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510(k) Data Aggregation
(21 days)
The MammoSite ML is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
The MammoSite ML applicator is used to position tissue and the radioactive Device source during breast brachytherapy treatments. It consists of a multi-lumen description polyurethane catheter with an inflatable balloon assembly at its distal end. The MammoSite ML has the same intended use, similar technological Technological characteristics, and similar materials/dimensions of the predicate devices. The characteristics indication for use is the same as the predicate devices. Testing indicates that the MammoSite ML is substantially equivalent to the legally marketed predicate devices. All MainmoSite devices provide a means of delivering a radiation therapy in a tumor or tumor cavity. The MammoSite positions the radioactive source for radiation therapy and utilizes a 192Ir seed as the radiation source with similar dosimetric properties.
Analysis of Acceptance Criteria and Device Performance for MammoSite Multi Lumen (ML) Radiation Therapy System (RTS) (K092405)
Based on the provided FDA 510(k) summary documents, the MammoSite ML Radiation Therapy System (RTS) was reviewed for substantial equivalence to predicate devices, rather than against specific performance-based acceptance criteria in a traditional clinical study format. The core of this 510(k) submission relies on demonstrating substantial equivalence to already legally marketed devices, the MammoSite Radiation Therapy System (RTS) (K041929) and the SAVI Applicator Kit (K081677).
Therefore, the "acceptance criteria" here are largely implicit in the demonstration of similar intended use, technological characteristics, and materials/dimensions to the predicate devices, substantiated by testing. The focus is on safety and effectiveness being comparable, not on achieving specific performance metrics in a standalone study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Intended Use: Device performs as intended for intracavitary breast brachytherapy. | The MammoSite ML has the same intended use as the predicate devices: "to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer." |
| Technological Characteristics: Similar to predicate devices, including mechanism of action. | Has similar technological characteristics to the predicate devices. It positions the radioactive source (192Ir seed) for radiation therapy and has similar dosimetric properties. |
| Materials/Dimensions: Comparable to predicate devices. | Uses similar materials/dimensions as the predicate devices. It consists of a multi-lumen polyurethane catheter with an inflatable balloon assembly. |
| Safety: Device operates without undue risk of harm. | "Testing indicates that the MammoSite ML is substantially equivalent to the legally marketed predicate devices." This implies safety is comparable to cleared devices. Note: A specific labeling limitation was added by the FDA: "The safety and effectiveness of the MammoSite ML Radiation Therapy System (RTS) as a replacement for whole breast irradiation in the treatment of breast cancer has not been established." This indicates a specific unproven claim rather than an inherent safety issue of the device itself for its cleared indication. |
| Effectiveness: Device achieves its stated purpose comparably to predicate devices. | As with safety, the claim of substantial equivalence implies comparable effectiveness for the cleared indication. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not describe a specific clinical "test set" in the context of human subjects or patient data. The evaluation for this device appears to be primarily based on bench testing and engineering comparisons to demonstrate similar technological characteristics and performance to predicate devices.
- Sample Size: Not applicable in the context of a clinical test set. The review focuses on device specifications and comparative analysis.
- Data Provenance: Not applicable. If any testing involved specific physical samples, they would be lab-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This 510(k) submission does not detail a study involving expert review to establish ground truth for a test set of clinical data. The judgment of "substantial equivalence" is made by the FDA's Office of Device Evaluation based on the provided technical documentation, testing reports (not detailed in the summary), and comparison to predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set requiring adjudication in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in these documents. The submission focuses on demonstrating substantial equivalence of the device's technical specifications and intended use to existing devices, not on evaluating its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to a physical device, an applicator system for brachytherapy, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The device's performance is inherently linked to its physical properties and interaction with a radioactive source and, ultimately, human medical professionals.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices. The MammoSite ML is deemed substantially equivalent because its intended use, technological characteristics, and materials/dimensions are similar, implying it will perform comparably to the devices that have already demonstrated their safety and effectiveness (as determined by prior FDA clearances).
8. The Sample Size for the Training Set
Not applicable. As this is a medical device (applicator system) approval based on substantial equivalence, there is no "training set" in the context of machine learning. The design and manufacturing processes follow established engineering principles and quality systems, which are implicitly "trained" through prior device development and regulatory experience.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device submission.
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