(47 days)
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:
| TEST | ACCEPTANCE CRITERIA | Reported Device Performance |
|---|---|---|
| 1. Visual inspection | When examined by normal vision or under 2.5 fold magnification, all components of the set are smooth, clean and free of flash, surface irregularities, detachable particles, and moulding or processing defects | Meets acceptance criteria (implicit, as stated below table) |
| 2. Effective tubing length | The effective tubing length is 350 ± 20mm | Meets acceptance criteria (implicit, as stated below table) |
| 3. Dead space volume | Dead space volume for sets with standard tubing: ≤ 0.40 ml; Dead space volume for sets with microbore tubing: ≤ 0.20 ml | Meets acceptance criteria (implicit, as stated below table) |
| 4. Air leakage (= integrity of set) | No leakage | Meets acceptance criteria (implicit, as stated below table) |
| 5. Air leakage luer adaptor | No leakage at the luer connection (according to ISO 594-1 and ISO 594-2) | Meets acceptance criteria (implicit, as stated below table) |
| 6. Liquid leakage luer adaptor | No leakage at the luer connection (according to ISO 594-1 and ISO 594-2) | Meets acceptance criteria (implicit, as stated below table) |
| 7. Conical fitting | The conical fitting shall be within level 1-3 (according to ISO 594-1 and ISO 594-2) | Meets acceptance criteria (implicit, as stated below table) |
| 8. Separation force of Luer slip tip connection | The fitting remains attached (according to ISO 594-1) | Meets acceptance criteria (implicit, as stated below table) |
| 9. Separation force of Luer lock connection | The fitting remains attached (according to ISO 594-2) | Meets acceptance criteria (implicit, as stated below table) |
| 10. Stress cracking on Luer conical fitting | No stress cracking on the conical fitting (according to ISO 594-1 and ISO-594-2) | Meets acceptance criteria (implicit, as stated below table) |
| 11. Unscrewing torque of Luer lock fittings | The fitting remains attached when the fitting between the hub and a reference fitting is tested according to ISO 594-2 | Meets acceptance criteria (implicit, as stated below table) |
| 12. Ease of assembly | A satisfactory fit is achieved when tested according to ISO 594-2 | Meets acceptance criteria (implicit, as stated below table) |
| 13. Overriding resistance of Luer lock systems | When the fitting between the hub and a reference fitting is tested, the reference fitting shall not override the threads or lugs of the fitting under test (according to ISO 594-2) | Meets acceptance criteria (implicit, as stated below table) |
| 14. Torque resistance cap - adapter | The torque force required to unscrew the cap from the adapter does not exceed 9 N.cm | Meets acceptance criteria (implicit, as stated below table) |
| 15. Bonding strength tube - adapter | The force required for separating the tube from the adapter is 15 N minimum. | Meets acceptance criteria (implicit, as stated below table) |
| 16. Bonding strength tube - wing hub | The force required for separating the tube from the wing hub is 15 N minimum. | Meets acceptance criteria (implicit, as stated below table) |
| 17. Air flow choke test | Air bubbles escape out of the set when immersed under water and connected to an airline of 20 kPa (0.2 bar) effective pressure, to create an airflow through the set. | Meets acceptance criteria (implicit, as stated below table) |
| 18. Flow rate | Flow rate for sets with standard tubing: 23G: ≥ 2.9 ml/min & 25G: ≥ 1.6 ml/min; Flow rate for sets with microbore tubing: 23G: ≥ 1.7 ml/min & 25G: ≥ 1.5 ml/min | Meets acceptance criteria (implicit, as stated below table) |
| 19. Bonding strength Surshield protector | The bonding strength between the Surshield protector and the SV-set is minimum 4 N | Meets acceptance criteria (implicit, as stated below table) |
| 20. Misalignment of Surshield Protector | The angle measured axially from the cannula between the horizontally positioned wings and the vertically positioned Surshield protector does not exceed 15°. | Meets acceptance criteria (implicit, as stated below table) |
| 21. Peel behaviour of blister | The blister is peeled by hand with minimal fibres and no paper splitting | Meets acceptance criteria (implicit, as stated below table) |
| 22. Peel strength | The peel strength of the pack seal is minimum 0.15 kN/m | Meets acceptance criteria (implicit, as stated below table) |
| 23. Package integrity | The integrity of the unit pack is minimum 4 kPa | Meets acceptance criteria (implicit, as stated below table) |
| 24. Kink stability of tubing | Free of deformation and kinking | Meets acceptance criteria (implicit, as stated below table) |
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.
§ 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.