(56 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility: Sterility Assurance Level (SAL) | SAL of 10⁻⁶ (as required by EN 556-1) - "The sterility... is assured by using a validated sterilization method qualified in accordance with EN 550: 'Sterilization of Medical Devices: Validation and routine control of ethylene oxide' and ISO 11135: 'Medical Devices: Validation and routine control of ethylene oxide sterilization' to a sterility assurance level (SAL) of 10⁻⁶ as required by EN 556-1." |
| Ethylene Oxide Residuals: | Ethylene Oxide: ≤ 10 ppm |
| Ethylene Chlorohydrin: ≤ 10 ppm - "Ethylene oxide residual levels... are in compliance with ISO 10993-7: 'Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals' and do not exceed the level proposed in the European Pharmacopeia monograph 3.2.6." (Specific values stated in table in text) | |
| Biocompatibility: | Blood contacting materials are biocompatible. - "The device's blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard EN ISO-10993, 'Biological Evaluation of Medical Devices Part-1: Evaluation and testing. Results of the testing demonstrate that the blood contacting materials are biocompatible." |
| Expiration Dating: | 5 years - "The expiration dating... has been established at 5 years." |
| Needle Protection Mechanism: | Shield cover can be manually activated to cover the needle, minimizing risk of accidental needle stick. Audible click upon activation. Allows user's finger to remain behind the needle point. Transparent for confirmation. - Described qualitatively; the "study" is likely verification and validation testing, but no quantitative performance metrics or acceptance criteria are detailed in this summary for the activation mechanism itself beyond functionality. |
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.
§ 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.