(29 days)
The Modrad Swabbable Valve Transfer Set (SVTS) is intended to be used in the delivery of contrast media and saline into a syringe. The SVTS is a needle-free system. Use of a needle-free system may aid in the prevention of needle-stick injuries.
The Medrad Swabbable Valve Transfer Set (SVTS) is a modified Medrad Transfer Set (K022431). The SVTS is a medical disposable device used to transfer contrast media and saline from a spikeable container to a power injector syringe. The SVTS is works in conjunction with the MR-CT Fill Station, and facilitates the delivery of contrast agent and/or saline into a syringe.
The provided document is a 510(k) premarket notification for a medical device modification, specifically the Medrad Swabbable Valve Transfer Set (SVTS). This type of document is a regulatory submission to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than a study proving performance against acceptance criteria in the way a clinical trial for an AI/ML device would.
Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, and MRMC studies) are not applicable to this submission. The document focuses on comparing the modified device to a predicate device and demonstrating substantial equivalence.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here refer to the design specifications and safety requirements that the modified device must meet and be "substantially equivalent" to in comparison with the predicate device. The performance is reported in terms of meeting these specifications and maintaining existing safety standards.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (vs. Predicate) |
|---|---|---|
| Device Components | Tubing Length | 23.0 in. (Predicate: 20.0 in.) - Change |
| Tubing Inner Diameter | 0.120 in. (Predicate: 0.110 in.) - Change | |
| Female Luer | Polycarbonate, Clear, Merit Medical Female Luer (Predicate: None) - Addition | |
| Dust Cap | No Dust Cap (Predicate: Polypropylene Dust Cap) - Removal | |
| Valve Type | Swabbable Threaded Valve (Halkey-Roberts) (Predicate: One-way Stopcock, Pinch Clamp) - Change | |
| Other Components (Spike, Adhesive) | Same as Predicate | |
| Safety Requirements | Biocompatibility | Tested to ISO/AAMI 10993-7 (Same as Predicate) |
| Sterility | Ethylene Oxide (EtO) Sterilized (Same as Predicate) | |
| Intended Use | Delivery of contrast media and saline into a syringe. | No change to the intended use. The SVTS is a needle-free system, potentially aiding needle-stick injury prevention. |
| Mechanical/Functional (Implied) | Functionality as a transfer set for contrast/saline with a power injector. | Implied "substantial equivalence" to the predicate, meaning it performs the same function safely despite modifications. No specific performance metrics like flow rates or durability are listed as "acceptance criteria" directly in this summary, but these would be part of an underlying design validation. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of this 510(k) submission. This is a device modification submission, not a study evaluating an AI/ML diagnostic or prognostic tool. The "test set" would typically refer to physical units of the device tested against engineering specifications and biocompatibility standards, not a dataset for an algorithm. Clinical trials or large-scale human data collection are generally not required for these types of Class II device modifications unless significant new risks are introduced.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There is no "ground truth" established by experts in the sense of AI/ML or clinical diagnosis. The "truth" here is engineering compliance and biocompatibility. The regulatory body (FDA) reviews the submission.
4. Adjudication Method for the Test Set
Not applicable. There's no "adjudication" of device performance in the sense of expert review for ambiguous cases. Device compliance is determined through testing against predetermined specifications and standards (e.g., ISO for biocompatibility).
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 a physical medical device (a transfer set), 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. This is not an algorithm or software device.
7. The Type of Ground Truth Used
The "ground truth" for this device modification is compliance with established engineering specifications, safety standards (e.g., ISO/AAMI for biocompatibility), and demonstration that the modified design maintains the intended function without raising new questions of safety or effectiveness when compared to the predicate device. This is based on design verification and validation testing results, not clinical outcomes or expert consensus on diagnostic images.
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.