(124 days)
The Biopsy Sciences, LLC. HydroMark Biopsy Site Marker is intended 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 Biopsy Sciences HydroMark Breast Biospy Site Markers are made of resorbable FocalSeal-L Surgical Sealant, the same material used in the Biopsy Sciences Lung Biopsy Site Marker and in the currently cleared HydroMark Breast Biopsy Site Marker. The HydroMark is visible under mammography, ultrasound and magnetic resonance imaging. It expands in the void created during biopsy and does not migrate. The FocalSeal-L hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The HydroMark is available with either stainless steel or titanium coils, depending on physician preference. Both coils provide permanent visibility under x-ray and MRI. The HydroMark Site Marker is provided pre-loaded in a sterile. disposable applicator that is compatible with the J&J Ethicon Endo-Surgery Mammotome probe. The HydroMark is deployed by the delivery system through the Mammotome probe and is left in the void created during the biopsy procedure.
The provided text describes a 510(k) submission for the HydroMark Breast Biopsy Site Marker. This submission is for modifications to an existing device (K060769) to include an option for a stainless steel coil in addition to the previously available titanium coil. The primary purpose of the submission is to demonstrate substantial equivalence to the predicate device, not to establish new performance criteria for the marker's primary function (marking tissue, visibility under imaging modalities).
Therefore, the study focuses on comparing the new stainless steel coil to the existing titanium coil for visibility under MRI, rather than establishing specific quantitative acceptance criteria for the overall device performance like accuracy or sensitivity.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stainless steel coil is readily visible under MRI with minimal artifacts. | Confirmed: "Both coils are readily visible under MRI with minimal artifacts." |
| Stainless steel coil is as safe and effective as the predicate titanium coil. | Confirmed: "Biopsy Sciences has determined, based on comparative studies, that the stainless steel coil is as safe and effective as the predicate titanium coil..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "comparative studies" and "comparing the MRI images of the stainless steel coil to the predicate titanium coil," but does not provide details on the number of samples (coils or imaging sequences) used.
- Data Provenance: Not explicitly stated. The study appears to be non-clinical, meaning it likely involved controlled laboratory testing of the coils rather than human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided. The study appears to be a technical comparison of imaging characteristics rather than a clinical interpretation task requiring expert consensus on diagnosis or efficacy. The "ground truth" here would be the physical properties and visual characteristics of the coils themselves and their MRI artifacts.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. As it's a technical comparison of MRI visibility and artifacts, expert adjudication in the sense of clinical decision-making is not 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
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (biopsy site marker) and its imaging properties, not an AI or software device evaluating images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical marker, not an algorithm.
7. The Type of Ground Truth Used
- The ground truth for this non-clinical study appears to be a direct comparison of the physical appearance and MRI characteristics of the stainless steel coil versus the predicate titanium coil. This would involve objective assessment of artifact size and visibility by engineers or imaging specialists, rather than expert consensus on a pathology or clinical outcome.
8. The Sample Size for the Training Set
- Not applicable. This is a non-clinical comparison for device modification, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable for the same reason as point 8.
§ 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.