Search Results

The Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) is intended to access the peripheral vascular system, for single-dose or short-term intravenous administration of fluids using a syringe or other compatible/appropriate devices. 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 23G and the 25G Terumo Surflo Winged Infusion Sets with Filter and Needle Protection (Surshield), are sterile, single use devices 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 the 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 device possesses a 350 mm length microbore tubing.

The provided text describes the acceptance criteria and a summary of verification activities for the SURFLO® Winged Infusion Set with Filter and Needle Protection (Surshield®). This device is a medical product, and the study described is a series of engineering and performance tests, not a clinical study involving human patients or algorithmic performance. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, training set information) are not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The Surflo Winged Infusion Sets with Filter and Needle Protection (Surshield), meet all acceptance criteria as indicated in table above."

2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each individual test. It only states that "All necessary verification and validation tests have been performed." Data provenance is not explicitly mentioned as "country of origin," but the submission is from "TERUMO EUROPE N.V." in Leuven, BELGIUM, so the testing likely occurred in Europe. The tests are prospective in nature, as they are performed on the newly designed devices to verify their performance against established criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are engineering and performance tests of a physical medical device, not a diagnostic algorithm requiring expert interpretation of medical images or data. The "ground truth" is defined by the technical specifications and international standards (e.g., ISO 594-1, ISO 594-2, EN ISO 11135-1, EN 556-1, EN ISO 10993-7).

4. Adjudication method for the test set
Not applicable. There is no adjudication method described as these are quantitative and qualitative engineering tests against predefined specifications.

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 not an AI-assisted diagnostic device.

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
The ground truth for these tests is established by international standards and technical specifications for sterile medical devices for intravascular administration. Examples include:

• ISO 594-1: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements
• ISO 594-2: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings
• EN ISO 11135-1: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• EN 556-1: Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - I: Requirements for terminally sterilized medical devices
• EN ISO 10993-7: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• FDA General Program Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing"

8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established
Not applicable.

Ask a specific question about this device