(28 days)
To mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.
The HydroMark Breast Biopsy Site Marker contains a resorbable hydrogel component and a metallic component for permanent marking. The hydrogel has features that are unique and highly desirable for breast tissue marking. The HydroMark Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The HydroMark is deployed by the delivery system and is left in the tract created during the biopsy procedure. This Special 510(k) addresses the addition of a smaller size HydroMark Breast Biopsy Site Marker which will be provided in a smaller, rigid, sharp delivery system for use under ultrasound deployment either directly or though a commercially available 16 gauge x 9 cm coaxial needle. This Special 510(k) also describes minor modifications to the delivery system used for the ATEC 9 Ga Biopsy System and the EnCore 10 Ga Directional Vacuum-Assisted Biopsy Devices, and includes compatibility testing to allow the existing Mammotome MR Targeting Set to be labeled for use with other commercial MRI biopsy devices. Associated changes to the IFU and labels are also provided.
The acceptance criteria regarding device performance and the study details for the HydroMark Biopsy Site Marker are outlined below.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Explicit or Implied) | Reported Device Performance |
|---|---|---|
| Visibility under Ultrasound | Visible under ultrasound for at least 6 weeks. | "The Hydrogel component... is clearly distinct from normal breast structure under ultrasound imaging." The submission states the device "be visible under ultrasound for at least 6 weeks," implying successful demonstration. |
| Permanent Visibility by X-ray | Permanently visible by x-ray. | "The internal stainless steel or titanium coil which provides permanent visibility under x-ray." The submission states the device "be permanently visible by x-ray," implying successful demonstration. |
| Permanent Visibility by MRI | Permanently visible by MRI. | "The internal stainless steel or titanium coil which provides permanent visibility under... MRI." The submission states the device "be permanently visible by... MRI," implying successful demonstration. |
| Accurate Marking | Accurately mark the biopsy site by fixating in the track of the needle biopsy. | "accurately marking the biopsy site by fixating in the track of the needle biopsy." |
| Ease of Insertion and Deployment | Usability for ease of insertion and deployment. | Performed as intended. (Evaluated through "Usability testing for ease of insertion and deployment") |
| Delivery System Integrity | Withstand tensile forces. | Performed as intended. (Evaluated through "Tensile testing of delivery system") |
| Penetration Force | Meet specifications for penetration. | Performed as intended. (Evaluated through "Penetration force" testing) |
| Hydration/Moisture Characteristics | Meet specifications for hydration and moisture. | Performed as intended. (Evaluated through "Hydration testing and moisture analysis") |
| Biocompatibility | Meet ISO 10993-1 requirements for biocompatibility. | Device continues to meet the ISO 10993-1 requirements for biocompatibility. |
| Sterilization | Successfully sterilized. | Performed as intended. (Evaluated through "Sterilization validation") |
| Dimensional & Visual Integrity | Meet visual and dimensional specifications. | Performed as intended. (Evaluated through "Visual and Dimensional testing") |
| New 18 Ga Marker Performance | The 18 gauge HydroMark Breast Biopsy Site Marker for use with a 16 gauge x 9 cm coaxial needle performs as intended. | "The 18 gauge HydroMark Breast Biopsy Site Marker for use with a 16 gauge x 9 cm coaxial needle performs as intended, accurately marking the biopsy site by fixating in the track of the needle biopsy." "The device works in an identical manner to previously cleared 15 ga HydroMark Breast Biopsy Site Markers for use with 13 gauge x 9 cm coaxial needles or for direct puncture." |
| Delivery System Modifications | Minor modifications to the delivery system for the ATEC 9 Ga Biopsy System and the EnCore 10 Ga Directional Vacuum-Assisted Biopsy Devices and compatibility with the Mammotome MR Targeting Set do not raise new questions of safety or efficacy. | "All other modifications to the delivery systems, device compatibility and associated IFU and label changes represent minor updates to the products." The submission concluded substantial equivalence, implying these modifications met acceptance for safety and efficacy. |
2. Sample size used for the test set and the data provenance:
- The submission does not explicitly state the sample size for the test set for any of the non-clinical performance tests.
- The data provenance is non-clinical bench testing and simulated use testing. No human subject data (country of origin, retrospective/prospective) is reported for this 510(k). This is a Special 510(k) for minor device modifications and a new size.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. Given that the testing was non-clinical bench and simulated use, it's unlikely that "experts" in the clinical sense (e.g., radiologists) were explicitly used to establish ground truth in the way they would for reading images. The ground truth for performance metrics (tensile strength, penetration force, hydration, visibility) would have been established by engineering specifications and objective measurements.
4. Adjudication method for the test set:
- This information is not applicable as the described studies are non-clinical bench and simulated use testing, not clinical studies requiring adjudicators for subjective outcomes.
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:
- No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (biopsy site marker), not an AI/software device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical implant, not an AI algorithm.
7. The type of ground truth used:
- The ground truth for the non-clinical performance data was based on engineering specifications, objective measurements, and established industry standards (e.g., ISO 10993-1 for biocompatibility). For visibility, the ground truth was the objective observation of the marker under the specified imaging modalities (ultrasound, x-ray, MRI) as per the intended use.
8. The sample size for the training set:
- This information is not applicable. There is no "training set" in the context of an AI/algorithm for this physical medical device submission.
9. How the ground truth for the training set was established:
- This information is not applicable as there is no training set for an AI/algorithm in this submission.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.