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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 the female component of DualCap™ disinfects needleless Luer access valves and the male component of DualCap™ disinfects the IV administration line male Luer connections; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

The DualCap™ is designed to fit securely on Luer access valves and IV administration line male Luer connections. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, latex free, non-pyrogenic, preservative free and DEHP free.

Additionally DualCap™, the device will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk sterile to the kitting manufacturer (DualCap™ will be packaged in metalized unit container and will be impervious to ETO). The Catheter Connections' DualCap™ will be incorporated into the procedure kit.

The provided text does not describe an acceptance criteria study for a medical device that makes use of AI/ML. The document is a 510(k) premarket notification for a device called "Catheter Connections DualCap," which is an alcohol-impregnated cap designed to disinfect Luer access valves and IV administration line male Luer connections.

Therefore, I cannot provide information for the following points as they are not applicable to the provided document:

1. A table of acceptance criteria and the reported device performance.
2. Sample sized used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices through design characteristics, intended use, and existing scientific methods for assessing safety and effectiveness (e.g., sterilization, biocompatibility, and performance testing), not through clinical studies involving human readers or AI/ML algorithms.

The document indicates that "The Catheter Connections' DualCap™ will meet all established acceptance criteria for performance testing" and that "Performance data gathered demonstrated that the Catheter Connections' DualCap™ is substantially equivalent to the noted predicate devices." However, it does not explicitly list these acceptance criteria or the detailed results of the performance testing. It mentions that "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols." The standards referenced are ISO 11137:2006 for sterilization and ISO-10993 for biocompatibility.

In summary, the provided text describes a traditional medical device (not an AI/ML device) and confirms that performance testing was conducted to demonstrate substantial equivalence, but it does not provide the specific details of acceptance criteria or study outcomes.

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