(161 days)
Cytophil Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant. The principle durable component is synthetic calcium hydroxylapatite. The semi-sold nature is created by suspending the calcium hydroxylapatite particles in a durable high yield strength thixotropic gel. The isotonic gel carrier consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The thixotropic high yield strength gel is created by the Carbopol 974P NF (USP). Cytophil Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. There is no ferrous material used in the formulation of the Cytophil Tissue Marker.
The provided document pertains to a 510(k) premarket notification for the Cytophil Tissue Marker. This type of filing demonstrates substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical trials with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document focuses on:
- Intended Use: To radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
- Product Description: Sterile, latex-free, non-pyrogenic, semi-solid, cohesive subdermal implant made primarily of synthetic calcium hydroxylapatite in a thixotropic gel.
- Substantial Equivalence: Claimed equivalence to BioForm Medical, Inc.'s Coaptite Tissue Marker and Coaptite FN Tissue Marker (K012955).
- Biocompatibility Evaluations: Preclinical safety and animal implant studies indicating biocompatibility when injected into soft tissues.
- Sterilization: Sterilized using steam by a contract sterilization company, validated to 10⁻⁶ SAL.
- Pre-Clinical Tests: In vivo and in vitro tests for irritation, sensitization, cytotoxicity, acute and sub-chronic toxicity, genotoxicity, and hemolysis, concluding the device is non-irritant, non-toxic, with no long-term safety concerns.
- Risk Assessment: Performed in accordance with EN 1441.
The FDA's review in the provided letter acknowledges the substantial equivalence claim based on the information submitted, allowing the device to be marketed. It specifically states that "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."
In summary, the provided text describes the regulatory pathway and pre-clinical safety assessments for a medical device (Cytophil Tissue Marker) based on substantial equivalence, and therefore, does not include a study or data on specific performance acceptance criteria as would be found for a device requiring a higher level of clinical evidence (e.g., a PMA or certain de novo applications).
§ 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.