(31 days)
The 14G CORMARK™ Biopsy Site Identifier is intended for use during an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.
The 14G CORMARK™ Biopsy Site Identifier is composed of a bioresorbable collagen plug embedded with a titanium non-resorbable radiopaque marker or clip.
At the completion of a breast biopsy procedure, the marker is deployed into the biopsy cavity, using a stainless steel syringe-like applicator with 1 cm markings to aid in needle placement. The marker is intended to help relocate the biopsy site for any subsequent intervention or diagnosis. The collagen slowly absorbs and the titanium radiopaque marker is left behind as the permanent identifier of the biopsy site.
The provided document is a 510(k) summary for the 14G CORMARK™ Biopsy Site Identifier, which seeks to establish substantial equivalence to a predicate device, the Caris™ Site Marker.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that the 14G CORMARK™ Biopsy Site Identifier is substantially equivalent to the predicate device, Artemis Caris™ Site Marker. This means the acceptance criteria are implicitly that the new device performs at least as well as the predicate device and that any modifications do not raise new issues of safety or effectiveness.
| Acceptance Criteria Category | Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (from text) |
|---|---|---|
| Intended Use | Same as predicate device (Caris™ Site Marker) | The 14G CORMARK™ Biopsy Site Identifier has the "same intended use" as the Caris™ Site Marker: "to mark the biopsy site during an open surgical or percutaneous breast biopsy procedure." |
| Principles of Operation | Same as predicate device | "The 14G CORMARK™ Biopsy Site Identifier... has the same... principles of operation... as the Artemis Caris™ Site Marker." |
| Materials | Same as predicate device | "The 14G CORMARK™ Biopsy Site Identifier... has the same... materials... as the Artemis Caris™ Site Marker." (Both are composed of a bioresorbable collagen plug embedded with a titanium radiopaque marker). |
| Technological Characteristics | Similar to predicate device, with minor modifications not impacting safety/effectiveness. | "The 14G CORMARK™ Biopsy Site Identifier... has the same... technological characteristics... as the Artemis Caris™ Site Marker." Minor modifications: a) change from Pebax to stainless steel syringe-like applicator, b) change in dimensions to accommodate 14G core needle biopsies. |
| Functionality | Similar to predicate device | "The 14G CORMARK™ Biopsy Site Identifier... is similar in... functionality as the predicate device." |
| Safety and Effectiveness | Modifications do not raise new issues of safety or effectiveness. | "The modifications are minor and do not raise any new issues of safety or effectiveness." "The device passed all design verification and validation tests conducted." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly describe a separate test set size or data provenance (e.g., country of origin, retrospective/prospective) for proving acceptance criteria in a clinical study. The submission relies on demonstrating substantial equivalence through design verification and validation tests, and by comparing the characteristics of the new device to the predicate device.
The study referenced is not a clinical trial with a "test set" in the typical sense of patient data. It is a series of "design verification and validation tests" related to the design modifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. As the submission relies on design verification and validation tests related to manufacturing and material properties rather than clinical outcomes on patients, the concept of "ground truth established by experts" in the context of clinical evaluation of performance is not applicable here.
4. Adjudication Method for the Test Set:
This information is not provided in the document. As noted above, the submission does not detail a clinical study with an adjudicated "test set" in the context of human interpretation or diagnostic accuracy. The "tests conducted" are likely engineering and bench-top tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not performed or reported in this document. The submission focuses on demonstrating substantial equivalence through design and material comparisons, and engineering tests. It does not evaluate human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study was not performed or reported. This device is a physical medical device (tissue marker and applicator), not an algorithm or software. Therefore, the concept of "algorithm only performance" does not apply.
7. Type of Ground Truth Used:
The "ground truth" for this submission would be defined by engineering specifications, material properties, and functional requirements established during the design process and verified through testing. For example, testing for proper deployment, bioresorption rates, radiopacity, and mechanical integrity would be compared against predefined specifications. The document states: "The device passed all design verification and validation tests conducted." This implies that the device met its pre-defined engineering and performance criteria, which serve as the "ground truth" for this type of submission.
8. Sample Size for the Training Set:
This information is not provided and is not applicable. The device is a physical medical implant, not an AI or machine learning model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and is not applicable for the same reasons 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.