(55 days)
The GRIPPER PLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.
The GRIPPER PLUS™ Needle is similar in design to the current GRIPPER® Needle, with the incorporation of a passive needle stick protection feature. The protection feature is made of a base and arm with a hinge on one end. As the needle is removed from a portal the hinge allows the needle to be pulled back and locked into the capture well in the base. There is an audible "click" when the needle is captured. The device is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. It does not protect against other routes of bloodborne pathogen transmission. The needle tip is fully protected after deployment of the needle stick protection feature and will not disengage with normal handling such that the needle tip becomes exposed.
The needle will be offered in various needle gauges and lengths, and with or without a slit-septum injection site cap.
The provided document describes the GRIPPER PLUS™ Needle, a medical device designed to protect against needlestick injuries. Below is an analysis of its acceptance criteria and the study used to demonstrate compliance.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the GRIPPER PLUS™ Needle are primarily functional, focusing on the successful activation of the needle-stick protection feature and the biocompatibility of its components.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Needle-stick protection feature activation | Successfully activated during all attempts in simulated use testing. |
| Protection against exposure to bloodborne pathogens | Designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. |
| Needle tip fully protected and will not disengage | Needle tip is fully protected after deployment and will not disengage with normal handling. |
| Function according to specifications | Functions according to specifications. |
| Biocompatibility of device components | Materials used in the device are biocompatible. |
| Acceptable for its intended use | Evaluated by healthcare professionals in simulated use and found acceptable for its intended use. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not explicitly state a numerical sample size for the "simulated use test." Instead, it mentions that the device was "evaluated by health care professionals during a simulated use test."
- Data Provenance: The testing was "in-vitro testing and simulated use testing." The country of origin for the data is not explicitly stated, but the submission is to the U.S. FDA, suggesting the testing was conducted to U.S. standards. The study was retrospective in the sense that the testing was performed to support the 510(k) submission after the device's design.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- Number of Experts: The document states the device was "evaluated by health care professionals." It does not specify the exact number of professionals involved.
- Qualifications of Experts: The qualifications are broadly stated as "health care professionals." Specific expertise (e.g., years of experience, specific medical field) is not detailed.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus). The assessment appears to be based on the direct observation and feedback from the "health care professionals" during the simulated use test, where the protection feature "successfully activated during all attempts."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was performed or cited. The document does not mention any comparison of human readers' performance with and without AI assistance, as AI is not a component of this device.
6. Standalone Performance Study
Yes, a standalone study was performed. The "functional testing" and "simulated use testing" evaluated the device's inherent performance. The key finding from this standalone testing was that the device's protection feature "successfully activated during all attempts."
7. Type of Ground Truth Used
The ground truth used for the acceptance criteria was primarily based on:
- Functional performance standards: The device's ability to activate its safety mechanism and protect the needle tip.
- Expert evaluation/observation: Healthcare professionals' assessment of the device's acceptability in simulated use.
- Biocompatibility testing: Laboratory results confirming material safety.
8. Sample Size for the Training Set
This device is a mechanical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used for algorithm development.
9. How Ground Truth for Training Set Was Established
Not applicable, as this is not an AI/machine learning 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.