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When left in place for five (5) minutes, DualCap Solo™ disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

The DualCap Solo™ is designed to fit securely on luer access valves. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, this device is not made with natural rubber latex, non-pyrogenic, preservative free and DEHP free.

This document is a 510(k) Summary of Safety and Effectiveness for the Catheter Connections DualCap Solo™. It doesn't describe an AI/ML device, but rather a medical device with an administrative change related to its packaging. Therefore, the requested information about AI model performance, training data, ground truth establishment, and expert involvement is not applicable.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (the Sponsor's Cleared Device - K113842) by proving that a change in packaging configuration does not alter the device's safety or effectiveness.

Here's an analysis of the provided information within that context:

1. Table of Acceptance Criteria and Reported Device Performance

The device is claiming substantial equivalence based on the packaging change not affecting the core characteristics or performance. The "acceptance criteria" here are essentially "identical" or "substantially equivalent" when compared to the previously cleared device.

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

The document does not specify a distinct "test set" in the context of an algorithm. Instead, it refers to various specifications and internal test methods.

• For hermetic foil/polymer lid material, polymer sealing surface, and sealing process, "specifications" are compared. It does not mention a sample size for this comparison, suggesting a review of documentation rather than a physical test on a sample.
• For indications for use, "label specifications" were compared, also implying documentation review.
• For design, materials, sterilization method, and method of operation, "requirements (design input) and verification (design output)" were compared. Again, no specific test set sample size is mentioned.
• For seal peel force/strength, an "Internal Test Method ATM 1208 based on ASTM F88" was used. The document mentions "performance data" but does not provide details on the sample size used for these tests.
• The data provenance is internal to Catheter Connections, Inc., as indicated by references to internal document designations (e.g., "MSP 21-PX008", "ASC 1168", "ATM 1208"). The data is implicitly prospective in the sense that the testing was performed on the new modified device for this submission.

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

Not applicable. This device is not an AI/ML device requiring expert ground truth for a test set. Ground truth, in this context, would be established by the engineering and quality control standards applied during the manufacturing and testing of the device, referencing industry standards (e.g., ISO-10993, ASTM F88).

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as would be used for clinical or image-based studies. The assessment is based on comparing specifications and performance data to established standards and the predicate device.

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 not an AI device.

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

Not applicable. This is not an AI device.

7. The Type of Ground Truth Used

The "ground truth" here is embodied by:

• Identicality to predicate device specifications: For material, sealing process, indications for use, and sterilization method.
• Substantial equivalence to predicate device characteristics: For design, materials (more broadly), and method of operation.
• Compliance with recognized standards: Such as ISO-10993 (biocompatibility) and ASTM F88 (peel strength).
• Risk Analysis: Performed according to internal methods to ensure no new safety or effectiveness questions are raised.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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When left in place for five (5) minutes, DualCap Solo™ disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

The DualCap Solo™ is designed to fit securely on luer access valves. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, this device is not made with natural rubber latex, non-pyrogenic, preservative free and DEHP free.

This document is a 510(k) Premarket Notification Summary for the Catheter Connections' DualCap Solo™. It does not contain a detailed study report with specific acceptance criteria and performance data in the format requested. Instead, it makes a general claim of substantial equivalence to a predicate device (DualCap™ K093229) based on performance testing.

Therefore, I cannot fulfill most of your request directly from the provided text. I can, however, extract the claimed Indications For Use and the general statement about performance data.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Cannot be provided specifically. The document states, "The Catheter Connections' DualCap Solo™ will meet all established acceptance criteria for performance testing," but does not list these criteria or the numerical results from the performance testing.

2. Sample size used for the test set and the data provenance:

• Cannot be provided. The document states "Verification testing was performed according to protocols," but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Cannot be provided. This type of information is usually relevant for studies involving subjective assessments, such as imaging or diagnostic AI. The DualCap Solo is a physical device for disinfecting and acting as a barrier, so "ground truth" would be established through microbiology and engineering testing, not expert interpretation of outputs.

4. Adjudication method for the test set:

• Not applicable/Cannot be provided. For the same reason as point 3, adjudication methods like 2+1 or 3+1 are not relevant for this type of device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable/Cannot be provided. This is an AI-specific study type, and the DualCap Solo is not an AI diagnostic or assistive device.

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

• Not applicable/Cannot be provided. The device is not an algorithm.

7. The type of ground truth used:

• Inferred based on device type: For a disinfectant and barrier cap, the "ground truth" would likely involve microbiological assays (to confirm disinfection efficacy) and physical barrier integrity tests (to confirm it prevents contamination). The document mentions "Biocompatibility requirements according to ISO-10993" and "Sterilization requirements of ISO 11137" which are examples of standards guiding such ground truth establishment.

8. The sample size for the training set:

• Not applicable/Cannot be provided. This device is not an AI model requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable/Cannot be provided. This device is not an AI model requiring a training set.

Summary of available information:

Indications For Use (as per K113842):
"When left in place for five (5) minutes, DualCap Solo™ disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed."

General Statement on Performance:
"Performance data gathered demonstrated that the Catheter Connections' DualCap Solo™ is substantially equivalent to the noted predicate (Sponsor's Cleared Device - DualCap™)."
"The Catheter Connections' DualCap Solo™ will meet all established acceptance criteria for performance testing."

Type of Ground Truth (Inferred):
Microbiological efficacy (disinfection), physical barrier effectiveness, biocompatibility, and sterility testing, based on standards like ISO 11137 and ISO 10993.

The document is a regulatory submission for substantial equivalence, which typically focuses on demonstrating that a new device is as safe and effective as an already cleared predicate device, rather than providing a detailed scientific study report with all raw data and acceptance criteria specifics.

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