Search Results

The SmartSite® VialShield 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® VialShield is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

The SmartSite® VialShield 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® VialShield is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

The SmartSite® VialShield is a mechanically closed device, designed to retain vapors produced from medications in the attached vial.

The SmartSite® VialShield is microbiologically closed. When used in a USP compliant pharmaceutical compounding and storage environment, the VialShield is capable of maintaining the sterility of vial medications for up to 7 days.

The subject SmartSite® Vialshield device is constructed of polymeric components:

• Upper and Lower Housings: Polycarbonate
• Check Valves: Silicone
• Lubricant: Silicone
• Hydrophobic Filter Membrane: PTFE, Polyester
• Loctite 3341: UV adhesive
• Barrier Film: Polyether Polyurethane
• SmartSite® valve, including:
  • Body: Acrylic
  • Cap: Polyurethane
  • Piston: Silicone
  • Lubricants: Silicone

The subject SmartSite® Vialshield device is provided with a molded polyethylene cap, considered part of the packaging, made using low density polyethylene.

The subject SmartSite® Vialshield materials do not contain natural rubber latex.

This document describes Yukon Medical's SmartSite® VialShield, a vial access device, and its successful 510(k) submission to the FDA. The submission demonstrates substantial equivalence to a predicate device through a comparison of technical and performance characteristics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" as a separate table with quantified values. Instead, it describes performance tests conducted and states that the device "meets all specified requirements" and "is as safe and effective as the legally marketed devices designated as predicate device."

However, we can infer some of the performance criteria based on the tests conducted. The table below outlines the tests and the general reported outcome:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact sample size used for each individual performance test. It mentions that "some performance characteristics of the predicate device were tested along with the subject SmartSite® Vialshield device," implying comparative testing was done.
• Data Provenance: The studies were conducted by Yukon Medical, LLC, and Gilero, LLC for regulatory submission in the USA. The studies are prospective as they were specifically conducted to demonstrate the device's performance for this 510(k) application.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state that experts were used to establish "ground truth" for the performance tests in the way it might be for a diagnostic AI device. The tests described are laboratory-based performance and safety tests (e.g., leak tests, filter integrity, biocompatibility). The "ground truth" in this context would be the objective measurement against established standards (e.g., ISO, USP guidelines) rather than expert consensus on diagnostic interpretations. Therefore, this question is not directly applicable in the same manner as it would be for AI-driven diagnostic imaging.

4. Adjudication Method for the Test Set

Given the nature of the performance tests (e.g., physical integrity, biological compatibility), an "adjudication method" in the sense of resolving discrepancies between expert opinions is not applicable or detailed in the document. The tests involve objective measurements and adherence to pre-defined protocols and acceptance criteria, likely performed and verified by trained technical personnel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for diagnostic devices, especially those incorporating AI to assess human reader performance with and without AI assistance. The SmartSite® VialShield is a mechanical medical device for drug preparation and administration, not a diagnostic imaging or AI-driven diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone study was not done. This question is also primarily relevant for AI-driven diagnostic devices. The SmartSite® VialShield is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for the performance characteristics was established by:

• Objective Measurements against Established Standards: For tests like Biocompatibility (ISO 10993), ISO-594 compliance for the Luer valve, and other physical performance tests, the "ground truth" is adherence to predefined specifications, industry standards, and regulatory requirements.
• Approved Protocols and Acceptance Criteria: For some tests, like "maintains drug sterility for 7 days," the document explicitly mentions "Approved protocol and acceptance criteria."

8. Sample Size for the Training Set

Not applicable. The SmartSite® VialShield is a mechanical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for this mechanical device, the concept of establishing ground truth for a training set does not apply.

Ask a specific question about this device