(40 days)
Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasma or ureaplasma from the collection site to the testing laboratory. UTM-RT can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture.
The Copan UTM-RT System includes a universal transport medium that is room temperature stable and that can sustain viability (and infectivity) of a plurality of organisms that include clinically important viruses, chlamydiae, mycoplasma and ureaplasma during transit to the testing laboratory. The formulation of UTM-RT medium includes protein for stabilization, antibiotics to minimize bacterial and fungal contamination, and a buffer to maintain a neutral pH.
Copan UTM-RT System medium is provided in screw-cap tubes designed for transport of the clinical sample. Copan UTM-RT System is also supplied as a sample collection kit that comprises a package which contains one screw-cap tube of UTM-RT medium and a peel pouch incorporating one or two sterile specimen collection swabs. A range of UTM-RT sample collection kits are available which incorporate different types of shaft swabs which facilitate the collection of specimens from different sites of the patient.
The provided text describes the Copan Universal Transport Medium (UTM-RT) System, a device intended for the collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasma, or ureaplasma. The document is a 510(k) summary submitted to the FDA, detailing the device's description, intended use, and performance testing for substantial equivalence.
Based on the information provided, here's a description of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state numerical or specific performance acceptance criteria for the Copan UTM-RT System. However, the objective of the performance testing was to demonstrate the device's ability to maintain the viability of various microorganisms, establishing substantial equivalence to predicate devices. The implicit acceptance criterion is that the Copan UTM-RT System performs comparably to or better than the predicate devices in maintaining viability and supporting culture.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Maintain viability (and infectivity) of clinically important viruses, chlamydiae, mycoplasma, and ureaplasma during transit to the testing laboratory, comparable to predicate devices. | "Recovery studies were performed using the Copan UTM-RT System and a comparative product to determine the ability of the products to maintain viability of various strains of viruses, chlamydiae, mycoplasma and ureaplasma during storage and use." The FDA's substantial equivalence determination implies that these studies sufficiently demonstrated comparable performance. |
| Room temperature stability of the medium, enabling effective transport. | "The Copan UTM-RT System includes a universal transport medium that is room temperature stable..." |
| Support processing using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma, and ureaplasma culture. | "UTM-RT can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture." |
| Supported 12-month expiration date. | "Stability testing was performed on aged Copan UTM-RT products to support the 12-month expiration date." |
| Substantial equivalence in design, intended use, and overall function to predicate devices. (Predicate devices: Multi-Microbe Collection & Transport System, M4 Medium by MicroTest Inc. (K910526) and REMEL - Apogent) | The FDA granted 510(k) clearance based on a determination of substantial equivalence. The document states: "The Copan Universal Transport Medium (UTM-RT) System products are substantially equivalent to the predicate transport medium devices. The Copan UTM-RT System product and the predicate devices are similar in design, intended use, and overall function." This implies that the performance studies demonstrated comparable results to what would be expected from the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "recovery studies were performed using the Copan UTM-RT System and a comparative product" to determine viability of "various strains of viruses, chlamydiae, mycoplasma and ureaplasma."
- The exact number of strains or replicates used for each microorganism is not specified in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission, it is highly likely these were prospective laboratory studies conducted by or for Copan Diagnostics Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document describes in vitro recovery and stability studies for microorganisms in transport media. For such studies, the "ground truth" is typically established by direct laboratory measurements of viable organism counts (e.g., plaque-forming units for viruses, colony-forming units for bacteria/mycoplasma) rather than expert interpretation of images or clinical cases.
- Therefore, the concept of "experts" establishing ground truth in the sense of clinical specialists is not applicable to this type of performance study for a transport medium. The expertise would lie in the microbiologists and laboratory personnel conducting the viability assays. Their qualifications are not detailed.
4. Adjudication Method for the Test Set
- The concept of an "adjudication method" (like 2+1, 3+1) is relevant for studies where human interpretation or diagnosis is involved, particularly in image analysis or clinical assessment.
- This is an in vitro diagnostic device for specimen transport, and the performance studies focused on microorganism viability and stability. Therefore, no adjudication method as typically understood in human-reader studies was employed or described. The results were based on quantitative laboratory assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used to evaluate the diagnostic performance of devices (often AI-based) and human readers in interpreting clinical cases.
- This device is a transport medium, not a diagnostic algorithm that interprets data. The performance studies focused on the physical and biological characteristics of the medium (viability, stability) in a laboratory setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the Copan UTM-RT System is a physical transport medium, not an algorithm or AI-based device. Its performance is inherent to its biochemical composition and physical characteristics, not an algorithm's output.
7. The Type of Ground Truth Used
- The ground truth for the performance studies was laboratory-measured viability (e.g., organism recovery/survival rates) and stability of specific strains of viruses, chlamydiae, mycoplasma, and ureaplasma. This implicitly serves as the "truth" against which the performance of the transport medium (Copan UTM-RT vs. comparator) was evaluated.
8. The Sample Size for the Training Set
- Not applicable. The Copan UTM-RT System is a biological transport medium, not an AI/machine learning model that requires a training set. The performance studies described are for validation of its intended function, not for training a computational model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the reasons stated in 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).