(24 days)
The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is a winged blood collection needle intended for venipuncture to collect blood specimens from patients.
The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.
Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Surshield Safety Winged Blood Collection Set is a sterile, single-use device consisting of a needle attached to a winged type hub, tubing, a female connector with a multi-sample luer adapter attached for blood collection. The Surshield Safety Winged Blood Collection Set is the same as the Surshield Safety Winged Infusion Set (K010104) except for the attached luer adapter (K983490).
A hinged safety shield, previously cleared under K010103, is attached to the wing just below the needle-to-wing junction. The safety shield 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 single-handed technique. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needlestick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it.
The provided document describes a 510(k) premarket notification for the TERUMO® SURSHIELD™ Safety Winged Blood Collection Set. This submission is for a medical device and not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML studies are not applicable.
Here's an analysis of the provided text in relation to the prompt:
1. A table of acceptance criteria and the reported device performance:
The document states that "The following performance tests were performed on the Surshield Safety Winged Blood Collection Set:
- Leakage at connector to luer adapter junction
- Blockage
- Connection strength of luer adapter to connector
- Valve Protector Fit"
It also explicitly states, "Additionally, a risk analysis was conducted and any potential issues were addressed through design modification, and/or labeling as appropriate. None of the data raises any new issues of safety and effectiveness."
This indicates that the device met the acceptance criteria for these tests, implicitly defined by "not raising any new issues of safety and effectiveness." However, specific numerical acceptance criteria or performance metrics for these tests are not detailed in the provided text. For example, it doesn't state "Leakage less than X mL/hr" or "Connection strength greater than Y Newtons."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| No new issues of safety and effectiveness for: | Met, as "None of the data raises any new issues of safety and effectiveness." |
| - Leakage at connector to luer adapter junction | Met (Implied by the overall statement) |
| - Blockage | Met (Implied by the overall statement) |
| - Connection strength of luer adapter to connector | Met (Implied by the overall statement) |
| - Valve Protector Fit | Met (Implied by the overall statement) |
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 specify the sample sizes used for the performance tests mentioned (Leakage, Blockage, Connection strength, Valve Protector Fit). It also does not explicitly state the country of origin of the test data or whether the tests were retrospective or prospective. Given that the manufacturer, Terumo Corporation, is in Tokyo, Japan, it is highly likely the testing was conducted there.
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 question is not applicable as the submission is for a physical medical device (blood collection set), not an AI/ML diagnostic or predictive algorithm that relies on expert interpretation for ground truth. The performance tests described are physical engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for a physical device's engineering performance tests. Adjudication methods are typically relevant for human interpretation of data, as in clinical studies or AI algorithm evaluations.
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. The device is a physical blood collection set, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical blood collection set, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's performance tests would be defined by engineering specifications and standards (e.g., maximum allowable leakage, minimum required connection strength). These are objective measurements rather than subjective human interpretations or clinical outcomes in the context of an AI/ML study.
8. The sample size for the training set:
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML algorithm that requires a training set.
§ 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.