(185 days)
The Luther Safety Huber Needle Set is a device intended to administer drugs to a patient from a container through a subcutaneous implanted port. The Huber Needle safety needle cover is manually activated. When the safety feature is activated, the device is designed to aid in the prevention of accidental needle sticks.
The Luther Safety Huber Needle Set is a standard right angle Huber needle and administration set with a needlestick prevention feature, designed for use with a vascular access infusion system. It is manufactured with conventional medical grade, biocompatible materials. The Luther Safety Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. It is supplied sterile for single use only.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Luther Safety Huber Needle Set:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Prevention of sharps injury | No incidences of sharps injury |
| Safety feature activation | No incidences where the safety feature failed to activate |
2. Sample Size and Data Provenance
- Test Set Sample Size: 692 Luther Safety Huber Needle Sets.
- Data Provenance: The study was a "simulated use clinical trial," which generally implies a prospective study. The document does not specify the country of origin of the data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish ground truth for this particular study. The assessment of sharps injuries and safety feature activation appears to be directly observed outcomes from the simulated use.
4. Adjudication Method
The document does not describe any adjudication method. Given the nature of the observed outcomes (sharps injury, safety feature activation), direct observation likely formed the basis of the data collection.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. The Luther Safety Huber Needle Set is a medical device designed for drug administration and sharps injury prevention.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study was done. This device does not involve an algorithm. Its function is mechanical/physical, relying on a safety feature to prevent needle sticks.
7. Type of Ground Truth Used
The ground truth used was direct observation of outcomes in a simulated use clinical trial:
- Presence/absence of sharps injuries.
- Successful/unsuccessful activation of the safety feature.
8. Sample Size for the Training Set
Not applicable. This device does not use machine learning or algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.