(463 days)
ACTIV Cap is intended for use on a needleless vascular access port as an active cleaning and disinfecting device prior to IV access and to act as a passive, protective barrier for up to 7 days if not removed. ACTIV Cap disinfects needleless vascular access ports in one (1) minute after application and achieves at least a >5-log reduction as tested in vitro against 6 organisms - Staphylococcus aureus, Staphylococcus epidermis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans.
The Subject Device is a sterile, single-use device that is used to clean and disinfect needleless vascular access ports and then act as a cover for the access port between uses. Covering between uses maintains the port's cleanliness. The Subject Device is made of a plastic inner threaded housing snapped into an outer cap and incorporates a foam substrate that protrudes into the central bore of the inner housing and is moistened with the active disinfectant, 70% Isopropyl Alcohol (IPA). The IPA-filled cap is sealed with a poly/foil film to prevent excessive loss of the active ingredient and maintain the sterile barrier.
The Subject Device reduces the risk of unintentional removal by requiring a slight compression force (i.e., pinching) on the cap's side to remove, which force causes the outer housing to engage the inner housing so as to allow the inner and outer housings to be rotated in unison in order to attach and remove the Subject Device from a threaded needleless vascular access port. Without compression, once secured to a needleless vascular access port the Subject Device's outer housing can be rotated in relation to the inner housing and needleless vascular access port to further clean the surface of the access port.
Once the Subject Device is installed on a needless vascular access port, the device passively disinfects the contacting surfaces with the 70% IPA moistened foam.
Ten (10) sealed devices are assembled onto a card hanger that can be hung in an IV pole. Twenty (20) assembled cards are packaged into an inner carton. The instructions for use are printed on the outside on the inner carton. Twenty-four (24) inner cartons are packaged into a corrugated shipper. The packaging shipper is sterilized by gamma irradiation to a Sterility Assurance Level (SAL) of 10-6.
The provided text is a 510(k) summary for the Cleansite Medical ACTIV™ Cap. This document is a premarket notification to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. As such, it primarily focuses on non-clinical testing and comparison to achieve regulatory clearance rather than a comprehensive clinical study to prove device effectiveness in a real-world setting with human subjects.
The document does not describe a study that proves the device meets acceptance criteria in the context of clinical effectiveness or a multi-reader multi-case (MRMC) study. Instead, it details non-clinical (laboratory) performance testing to show substantial equivalence to a predicate device and demonstrate safety and basic function.
Therefore, the following information cannot be extracted from the provided text:
- Sample size used for the test set and data provenance (retrospective or prospective): The document refers to laboratory tests, not a clinical test set with human data.
- Number of experts used to establish ground truth and qualifications: Ground truth for a clinical study would typically involve medical professionals interpreting patient data, which is not applicable here.
- Adjudication method: Not applicable for non-clinical lab tests.
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size: This type of study involves human readers, which is not described.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth, in a clinical sense, is not established or used. The "ground truth" for the non-clinical tests is the established laboratory standard and organism counts.
- Sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
However, I can provide the acceptance criteria and reported device performance from the "Summary of Testing Performed" table, along with information available about the context of these tests.
Acceptance Criteria and Reported Device Performance (Non-Clinical)
The device's performance is evaluated against various non-clinical standards and internal criteria to demonstrate safety and basic functional equivalence to a predicate device. The "Summary of Testing Performed" table outlines these criteria and the results.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test Interval | Evaluation Category | Performance Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| T=0 | Biocompatibility | ISO 10933-1 (FDA No. 2-258) - Absence of cytotoxicity, sensitization, intracutaneous reactivity, material medicated pyrogen, systemic toxicity, hemocompatibility. Constituents should not pose significant systemic risks. | Acceptable |
- Not considered to have a cytotoxic effect.
- Did not elicit sensitization reactions.
- No irritation was observed.
- Non-pyrogenic
- No acute systemic toxicity was observed.
- Non-hemolytic
- Organic/inorganic constituents detected do not pose significant systemic risks to the patient. |
| T=0 | Sterilization Validation (Gamma, VDmax25) | ISO-11137-2 (FDA No. 14-409) - Sterility Assurance Level (SAL) of 10^-6. | Acceptable - SAL 10^-6
- Bioburden: 21-35 CFUs
- Product Sterility: No positives |
| T=0 | Transportation Challenger | ASTM D4169 (FDA No. 14-499), ASTM D4322 (FDA No. 5-99). Acceptance: No damage to the device or its sterile barrier. | Acceptable - No Damage to the device or its sterile barrier. |
| T=0 | Endotoxin | ANSI/AAMI ST72 (FDA No. 14-541). Acceptance: Low endotoxin levels. | Acceptable - . Acceptance: Met all criteria with regard to subvisible particulates greater than 10 microns. | Acceptable
- Met all acceptance criteria with regard to subvisible particulates greater than 10 microns. |
| T=0 | Torque to Needleless Access Port | N/A - Reference Only; Comparable to predicate device. | Reference Only - Comparable to predicate device |
| T=0 | IPA Ingress | N/A - Acceptance: Average IPA dosages below 14 mmol/L ("mM") "critical concentration" calculated for neonatal patients in the Sauron article. | Acceptable - The results show that the average IPA dosages were below the 14 mmol/L ("mM") "critical concentration" calculated for neonatal patients in the Sauron article. |
| T=0, T=6 Months | Packaging Integrity | ASTM F1886/F1886M (FDA No. 14-501), ASTM F2096 (FDA No. 14-482), ASTM F88/F88M (FDA No. 14-482). Acceptance: No visual defects, no air leak at test pressure, seal strength >1.0 lbs. | Acceptable - No visual defects observed.
- No air leak at test pressure
- Seal strength >1.0 lbs. |
| T=0, T=6 Months | Functionality/Needleless Connector Displacement | N/A - Acceptance: No leaks when submerged in water for devices installed on needleless valve types. | Acceptable - None of the devices installed on each needleless valve type were observed with a leak when submerge in water. |
| T=0, T=6 Months | Resistance to Separation from Axial Load | ISO 80369-7 (FDA No. 5-133). Acceptance: None of the devices separated below the minimum specification of 7.86 lb. | Acceptable - None of the devices separated below the minimum specification of 7.86 lb. |
| T=0, T=6 Months | Microbial Inactivation | N/A - Acceptance: At least a >5-log reduction at 1-minute and 7-day contact exposure, against S. aureus, S. epidermidis, E. coli, P. aeruginosa, C. albicans, and C. glabrata, at a 99.9% confidence level. (This is based on the Indications for Use statement). | Acceptable - At 1-minute and 7-day contact exposure minimum of 5 log reduction achieved at a 99.9% confidence level. |
2. Sample Sized Used for the Test Set and the Data Provenance:
The document describes non-clinical, laboratory-based performance testing rather than a clinical "test set" from patient data. The "sample sizes" for these tests would refer to the number of device units or test replicates used in each specific lab procedure. These specific numbers are not provided in the summary but would be detailed in the full test reports referenced by the standards (e.g., ISO, ASTM, USP).
- Data Provenance: The data comes from in vitro (laboratory) testing performed on the device itself, not from human subjects or clinical settings, therefore it is not retrospective or prospective in the clinical sense. The tests are performed on the device components and assembled units under controlled lab conditions. The "country of origin of the data" is not specified but would typically be associated with the testing labs.
3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The "ground truth" for non-clinical performance tests is established by documented industry standards (ISO, ASTM, USP) and the measurable outcomes of the tests (e.g., bacterial log reduction, force measurements, chemical concentration). These tests are performed by qualified lab technicians and scientists, not "experts" in the sense of clinical reviewers establishing diagnostic ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for clinical studies that involve expert review of ambiguous or complex patient data. Here, the results are quantitative measurements against defined standards.
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 device is a physical medical device (an antiseptic cap for IV ports), not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI algorithms.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
The "ground truth" for the performance claims (e.g., microbial inactivation) in this context is the measured log reduction of specified microorganisms in in vitro laboratory tests, compared against the predefined acceptance criterion of ">5-log reduction". For other tests, the "ground truth" is adherence to established engineering, material, and sterilization standards (e.g., ISO, ASTM, USP as listed).
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning 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.