(101 days)
StemPro® MSC SFM Medium is a liquid tissue culture medium products intended for human ex vivo tissue and cell culture processing applications.
StemPro® MSC SFM is a serum-free medium (SFM) specially formulated for the growth and expansion of human mesenchymal stem cells (MSCs). StemPro® MSC SFM enables human MSC growth and increased consistency compared to classical serum-supplemented medium. In addition, human MSCs can be expanded for multiple passages while maintaining their multipotential phenotype (i.e. ability to differentiate into osteogenic, chondrogenic, adipogenic lineages). StemPro® MSC SFM contains two components: StemPro® MSC SFM Basal Medium and StemPro® MSC SFM Supplement.
This is a 510(k) premarket notification for a tissue culture medium, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies are not applicable.
Here's the relevant information based on the provided text:
Device Name: StemPro® MSC SFM Medium
Predicate Device: Knockout™ SR Medium (K100616)
Intended Use: StemPro® MSC SFM Medium is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications. This device is a chemically defined tissue culture media used to support the growth or maintenance of human tissue or cells in culture.
Acceptance Criteria and Reported Device Performance
The device demonstrates substantial equivalence to its predicate by meeting performance standards outlined in a "Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications".
| Acceptance Criteria (Special Control Objective) | Reported Device Performance (Life Technologies Corporation's Equivalent Tests) |
|---|---|
| Demonstrate lack of potential toxicity of materials in the media to cells or tissue and demonstrate support of tissue and cell growth | StemPro® MSC SFM Performance Assay |
| Demonstrate lack of endotoxin or pyrogen contamination | Limulus Ameobocyte (LAL) test (25 USP Monograph ) |
| Validation of Aseptic Processing and Sterility Assurance Level (SAL) | Determination of SAL to be ≥ 10-3 and compliance with GMP requirements |
| Demonstrate Chemical purity | Incoming Raw Material testing using USP, ACS, FCC, GIBCO, or Cell Culture requirements |
| Stability/Shelf-Life (pH, non-cytotoxicity, support of cell growth) | pH continues to meet specifications; media is not cytotoxic and supports mammalian cell growth over 12 months. Container/closure system protects from microbial contamination. |
Study Details (Not applicable for AI/ML device)
This is a medical device submission for a tissue culture medium, not an AI/ML enabled device. Therefore, the following AI/ML-specific questions are not applicable:
- Sample size used for the test set and the data provenance: Not applicable. Performance testing involved laboratory assays rather than clinical data sets.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance studies of tissue culture media relies on established laboratory testing methodologies and specifications.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For performance tests like cytotoxicity, LAL, and chemical purity, the ground truth is established by the specified assay results conforming to pre-defined scientific and regulatory standards (e.g., USP monographs, internal specifications). For cell growth, it's the observed ex vivo cell proliferation and maintenance of phenotype.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.”