(47 days)
MammoSTAR Biopsy Site Identifier is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.
MammoSTAR Biopsy Site Identifier is a sterile, single use tissue marker consisting of pyrolytic carbon coated zirconium oxide discrete marker e that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) incorporated into lyophilized BiomarC Delivery Gel. MammoSTAR is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
Based on the provided FDA 510(k) clearance letter, the "MammoSTAR Biopsy Site Identifier" is cleared without new device performance data. The clearance is based on the device being identical to its predicate device (K100994) with only one difference being an added contraindication and an extended shelf life, which was verified through testing. Therefore, there is no specific performance data from a new study presented in this document to describe or prove the device meets acceptance criteria.
The document indicates that no new performance data was required because the device is deemed identical to the predicate device, and thus, already meets the established criteria for safety and effectiveness based on the predicate's clearance.
Here's an attempt to answer your request based on the information provided and inferred within the document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this 510(k) is a "Change Being Effected (CBE) determination" where the device is considered identical to its predicate except for an added contraindication and an extended shelf-life, explicit "acceptance criteria" and "reported device performance" from a new study are not provided for the claims of equivalency in the typical sense. Instead, the acceptance criteria are implicitly met by being identical to the predicate device, which was previously deemed safe and effective.
The only "performance" mentioned that might resemble a test is the shelf-life verification.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Implied/Verified) |
|---|---|
| Safe and effective for its indicated use (as per predicate) | Substantially equivalent to predicate device K100994 |
| Radiopaque marker material performance (as per predicate) | Pyrolytic Carbon Coated Zirconium Oxide, ≥ 200 DHP, ≥ .0005 inch thickness, 95% free from inclusions/banding/cracks |
| Biocompatibility (as per predicate) | Patient-Contact Marker Material: Pyrolytic Carbon; Patient-Contact Marker Carrier Composition: Lyophilized Beta Glucan |
| Sterility (as per predicate) | SAL > 1 x 10⁻⁶; Gamma Irradiation; Pyrogen testing |
§ 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.