(29 days)
FreshCells™ are indicated for use in the isolation of 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, JAC-MK2, Mv1Lu, NCI H292, Vero and WI-38 cells (in addition to MRC-5, MCCOY, BGMK, and CV-1, under 510 (k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cells™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.
This document describes a 510(k) submission for "FreshCells™", which are cultured animal and human cells intended for use as hosts for the isolation and identification of specific viruses. The submission is a "Substantially Equivalent" determination, meaning the device's performance does not need to be "proven" in the same way a novel device would. Instead, the submission demonstrates that the new FreshCells™ lines are as safe and effective as a previously marketed predicate device.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy against a gold standard) because the submission is for cell lines acting as a medium, not a diagnostic test with a direct output. Instead, the "acceptance criteria" are implied by the comparison to the predicate device and the non-clinical tests performed to characterize the cell lines' capabilities.
| Characteristic / "Acceptance Criterion" | Predicate Device Performance | Subject Device Performance (FreshCells™) |
|---|---|---|
| Source of Cell Line | ATCC or another approved supplier | Same as predicate device (ATCC or another approved supplier) |
| Provided as nearly confluent monolayers | Provided routinely as nearly confluent monolayers | Same as predicate device (provided as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period) |
| Intended Use (Isolation & Confirmation of specific viruses) | Isolation & Confirmation of specific viruses | Same as predicate device (Isolation & Confirmation of specific viruses) |
| Specific Viruses Susceptible to Isolation/Confirmation | Not explicitly detailed for predicate in this summary; implied by predicate's intended use | As listed in the table in the submission for each cell line (e.g., HEL/Human Embryonic Lung is susceptible to Adenovirus, CMV, Echovirus, HSV, Poliovirus, Rhinovirus, Vesicular stomatitis (Indiana Strain) virus and VZV.) |
| Appearance | Not explicitly detailed | Characterized (part of non-clinical tests) |
| Growth Characteristics | Not explicitly detailed | Characterized (part of non-clinical tests) |
| Sterility | Not explicitly detailed | Characterized (part of non-clinical tests) |
| Isoenzyme Analysis | Not explicitly detailed | Characterized (part of non-clinical tests) |
| Virus Susceptibility (qualitative confirmation for specific viruses) | Not explicitly detailed | Characterized for the specific viruses listed for each cell line (part of non-clinical tests) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a traditional "test set" with a sample size for evaluating a diagnostic algorithm's performance against a ground truth. Instead, the "testing" involved characterizing the cell lines themselves. The "non-clinical tests" mentioned (appearance, growth characteristics, sterility, isoenzyme analysis, and virus susceptibility) would have involved a sufficient number of cell cultures/batches to demonstrate their consistency and performance.
- Sample Size: Not specified as a numerical sample size of "cases" or "patients." These are in-vitro studies characterizing batches of cell lines.
- Data Provenance: The document implies these are internal characterization studies ("The non-clinical tests consist of those used to characterize the product..."). There is no mention of country of origin of data or whether it was retrospective or prospective in the context of clinical samples, as the study is on the cell lines themselves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. There is no "ground truth" derived from human experts in the context of clinical images or patient data because the device is a cell culture medium, not an interpretative diagnostic device. The "ground truth" for the cell lines themselves would be established by standard cell biology, virology, and quality control methods.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication method described or required for this type of in-vitro diagnostic component.
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
Not applicable. This device is not an AI-powered diagnostic tool, nor is it subject to an MRMC study. It is a biological product (cell cultures) used as a growth medium for viruses.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm, but a physical biological product.
7. The Type of Ground Truth Used
The "ground truth" relevant to this device is established through various scientific and quality control methods:
- Cell Line Identity and Purity: Confirmed by isoenzyme analysis, morphological assessment (appearance), and sterility testing.
- Growth Characteristics: Verified through standard cell culture techniques to ensure they form "nearly confluent monolayers."
- Virus Susceptibility: Confirmed by inoculating the cell lines with known reference viral strains and observing the expected cytopathic effects or viral replication. This is the qualitative "performance" for their intended use.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of machine learning or AI for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 864.2280 Cultured animal and human cells.
(a)
Identification. Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.