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Star Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical procedure or for future surgical procedures

The Star Tissue Marker consists of a radiographic soft tissue marker and the delivery system. The Star Tissue Marker includes a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength.

This submission is for a new cross sectional profile of the tissue marker. The delivery system is sterile, single patient use, and is pre-loaded incorporating the tissue marker. The delivery system has a 12 cm /14 gauge needle with 1 cm depth marks. The delivery system consists of a cannula with a handle with integral tabs to retain the tissue marker, a push rod with a plunger, and a tip cover. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle.

This document is a 510(k) premarket notification for the "Star Tissue Marker," an implantable clip used to radiographically mark soft tissue. The submission claims substantial equivalence to a predicate device, the "Beacon Tissue Marker" (K140835).

Since this is a 510(k) premarket notification for a Class II device claiming substantial equivalence to a predicate device, it does not typically include a clinical study with detailed acceptance criteria and performance data like a PMA application would. The FDA's 510(k) pathway focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through non-clinical testing and comparison. Therefore, the requested information regarding acceptance criteria and a study proving performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, is generally not found in these types of submissions for this device.

The document states:

• The device is a "Star Tissue Marker" and the predicate device is the "Beacon Tissue Marker" cleared on May 20th, 2014 (K140835).
• The submission is for a "new cross sectional profile of the tissue marker."
• "The results of assessment of the change to the new tissue marker conducted under Design Controls, support that the new offering is substantially equivalent to the predicate tissue marker."

This implies that the "study" demonstrating equivalence would be a series of engineering and material assessments comparing the new tissue marker's design, materials (PEKK), and radiographic visibility (X-ray, mammography, ultrasound, MRI up to 3.0 Tesla) to the predicate device, rather than a clinical trial with human subjects. The acceptance criteria would likely be defined by these engineering and performance standards to match or exceed those of the predicate device.

Without more detailed information from the original submission (which is beyond this document), it's not possible to provide the specific data requested in the format of acceptance criteria and proven device performance from a clinical study. The FDA's review for a 510(k) largely relies on non-clinical data and comparisons to the predicate, as evidenced by the mention of "Compliance with Design Controls" and "Compliance with Standards" (ISO 15223-1:2012, ISO 14971:2007, EN 1041:2008).

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