(124 days)
Medical Wire & Equipment Virocult® Virus Collection and Transport System is intended to preserve the viability and infectivity of viral specimens for viral culture after their collection and during transport from the collection site to the testing laboratory. Virocult specimens are processed using standard clinical laboratory operating procedures for viral and cell culture.
Each Virocult® device comprises a sterile peel pouch containing a rayon- tipped swab used to collect the sample and a tube containing an open cell polyurethane pad soaked with Virocult® virus transport medium. After sampling, the swab applicator is placed inside the tube, where the bud is bathed with the liquid from the foam pad.
Virocult® medium consists of a phosphate-buffered balanced salt solution, glucose, lactalbumin hydrolysate to stabilise the virus particles, and antibiotics to inhibit the growth of other microorganisms that may be present in the clinical specimen.
The rayon- tipped swab will suit most general applications such as mouth, nose, throat and skin.
To use Virocult®, the sterile peel pouch is opened, and the cap removed from the transport tube. The applicator swab is removed from the pouch and used to collect the clinical specimen. During specimen collection, the applicator should only fouch the area where the infection is suspected.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medical Wire Virocult® Virus Collection and Transport System:
Based on the provided 510(k) summary, the device is a virus collection and transport system, not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study designs associated with AI medical devices (like those involving expert adjudication, multi-reader multi-case studies, or AI standalone performance) are not applicable to this submission.
The "acceptance criteria" for a device like this would primarily revolve around its ability to preserve viral viability and infectivity, its stability over time, and its pH, recovery, and toxicity characteristics as a transport medium. The study done proves its performance against these criteria.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| CLSI (NCCLS) M40-A Compliance | Simulating transport at 4°C | Tests were done to simulate transport at 4°C and at 23°C for swabs within date and swabs 2 months beyond expiry. The submission implies compliance without giving specific performance metrics against a defined standard (e.g., "X% viral recovery"). |
| Simulating transport at 23°C | Tests were done to simulate transport at 4°C and at 23°C for swabs within date and swabs 2 months beyond expiry. The submission implies compliance without giving specific performance metrics against a defined standard (e.g., "X% viral recovery"). | |
| Expiration Date Support | 12-month shelf life validation | Stability studies were performed to support a 12-month expiration date. |
| Recovery testing | Demonstrated stability over its 12-month shelf life. | |
| pH testing | Demonstrated stability over its 12-month shelf life. | |
| Toxicity testing | Demonstrated stability over its 12-month shelf life. | |
| Visual inspection | Demonstrated stability over its 12-month shelf life. |
Study Details
Given this is a 510(k) for a physical medical device (transport medium), the study details differ significantly from those for AI/Software as a Medical Device (SaMD).
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Sample sizes used for the test set and the data provenance:
- The document does not specify exact sample sizes (e.g., number of swabs, number of viral strains, number of tests conducted) for the performance testing. It generally states that "Tests were done to simulate transport" and "Stability studies were performed."
- Data Provenance: The studies were conducted by the manufacturer, Medical Wire & Equipment Company (Bath) Ltd., as part of their 510(k) submission. The country of origin for the testing would presumably be the UK, where the company is based. The studies appear to be laboratory-based performance evaluations rather than clinical trials with patient data, so they are prospective in the sense of being planned experiments.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device used to collect and transport biological samples, not an AI system making diagnostic interpretations. "Ground truth" in this context would be defined by the known initial viral concentration in the samples used for testing, and the known conditions (temperature, time) that the samples were subjected to. These would be laboratory-controlled parameters, not expert-adjudicated diagnoses.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication of diagnostic outcomes is involved. The evaluation relies on laboratory measurements of viral viability/recovery.
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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 is a physical collection and transport device, not an AI system or an AI-assisted diagnostic tool. There are no "human readers" (e.g., radiologists, pathologists) whose performance would be improved by this device in a diagnostic context, nor is there any AI involved.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the performance testing (viral recovery, stability), the ground truth is primarily established through laboratory standards and controls. This would involve:
- Known initial concentrations of specific viruses (reference strains).
- Standardized methods for viral culture and quantification (e.g., plaque assays, PCR measurement of viral load) to determine recovery rates after transport.
- Measurement against established benchmarks for acceptable viral viability post-transport (likely derived from CLSI guidelines or internal validation against predicate devices).
- For the performance testing (viral recovery, stability), the ground truth is primarily established through laboratory standards and controls. This would involve:
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The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/machine learning model that requires a "training set."
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How the ground truth for the training set was established:
- Not Applicable. As there is no AI or machine learning model, there is no "training set" or ground truth for it. The product's formulation and specifications are based on scientific principles of viral preservation and chemical stability, not trained data.
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.