(88 days)
The Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) is intended to access the peripheral vascular system for intravenous administration of fluids using a syringe, or other compatible/appropriate devices and may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.
The Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) is a sterile, single use device consisting of a needle attached to a winged hub, microbore tubing, adapter with integrated 20 um filter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-to-wing junction. The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto needle using a one- or two- handed technique. An audible click is noted upon activation. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it. The Surflo Winged Infusion Sets with Filter and Needle Protection (Surshield) are available with a cannula with a needle size of 23 gauge (0.6 mm) or 25 gauge (0.5 mm) and a length of 19 mm (3/4"). The device possesses 350 mm length tubing.
Here's an analysis of the provided text regarding the "SURFLO® Winged Infusion Set with Filter and Needle Protection (Surshield™)":
It's important to note that the provided 510(k) summary does not contain details about specific acceptance criteria or a dedicated study proving performance against those criteria in the way one might expect for a software or AI/ML device. This document is for a physical medical device (an infusion set), and the "study" mentioned is primarily focused on demonstrating substantial equivalence to previously cleared devices through material compatibility, sterilization validation, and shelf-life testing, rather than an AI-driven performance study.
Therefore, many of the requested fields regarding AI/ML-specific performance metrics (like sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to this document.
However, I can extract the information that is present and explain why other requested details are absent.
Analysis of SURFLO® Winged Infusion Set with Filter and Needle Protection (Surshield™) 510(k) Summary
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, this document does not present explicit performance acceptance criteria in the format typically seen for novel diagnostic or AI devices (e.g., sensitivity, specificity thresholds). Instead, the "performance" demonstrated is through substantial equivalence and compliance with relevant standards.
| Acceptance Criterion (Implied by Regulatory Compliance) | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) | Achieved 10⁻⁶ SAL per EN 550 and ISO 11135 |
| Ethylene Oxide Residual Levels | In compliance with ISO 10993-7 |
| Biocompatibility of Blood Contacting Materials | Materials demonstrated to be biocompatible per ISO 10993-1 |
| Shelf-Life/Expiration Dating | Established at 5 years |
| Needle Protection Feature Functionality | Substantially equivalent to predicate device (K052887) |
| Overall Functionality (Infusion Set) | Substantially equivalent to predicate device (K033350) |
2. Sample Size for the Test Set and Data Provenance
- Not Applicable in the context of an AI/ML device's "test set."
- For the physical device, "testing" would involve laboratory evaluations for sterility, material properties, and shelf-life. The sample sizes for these types of tests are not specified in this summary but would typically follow established validation protocols for manufacturing and quality control.
- Data Provenance: The studies (sterilization, biocompatibility, shelf-life) are conducted by the manufacturer, Terumo Europe N.V. The country of origin of the data is implicitly Belgium (where Terumo Europe N.V. is located). These are more akin to prospective laboratory or manufacturing validation studies rather than retrospective clinical data analysis.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is not a device that relies on expert interpretation for its "ground truth" performance in a clinical context (like image analysis). Ground truth relates to objective measurements for sterility, chemical residuals, and material compatibility standards.
4. Adjudication Method for the Test Set
- Not Applicable. There is no "adjudication" in the sense of resolving discrepancies between expert opinions on a test set, as this is not an interpretive device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for diagnostic devices where human readers interpret outputs (e.g., radiologists reading images with and without AI assistance). This device is an intravenous administration set, not a diagnostic tool requiring human interpretation for its primary function.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for relevant testing includes:
- Standardized Sterility Assurance Level (SAL): Defined by international standards (EN 550, ISO 11135) to be 10⁻⁶.
- Reference Limits for Chemical Residues: Defined by international standards (ISO 10993-7) for ethylene oxide residuals.
- Biocompatibility Standards: Defined by international standards (ISO 10993-1).
- Performance Specifications: The core "ground truth" for the device's functionality and safety features is its ability to meet the design specifications and be substantially equivalent to predicate devices that have already demonstrated safety and effectiveness for their intended use.
8. The Sample Size for the Training Set
- Not Applicable. This refers to AI/ML model training, which is not relevant for this device.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
Summary of Device and Regulatory Context:
The 510(k) for the SURFLO® Winged Infusion Set with Filter and Needle Protection (Surshield™) is a submission for a Class II physical medical device. The primary goal of this type of submission is to demonstrate substantial equivalence to predicate devices already on the market. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
The "studies" referenced are primarily:
- Comparison to Predicate Devices: Demonstrating similarity in design and function to previously cleared infusion sets.
- Compliance with International Standards: Validation of manufacturing processes (sterilization), material safety (biocompatibility, chemical residuals), and performance (shelf-life).
This is distinctly different from the type of information requested for a software as a medical device (SaMD) or AI/ML-powered diagnostic device, where performance metrics like sensitivity, specificity, and results from clinical studies (often involving human readers) are central to the submission.
§ 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.