(119 days)
Puritan UTM – RT Collection and Transport System is intended for the collection and transport of clinical samples containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the testing laboratory. The specimen transported in the Puritan UTM - RT can be used in the laboratory to perform viral, chlamydial, mycoplasmal and ureaplasmal culture.
Puritan UTM-RT is an enclosed system recommended for the collection and transport of viruses, chlamydiae, mycoplasmas and ureaplasma. The osmotically balanced and buffered culture medium contains Hank's balanced salt solution with a pH indicator, sucrose as a preservative, protein and gelatin as stabilizers. Antimicrobial agents are incorporated to minimize commensal bacterial and fungus contamination.
Puritan UTM-RT is comprised of a conical polypropylene vial filled with three 3-mm glass beads and 1.5ml or 3 ml of the transport medium, affixed with a high density polyethylene cap. Each unit of Puritan UTM-RT is provided in a peel pouch containing one of the following swab combinations:
1ml UTM with ultrafine tip HydraFlock® Swab .
3ml UTM with one elongated tip HydraFlock® and one ultrafine tip swab
3ml UTM with elongated tip HydraFlock®® swab .
. 3ml UTM with mini-tip HydraFlock® swab, scored shaft
3ml UTM with ultrafine HydraFlock® tip swab
. 3ml UTM vial with 2 reg polyester tip swabs, scored shaft
3ml UTM vial with regular polyester tip and one wire/plastic shaft with polyester tip
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device: Puritan UTM-RT Collection and Transport System (UTM-RT)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Microbial Recovery: Ability to sustain viability and recover specified viruses, chlamydiae, mycoplasmas, and ureaplasmas. | Positive: "The results demonstrate the ability of Puritan Medical Products UTM-RT to sustain the viability and recovery of test bacteria and viruses for at least 48 hrs at 4° C and room temperature (20-25° C)." |
| Shelf Life Stability (Microbial Recovery): Maintain microbial recovery performance up to and including the expiration date. | Positive: "Storage stability testing indicated maintenance of the test device performance up to and including the expiration date." (Quantified through 48 hours at two storage temperatures, with higher recovery at refrigerated storage). |
| pH Stability: Maintain pH within the specified target range (7.3 ± 0.2). | Positive: "All samples tested were found to maintain pH within the specified target range." (Tested up to 18 months). |
| Antibiotic Stability: Ability to control bacterial activities (in the medium) for a specified duration. | Positive: "All products tested the ability to control bacterial activities up to 72 hours." |
| Non-Cytotoxicity: Absence of cellular toxicity. | Positive: "Cytotoxicity testing... demonstrated no cellular toxicity associated with three lots of test devices when statistically compared to negative controls." |
| Sterility: Meet sterility requirements. | Positive: "Representative samples from each lot... are tested according to the USP 34 NF, 29:2011, , Sterility Tests." (Implies compliance, but no specific pass/fail rate is provided). |
| Substantial Equivalence to Predicate Device: Similar design, manufacturing, packaging, and intended use. | Positive: The comparison table (section 3.7.C) shows strong similarities in most aspects, with minor differences (swab tip material, shelf life) not deemed to impact substantial equivalence for the specified performance tests. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Microbial Recovery:
- Microorganisms: Adenovirus, Cytomegalovirus, Echovirus Type 30, Herpes Simplex Virus Type II, Influenza A, Respiratory Syncytial Virus, Parainfluenza Type 3, Varicella Zoster Virus, Herpes Simplex Virus Type I (9 viruses), Chlamydia pneumonia Strain CM-1, Chlamydia trachomatis Type 1 Strain UW-12/UR (2 chlamydiae), Mycoplasma hominis, Mycoplasma pneumonia, Ureaplasma urealyticum (3 mycoplasmas/ureaplasmas). A total of 14 specific strains/organisms.
- Replicates: For each organism, "100 µl were directly inoculated onto swabs in triplicate." This means 3 swabs per organism per dilution.
- Dilutions: "Two different dilutions of neat stock suspensions were prepared."
- Storage Conditions: "held at both 4° C and room temperature (20-25° C)."
- Time Points: "At key time points following inoculation (0, 24, and 48 h)."
- Total for Microbial Recovery (excluding initial stock prep variations): 14 organisms * 3 replicates * 2 dilutions * 2 storage temperatures * 3 time points = 1008 test samples.
- Sample Size for Shelf Life Stability:
- Lots: "Three lots of the test device beyond the expiration point and one newly prepared lot" = 4 lots.
- Microorganisms: Cytomegalovirus, Herpes Simplex Virus Type II, Respiratory Syncytial Virus, Chlamydia pneumonia, Mycoplasma pneumonia (5 specific strains).
- Swabs: "spiking swabs that accompanied each transport system with the chosen test dilution."
- Storage Temperatures: "stored at different temperatures (refrigerated and room temperature)."
- Time Points: "held at 0, 24 and 48 hours."
- Total (excluding replicates which are not explicitly stated for stability but would typically be used): 4 lots * 5 organisms * 2 storage temperatures * 3 time points = 120 test conditions.
- Sample Size for pH Stability: "random samples from three different lots of Puritan UTM-RT." (Number of samples not specified, but multiple samples per lot).
- Sample Size for Antibiotics Stability Test: "3 expired lots and a new lot of test device" = 4 lots.
- Sample Size for Cytotoxicity: "three lots of test devices."
- Data Provenance: The study appears to be a prospective bench study conducted by Puritan Medical Products LLC, an American company. The country of origin of the data is therefore USA (Guilford, ME).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.
- The ground truth in this context (viability/recovery of microorganisms) is established through laboratory-based culture methods and microscopic examination (immunostaining and enumeration of fluorescent foci or colony forming units). While these methods require trained personnel, the document refers to "standard laboratory techniques" and does not imply a consensus panel of clinical experts for interpretation.
4. Adjudication Method for the Test Set
- The document describes laboratory-based assays, such as shell vial assay followed by immunostaining and enumeration of fluorescent foci, or direct culture methods followed by enumeration of colony-forming units.
- There is no mention of an adjudication method involving multiple human readers/experts for the interpretation of results. The assessment appears to be based on objective lab measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a MRMC comparative effectiveness study was not done.
- This type of study is typically used for diagnostic devices that involve human interpretation of images or other data to assess the impact of AI on reader performance. The Puritan UTM-RT is a specimen collection and transport system, and its performance is evaluated through direct microbial recovery, not by assessing human reader accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- This question is not applicable to the Puritan UTM-RT device.
- The device itself is a collection and transport medium, not an algorithm. The performance tests are for the ability of the physical medium and swabs to preserve biological samples.
7. The Type of Ground Truth Used
- The ground truth used is primarily direct microbial viability/culturability.
- For viruses and chlamydiae: Viability determined by shell vial assay followed by immunostaining and enumeration of fluorescent foci.
- For mycoplasmas and ureaplasmas: Viability determined using direct culture methods onto appropriate growth media followed by enumeration of colony forming units (CFU).
- For pH: Direct measurement using a calibrated pH meter.
- For cytotoxicity: Sulforhodamine B assay for cellular toxicity.
8. The Sample Size for the Training Set
- The Puritan UTM-RT is a physical collection and transport system, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The studies described are performance validation studies for the physical product.
9. How the Ground Truth for the Training Set was Established
- As there is no AI/ML component, the concept of a "training set" and its associated ground truth establishment is not applicable.
§ 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).