Search Results

The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vasular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, fuer adapter, or other compatible/ appropriate devices. Additionally, after withdrawal of 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 Needle Protection (Surshield), are sterile, single use devices consisting of a needle attached to a winged hub, standard or microbore tubing, adapter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-towing 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 standard or microbore tubing.

The document provides information on the Surflo Winged Infusion Set with Needle Protection (Surshield). It details the acceptance criteria and summarizes verification activities to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Device Performance Note: The document explicitly states: "The Surflo Winged Infusion Sets with Needle Protection (Surshield), with standard and microbore tubing, meet all acceptance criteria as indicated in table above. None of the obtained data raises any new issue of safety and effectiveness."

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual verification test. It generally refers to "all necessary verification and validation tests" having been performed.
• Data Provenance: The document was prepared by Terumo Europe N.V. in Belgium. The tests were performed to demonstrate substantial equivalence to predicate devices cleared by the FDA (K052887, K072894, K100946). The nature of these tests (e.g., physical, mechanical, functional) suggests they were conducted prospectively to evaluate the modified device's performance.

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

This information is not applicable as the verification activities are focused on the physical, mechanical, and functional performance of a medical device (infusion set) against defined engineering and safety standards (e.g., ISO standards), rather than diagnostic accuracy or interpretation by human experts. Therefore, there is no "ground truth" in the clinical diagnostic sense established by experts.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. The testing involves objective measurements against predefined acceptance criteria, not subjective interpretation requiring adjudication among experts.

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:

This information is not applicable. The device is an intravenous administration set, not an AI-powered diagnostic or interpretive tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the verification activities comprises pre-defined acceptance criteria based on established engineering standards (e.g., ISO 594-1, ISO 594-2, EN ISO 11135-1, EN ISO 10993-7) and internal specifications. These criteria are objective and measurable, ensuring the device's physical, mechanical, and sterile properties.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reasons as point 8.

Ask a specific question about this device

The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, 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 25 Gauge Terumo Surflo Winged Infusion Set with Needle Protection (Surshield) is a sterile, single use device consisting of a needle attached to a winged hub, tubing, adapter 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 twohanded 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 350 mm length tubing.

The provided document is a 510(k) summary for a medical device, specifically an infusion set. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. The document primarily focuses on demonstrating substantial equivalence to a predicate device and outlining basic safety information as required for FDA clearance of a traditional medical device (like an infusion set), not an AI algorithm.

Therefore, I cannot provide the requested information from this document. The questions you've asked are typically relevant for the evaluation of AI/ML-powered medical devices, which this document does not describe.

Ask a specific question about this device

The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, 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 Terumo Surflo Winged Infusion Set with Needle Protection (Surshield) is a sterile, single use device consisting of a needle attached to a winged hub, tubing, adapter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-towing 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 device possesses 350 mm length tubing.

The provided 510(k) summary (K052887) describes the "Surflo® Winged Infusion Set with Needle Protection (Surshield™)", which is an intravascular administration set. The primary focus of the submission is to demonstrate substantial equivalence to a previously cleared device (K031266). The document does not describe a study involving detailed performance data with acceptance criteria for the new device itself, but rather relies on the substantial equivalence to the predicate device and standardized testing for sterility and biocompatibility.

However, based on the information provided, we can infer some "acceptance criteria" related to critical safety aspects (sterility, ETO residuals, and biocompatibility) and the "study" that proves the device meets these criteria. The device's primary novel feature is the needle protection mechanism, for which performance is described qualitatively rather than with quantitative metrics and acceptance criteria in this specific document.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information

The document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence rather than a detailed report of a single, comprehensive clinical or performance study for the new device. The "studies" mentioned are largely compliance with established standards and tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Needle Protection Mechanism: No specific sample size or data provenance is detailed for verification of the needle protection mechanism's performance in this summary. The description of its function (manual activation, audible click, finger protection) implies engineering testing and validation, but quantitative data (e.g., success rate of activation, force required, etc.) and associated sample sizes are not provided.
• Sterility, ETO Residuals, Biocompatibility, Expiration Dating: These are typically evaluated using laboratory testing on specific batches of the device components or finished product. The sample sizes would depend on the specific validation protocols for each standard (EN 550, ISO 11135, ISO 10993-7, ISO 10993-1, internal aging studies). These are typically prospective laboratory tests. The country of origin for the data is not explicitly stated, but the manufacturer is Terumo Europe N.V., and the predicate device was manufactured in Hangzhou, China. The standards cited (EN, ISO, European Pharmacopeia) are international/European.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable in the context of this 510(k) summary. The "ground truth" for the tests mentioned (sterility, biocompatibility, ETO residuals, expiration dating) is defined by objective, measurable laboratory standards and predetermined thresholds, not by expert consensus in the typical sense for diagnostic or prognostic devices. For the needle protection mechanism, its functional "truth" would be established through engineering tests and user validation, but no details are provided here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. The tests described are objective, laboratory-based physical and chemical tests, not clinical evaluations requiring adjudication of subjective outcomes.

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 an intravascular administration set, not a diagnostic imaging device using AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a medical instrument (hardware), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Sterility: Achieved SAL of 10⁻⁶, as measured by microbiological testing and adherence to validated sterilization cycles (objective laboratory measurement against a standard).
• ETO Residuals: Measured levels of Ethylene Oxide and Ethylene Chlorohydrin (objective chemical analysis against a standard).
• Biocompatibility: Response to biological tests (e.g., cytotoxicity, irritation, sensitization), showing no adverse reaction (objective laboratory measurement against a standard).
• Expiration Dating: Stability testing data showing maintenance of device properties over time (objective physical/chemical measurement against specifications).
• Needle Protection Mechanism: Functional activation and covering of the needle (objective observation of mechanism function).

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning product and does not involve a "training set."

9. How the ground truth for the training set was established

• Not applicable.

Ask a specific question about this device