(38 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 Breast Biopsy Site Marker is made of a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymers degrade and resorb in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The site markers are deployed through an applicator that fits in commercially available biopsy probes. The V-Mark Breast Biopsy Site Marker 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 marker over time. The V-Mark contains a titanium component for permanent radiographic visibility. The V-Mark Breast Biopsy Site Marker has been modified to remove the contrast agent that was incorporated into the polymer to provide radiopacity. The titanium component of the device provides for permanent radiographic visibility, eliminating the need for contrast agent in the resorbable polymer. V-Mark Breast Biopsy Site Markers are made of 75/25% poly(D,L-lactide-co-glycolide) copolymer. No other changes have been made to the formulation other than the elimination of the contrast agent. The site markers are deployed into the biopsy needle tract using a hand held applicator with a two finger-push control rod that delivers a single marker. The site markers are deployed through an applicator that fits commercially available biopsy probes or coaxial needles including the J&J Ethicon Mammotome biopsy probe, the Pro-Mag Coaxial Introducer with Blunt Obturator, the Bio-Pince Co-axial Introducer with Blunt Obturator, the Medical Device Technologies V-Core Co-axial Introducer, and the Suros Vacuum Assisted Biopsy System. For physicians who desire to perform biopsy under ultrasound guidance, a delivery system cannula with an echogenic tip is also available for multiple coaxial applications.
The acceptance criteria and study details for the InterV brand V-Mark® Breast Biopsy Site Marker with Titanium Anchor are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes a special 510(k) where the primary change is the removal of a contrast agent from the polymer while retaining a titanium component for radiographic visibility. The acceptance criteria are implicitly tied to the performance of the original predicate device (Medical Device Technologies, Inc. InterV brand V-Mark Breast Biopsy Site Marker, K051421). The key performance aspects are related to the marker's visibility and deployment.
| Acceptance Criteria (Implied from Predicate/Original Design Specifications) | Reported Device Performance (Modified Device) |
|---|---|
| Visibility under MRI and ultrasound for at least 6 weeks (from intended use statement) | Not explicitly re-evaluated and reported in detail for the modified device, but since the core mechanism for visibility (titanium) remains and the change is in the resorbable polymer, it's implied to meet this. The filing states "The titanium component of the device provides for permanent radiographic visibility, eliminating the need for contrast agent in the resorbable polymer." |
| Permanent visibility by fluoroscopy (from intended use statement) | "The titanium component of the device provides for permanent radiographic visibility." This directly addresses and meets the criterion. |
| Wire retention in the polymer (without contrast, equivalent to polymer with contrast) | "Wire retention in the polymer without contrast was equivalent to retention in polymer with contrast." This explicitly meets the criterion. |
| Deployment through the delivery system (meeting original design specifications) | "Finished product testing of the device without contrast, including deployment through the delivery system, met the original design specifications." This explicitly meets the criterion. |
| Overall device performance (substantially equivalent to the original product and meets the same finished product specifications for performance) | "Removal of contrast agent from the polymer did not affect device performance." and "The V-Mark Breast Biopsy Site Marker... is substantially equivalent to the original product and meets the same finished product specifications for performance." This overarching claim indicates all original criteria are met. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of a clinical study with patients. The performance data seems to be derived from engineering/bench testing. The document mentions "Finished product testing of the device without contrast, including deployment through the delivery system."
- Data Provenance: The data appears to be from internal laboratory/bench testing ("All testing was performed post sterilization"). No country of origin is specified for the data itself, but the manufacturer is based in Gainesville, Florida, USA. The testing is retrospective in the sense that it's comparing a modified device to a previously approved one, but the specific tests performed on the modified device would be prospective for that particular modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was not a human-in-the-loop study requiring ground truth established by experts. The evaluation focused on material properties and mechanical performance.
4. Adjudication method for the test set:
- Not applicable. There was no need for adjudication for this type of performance testing.
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. This study is not an MRMC comparative effectiveness study and does not involve AI assistance or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is not an algorithm; it is a physical medical device. The "standalone" performance here refers to the device's physical and material properties, which were tested without human-in-the-loop performance in a clinical scenario for this submission.
7. The type of ground truth used:
- The "ground truth" for the performance evaluation appears to be the original design specifications and the established performance of the predicate device (K051421). For example, "Wire retention in the polymer without contrast was equivalent to retention in polymer with contrast" implies the predicate device's wire retention served as the benchmark. Similarly, meeting "original design specifications" for deployment implies those specifications served as the ground truth.
8. The sample size for the training set:
- Not applicable. This submission concerns a modification to an existing physical device and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied.
§ 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.