(61 days)
The Surecan™ Safety Huber Needle Infusion Set is a passive needlestick prevention device which is designed to minimize inadvertent needlesticks. The device is intended to provide implanted subcutaneous port access, used in conjunction with IV administration of chemotherapy and other injectable drugs and/or to withdraw blood.
The Surecan™ Safety Huber Needle Infusion Set consists of a standard right angle non-coring Huber needle with a passive safety mechanism clip, hub grip, base plate, extension set with an on-off clamp and a female luer lock connector. The Huber needles range in size from 19 Gauge to 22 Gauge and has an overall needle length ranging from 34 inch to 1-1/2 inch. The Surecan™ Safety Huber Needle Infusion Sets will also be available in two configurations: one with an Ultrasite Valve (previously known as a V2 injection site)/y-site and one without the Ultrasite Valve/y-site. The safety clip mechanism reduces the risk of accidental needlestick injuries by shielding the needle. The safety clip mechanism will activate once the huber needle is pulled from the base plate.
The provided text describes a 510(k) premarket notification for the Surecan™ Safety Huber Needle Infusion Set. The submission focuses on demonstrating substantial equivalence to predicate devices, particularly regarding a passive safety mechanism designed to prevent needlestick injuries. The available information primarily describes the device, its intended use, and the basis for substantial equivalence, rather than a detailed study report with specific acceptance criteria and performance metrics in the format requested.
However, based on the provided text, we can infer some information relevant to the request.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria. Instead, it relies on demonstrating that the device is "similar in indications for use, has a safety feature to help minimize accidental needlestick injuries, and has a similar design" to predicate devices. The key performance aspect mentioned is the prevention of needlestick injuries.
| Acceptance Criteria (Inferred from "Functional Testing") | Reported Device Performance |
|---|---|
| Prevention of accidental needlestick injuries | "No sharp injuries or failures of the needlestick prevention feature/safety mechanism occurred." |
| Functionality in conjunction with IV administration of chemotherapy and other injectable drugs and/or to withdraw blood | The device is intended for this use, and functional testing supported no new safety/effectiveness issues. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the Surecan™ Safety Huber Needle Infusion Set." However, it does not specify the sample size used for this functional testing or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The study described is functional testing of a device's mechanical safety feature, not a diagnostic or AI-driven assessment where expert ground truth establishment is typically required.
4. Adjudication Method:
This information is not provided and is not typically relevant for functional device testing of this nature.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not performed as this is a medical device (infusion set) with a mechanical safety feature, not an AI or imaging diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study was not performed as this device does not involve an algorithm. The "functional testing" relates to the mechanical safety mechanism.
7. Type of Ground Truth Used:
For the functional testing of the safety mechanism, the "ground truth" would be the direct observation of the device's performance – specifically, whether the safety mechanism activated as intended and whether any sharp injuries or failures occurred. This could be considered outcome data related to the device's primary safety function.
8. Sample Size for the Training Set:
The document does not mention a training set as this device does not employ machine learning or AI. The referenced "functional testing" is for product validation, not for training an algorithm.
9. How Ground Truth for the Training Set Was Established:
This is not applicable as there was no 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.