(14 days)
The MammoSite Cavity Evaluation Device (CED) may be used to assess the lumpectomy cavity and aid in the selection of the appropriate MammoSite Radiation Therapy System (RTS) applicator. It may be used during surgery to assess skin spacing and conformance. The CED may also be left in the lumpectorny cavity as a placeholder until it is exchanged for the MammoSite RTS applicator.
The MammoSite CED is used to assess the lumpectomy cavity and aid in the selection of the appropriate MammoSite RTS applicator for delivery of intracavitary radiation. It may be used during surgery to assess skin spacing and conformance, but it is not intended to deliver radiation therapy. It may be left in the lumpectomy cavity as a placeholder for up to 29 days until it is exchanged for the MammoSite RTS applicator.
The CED consists of a single-lumen silicone shaft, approximately six and one half inches long, with an inflatable silicone balloon bonded to the distal end of the catheter shaft. A rounded silicone tip caps the distal end of the catheter. A female luer and valve are connected to the proximal end of the catheter shaft. The silicone shaft has an outer diameter of 0.214" and a durometer of 65 Shore A. The MammoSite CED is available in a spherical 4-5 cm. balloon size.
The MammoSite Cavity Evaluation Device (CED) is a balloon catheter intended to be placed in a lumpectomy cavity for assessment and temporary maintenance of the cavity. The device's acceptance criteria and performance are established through non-clinical bench testing, as no clinical performance data was collected.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visual Inspection | |
| Rough edges | Not explicitly stated as "passed," but the overall conclusion is that "the device meets or exceeds its performance specification." Implicitly, no rough edges were observed. |
| Appropriate printed shaft markings | Not explicitly stated as "passed," but the overall conclusion is that "the device meets or exceeds its performance specification." Implicitly, markings were appropriate. |
| Ink adherence (after wiped with alcohol and saline) | Not explicitly stated as "passed," but the overall conclusion is that "the device meets or exceeds its performance specification." Implicitly, ink adherence was satisfactory. |
| Balloon Dimensional Consistency | |
| Inflated dimensions at 1st, 4th, and 8th cycle | Measured and evaluated. Implies consistency was within acceptable limits, contributing to the conclusion that "the device meets or exceeds its performance specification." The testing covers a safety factor of 1.6 times the anticipated clinical inflation cycles. |
| Balloon Assembly Integrity | |
| Strength of bonds | Assessed by inflating to failure with water after 8 inflation cycles. Results are not explicitly quantified but contribute to the conclusion that "the device meets or exceeds its performance specification." |
| Strength of balloon material | Assessed by inflating to failure with water after 8 inflation cycles. Results are not explicitly quantified but contribute to the conclusion that "the device meets or exceeds its performance specification." |
| Strength of joint between shaft and barb adapter | Tested to failure separately with a tensile test after the balloon burst. Results are not explicitly quantified but contribute to the conclusion that "the device meets or exceeds its performance specification." |
| Sterilization Compatibility | |
| Device integrity after gamma sterilization (25-40kGy) | Tested and visually inspected for rough edges, printed shaft markings, and ink adherence. Implies compatibility, as the testing was performed after sterilization and led to the conclusion that "the device meets or exceeds its performance specification." |
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Sample Size Used for Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify the exact number of CED catheters tested for each non-clinical performance test. It states "samples in the verification were tested to 8 cycles" for balloon inflation, and "The sterilized CED catheters and components were tested." This implies multiple units were used, but the specific count is not provided.
- Data Provenance: The data is based on non-clinical bench testing performed by Hologic, Inc. (the submitter) in Marlborough, MA. This is internal, prospective testing conducted specifically for this 510(k) submission. No external or retrospective data sources are mentioned.
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Number of Experts Used to Establish Ground Truth for Test Set and Qualifications:
- Not applicable. The ground truth for the non-clinical bench testing is based on objective measurements and engineering specifications, not expert consensus or human interpretation.
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Adjudication Method for the Test Set:
- Not applicable, as the tests are objective mechanical and material performance evaluations, not subjective clinical assessments requiring adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. No clinical performance data was collected, and therefore no human-in-the-loop studies were performed. The device is a physical medical device (balloon catheter), not an AI or imaging diagnostic tool that would typically involve MRMC studies.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device is a physical medical device, not an algorithm. The non-clinical testing evaluates the inherent physical and mechanical properties of the device itself.
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Type of Ground Truth Used:
- Engineering specifications and objective physical measurements. For example, visual inspections against defined criteria, dimensional measurements, and force-to-failure testing. The "ground truth" aligns with pre-defined performance requirements for the device.
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Sample Size for the Training Set:
- Not applicable. This is a physical medical device undergoing non-clinical bench testing, not an algorithm that requires a training set. The device's design was likely refined through iterative development, but there's no "training set" in the context of an algorithm.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set. The design of the CED leverages the established design principles and materials of its predicate device, the MammoSite Radiation Therapy System (RTS) applicator, which would have undergone its own developmental and testing phases.
§ 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.