(269 days)
The Avantik VTM is intended for the collection and transport of upper respiratory clinical specimens containing respiratory viruses, from the collection site to the testing laboratory. The collection system is a culture-based media that is intended to be used with standard laboratory examination, culture or with other assays that utilize stable recoverable infectious viral particles.
The Avantik VTM is a Non-Propagating Transport Medium Device designed to facilitate the secure collection and transportation of biological samples for diagnosing viral infections. The device contains a transport medium that maintains the viability and infectivity of clinically significant viruses en route to testing laboratories. The device can be stored between 2 - 25°C for up to 12 months and is only for use by Health Care Professionals. Upon collection, samples should be immediately placed in the transport tube to maintain optimal conditions. It is recommended to refrigerate the samples between 2 - 8°C or store them on wet ice to maintain a temperature of 2 - 8°C during transit. Post-collection, the specimen can be transported at 2 - 25°C and should be processed within 48 hours. The transport system allows for specimen collection, maintenance through a buffered medium, and contains a pH indicator. The liquid medium consists of a mixture of Hank's balanced salt solution, BSA (Bovine Serum Albumin), L-cysteine, Gelatin, Sucrose, L-glutamic acid, HEPES, Vancomycin, Amphotericin B, Colistin, and Phenol Red. The liquid medium inhibits the growth of competing bacteria and fungus, is non-toxic to mammalian host cells, and supports viral viability during transportation. The device includes a conical polypropylene vial filled with 3 ml of culture medium, secured with a high-density polyethylene screw-on cap.
The document describes the Avantik VTM, a viral transport medium, and its performance data to support substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance (Avantik VTM) |
|---|---|
| Reagent Stability | |
| Visual Inspection | All samples from all testing conditions gave passing results. |
| Weight | All samples from all testing conditions gave passing results. |
| pH | 7.3 ± 0.5 maintained up to 12 months. All samples from all testing conditions gave passing results. |
| Contamination Checks | All samples from all testing conditions gave passing results. |
| Shelf-life | 12 months from the date of manufacture. |
| Stability under stressed shipping conditions | Maintained acceptable stability (per ASTM D4169-16/D4332 testing). |
| Viral Recovery (Percent Reduction in Virus Infectivity After 48 Hours) | (Relative to 0h infectivity) |
| Influenza A (4°C) | Lot 1: 21.97 ± 3.64%; Lot 2: 9.52 ± 6.79%; Lot 3: 7.06 ± 1.14% |
| Influenza A (22°C) | Lot 1: -9.89 ± 5.86%; Lot 2: 6.13 ± 2.04%; Lot 3: 11.70 ± 3.15% |
| RSV (4°C) | Lot 1: 59.26 ± 5.90%; Lot 2: 55.24 ± 3.13%; Lot 3: 65.27 ± 4.02% |
| RSV (22°C) | Lot 1: 76.18 ± 3.50%; Lot 2: 75.85 ± 2.85%; Lot 3: 70.16 ± 1.22% |
| hCoV (4°C) | Lot 1: -23.55 ± 7.85%; Lot 2: 1.50 ± 5.21%; Lot 3: -18.26 ± 3.99% |
| hCoV (22°C) | Lot 1: 4.84 ± 3.25%; Lot 2: 21.06 ± 1.55%; Lot 3: -1.92 ± 3.86% |
| Cytotoxicity | Non-toxic to mammalian host cells. |
Note: The document does not explicitly state numerical "acceptance criteria" for viral recovery in terms of a maximum allowable percentage reduction. It presents the "reported device performance" as the observed percentages of reduction. The conclusion states that the device "meets the requirements that are considered essential for its intended use," implying these results were deemed acceptable.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The viral recovery study was conducted using three lots of the candidate device. For each lot, three viral strains (Influenza A, RSV, Human Coronavirus NL63) were evaluated at two temperatures (4°C and 22°C) for two time points (0h and 48h). The document does not specify the number of replicates per virus/temperature/timepoint test condition, but the presentation of mean ± standard deviation for percentage reduction suggests multiple measurements were taken for each condition.
- Data Provenance: The document does not explicitly state the country of origin of the data. It is associated with HanChang Medic Co., Ltd. from Republic of Korea, which implies the studies were conducted in relation to this company. The studies are described in a factual manner without indicating whether they were retrospective or prospective, but performance studies for device clearance are typically prospective to gather specific data for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a viral transport medium, not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The "ground truth" for the viral recovery study is the quantitative measurement of virus infectivity (e.g., titer) after specific incubation times and temperatures, compared to time 0. This is an objective laboratory measurement, not based on expert consensus or interpretation.
4. Adjudication method for the test set
This section is not applicable for the same reasons as point 3. No expert adjudication was involved in determining the quantitative viral infectivity measurements.
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
This section is not applicable. The Avantik VTM is a viral transport medium, not a diagnostic AI system or an imaging device. Therefore, MRMC studies and assessments of human reader improvement with AI assistance are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The Avantik VTM is a physical transport medium, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the viral recovery study, the "ground truth" was established by quantitative measurement of virus infectivity. This is typically done through techniques like plaque assay (PFU/mL) or Tissue Culture Infectious Dose 50% (TCID50/mL), which objectively determine the concentration of viable virus. The "percent reduction in virus infectivity" is calculated based on these measurements at different time points (0h vs 48h).
8. The sample size for the training set
This section is not applicable. This is a physical medical device (viral transport medium), not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
§ 866.2390 Transport culture medium.
(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).