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510(k) Data Aggregation
(118 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 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, microbore tubing, adapter and adapter cap, und 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 injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it. The device possesses a 350 min length microbore tubing.
The provided text describes the acceptance criteria and the verification activities for the SURFLO® Winged Infusion Set with Needle Protection (Surshield™) (K100946).
Here's an analysis of the requested information:
1. Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1. Flow rate | The flow rate for the set with a 23 G needles is ≥ 1.7ml/min & for a set with a 25 G needles is ≥ 1.5 ml/min | Met all acceptance criteria. |
| 2. Dead space volume | Dead space volume for sets with 23 G & 25G needle ≤ 0.25 ml | Met all acceptance criteria. |
| 3. Air flow choke test | No obstruction of fluid through the set | Met all acceptance criteria. |
| 4. Air leakage set (= Integrity of the set) | No air leakage from the set (European Pharmacopoeia.3.2.6.) | Met all acceptance criteria. |
| 5. Air leakage adapter | No air leakage at the luer fitting (EN 1707) | Met all acceptance criteria. |
| 6. Liquid leakage adapter | No liquid leakage at the luer fitting (EN 1707) | Met all acceptance criteria. |
| 7. Conical fitting | 6% luer (EN 20594-1) | Met all acceptance criteria. |
| 8. Fitting strength. protector | The force to pull the protector from the wing hub is ≥ 0.3 N and ≤ 12N | Met all acceptance criteria. |
| 9. Torque resistance cap/adapter | The torque force required to unscrew the cap from the adapter is ≤ 9N.cm. | Met all acceptance criteria. |
| 10. Bonding strength Cannula | The bonding strength between the cannula and the wing hub is ≥ 20N | Met all acceptance criteria. |
| 11. Force at break | The force to separate the the tubing from the wing/connector is ≥ 15N | Met all acceptance criteria. |
| 12. Needle penetration resistance | Needle point ≤ 0.14N; Drag ≤ 0.03N | Met all acceptance criteria. |
| 13. Break strength of shield cover joint | The force to detach the Surshield protector from the wing hub is ≥ 4N | Met all acceptance criteria. |
| 14. Force to unlock the safety feature | The force required to unlock the Surshield protector from the cannula is ≥ 2N | Met all acceptance criteria. |
| 15. Misalignment Surshield Protector | The angle measured axially from the cannula between the horizontally positioned wings and the vertically positioned Surshield protector does not exceed 15° | Met all acceptance criteria. |
The document states, "The Surflo Winged Infusion Sets with Needle Protection (Surshield) met 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 the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each test. It refers to "All necessary verification and validation tests" being performed. The data provenance (country of origin, retrospective/prospective) is not specified.
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)
This device is a physical medical device (infusion set), not a diagnostic or AI-based system that requires expert interpretation for ground truth establishment. The ground truth for its performance is based on standardized physical and mechanical tests. Therefore, this question is not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The verification activities involve objective physical and mechanical measurements against predefined criteria, not subjective human assessment requiring adjudication.
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 or diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI system. The performance tests are for the physical device itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for this device's performance is based on established engineering standards and physical properties, such as flow rate measurements, force measurements, leakage tests, and dimensional checks, adhering to relevant international standards (e.g., European Pharmacopoeia, EN 1707, EN 20594-1, EN ISO 11135-1:2007, EN 556-1, EN ISO 10993-7).
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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