(266 days)
The Curos Jet™ Disinfecting Cap is intended for use on needleless connectors only as a disinfecting cleaner prior to I.V. access and to act as a cover between line accesses. The cap will disinfect the needleless connector one (1) minute after application and protect from contamination between accesses for up to seven (7) days if not removed. The effectiveness of the cap was tested in vitro against Staphylococcus aureus, Staphylococus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans and was found to have >4 log reduction. The cap may be used in the home or healthcare facility.
The 3M™ Curos Jet™ Disinfecting Cap is a single use, sterile cap that contains 70% Isopropy Alcohol and is intended to disinfect and protect needleless connectors. The Curos Jet™ Disinfecting Cap is translucent green in color. The device consists of a molded high-density polyethylene (HDPE) cap designed to fit onto female threads of a needleless connector, containing a HDPE plunger within. This plunger, when the cap is screwed onto a connector, travels towards a reservoir of 70% Isopropyl Alcohol, releasing it onto the needleless connector for disinfection. The Curos Jet™ Disinfecting Cap is offered in one size only, however it is packaged in "single" (1-cap) and "strip" (5-cap) configurations on a foil seal.
The provided document is a 510(k) summary for the 3M™ Curos Jet™ Disinfecting Cap. It describes the device, its intended use, comparison to predicate/reference devices, and non-clinical performance testing. However, it does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device, which is implied by several of your questions (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)").
This document is for a medical device, specifically a disinfecting cap, not an AI/ML software as a medical device (SaMD). Therefore, many of your questions related to AI/ML device testing (such as ground truth establishment for training/test sets, expert consensus, MRMC studies, and human-in-the-loop performance) are not applicable to the information provided in this regulatory submission.
The acceptance criteria and performance data relate to the disinfection efficacy of the physical cap.
Here's a breakdown of the relevant information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for disinfection efficacy is defined as "≥ 4 Log count reduction" against specific microorganisms.
| Microorganism | Acceptance Criteria (Log Reduction) | Reported Mean Log Reduction (1-Minute) | Reported Mean Log Reduction (7-Day) |
|---|---|---|---|
| Candida albicans | ≥ 4 | 5.25 | 5.25 |
| Candida glabrata | ≥ 4 | 4.53 | 5.46 |
| Escherichia coli | ≥ 4 | 4.57 | 4.94 |
| Pseudomonas aeruginosa | ≥ 4 | 5.03 | 5.55 |
| Staphylococcus aureus | ≥ 4 | 5.36 | 5.15 |
| Staphylococcus epidermis | ≥ 4 | 4.70 | 5.22 |
Note: The document also mentions other acceptance criteria for "foil seal peel strength, cap retention force to needleless connectors, as well as cap compatibility with needleless connectors via pressure/vacuum leak testing," but the specific numerical acceptance values for these are not provided in this summary. The summary states that "All testing was completed in accordance with approved company protocols and was completed to demonstrate that the Subject Device seals and acts as a cover for needleless connectors."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of caps or tests) used for the microbiology efficacy testing. It refers to "test results" and "mean Log reduction" which suggests multiple trials were conducted.
- Data Provenance: The efficacy testing was conducted in vitro. The document does not specify the country of origin for the data collection, but given it's part of a US FDA submission by a US company (3M Company, St. Paul, Minnesota), it's highly likely the tests were conducted in the US or in labs compliant with US regulatory standards for medical devices. The testing is described as "non-clinical performance test data," implying it's laboratory-based, not patient-based data. It is retrospective in the sense that the testing was completed and results summarized for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This question is not applicable. The "ground truth" for this device's performance is objective laboratory measurement of microbial reduction, not subjective expert interpretation of, for instance, medical images.
4. Adjudication Method for the Test Set
- This question is not applicable. There is no human interpretation or adjudication involved in the microbial log reduction testing.
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
- This question is not applicable. This is a physical medical device, not an AI/ML diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This is a physical medical device, not an algorithm. The "performance" is the inherent disinfectant action of the cap.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the primary efficacy claim (disinfection) is objective laboratory measurement of microbial reduction (colony-forming unit counts before and after disinfection), which is a direct measure of the device's intended biological effect on microorganisms.
- For other performance aspects (foil seal peel strength, cap retention force, compatibility, sterility, biocompatibility), the ground truth is established through physical, chemical, and biological testing according to established international standards (e.g., ISO, FDA guidance).
8. The Sample Size for the Training Set
- This question is not applicable. This device does not involve an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- This question is not applicable. This device does not involve an AI/ML algorithm that requires a "training set."
In summary, the provided document details the non-clinical performance testing of a physical medical device (disinfecting cap) based on a defined microbiological acceptance criterion. It does not involve AI/ML technology or human reader studies.
§ 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.