(29 days)
Cell cultures to be used as hosts for the isolation and identification of specific viruses. The subject of this 510(k) Notification, the cell lines HEL, HFF, LLC-MK2, MvlLu, NCI H292, Vero and WI-38 are susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus, CMV, Echovirus, HSV, Poliovirus, Rhinovirus, Vesicular stomatitis (Indiana Strain) virus and VZV; Adenovirus, CMV, Echovirus, HSV, Mumps, Poliovirus, Rhinovirus, VZV; Poliovirus type 1, Enterovirus, Rhinovirus, Myxovirus and Poxvirus groups; HSV, CMV; Vaccinia virus, HSV, Adenovirus, BK polyomavirus, Reoviruses, Measles virus, RSV, some strains of Influenza type A, most Enteroviruses and Rhinoviruses, Parainfluenza and Mumps; Adenovirus, Coxsackie B, HSV, Measles, Mumps, Poliovirus type 3, Rotavirus, Rubella; Adenovirus, CMV, Echovirus, HSV, Influenza, Mumps, Poliovirus, Rhinovirus, RSV, VZV.
FreshCella™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens.
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 510 (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 510(k) summary for K973211 describes the "FreshCells™" product, which consists of various cell lines intended for the isolation and identification of specific viruses. However, the document does not present a typical device performance study with quantitative acceptance criteria as might be seen for a diagnostic test with metrics like sensitivity or specificity.
Instead, the acceptance criteria are implicitly defined by a comparison to a predicate device and a demonstration of the cell lines' suitability for their intended use through characterization tests.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are performance characteristics, and the device performance is stated as being "Same as predicate device" for these characteristics.
| Acceptance Criteria (Characteristic) | Reported Device Performance (Subject Device) |
|---|---|
| Source of Cell Line | ATCC or another approved supplier (Same as predicate device) |
| Provided as nearly confluent monolayers | Cells are provided routinely as nearly confluent monolayers (Same as predicate device) |
| Intended Use | Isolation & Confirmation of specific viruses (Same as predicate device) |
| Susceptibility to Specific Viruses | Refer to Table 1: Cell Line Susceptibility to Viruses below, demonstrating susceptibility for the listed viruses. |
| Appearance | Characterized (Non-clinical tests performed) |
| Growth characteristics | Characterized (Non-clinical tests performed) |
| Sterility | Characterized (Non-clinical tests performed) |
| Isoenzyme analysis | Characterized (Non-clinical tests performed) |
| Virus susceptibility | Characterized (Non-clinical tests performed), and demonstrated for specific viruses |
Table 1: Cell Line Susceptibility to Viruses (Part of Device Performance demonstrating acceptance of virus susceptibility)
| CELL LINE/ORIGIN | SPECIFIC VIRUSES |
|---|---|
| HEL/Human Embryonic Lung | Adenovirus, CMV, Echovirus, HSV, Poliovirus, Rhinovirus, Vesicular stomatitis (Indiana Strain) virus and VZV. |
| HFF/Human Foreskin Fibroblasts | Adenovirus, CMV, Echovirus, HSV, Mumps, Poliovirus, Rhinovirus, VZV. |
| LLC-MK2, Original/Rhesus Monkey Kidney | Poliovirus type 1, Enterovirus, Rhinovirus, Myxovirus and Poxvirus groups. |
| Mv1Lu/Mink Lung | HSV, CMV. |
| NCI-H292/Human, Pulmonary muco-epidermoid carcinoma. | Vaccinia virus, HSV, Adenovirus, BK polyomavirus, Reoviruses, Measles virus, RSV, some strains of Influenza type A, most Enteroviruses and Rhinoviruses, Parainfluenza and Mumps. |
| Vero/African Green Monkey | Adenovirus, Coxsackie B, HSV, Measles, Mumps, Poliovirus type 3, Rotavirus, Rubella |
| WI-38/Human Lung | Adenovirus, CMV, Echovirus, HSV, Influenza, Mumps, Poliovirus, Rhinovirus, RSV, VZV. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in terms of clinical samples with a defined sample size. The testing appears to be primarily laboratory-based characterization of the cell lines themselves. Therefore, information on data provenance (country of origin, retrospective/prospective) is not provided and not applicable in the context of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The "ground truth" for cell line characteristics is established through standard laboratory assays and adherence to established cell culture practices (e.g., verifying sterility, growth rates, isoenzyme analysis). The "ground truth" for virus susceptibility is based on the known tropism of viruses for specific cell lines, which is part of general scientific knowledge in virology and cell biology, rather than being established by a panel of experts for a specific test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a human expert adjudication process for a test set in the context of the device's assessment.
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 a biological reagent (cell culture) and not an AI-powered diagnostic system. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a biological reagent (cell culture) and not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance, i.e., the proper functionality of the cell lines, is based on:
- Laboratory Characterization: Demonstrating expected appearance, growth characteristics, sterility, and isoenzyme analysis according to established scientific and quality control standards for cell cultures.
- Established Viral Tropism: The susceptibility of the cell lines to specific viruses is based on well-known scientific literature and established laboratory practices in virology.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm.
§ 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.