(80 days)
Puritan Liquid Amies Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.
Puritan Liquid Amies Collection and Transport System is comprised of a sterile peel pouch containing a polyester flock swab applicator for collecting specimen and a polypropylene vial containing 1 ml of modified Amies liquid transport medium. The polyester flock swab applicators are provided in two different tip sizes to accommodate various specimen types. Amies liquid medium is a nonnutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, calcium chloride and magnesium chloride to provide essential ions that help maintain osmotic balance. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of aerobic, anaerobic and fastidious bacteria during the transport to the laboratory.
The Puritan Liquid Amies Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobic, anaerobic, and fastidious bacteria. The pivotal study demonstrating its performance is the "Recovery Testing" described in section 5.8 of the 510(k) summary. This study compared the Puritan system to a predicate device (BD (Copan) Liquid Amies Collection and Transport System, K061301) to demonstrate substantial equivalence.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Recovery (Viability) | Recovery of bacteria within acceptance criteria as defined by CLSI M40-A guidelines (details of specific criteria not provided, but generally involves maintaining viability within a certain log range compared to initial inoculum) | The Puritan Liquid Amies system showed recovery of bacteria within the acceptance criteria, comparable to the predicate device. |
| pH Stability | pH within the specified range (7.3 ± 0.2) | All samples tested were found to maintain pH within the specified range after 18 months. |
| Cytotoxicity | No evidence of cytotoxicity | No evidence of cytotoxicity was detected using the ISO Elution Method-1X MEM Extract for glue, shaft, and polyester (flock) swabs. |
| Sterilization | Validation following ANSI/AAMI/ISO 11137:2006 guidelines | Puritan Liquid Amies Transport Systems are sterilized by gamma irradiation and validated following ANSI/AAMI/ISO 11137:2006. |
| Shelf Life | Maintain microbial recovery up to the expiry date (18 months) | Stability tests verified the ability of the aged products to maintain microbial recovery up to the expiry date. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "known inocula of ATCC type culture and clinically significant microorganisms" were inoculated. It also states "random samples from three different lots of Puritan Liquid Amies Collection and Transport System" were used for pH stability. However, the exact number of microorganisms tested, replicates per microorganism, or total sample size for the core bacterial recovery study is not explicitly stated in the provided text.
- Data Provenance: The origin of the data is from laboratory testing (in vitro) comparing the Puritan device to a predicate device. It is not patient or country-specific data, but rather controlled experimental data. The study is prospective in the sense that the experiments were conducted specifically to evaluate the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided for this type of device (microbiological transport system). The ground truth for bacterial viability is established through quantitative laboratory methods (e.g., colony counting) and comparison to established standards (CLSI M40-A), not by expert consensus or interpretation of images/clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation (e.g., radiology for diagnostic devices) where multiple readers disagree. For this in vitro microbiological test, the results are quantitative and objective, eliminating the need for adjudication.
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. The Puritan Liquid Amies Collection and Transport System is a medical device for specimen collection and transport, not an AI-powered diagnostic tool involving human readers. Therefore, an MRMC study or AI assistance is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This device is not an algorithm. Its performance is evaluated independently (standalone in a laboratory setting) by assessing its ability to maintain bacterial viability, followed by subsequent testing by laboratory personnel. There is no human-in-the-loop aspect for the function of the transport medium itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for the bacterial recovery test is based on quantitative microbiological methods, specifically the known initial inoculum of ATCC type cultures and clinically significant microorganisms, and their subsequent viability over time. The Clinical and Laboratory Standards Institute (CLSI) M40-A guidelines likely define the acceptable range of recovery, acting as the reference standard.
8. The sample size for the training set:
There is no training set in the context of this device. This is a laboratory-tested medical device, not a machine learning model.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.