(15 days)
The SmartSite® Vented Vial Access Device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
The 20mm SmartSite® Vented Vial Access Device is a stand alone, sterile, single-use, disposable device which permits access to a medication vial without the use of a needle. It consists of a spike, locking shroud, hydrophobic filter, and SmartSite® needle-free access valve for Luer access.
The SmartSite® Vented Vial Access Device is microbiologically closed. When used in a USP compliant pharmaceutical compounding and storage environment, the SmartSite® Vented Vial Access Device is capable of maintaining the sterility of vial medications for up to7 days.
This document is a 510(k) summary for the SmartSite® Vented Vial Access Device, which is a medical device for accessing medication vials. The summary primarily focuses on demonstrating substantial equivalence to a predicate device and does not involve AI/ML performance evaluation. Therefore, many of the requested categories related to AI/ML studies are not applicable.
Here's the information extracted and categorized based on your request, with "Not Applicable" for sections where the document does not provide the requested AI/ML related details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" against which a device's AI/ML performance is measured, as this is a traditional medical device submission, not an AI/ML one. However, it lists various tests performed to demonstrate the device's functional and safety characteristics, primarily against a predicate device.
| Test Performed (Performance Characteristic) | Device Tested | Result | Note/Interpretation |
|---|---|---|---|
| Attachment Force | Subject & Predicate | Met specified requirements | Demonstrated equivalency during testing. |
| Filter Misuse Pressure | Subject & Predicate | Met specified requirements | Demonstrated equivalency during testing. |
| Residual Fluid Volume | Subject & Predicate | Met specified requirements | Demonstrated equivalency during testing. |
| Flow Rate | Subject & Predicate | Met specified requirements | Demonstrated equivalency during testing. |
| Tests Performed on Subject Device Only: | |||
| Packaging maintains sterile barrier | Subject | Met specified requirements | Performed to establish safety and effectiveness. |
| Device packaging opens with gloved hands | Subject | Met specified requirements | Performed to establish usability. |
| Packaging materials are radiation sterilizable | Subject | Met specified requirements | Performed to establish manufacturing compatibility. |
| Device materials are radiation sterilizable | Subject | Met specified requirements | Performed to establish manufacturing compatibility. |
| Vial septum visibility | Subject | Met specified requirements | Performed to establish usability. |
| Device usable with gloved hands | Subject | Met specified requirements | Performed to establish usability. |
| Priming Volume | Subject | Met specified requirements | Performed to establish functional characteristic. |
| SmartSite bond strength | Subject | Met specified requirements | Performed to establish structural integrity. |
| Stopper coring | Subject | Met specified requirements | Performed to establish functional characteristic and prevent contamination. |
| Device locks with >= 2 fingers | Subject | Met specified requirements | Performed to establish usability and security. |
| Spike breakage | Subject | Met specified requirements | Performed to establish durability. |
| Shroud breakage | Subject | Met specified requirements | Performed to establish durability. |
| Vertical and horizontal detachment force | Subject | Met specified requirements | Performed to establish security of attachment. |
| Negative pressure leakage | Subject | Met specified requirements | Performed to establish functional integrity. |
| Filter prevents >=99.9% | Subject | Met specified requirements | Performed to establish filtration effectiveness. |
| Shelf life (accelerated) | Subject | Met specified requirements | Performed to establish product lifespan. |
| Storage temperature | Subject | Met specified requirements | Performed to establish storage conditions. |
| Biocompatibility ISO 10993 (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Hemocompatibility) | Subject | Met specified requirements | Performed to establish biological safety. |
| Chemotherapy and Hazardous Drug Compatibility | Subject | Met specified requirements | Performed to establish chemical compatibility and safety. |
| Tests Leveraged from Predicate (SmartSite® needle free valve): | |||
| Needle-free Valve Activations >45 | Subject & Predicate | Previously evaluated & cleared | Demonstrated robust performance of the shared component. |
| Needle-free Valve ISO-594 Luer Compatibility | Subject & Predicate | Previously evaluated & cleared | Demonstrated standard compatibility of the shared component. |
| Microbial ingress | Subject & Predicate | Previously evaluated & cleared | Demonstrated integrity of the shared component. |
| Leakage | Subject & Predicate | Previously evaluated & cleared | Demonstrated integrity of the shared component. |
| Additional Test for Subject Device Specifics: | |||
| Maintains drug sterility for 7 days | Subject | Met specified requirements | Addresses the "microbiologically closed" characteristic of the subject device. |
2. Sample size used for the test set and the data provenance
Not Applicable (This is a traditional medical device; no "test set" in the context of AI/ML data). The document refers to "tests conducted" on the device itself and the predicate device. The specific sample sizes for these engineering and biological tests are not detailed in this summary. Data provenance is not described as it relates to physical device testing rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable (No AI/ML system involved in a clinical study to establish ground truth).
4. Adjudication method for the test set
Not Applicable (No AI/ML system involved in a clinical study requiring adjudication).
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, not an AI/ML diagnostic or assistive tool).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable (No AI/ML algorithm involved).
7. The type of ground truth used
Not Applicable (No AI/ML system requiring a ground truth in the context of expert consensus, pathology, or outcomes data). The "ground truth" for this device would be its adherence to established engineering, safety, and performance specifications as measured by laboratory testing and previous FDA clearances for its components.
8. The sample size for the training set
Not Applicable (No AI/ML model with a training set).
9. How the ground truth for the training set was established
Not Applicable (No AI/ML model with a training set).
§ 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.