(79 days)
Medical Packaging Corporation's SNAP SWAB™ Culture Collection and Transport System, with Modified Stuart's, Modified Amies, and Cary-Blair Transport Media is intended for use as a disposable, sterile culture Collection device for use in the collection, preservation, and transportation of microbiological specimens.
Medical Packaging Corporation's SNAP SWAB™ Culture Collection and Transport System is intended to be used for the collection, preservation, and transport of bacteriological specimens to the laboratory for evaluation. The media is intended to preserve the integrity of the specimen as well as minimize overgrowth of other organisms during transport.
Medical Packaging Corporation's SNAP SWAB™ Culture Collection and Transport System, available with Modified Stuart's, Modified Amies, and Cary-Blair Transport Media, is substantially equivalent to Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K936078) and ( K932337/S1), CULTURE-PAK ™ Collection and Transport System, Modified Amies Transport Media, K964637, and CULTURE-PAK™ Collection and Transport System, Clinical Transport Media (K970597). Listed devices are intended to collect, preserve, and transport clinical specimens to the laboratory for microbiological analysis. Devices are composed of two plastic parts:
- The top plastic part of the single swab device holds 0.4 mL of transport media . and a plastic shaft, Rayon® tipped swab. The top plastic part of the dual swab device holds 0.6 mL of transport media and two plastic shaft, Rayon® tipped swabs , and the top plastic part of the device with the Rayon® Mini-Tip swab holds 0.3 mL of transport media. The aluminum shaft, Rayon® Mini-Tip swab is for collection of either male urethral or nasopharyngeal specimens.
- The bottom plastic part of the device protects the swab(s) { hereafter referred . to as: Culture Collection device ) and fits tightly into the top plastic part. The SNAP SWAB™ Culture Collection and Transport System is packaged sterile. Sterilization is conducted at SteriGenics, International, Inc., and validated by North American Science Associates, Inc. for all configurations.
The two plastic parts are pulled apart, exposing the swab(s). After the culture is collected, the bottom is refitted into the top. The media seal is broken and the fluid is forced into the bottom extrusion to keep the Culture Collection device moist for up to 72 hours at room temperature.
(1) The release of media from the cap through the hollow shaft of the SNAP SWAB™ is accomplished by breaking the swab shaft within the cap rather than breaking the plastic snap valve. The action required for breaking the swab and the snap valve are identical. Once the shaft is broken, the media flow through the shaft is identical to the CULTURE-PAK™ device. (2) The SNAP SWAB™ culture tube is individually labeled and is packaged 50 to a labeled foil pouch.
Like the CULTURE-PAK™, the SNAP SWAB™ sealed hollow shaft is seated in the plug that holds the media in the top part of the device. The top is bent 45 ° to break the shaft allowing the media to flow through the exposed open shaft orifice into the bottom of the tube. The SNAP SWAB™ Culture Collection and Transport System, will also be available with two plastic shaft, Rayon® tipped swabs, and with an aluminum shaft Rayon® Mini-Tip ( Universal ) rayon swab.
The provided K972726 document for the SNAP SWAB™ Culture Collection and Transport System does not contain acceptance criteria or a study that evaluates device performance against such criteria.
Instead, this document is a 510(k) premarket notification for a Class I medical device. Its primary purpose is to demonstrate substantial equivalence to previously cleared predicate devices, not to present a de novo performance study with defined acceptance criteria.
The core of the submission revolves around showing that the SNAP SWAB™ device has the same intended use, similar technological characteristics, and performs in a substantially equivalent manner to existing predicate devices (CULTURE-PAK™ Collection and Transport Systems). The document focuses on describing the device's design, materials, and method of use, and how they compare to the predicates.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample size used for the test set and the data provenance: No specific test set data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set or ground truth establishment is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone performance study was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as this is not an AI/ML device that undergoes training.
- How the ground truth for the training set was established: Not applicable.
The document's "SUMMARY OF SAFETY AND EFFECTIVENESS" is a regulatory summary demonstrating substantial equivalence, not a summary of a performance study with acceptance criteria.
§ 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).