(38 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 manufactured by Terumo Medical Products in Hangzhou, China is a sterile, single-use device consisting of a needle attached to a winged type hub, tubing, female connector with a multi-sample luer adapter attached for blood collection.
A hinged shield cover is attached 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 two- handed technique. 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.
Here's a breakdown of the acceptance criteria and study information for the TERUMO® SURSHIELD™ Safety Winged Blood Collection Set, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for each test. Instead, it states that the performance tests were performed and the conclusion is that the device is "substantially equivalent" to a predicate device, which implies the test results either met the predicate's performance or fell within acceptable manufacturing tolerances. For some tests, the document describes the design intent or functionality, which implicitly forms the basis of acceptance.
| Test Performed | Implied Acceptance Criteria (Based on Substantial Equivalence and Design) | Reported Device Performance |
|---|---|---|
| Shield cover/Needle Locking Strength | The shield cover must effectively and securely lock the needle after activation, preventing accidental exposure. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Break strength of the shield cover joint | The joint must withstand normal handling during activation without breaking, ensuring the safety mechanism remains intact. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Force to lock the needle in the shield cover (Force to activate safety feature) | The activation force should be reasonable for user operation while ensuring positive locking. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Puncture Resistance of Shield Cover | The shield cover must adequately resist needle puncture once locked, preventing accidental needlesticks. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Flow Rate | The device should allow for efficient blood collection and fluid administration. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Wing to Tubing Connection Strength | Connections must be robust to prevent leaks or detachment during use. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Tubing to Connector Connection Strength | Connections must be robust to prevent leaks or detachment during use. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Needle to Wing Connection Strength | Connections must be robust to prevent leaks or detachment during use. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Needle Penetration Resistance | Not explicitly defined for the safety feature (likely applies to the needle itself, ensuring proper venipuncture efficacy). | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Wing Needle Protector Fit | The protector must fit securely on the wing, likely referring to the design and integration of the safety feature. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Leak Test | The device must not leak during normal use for blood collection or fluid administration. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Blockage Test | The device must remain unblocked, allowing for proper fluid flow. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Connection Strength of Winged Infusion Set and Luer Adaptor Joint | The connection between the set and luer adaptor must be secure. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Valve Protector Fit | Likely refers to the fit and function of any valve mechanisms, ensuring proper seal and operation. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Sterility Assurance Level (SAL) | SAL of 10^-6 (implied by EN550 validation to 10^-9 means it meets this common standard). | Validated to provide a Sterility Assurance Level (SAL) of 10^-9. |
| Ethylene Oxide Residual Levels | Ethylene Oxide: 25 ppm; Ethylene Chlorohydrin: 25 ppm. | Ethylene Oxide: Does not exceed 25 ppm; Ethylene Chlorohydrin: Does not exceed 25 ppm. |
| Biocompatibility | Materials must be biocompatible according to ISO-10993 Part-1. | Blood contacting materials are biocompatible. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for any of the performance tests.
- Data Provenance: The tests were performed on the "Surshield Safety Winged Blood Collection Set manufactured by Terumo Medical Products in Hangzhou, China." The data is thus prospective for this specific device model from that manufacturing location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The study described is primarily a device performance and substantial equivalence assessment, not one relying on expert interpretation of results. Physical and chemical tests were performed.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the tests (mechanical, chemical, flow rates), an adjudication method as typically used for clinical or imaging data (e.g., 2+1) would not be applicable. The tests likely involved standardized methods with objective pass/fail criteria or measurements.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document is for a physical medical device (blood collection set), not an AI-powered diagnostic or interpretive system. Therefore, the concept of "human readers" or "AI assistance" is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, this is not an algorithm-only or AI-based device. It is a physical medical device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests was based on engineering specifications, industry standards (e.g., EN550, ISO-10993), and the performance characteristics of the predicate device. For example, the ground truth for "Shield cover/Needle Locking Strength" would be defined by the predicate device's measured locking strength or a specific force threshold required by relevant standards for safety features.
8. The Sample Size for the Training Set
Not Applicable. This is a physical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As above, no training set was used.
§ 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.