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510(k) Data Aggregation
(29 days)
FRESH CELLS VERO
FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.
The subject device provides HEL, HFF, LLC-MK2, Mv1Lu, NCI H292, Vero and WI-38 cells (in addition to MRC-5, McCOY, BGMK, and CV-1, under S10(k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cella™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.
The provided text is a 510(k) summary for a medical device (FreshCells™) and does not describe a study that uses acceptance criteria and reports device performance in the way typically expected for an AI or imaging device submission. Instead, it's about the substantial equivalence of cell cultures for virus isolation. Therefore, many of the requested categories are "Not Applicable" or cannot be extracted from the given information.
Here is an attempt to structure the information based on the request, highlighting where information is not available for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Technological Characteristics (Comparison to Predicate) | ||
| Source of Cell Line | ATCC or another approved supplier (Same as predicate device). | "Same as predicate device." - Implies FreshCells™ cell lines are sourced from ATCC or other approved suppliers, meeting this criterion. |
| Provision as nearly confluent monolayers | Cells are provided routinely as nearly confluent monolayers (Same as predicate device). FreshCells™ are provided "as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period." | "Same as predicate device." - Implies FreshCells™ meet this criterion. The description explicitly states they are provided "as nearly confluent monolayers ready for use upon receipt." |
| Intended Use | Isolation & Confirmation of specific viruses (Same as predicate device). FreshCells™ are "to be used as hosts for the isolation and identification of specific viruses." | "Same as predicate device." - Implies FreshCells™ meet this criterion. The listed viruses for each cell line further specifies the performance for isolation and identification, consistent with the intended use. (e.g., HEL/Human Embryonic Lung: Susceptible to Adenovirus, CMV, Echovirus, HSV, Poliovirus, Rhinovirus, Vesicular stomatitis (Indiana Strain) virus and VZV.) |
| Non-Clinical Test Results | ||
| Appearance | Implicitly, acceptable visual characteristics for cell cultures. | Non-clinical tests were conducted to characterize the product, including "appearance." The document implies that the appearance was acceptable, as the device received 510(k) clearance. (Specific quantitative performance not provided). |
| Growth Characteristics | Implicitly, acceptable growth rates and morphology for the specified cell lines. | Non-clinical tests included "growth characteristics." The document implies these were acceptable. (Specific quantitative performance not provided). The description states cells are "nearly confluent monolayers ready for use," indicating good growth. |
| Sterility | Implicitly, absence of contaminating microorganisms. | Non-clinical tests included "sterility." The document implies these were acceptable. (Specific quantitative performance not provided). |
| Isoenzyme Analysis | Consistent isoenzyme profiles for the respective cell lines. | Non-clinical tests included "isoenzyme analysis." The document implies these were acceptable, confirming cell line identity. (Specific quantitative performance not provided). |
| Virus Susceptibility | The specific cell lines must be susceptible to the listed viruses. (e.g., HEL/Human Embryonic Lung must be susceptible to Adenovirus, CMV, Echovirus, HSV, etc.) | Non-clinical tests included "virus susceptibility." The table in section a.5. lists the specific viruses each cell line is susceptible to, indicating that the device performs as expected in hosting these viruses. (e.g., HEL is explicitly stated to be susceptible to the listed viruses, demonstrating it meets this specific aspect of performance.) The 510(k) clearance confirms these characteristics were deemed acceptable for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The non-clinical tests involved "characterizing the product," which would include testing batches of the cell lines for the listed parameters. The specific number of cell batches or individual cell cultures tested is not provided.
- Data Provenance: Not explicitly stated, but based on the nature of cell culture characterization tests, the data would be generated internally by Diagnostic Hybrids, Inc. It's prospective in the sense that these tests were performed on the manufactured product to demonstrate its characteristics. Country of origin would be the USA (Diagnostic Hybrids, Inc., Athens, OH).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable in the context of this device. The "ground truth" for cell culture characterization and virus susceptibility is established through standard laboratory methodologies and accepted scientific benchmarks (e.g., ATCC standards for cell lines, established virology protocols).
- Qualifications of Experts: Not applicable. The work would be performed by qualified laboratory personnel following established protocols.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is not a study requiring expert adjudication of results. The results of the non-clinical tests (e.g., sterility, isoenzyme analysis, growth characteristics, virus susceptibility) are objective laboratory measurements against defined standards.
5. 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
- MRMC Study: No. This device is a cell culture medium, not an AI or imaging device with human readers.
- Effect Size: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth is based on established scientific principles and laboratory standards for cell biology and virology.
- Cell Line Identity: Confirmed through methods like isoenzyme analysis against known ATCC (American Type Culture Collection) standards.
- Sterility: Absence of microbial growth in standard sterility tests.
- Growth Characteristics: Expected cell morphology and proliferation rates for the specific cell lines.
- Virus Susceptibility: Demonstrated ability of the cell line to support replication of specific viruses based on established virological assays.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set. The cell lines themselves are "trained" over passages based on established cell culture techniques, but this is not data-driven training in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. (See #8). The "ground truth" for the cell lines' characteristics is inherent in their established biological properties and validated through standard cell culture and molecular biology methods.
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