(150 days)
The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.
The Tissue Site Marking System is supplied as a sterile device and is intended for single patient use only. The Tissue Site Marking System is composed of two elements: 1) an implantable device (marker) including a bioabsorable component and a permanent component and 2) a deployment device. The Tissue Site Marking System is intended for use with the manual method of deployment under the following imaging modalities: ultrasound, x-ray, magnetic resonance, nuclear, computed tomography, and direct visualization.
The provided text does NOT contain information about acceptance criteria, device performance, or any studies involving AI, human readers, or ground truth establishment.
The document is a 510(k) summary for a "Tissue Site Marking System," which is a medical device for marking sites in soft tissue. It primarily focuses on the regulatory aspects of the device, including:
- Classification Information: Device name, common name, proprietary name, classification, and regulation number.
- Owner/Operator Information: Company details and contact person.
- Device Description: Two components (implantable marker and deployment device) and its intended use with various imaging modalities.
- Indications for Use: Permanent radiographic marking of sites in soft tissue.
- Contraindications: None known.
- FDA Communication: A letter from the FDA confirming substantial equivalence to predicate devices and outlining regulatory responsibilities.
- Indications for Use Form: A standard FDA form reiterating the indications for use.
Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.
§ 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.