceptance criteria from the document:
The BioLucent Applicator is a Class II device, specifically a "Remote Controlled Radionuclide Applicator System." This 510(k) submission is a "Special" submission, indicating minor changes to an already cleared device, allowing for reliance on substantial equivalence to predicate devices rather than new extensive clinical trials.
- Acceptance Criteria (Implied): The device's "integrity, suitability and substantial equivalence" to predicate devices (BioLucent Applicator (K062830, K061241), Wright Vaginal Cuff Applicator (K980601), Comfort Catheters (K032372), Shielded Rectal Applicator Set (K033371)). This would involve ensuring the device mechanically performs as intended, is biocompatible, sterile, and safe for its intended use in delivering radiation during brachytherapy.
- Study Proving Acceptance: "Performance testing was conducted on the BioLucent Applicator to demonstrate the integrity, suitability and substantial equivalence of the device." No specific details of these tests (e.g., number of units tested, types of tests like tensile strength, leakage, dose distribution verification) are provided in this summary, as they are typically detailed in a separate section of the full 510(k) submission not included here.
- Conclusion: Based on this performance testing, BioLucent, Inc. concluded that the device is "substantially equivalent to existing legally marketed devices" regarding its "intended use, principle of operation and overall technological characteristics." The FDA concurred with this determination, as indicated by the clearance letter.
Important Note: The FDA's clearance letter includes a specific warning required to be added to the device's labeling: "The safety and effectiveness of the BioLucent Applicator Kit for Brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established." This indicates a specific unmet acceptance criterion or an unproven extended indication, which the manufacturer must disclose. This is a crucial piece of information about limitations on the device's accepted use.
§ 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.