Search Results

Ask a specific question about this device

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:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample size used for the test set and the data provenance: No specific test set data is provided.
3. 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.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone performance study was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable as this is not an AI/ML device that undergoes training.
9. 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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, with Modified Amies 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 CULTURE-PAK™ Collection and Transport System. Modified Amies Transport Media, is substantially equivalent to Medical Packaging Corporation's Culture Collection and Transport Device (K881105), and CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K936078) and ( K932337/S1). 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 holds 0.4 mL of clinical transport media and a plastic shaft, Rayon® tipped swab. Configuration of the CULTURE-PAK™ Collection and Transport System, Modified Amies 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; or a CytoSoft™ cytology brush.
• 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™ and the Culture Collection and Transport Device are packaged sterile. Sterilization is conducted at SteriGenics, International, Inc., and validated by North American Science Associates, Inc. for both devices.

The methods for use are similar for the CULTURE-PAK™ and the Culture Collection and Transport Device. The two plastic parts are pulled apart, exposing the swab(s) or brush. 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 collection device moist for up to 48 hours at room temperature.

The primary differences between Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System and the Culture Collection and Transport Device are how the media is contained, how to free the media so it will flow down into the bottom plastic part, and the provision of additional specimen collection devices as configured. The CULTURE-PAK™ has a plastic plug that holds the media in the top part. The top is bent 45 ° to break the plug allowing the media to flow into the bottom. The Culture Collection and Transport Device has a glass ampule that holds the media in the top plastic part. The top is squeezed to crush the ampule allowing the media to flow into the bottom. The CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media will also be available with an aluminum shaft Rayon® Mini-Tip rayon swab and a CytoSoft™ cytology brush.

This submission describes a medical device, the CULTURE-PAK™ Collection and Transport System, with Modified Amies Transport Media, which is a sterile device for collecting and transporting microbiological specimens. This is not an AI/ML device and therefore no studies on acceptance criteria based on algorithm performance are included in the provided text.

Here's an analysis based on the provided text, specifically addressing the questions you've posed, but adapted to the nature of this non-AI device:

Analysis of Acceptance Criteria and Device Performance for CULTURE-PAK™ Collection and Transport System

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are related to its functional equivalence to predicate devices and sterility validation. "Reported device performance" directly refers to the outcomes of these validation studies and comparisons.

2. Sample Size Used for the Test Set and Data Provenance

The provided summary does not detail a "test set" in the context of an algorithm's performance evaluation or a clinical trial with patient samples. The studies mentioned are primarily related to sterilization validation and substantial equivalence claims based on design and functional similarity to predicate devices.

• Sample Size for Sterilization Validation: Not specified within this document. Sterilization validation typically involves specific sample sizes determined by validation protocols (e.g., AAMI standards).
• Data Provenance: Not specified, but given the nature of the device and the submission date (1996), any comparative or validation data would likely be from laboratory settings or internal testing. It is not clear if it's retrospective or prospective for a patient-level study as no such study is described.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This concept is not applicable here as there is no "test set" for an algorithm, nor a need for expert-established ground truth in the traditional sense. The "ground truth" for this device would be its ability to maintain specimen viability, which is typically assessed via microbiological culture studies, not expert consensus on images or diagnostic data.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" (in the context of diagnostic performance) or expert review process described.

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 manual specimen collection and transport device, not an AI-powered diagnostic system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's efficacy would broadly be microbiological viability/growth studies demonstrating that collected specimens remain viable for culture over the specified transport time (e.g., 48 hours at room temperature). This involves comparing the growth of microorganisms from specimens transported in the device versus a control or predicate device under controlled laboratory conditions. The document states its intended use for "collection, preservation, and transportation of microbiological specimens" and that it keeps the "collection device moist for up to 48 hours at room temperature," implying these types of studies were performed or referenced in establishing substantial equivalence. However, the specific study details are not provided in this summary.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device and does not involve a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable.

Ask a specific question about this device