(248 days)
Disposable Urine Collection Tube is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory, urine specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.
The Disposable Urine Collection Tubes for the collection, transport and preservation system consist of a safety rubber plug, a plastic cap and boric acid as an additive inside the tube. The tube is made of Polyethylene terephthalate (PET) and the safety plug is made of butvl-rubber while the disposable cap is made of Polyethylene (PE). The disposable tube device sustains the viability of organisms during transport for up to 48 hrs. at 2-4°C and 22-25°C.There are two main tube types (round and conical bottom), and four configurations by volume of urine for the round bottom tubes (4 ml, 7 ml, 8 ml, 10 ml). The conical bottom tubes only have one configuration by volume (8 ml). Each volume is available in yellow and white caps.
This document describes the premarket notification (510(k)) for the Disposable Urine Collection Tube, which is a Class I medical device. The information provided outlines the device's intended use, comparison to a predicate device, and performance data from analytical studies.
Here's an analysis of the provided text in relation to the requested information:
1. A table of acceptance criteria and the reported device performance
The document details performance studies, primarily for microbial recovery and fill volume impact.
| Acceptance Criteria (from CLSI document M40-A2 and internal study criteria) | Reported Device Performance (from Tables 2 & 3) |
|---|---|
| Microbial Recovery: Within 1 log10 of the initial microorganism count. | All strains tested (Candida albicans, Escherichia coli, Enterococcus Faecalis, Pseudomonas aeruginosa, Proteus mirabilis, Staphylococcus saprophyticus, Citrobacter freundii, Candida glabrata, Enterobacter cloacae, Morganella morganii, Streptococcus agalactiae) showed a change in Log10 (0 - 48 hrs) within the range of -0.17 to -0.51 at both 2-4°C and 22-25°C. All reported values are within the 1 log10 acceptance criterion. |
| Fill Volume Impact Recovery: Less than 1 log10 change when the fill volume is above or below the nominal line. | For E. coli, P. aeruginosa, and P. mirabilis at 90% and 110% fill volumes, the change in Log10 (0 - 48 hrs) ranged from -0.42 to -0.55. All reported values are within the 1 log10 acceptance criterion. |
| Shelf Life:** | |
| Appearance, Vacuum, Leak testing, Strength test, 50Kpa Pressure Test, PET tube's mechanical stress testing, Sterility test, Standards of boric acid content, Package integrity must pass over 18 months. | All samples passed the real-time aging test for 18 months at 22-25°C for all listed criteria. |
2. Sample size used for the test set and the data provenance
- Microbial Recovery Studies:
- Sample Size: "Three lots of the Disposable Urine Collection Tubes with three samples per lot were evaluated" (3 lots * 3 samples/lot = 9 total samples per condition/time point). The table indicates N=9 for average CFU/ml recovered.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies used "pooled human negative clinical urine matrix." The study is presented as part of a 510(k) submission to the US FDA by a Chinese manufacturer. It is a prospective analytical study comparing the device's performance over time.
- Fill Volume Impact Recovery Study:
- Sample Size: "Three production lots were tested in three replicates with each urine samples spiked with E. coli, P. aeruginosa or P. mirabilis" (3 lots * 3 replicates/lot = 9 total samples per microorganism/fill volume/time point). The table indicates N=9 for average CFU/ml recovered.
- Data Provenance: Similar to microbial recovery, not explicitly stated beyond being an analytical study supporting the device's performance from a Chinese manufacturer.
- Shelf Life Study:
- Sample Size: "Six lots of varying production were used for the studies." Specific number of samples per lot or per test is not detailed beyond that.
- Data Provenance: Not explicitly stated. This is a prospective real-time aging study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a urine collection, transport, and preservation tube, not an AI or diagnostic imaging device that requires expert interpretation of output. The "ground truth" for its performance studies is established by quantitative microbiological methods (e.g., counting colony-forming units (CFU/ml) and comparing them to initial counts), and physical/chemical tests (e.g., vacuum, leak, strength, borid acid content). Therefore, the concept of "experts" in the context of radiologists or similar interpretive professionals establishing ground truth is not applicable here. The ground truth is objective, laboratory-derived data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is an analytical device where performance is measured objectively through laboratory tests (microbial culture, physical properties) rather than through subjective human interpretation or consensus. No adjudication method for "ground truth" is needed in this context.
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
Not applicable. This is a medical device for specimen collection and transport, not an AI-assisted diagnostic tool. No MRMC study or AI assistance evaluation was conducted.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device's performance is:
- Microbiological Culture Counts (CFU/ml): For microbial recovery and fill volume impact studies, the "ground truth" is the quantitative measurement of viable microorganisms at different time points and conditions. This is an objective, laboratory-based measurement.
- Physical and Chemical Test Results: For shelf-life studies, the "ground truth" is determined by objective measurements of vacuum, leak integrity, mechanical strength, sterility, and boric acid content.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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).