(74 days)
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.
| Characteristic | Acceptance Criteria (Compared to Cleared Device) | Reported Device Performance (Modified Device) | Result |
|---|---|---|---|
| Hermetic foil/polymer lid material | Identical | Identical | Met |
| Polymer sealing surface | Identical | Identical | Met |
| Process used to seal the hermetic foil/polymer lid | Identical | Identical | Met |
| Indications for Use Statements | Identical | Identical | Met |
| Design | Substantially Equivalent | Substantially Equivalent | Met |
| Materials | Substantially Equivalent | Substantially Equivalent | Met |
| Sterilization method | Identical | Identical | Met |
| Method of operation (Instructions for Use) | Substantially Equivalent | Substantially Equivalent | Met |
| Safety and Effectiveness | Equivalent (No new questions) | Equivalent (No new questions) | Met |
| Sterilization Validation | Substantially Equivalent | Substantially Equivalent | Met |
| Biocompatibility | Substantially Equivalent | Substantially Equivalent | Met |
| Seal Peel Force / Seal peel strength (performance data) | Identical | Identical | Met |
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.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.