(113 days)
The Biomac Fiducial Marker is indicated for use to radiographically mark soft tissue for future surgical procedures.
The BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, carbon/metallic composite discrete marker that is visible on standard radiographs and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible delivery devices chosen by the user.
This document is a 510(k) Pre-market Notification Summary for the BiomarC Fiducial Marker. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving a device meets specific performance acceptance criteria for a new clinical efficacy claim. Therefore, much of the requested information regarding clinical study design and results is NOT applicable or available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific quantitative acceptance criteria or detailed performance metrics in the way one would expect for a study proving clinical efficacy (e.g., sensitivity, specificity, accuracy for a detection algorithm). Instead, the "performance" discussed relates to a qualitative assessment of technological characteristics and safety.
| Feature/Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Technological Equivalence | Equivalent to predicate devices (BiomarC Tissue Marker (K063193) and EchoTip® Ultra Fiducial Needle (K111895)). | "The technological characteristics are equivalent to the predicate devices." |
| Risk Assessment | Risks associated with modifications are acceptable. | "A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced." (Conclusion implicitly acceptable as the device received clearance). |
| Biocompatibility | Biocompatibility is acceptable. | "A biocompatibility... evaluation confirmed that the modified device, BiomarC Fiducial Marker, was substantially equivalent to the predicate devices." |
| Visibility | Visible on standard radiographs and Magnetic Resonance Imaging (MRI). | "A... visibility... evaluation confirmed that the modified device, BiomarC Fiducial Marker, was substantially equivalent to the predicate devices." (Device description states: "carbon/metallic composite discrete marker that is visible on standard radiographs and Magnetic Resonance Imaging (MRI).") |
| MR Safety / Compatibility | MR Safety / Compatibility is acceptable. | "A... MR safety / compatibility... evaluation confirmed that the modified device, BiomarC Fiducial Marker, was substantially equivalent to the predicate devices." |
| Sterilization & Packaging | Sterilization and packaging maintain sterility and shelf life, equivalent to predicates. | "A... sterilization and packaging / shelf life adoption evaluation confirmed that the modified device, BiomarC Fiducial Marker, was substantially equivalent to the predicate devices." |
| Indication for Use | To radiographically mark soft tissue for future surgical procedures. | "The BiomarC Fiducial Marker is indicated for use to radiographically mark soft tissue for future surgical procedures." (Consistent with the stated indication). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document describes a substantial equivalence submission, not a study with a test set of patient data to assess a clinical performance metric. The "evaluations" mentioned are likely preclinical (e.g., material testing, MR compatibility testing) rather than human subject clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This information is relevant for studies assessing diagnostic accuracy or image interpretation, which is not the primary focus of this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable.
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 is not an AI-assisted device, nor does the submission describe an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (fiducial marker), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the evaluations performed (biocompatibility, visibility, MR safety, sterilization, packaging), the "ground truth" would likely be based on:
- Biocompatibility: In vitro and/or in vivo testing against established ISO standards and material specifications.
- Visibility: Imaging phantom studies and comparison to predicate device visibility characteristics.
- MR Safety/Compatibility: Testing according to ASTM standards for MR safety (e.g., heating, artifact, force).
- Sterilization and Packaging: Adherence to ISO standards for sterilization and package integrity testing over shelf life.
These are not "clinical ground truths" derived from patient data in the typical sense.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an algorithm being developed.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.