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The Beacon Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The proposed Beacon Tissue Marker consists of a radiographic soft tissue marker and the delivery system. The proposed Beacon Tissue Marker is 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. The proposed Beacon Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

The proposed Beacon Tissue Marker is comprised of Oxford Performance Materials (OPM) OXPEKK-IG200 filled with Barium Sulfate (Polyetherketoneketone with 20% BaSO4 by wt%). OXPEKK-IG200 is a radiolucent material and serves as the carrier for the radiopaque BaSO4.

The proposed Beacon Tissue Marker delivery system is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the Beacon Tissue Marker. The delivery system consists of a cannula with a handle, a push rod with a plunger, and an end cap. 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. The Beacon Tissue Marker delivery system is used to place the Beacon Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a beveled 12 cm / 14 gauge needle with 1 cm depth marks and a plunger.

The provided document is a 510(k) summary for the Beacon Tissue Marker, which describes a device modification. It states that the purpose of the submission is to seek clearance for a modification to an already cleared tissue marker to be inserted into an already cleared delivery system.

Therefore, this document does not describe a study that proves the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to pre-existing predicate devices based on the modification of components already cleared by the FDA. The submission largely relies on the prior clearance of its constituent parts and asserts that the combined device does not raise new questions of safety or efficacy.

As a result, I cannot provide the specific details requested in your prompt regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance. These types of studies would typically be conducted for novel devices or significant modifications, which is not the case described here.

The document indicates that the change is the combination of:

• KMD-Mark1 Tissue Marker (K093473) - already cleared
• BiomarC® Tissue Marker delivery system (K063193) - already cleared

The document states: "Scion Medical Technologies, LLC believes that the proposed Beacon Tissue Marker... does not raise any new or significant questions of safety and efficacy and is substantially equivalent to the predicate Kent Medical Devices, Inc. KMD-Mark1 Tissue Marker (K093473)... and the predicate Carbon Medical Technologies, Inc. BiomarC Tissue Marker (K063193)."

This type of submission often relies on a comparison of technical characteristics and existing performance data of the predicate devices rather than new, extensive clinical studies for the combined product.

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