(252 days)
The Copan FecalSwab Collection, Transport and Preservation System is intended for the collection of rectal swab and fecal specimens and to preserve the viability of enteric pathogenic bacteria during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture.
The Copan FecalSwab Collection, Transport and Preservation System (Copan FecalSwab System) is supplied in a sterile collection kit format. Each collection kit consists of a package containing a plastic screw-cap tube with conical shaped bottom filled with 2ml of FecalSwab transport and preservation medium and a specimen collection swab that has a tip flocked with soft nylon fiber. The FecalSwab transport and preservation medium is a maintenance medium comprised of: Chloride salts, Sodium salts, Phosphate buffer, L-Cysteine and Agar. The medium is designed to maintain the viability of enteric pathogenic bacteria during transit to the testing laboratory. The nylon flocked specimen collection swabs provided with the Copan FecalSwab Collection, Transport and Preservation System have a solid plastic shaft with a molded breakpoint site.
The provided document is a 510(k) premarket notification for a medical device (Copan FecalSwab Collection, Transport and Preservation System). This type of document is for regulatory approval and focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical acceptance criteria in the same way a new drug or novel medical device might through a large-scale clinical trial.
Therefore, many of the requested elements are not applicable in this context, as the study presented is a non-clinical performance study designed to show the device functions similarly to an already approved device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the performance of the predicate device and the general expectation for transport media to maintain organism viability. The study aims to demonstrate that the Copan FecalSwab performs at least as well as the predicate device in terms of bacterial viability.
| Acceptance Criteria (Implicit) | Reported Device Performance (Copan FecalSwab) |
|---|---|
| Viability of target micro-organisms: | Viability of target micro-organisms: |
| Up to 48 hours at room temperature for general enteric pathogens. | In PBS: |
| Viability of C. difficile up to 48 hours at 2-8°C. | - All tested enteric pathogens (E. coli, E. coli O157:H7, S. typhimurium, S. sonnei, V. parahaemolyticus, E. faecalis VRE, Y. enterocolitica) showed viability and/or growth (positive LOG increase) at 20-25°C after 48 hours. |
| Viability of C. difficile up to 24 hours at 20-25°C. | - Clostridium difficile ATCC 9689: |
| Viability up to 72 hours at 2-8°C for general pathogens. | - Maintained viability at 2-8°C for 48 hours (LOG reduction -1.85, still detectable viable cells). |
| - Showed a LOG reduction of -1.92 at 20-25°C after 24 hours, indicating a decrease but still viable cells were detected at time 6 hours. | |
| - All tested enteric pathogens (except C. difficile and Campylobacter jejuni) maintained viability (LOG reduction ≤ -0.17 or positive increase, with detectable CFU) at 2-8°C up to 72 hours. | |
| Performance in fecal matrix (Escherichia coli O157:H7, | In Fecal Matrix: |
| Salmonella typhimurium, Vibrio parahaemolyticus) - | - All three tested organisms (E. coli O157:H7, S. typhimurium, V. parahaemolyticus) demonstrated viability and growth (positive LOG increase) at 20-25°C after 48 hours. |
| viability maintained. | - All three organisms also maintained viability (positive LOG increase or minor LOG reduction) at 2-8°C up to 72 hours. |
"Acceptance Criteria" Explanation: For a 510(k) submission, the "acceptance criteria" for performance studies like this are typically that the new device performs at least as well as or is comparable to the predicate device. The CLSI M40-A2 guideline mentioned (which details standards for transport media) would define what constitutes acceptable recovery and viability for such devices. The positive LOG increases for many organisms suggest that the transport medium not only preserves but in some cases, may even support proliferation, which is generally acceptable as long as it doesn't lead to overgrowth that masks other pathogens. For C. difficile and C. jejuni, where there were LOG reductions, the criteria would be that a sufficient number of viable organisms remain for detection within the specified timeframe. The document states "Viability of target micro-organisms up to 48 hours at room temperature and 72 hours at 2°C-8°C. For C. difficile, up to 48 hours at 2 – 8 °C and up to 24 hours at 20 – 25 °C" as the performance characteristic of the FecalSwab, implying these were the targets to be met to demonstrate equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The tables indicate "N = 3 LOTS TESTED" for all bacterial recovery experiments. This refers to 3 different manufacturing lots of the Copan FecalSwab device being tested. For each organism and condition (temperature/time point), there would have been multiple replicates per lot.
- Data Provenance: The study is non-clinical (laboratory-based). The organisms used are specific ATCC (American Type Culture Collection) strains, which are standardized reference microorganisms. Therefore, there is no country of origin for human data or retrospective/prospective designation in the human sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- N/A. This was a laboratory performance study of bacterial viability in a transport medium, not a study requiring expert interpretation of clinical data or images. The "ground truth" was established by quantitative microbiological methods (CFU recovery).
4. Adjudication Method for the Test Set
- N/A. As this was a microbiology laboratory study, there was no adjudication method involving human experts interpreting results in a consensus manner. Results were quantitative Colony Forming Unit (CFU) counts.
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
- N/A. This is not an AI or imaging device, and no human reader study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device (transport medium and swab), not an algorithm or software. The "standalone" performance here refers to the device's ability to maintain bacterial viability on its own, without human intervention affecting the measurement of viability post-collection. The reported CFU counts are precisely this type of standalone performance.
7. The Type of Ground Truth Used
- Quantitative Microbiological Culture (CFU counts): The ground truth for bacterial viability was established by performing standard quantitative microbiological culture methods to determine Colony Forming Units (CFU) per milliliter or per sample at various time points and temperatures. This is a direct measure of viable bacterial cells. The organisms were diluted in either Phosphate Buffered Saline (PBS) or a fecal matrix.
8. The Sample Size for the Training Set
- N/A. This is not a machine learning or AI device that requires a "training set." The study involved testing the physical device’s performance.
9. How the Ground Truth for the Training Set was Established
- N/A. See 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).