(34 days)
Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, with Clinical Transport Media, (Cary-Blair Transport Media Option) is intended for use as a disposable, sterile culture collection device for use in the collection, preservation, and transportation of microbiological specimens.
Devices are composed of two plastic parts:
- The top plastic part holds 0.4 mL of clinical transport media and a plastic . shaft, Rayon® tipped swab. Configuration of the CULTURE-PAK™ Collection and Transport System, Clinical Transport Media, will also provide two plastic shaft, Rayon® tipped swabs; an aluminum shaft, Rayon® Mini-Tip swab for collection of either male urethral or nasopharyngeal specimens.
- The bottom plastic part protects the swab(s) or brush ( hereafter referred to . as: collection device ) and fits tightly into the top plastic part. The CULTURE-PAK™ Collection and Transport System is packaged sterile.
- Sterilization is conducted at SteriGenics, International, Inc., and validated by North American Science Associates, Inc. for both devices.
The provided text describes a medical device, the CULTURE-PAK™ Collection and Transport System with Clinical Transport Media (Cary-Blair Transport Media Option), and claims substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data in the typical sense of a novel AI/software medical device.
Therefore, the information for some requested fields will be "Not Applicable" or "Not Provided" because the submission is for a collection and transport system, not an AI or software-based device that would typically undergo such a study.
Here's an attempt to answer based on the provided text, interpreting where possible:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a transport media and not an AI or diagnostic device with accuracy metrics, explicit "acceptance criteria" in terms of performance thresholds (e.g., sensitivity, specificity) are not provided in the text. The "performance" described is in relation to its intended function of preserving and transporting microbiological specimens. The claim is substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Microbiological Specimen Preservation | The media seal is broken and the fluid is forced into the bottom extrusion to keep the collection device moist for up to 72 hours at room temperature. (Implied to be comparable to predicate devices for preservation effectiveness) |
| Sterility | "The CULTURE-PAK™ Collection and Transport System is packaged sterile. Sterilization is conducted at SteriGenics, International, Inc., and validated by North American Science Associates, Inc. for both devices." |
| Physical Characteristics/Components | - Top plastic part holds 0.4 mL of clinical transport media and a plastic shaft, Rayon® tipped swab. |
- Option: two plastic shaft, Rayon® tipped swabs; or an aluminum shaft, Rayon® Mini-Tip swab.
- Bottom plastic part protects swab(s) and fits tightly into the top.
- Plastic plug holds media, which can be broken by bending the top 45°. |
| Methods for Use | Same as predicate devices (CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media and Modified Amies Transport Media). |
| Safety | "All used materials should be treated as potentially infectious and biohazardous. Proper handling and disposal methods should be employed." (Standard safety consideration, no specific performance metric provided). |
Study Details:
The provided text outlines a 510(k) Notification for a medical device. This type of submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting new-performance studies with hard acceptance criteria in the way an AI diagnostic device would.
Therefore, many of the typical study-related questions are not directly applicable or the information is not provided in the scope of this regulatory document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This document does not describe a clinical study in this manner. The "test set" would primarily refer to the device itself and its components, and comparisons to predicate devices.
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)
- Not Applicable / Not Provided. Ground truth for typical diagnostic tests is not established in this type of device submission. The "ground truth" for a transport media would be its ability to maintain microbial viability, which is typically established through laboratory validation methods (not expert consensus on a test set).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. This type of adjudication method is relevant for expert-driven diagnostic interpretations, which is not the nature of this device or its submission.
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 collection and transport system, not an AI or diagnostic tool that assists human readers.
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)
- Not Applicable / Not Provided in this document. For a transport media, the "ground truth" would be the demonstrated viability and recovery rate of various microorganisms after transport, as determined by standard microbiological culture techniques. This document focuses on substantial equivalence rather than presenting such detailed validation data.
8. The sample size for the training set
- Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable. This device does not involve a "training set" or a ground truth established in this manner.
§ 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).