(196 days)
Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.
Puritan Opti-Tranz Cary-Blair Collection and Transport System is comprised of a sterile peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene tube containing 5 ml of Cary-Blair medium.
Cary-Blair medium is a nonnutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of enteric bacteria during the transport to the laboratory.
The document describes the Puritan Opti-Tranz Cary-Blair Collection and Transport System, a device for collecting and transporting clinical fecal and rectal swab specimens to preserve enteric bacteria viability for bacteriological examination and culture.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Microbial Recovery | Maintain viability of different strains of enteric bacteria comparable to predicate device. | "No notable differences in recovery were detected between the Puritan Opti-Tranz Cary-Blair Collection and Transport System and the predicate device." |
| Fecal Material Impact on Recovery | Clinical fecal material should not notably alter recovery of challenge organisms. | "It was determined that clinical fecal material does not notably alter the recovery of the challenge organisms from the Puritan Opti-Tranz Cary-Blair Collection and Transport System." |
| pH Stability | Maintain pH within the specified range (6.90-7.50) over the shelf life. | "All samples tested were found to maintain pH within the specified range." (up to 20 months) |
| Cytotoxicity | No evidence of cytotoxicity from device components. | "No evidence of cytotoxicity was detected." |
| Sterilization | Sterilization validated according to ANSI/AAMI/ISO 11137:2006. | "Sterilized by gamma irradiation and validated following ANSI/AAMI/ISO 11137:2006." |
| Shelf Life | Maintain performance up to the expiry date (20 months). | Stability tests performed "up to the expiry date." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific tests (e.g., microbial recovery, pH stability). For microbial recovery, "known inoculum of clinically significant ATCC type culture microorganisms" were used, along with "three representative challenge organisms" for the fecal material impact test. For pH stability, "random samples from three different lots" were used.
- Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." All studies appear to be laboratory-based performance tests conducted by the manufacturer, Puritan Medical Products LLC, for regulatory submission purposes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the device is not an AI/diagnostic device that requires expert-derived ground truth from an image or clinical assessment. The ground truth for this device's performance relates to objective laboratory measurements (e.g., microbial viability, pH levels, cytotoxicity, sterility).
4. Adjudication Method for the Test Set
- This information is not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies among human readers in diagnostic studies.
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
- This information is not applicable. This is a medical device for specimen collection and transport, not an AI diagnostic tool or software.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the performance claims of this device is established through:
- Objective laboratory measurements: Microbial counts/viability for recovery testing.
- Predicate device comparison: Performance is compared against a legally marketed predicate device (Copan Venturi Transystem Cary-Blair Medium product (132C)).
- Standardized methods: Adherence to guidelines like CLSI M40-A2 for microbial recovery and ANSI/AAMI/ISO 11137:2006 for sterilization.
- Physicochemical tests: pH measurements, cytotoxicity assays.
8. The Sample Size for the Training Set
- This information is not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as 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).