(142 days)
PRIME-XV FreezIS DMSO-Free MD is for use in human ex vivo tissue and cell culture processing applications.
PRIME-XV Freez/S DMSO-Free MD is a liquid medium intended for use in human ex vivo tissue and cell culture processing applications.
It is a chemically defined cryogenic preservation solution for human cells for use in a professional Healthcare Facility that performs cell culture and cell handling. It has comparable post-thaw cell viability as solutions containing dimethyl sulfoxide (DMSO), maintains potency of stem cells throughout cryopreservation, eliminates the risk of DMSO in stem cell therapy applications, is animal componentfree, enables cell preservation at -80°C to -196°C environments and is manufactured under cGMP conditions.
The provided text describes a medical device, PRIME-XV FreezIS DMSO-Free MD, which is a tissue culture medium. It presents the device's indications for use, technological characteristics, and a comparison to predicate devices, but it does not contain information about an AI-powered device or a study involving human readers or a test set to establish ground truth for performance metrics like sensitivity or specificity.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for an AI device. The document is a 510(k) summary for a biological/chemical product, not a software device or an AI diagnostic tool.
The acceptance criteria provided in the document relate to the quality and performance of the tissue culture medium itself, such as:
- High cell viability, robust cell expansion post-cryopreservation, maintenance of cell function, phenotype and differentiation potential: To demonstrate lack of potential toxicity and support of tissue/cell growth.
- **Endotoxin testing per USP , mycoplasma testing per USP **: To demonstrate lack of endotoxin or pyrogen contamination.
- Compliance with GMP requirements regarding aseptic processing: For validation of Aseptic Processing and Sterility Assurance Level (SAL).
- Incoming raw materials are of high quality and are lot-tested for identity and purity: To demonstrate chemical purity.
- 24-month shelf life when stored at 2 – 8 °C: Based on stability testing confirming pH, osmolality, non-cytotoxicity, and protection against microbial contamination.
These are established through laboratory testing directly on the medium and its interaction with cells, not through studies involving expert readers or ground truth adjudication as would be relevant for an AI diagnostic device.
§ 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.”