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510(k) Data Aggregation
(203 days)
OmniTrans™ Transport System is intended for use in the collection of clinical specimens (i.e., sputum, throat/ oropharyngeal swab, whole blood, urine, skin lesion material or exudate) potentially containing viruses, chlamydiae, mycoplasma, or ureaplasma and in their transport from the collection site to the testing laboratory. The system can be processed using standard clinical laboratory operating procedures for culture of clinical specimens.
OmniTrans™ Transport System includes a screw-cap tube containing transport medium, which can be supplied alone, or in a kit with one of two possible collection swab options in a sterile peel pouch or with two collection swabs in sterile peel pouches.
The in-tube-only format contains labeled screw-cap tubes pre-filled with 1 mL, 1.5 mL, or 3 mL of transport medium. The in-kit screw-cap tube format is pre-filled with 1 or 3 mL of transport medium for safe transportation of biological specimens.
The format in kit is supplied in pre-packaged collection sets containing one of the two swab types or both of two swab types:
Minitip flocking swab with 8 cm breaking point.
Regular flocking swab with 3 cm breaking point.
A specimen bag, with appropriate biosafety warning labels, is also provided with the device for safe transportation of clinical specimens in the transport medium.
The provided text describes the OmniTrans Transport System, a device for collecting and transporting clinical specimens. The key acceptance criteria and performance data are primarily focused on the device's ability to maintain the viability of various microorganisms (viruses, chlamydiae, mycoplasma, and ureaplasma) over time and temperature during transport.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (OmniTrans Transport System) |
|---|---|
| Shelf-Life Stability (18 months at 2-25°C) | |
| Appearance | Intact package, no leakage; media red and transparent without color change, turbidity, or precipitation. (Passed for all lots at all time points) |
| Net Content | Not less than the labeled volume. (All tubes met pre-defined criteria) |
| pH Value | pH within 7.3 ± 0.2. (All tubes within range for all lots at all time points) |
| Sterility (Aseptic status) | No microbial growth after 14 days incubation in fluid thioglycolate medium (30-35°C) and trypticase soy broth (20-25°C). (Confirmed for media in tubes from various aged lots). Swabs are individually packaged and sterile. |
| Microbial Stasis | No increase in microbial counts (Staphylococcus aureus, Escherichia coli, Candida albicans) at 48 hours when inoculated to 10-10° CFU/mL and incubated at 37°C. (Both old and new lots passed) |
| Microbial Recovery (after 48 hours at 2-8°C or 20-25°C) | |
| Viruses & Chlamydiae (Fluorescent Foci Counts) | Recovery within 1 Log₁₀ (±90%) of initial counts at time 0. (All tested viruses and chlamydiae met this criterion for both temperature ranges and for lots of different ages) |
| Mycoplasma & Ureaplasma (CFU counts - Roll Plate & Swab Elution) | Recovery within 1 Log₁₀ (±90%) of initial counts at time 0. (All tested mycoplasma and ureaplasma met this criterion for both temperature ranges and for lots of different ages) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a single number. The shelf-life stability tests involved "all lots tested at each time point," "five replicates from each lot," and "medium lots of serial post-production ages (0-, 6-, 12-, 18-, and >18-months) and "an old (>18 months at test) and a new (<3 months) lot." For microbial recovery studies, "each dilution was transferred with a swab into OmniTrans™ Transport System in triplicate."
- Data Provenance:
- Country of Origin: Shenzhen Dakewe Bio-engineering Co., Ltd. is based in Shenzhen, Guangdong, China. The clinical matrices were obtained from "donors testing negative for respective target pathogens." No specific country of origin for these donors is mentioned, but it's likely where the company operates or conducts its studies.
- Retrospective or Prospective: The shelf-life stability tests were prospective in nature, involving "serially conducted real-time aging performance tests at post-production time points." The microbial recovery studies also appear to be prospective laboratory studies using laboratory-created inocula and negative clinical matrices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number of experts, their qualifications, and their role in establishing ground truth) is not applicable to this device. The OmniTrans Transport System is a transport medium, and its performance is evaluated based on the viability of microorganisms, which is determined through laboratory assays (fluorescent foci counts and CFU counts), not expert interpretation of clinical images or data.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used when human interpretation (e.g., radiology reads) is involved and discrepancies need to be resolved to establish ground truth. For this device, ground truth is established by quantitative laboratory measurements of microbial viability.
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
No, an MRMC comparative effectiveness study was not done. This type of study relates to human interpretation, often in the context of AI assistance, which is not relevant for a microorganism transport medium.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is not an algorithm or AI system. Its performance is entirely "standalone" in that it's a physical transport medium designed to maintain microbial viability.
7. The Type of Ground Truth Used
The ground truth used for evaluating the OmniTrans Transport System is laboratory-based quantitative microbial viability data. This includes:
- Fluorescent Foci Counts: For viruses and chlamydiae, indicating the number of infectious particles.
- Colony Forming Units (CFUs): For mycoplasma and ureaplasma, indicating the number of viable bacteria.
- Qualitative and Quantitative Measures for Physical/Chemical Stability: Visual inspection for appearance, volumetric measurements for net content, and pH measurements.
- Microbial Growth/No Growth: For sterility testing.
- Microbial Count Changes: For microbial stasis testing.
8. The Sample Size for the Training Set
This is not applicable. The OmniTrans Transport System is a physical product (a transport medium), not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this device.
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