(90 days)
The InterV brand V-Mark Breast Biopsy Site Marker with Titanium Anchor is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under MRI and ultrasound for at least 6 weeks, and be permanently visible by fluoroscopy.
The V-Mark biopsy site marker is made of two components; a resorbable copolymer, a polyester derivative of lactic and glycolic acids, and a titanium anchor. Polylactic/polyglycolic acid copolymers degrade and resorb in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The titanium anchor provides a permanent component to the marker of the biopsy site. The site markers are deployed through an applicator that fits commercially available biopsy probes or coaxial needles including the J&J Ethicon Mammotome 11 gauge biopsy probe, the Pro-Mag Coaxial Introducer with Blunt Obturator, the Bio-Pince Co-axial Introducer with Blunt Obturator, and the Medical Device Technologies V-Core Co-axial Introducer. The V-Mark device marks the site of biopsy tissue sample, and is visible for up to 6 weeks by x-ray, ultrasound and MRI. The body then metabolizes the copolymer portion of the marker over time. The titanium anchor provides permanent radiographic visibility.
The provided documents do not contain a detailed study demonstrating that the device meets specific acceptance criteria. The 510(k) submission is a "Premarket Notification" which indicates the device is substantially equivalent to a legally marketed predicate device. This process typically relies on demonstrating equivalence rather than proving performance against predefined acceptance criteria from a new clinical study.
However, based on the intended use and technological characteristics described, we can infer what the implicit performance characteristics are and how they were asserted rather than rigorously proven with a clinical study in this specific documentation.
Here's a breakdown based on the available text:
Inferred Acceptance Criteria and Reported Device Performance (Asserted)
| Acceptance Criteria (Inferred from Intended Use) | Reported Device Performance (Asserted in Device Description) |
|---|---|
| Visibility under X-ray/Fluoroscopy: Permanent visibility. | "The titanium anchor provides permanent radiographic visibility." (Device Description) |
| "permanently visible by fluoroscopy." (Intended Use) | |
| Visibility under Ultrasound: Visible for at least 6 weeks. | "visible for up to 6 weeks by x-ray, ultrasound and MRI." (Device Description) |
| "be visible under MRI and ultrasound for at least 6 weeks" (Intended Use) | |
| Visibility under MRI: Visible for at least 6 weeks. | "visible for up to 6 weeks by x-ray, ultrasound and MRI." (Device Description) |
| "be visible under MRI and ultrasound for at least 6 weeks" (Intended Use) | |
| Resorption of Copolymer: Degradation and resorption of the copolymer portion. | "Polylactic/polyglycolic acid copolymers degrade and resorb in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body." (Device Description) |
| "The body then metabolizes the copolymer portion of the marker over time." (Device Description) | |
| Deployment: Deployable through commercially available biopsy probes/coaxial needles. | "The site markers are deployed through an applicator that fits commercially available biopsy probes or coaxial needles including the J&J Ethicon Mammotome 11 gauge biopsy probe, the Pro-Mag Coaxial Introducer with Blunt Obturator, the Bio-Pince Co-axial Introducer with Blunt Obturator, and the Medical Device Technologies V-Core Co-axial Introducer." (Device Description) |
Study Information (Based on limitations of the provided document):
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided documents. The 510(k) summary provided appears to be a description of the device and its intended use, rather than a clinical study report with a test set. This type of submission would usually rely on bench testing and material characterization to support claims, and potentially existing predicate device data, rather than a new clinical "test set" in the context of human subjects.
- Data Provenance: Not specified. It's likely that any supporting data would have come from internal testing or literature reviews for the materials used, rather than a specific clinical study with a defined test set of patients.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. A clinical "ground truth" for a test set is not described or required for this type of 510(k) submission, which focuses on substantial equivalence of a physical implantable marker. The claims appear to be based on the known properties of the materials (resorbable polymers, titanium) and in vitro or ex vivo testing for visibility characteristics.
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Adjudication method for the test set:
- Not applicable/Not specified.
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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 device is a physical biopsy site marker, not an AI-powered diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical biopsy site marker, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated as a "ground truth" for a clinical study. The claims regarding visibility and resorption are based on the known physical and chemical properties of the device materials (poly(D,L-lactide-co-glycolide) copolymer and titanium) and likely supported by in vitro or ex vivo laboratory testing. For example, radiopacity of materials can be characterized in a lab without human subjects.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that would require a training set.
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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.