(89 days)
The Surflo Winged Infusion Set is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimans using a syringe, luer adapter, or other compatible/appropriate devices.
The Terumo Surflo Winged Infusion Set is a sterile, single use device consisting of a needle attached to a winged hub, tubing, adapter and adapter cap. The device possesses 300 mm length tubing.
This 510(k) premarket notification (K070362) for the SURFLO® Winged Infusion Set does not contain the level of detail typically found in a clinical study report for AI/software-based medical devices. This submission pertains to a physical medical device (an infusion set) and focuses on demonstrating substantial equivalence to a predicate device rather than evaluating the performance of an algorithm or AI system.
Therefore, many of the requested categories like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable or not provided in this document.
However, I will extract and present applicable information based on the provided text, primarily focusing on the regulatory and performance aspects that are discussed for this physical device.
Acceptance Criteria and Device Performance (SURFLO® Winged Infusion Set)
This submission is a 510(k) for a physical medical device, not an AI/software product. Therefore, the "acceptance criteria" discussed are primarily related to general performance, safety, and manufacturing standards for such devices. The "reported device performance" refers to the demonstration of compliance with these standards and substantial equivalence to a predicate device.
| Acceptance Criteria Category | Reported Device Performance/Evidence |
|---|---|
| Intended Use | Meets Intended Use: Intended to access the peripheral vascular system for intravenous fluid administration and/or blood specimen withdrawal. The submission states the device is "substantially equivalent in intended use" to the predicate device. |
| Sterility | Sterile: Sterility is assured by a validated sterilization method (Ethylene Oxide) qualified in accordance with EN 550 and ISO 11135 to a Sterility Assurance Level (SAL) of 10⁻⁶, as required by EN 556-1. |
| Ethylene Oxide (EtO) Residuals | Compliant: EtO residual levels comply with ISO 10993-7 ("Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals"). |
| Biocompatibility | Biocompatible: Blood-contacting materials were tested in accordance with FDA General Program Memorandum #G95-1 (5/1/95) and EN ISO-10993 Part-1. Results demonstrate that the blood-contacting materials are biocompatible. |
| Expiraton Dating / Shelf Life | Established Shelf Life: An expiration dating of 5 years has been established for the device. |
| Substantial Equivalence (Overall Device) | Substantially Equivalent: The device is concluded to be "substantially equivalent in intended use, description, specifications, technology/principles of operation, materials and performance" to the cleared predicate device (K891063, "Surflo Winged Infusion Set" manufactured by Terumo Medical Corporation). The submission states "Differences between the devices do not raise any new issues of safety or effectiveness." This is the primary "acceptance criterion" for a 510(k) submission. |
Study Details (Not Applicable for AI/Software)
As this submission is for a physical medical device and not an AI/software product, the following requested information regarding AI/algorithm performance studies is not provided or not relevant to this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This information is not relevant for the type of device and submission. Performance is demonstrated through compliance with standards (sterility, biocompatibility) and comparison of physical characteristics to a predicate device, rather than a data-driven test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: No "ground truth" in the context of expert labels for data is established in this type of submission. Performance is assessed through engineering testing and regulatory compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No adjudication method for a test set is used.
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 / Not Provided: This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: No "ground truth" in the context of data labeling is used. Performance relies on established engineering and biological standards.
8. The sample size for the training set
- Not Applicable / Not Provided: Not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: Not an AI/ML device.
§ 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.