(39 days)
The Surshield Safety Winged Infusion Set is intended for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. The winged infusion set may be used for any patient population with consideration given to patient size. 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 needlestick.
The Surshield Safety Winged Infusion Set is a sterile, single-use device consisting of a needle attached to a winged type hub, tubing, connector and connector cap, and a hinged shield cover that attaches to the wing just below the needle-to-wing junction. The Surshield Safety Winged Infusion Set manufactured by Terumo Medical Products in Hangzhou, China is the same as the Surshield Winged Infusion Set manufactured by Terumo Corporation in Kofu, Japan and cleared under K010103. 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 both 90 and 300mm length tubing.
The provided text describes a medical device, the SURSHIELD™ Safety Winged Infusion Set, and its substantial equivalence to a previously cleared device. However, the text does not contain information about specific acceptance criteria or a detailed study that proves the device meets those criteria in a quantitative sense as might be expected for an AI/software device or a study with statistical performance metrics.
Instead, the document details physical and functional tests performed to demonstrate that the new device (manufactured in China) is identical to the predicate device (manufactured in Japan) already cleared by the FDA. The safety and effectiveness are established by showing substantial equivalence, meaning the design, materials, manufacturing, and performance are the same as or very similar to the predicate device, and thus raise no new safety or effectiveness concerns.
Here's an analysis based on the provided text, addressing your questions to the extent possible:
1. A table of acceptance criteria and the reported device performance
The document lists "Performance" tests but does not provide specific quantitative acceptance criteria or detailed results. It simply states that the "following tests were performed."
| Performance Test | Reported Device Performance | Acceptance Criteria (Not Explicitly Stated in Document) |
|---|---|---|
| Shield cover/Needle Locking Strength | Performed (Implied satisfactory outcome for substantial equivalence) | (Likely internal specifications matching predicate device) |
| Break strength of the shield cover joint | Performed (Implied satisfactory outcome for substantial equivalence) | (Likely internal specifications matching predicate device) |
| Force to lock the needle in the shield cover (Force to activate safety feature) | Performed (Implied satisfactory outcome for substantial equivalence) | (Likely internal specifications matching predicate device) |
| Puncture Resistance of Shield Cover | Performed (Implied satisfactory outcome for substantial equivalence) | (Likely internal specifications matching predicate device) |
| Flow Rate | Performed (Implied satisfactory outcome for substantial equivalence) | (Likely internal specifications matching predicate device) |
| Priming Volume | Performed (Implied satisfactory outcome for substantial equivalence) | (Likely internal specifications matching predicate device) |
| Wing to Tubing Connection Strength | Performed (Implied satisfactory outcome for substantial equivalence) | (Likely internal specifications matching predicate device) |
| Tubing to Connector Connection Strength | Performed (Implied satisfactory outcome for substantial equivalence) | (Likely internal specifications matching predicate device) |
| Needle to Wing Connection Strength | Performed (Implied satisfactory outcome for substantial equivalence) | (Likely internal specifications matching predicate device) |
| Needle Penetration Resistance | Performed (Implied satisfactory outcome for substantial equivalence) | (Likely internal specifications matching predicate device) |
| Wing Needle Protector Fit | Performed (Implied satisfactory outcome for substantial equivalence) | (Likely internal specifications matching predicate device) |
| Leak Test | Performed (Implied satisfactory outcome for substantial equivalence) | (Likely internal specifications matching predicate device) |
| Blockage Test | Performed (Implied satisfactory outcome for substantial equivalence) | (Likely internal specifications matching predicate device) |
Key takeaway: The document focuses on demonstrating that the new device is the same as the predicate device by performing physical and functional tests, rather than setting and meeting novel acceptance criteria.
The remaining questions are largely not applicable or cannot be answered from the provided text, as they pertain to clinical or AI algorithm studies, which are not described here. This document is a 510(k) submission for a physical medical device demonstrating substantial equivalence, not a clinical trial report or AI performance study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for the performance tests.
- Data provenance is implicitly for the device manufactured by Terumo Medical Products in Hangzhou, China, but no specific "data" in the clinical sense is presented. The tests are likely laboratory bench tests.
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. This is not a study requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 a study involving human readers or AI assistance.
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 device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is likely adherence to engineering specifications and functional equivalence to the predicate device, as demonstrated through product performance testing. There isn't a "ground truth" derived from clinical outcomes or expert consensus in the way one would for diagnostic tools.
8. The sample size for the training set
- Not applicable. There is no "training set" for this physical device.
9. How the ground truth for the training set was established
- Not applicable.
In summary, the provided document is a regulatory submission for a physical medical device, primarily demonstrating substantial equivalence. It describes a series of mechanical and functional tests rather than clinical studies or AI performance evaluations, and therefore, most of the requested information about acceptance criteria and study details (especially those related to ground truth, expert review, or AI performance) is not present.
§ 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.