(164 days)
MoFi is a liquid culture medium intended for human ex vivo tissue and cell culture processing applications.
MoFi is a basal medium based on Iscove's Modified Dulbecco's Medium (IMDM) and cell-degradabe polysaccharide, made of water, carbohydrate, amino acid and salt. It can be mixed with various serums or additional additives to form a complete medium, which can be used to culture suspension/adherent primary cultured cells or cell lines. MoFi provides cells with energy to maintain survival and promote growth.
The provided document describes the FDA 510(k) premarket notification for "MoFi" Cell Culture Basal Medium. This K-submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing details on a study performed by the applicant (DuoGenic StemCells Corporation) to prove performance against specific acceptance criteria for an AI/ML powered device. The document describes a biologically-based product (cell culture medium), not an AI/ML-powered medical device.
Therefore, the requested information regarding acceptance criteria, AI/ML study design (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance), and training set details for an AI/ML device cannot be extracted from this document as it does not pertain to such a device.
The document discusses the following performance characteristics for the MoFi Cell Culture Basal Medium:
1. Acceptance Criteria and Reported Device Performance (for a cell culture medium, not an AI/ML device):
| Acceptance Criteria (for MoFi Medium) | Reported Device Performance (for MoFi Medium) |
|---|---|
| Appearance: Transparent yellowish liquid | Met (as implied by successful testing) |
| pH: 7.0-8.0 | Met (as implied by successful testing) |
| Cell viability: Good cell viability | Good cell viability of four kinds of cells (suspension primary culture cells, suspension cell lines, adherent primary culture cells, and adherent cell lines) |
| Sterility: Negative or not detected | Negative or not detected |
| Endotoxin: |
§ 876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications.
(a)
Identification. Tissue culture media for human ex vivo tissue and cell culture processing applications consist of cell and tissue culture media and components that are composed of chemically defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the ex vivo development, survival, and maintenance of tissues and cells of human origin. The solutions are indicated for use in human ex vivo tissue and cell culture processing applications.(b)
Classification. Class II (special controls): FDA guidance document, “Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Processing Applications; Final Guidance for Industry and FDA Reviewers.”