(64 days)
- The MiniLoc™ Safety Infusion Set device is a safety intravascular administration . set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports.
- The integral MiniLoc™ Safety Infusion Set safety mechanism is manually . activated during the removal of the MiniLoc™ Safety Infusion Set needle from a surgically implanted vascular port. The safety mechanism reduces the risk of accidental needlestick injuries by shielding the needle.
- The MiniLoc™ Safety Infusion Set is intended for use in the administration of . fluids and drugs, as well as blood sampling through surgically implanted ports.
- The MiniLoc™ Safety Infusion Set will be marketed as a sterile, non-pyrogenic, . single use device.
- The MiniLoc™ Safety Infusion Set may be used in any appropriate patient . population.
The MiniLoc™ Safety Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needlestick prevention feature. The MiniLocTM Safety Infusion Set is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling. The MiniLocTM Safety Infusion Set is supplied sterile and non-pyrogenic, for single use only.
Here's an analysis of the provided text regarding the MiniLoc™ Safety Infusion Set, broken down by your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a simulated use study to demonstrate the safety feature of the MiniLoc™ Safety Infusion Set. While explicit "acceptance criteria" are not formally enumerated with numerical thresholds in the 510(k) summary, the objective of the study was to show successful activation of the safety mechanism and absence of sharps injuries.
Implied Acceptance Criteria:
- The integral needlestick prevention feature/safety mechanism must successfully activate upon removal.
- There should be no sharps injuries during simulated use.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Successful activation of integral needlestick prevention feature/safety mechanism. | "A total of 500 MiniLoc™ Safety Infusion Sets were successfully inserted by clinicians into simulated tissue and activated." |
| Absence of sharps injuries related to the safety mechanism during simulated use. | "No sharps injuries of the integral needlestick prevention feature/safety mechanism occurred." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 500 MiniLoc™ Safety Infusion Sets.
- Data Provenance: The study was a "simulated use study," indicating it was conducted in a controlled, artificial environment, not directly on human patients (
in vitroorex vivousing simulated tissue). The country of origin for the data is not specified, but the submitting company is based in Bountiful, Utah, USA. The study appears to be prospective since it involves newly manufactured devices being tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: The document states that the sets were "successfully inserted by clinicians." It does not specify the number of clinicians or experts involved in performing the insertions or evaluating the outcomes.
- Qualifications of Experts: The general term "clinicians" is used. Their specific qualifications (e.g., years of experience, specialty) are not detailed.
4. Adjudication Method
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The nature of the test (successful insertion and activation, absence of sharps injuries) suggests a direct observation and binary outcome rather than a subjective assessment requiring expert consensus or adjudication. The outcome (successful activation, no sharps injuries) appears to be objectively verifiable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. The described study is a "simulated use study" focused on the standalone performance of the device's safety feature, not a comparative effectiveness study involving human readers or the improvement of human performance with AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance)
- Yes, a standalone study was done, in essence. The "simulated use study" evaluates the functional performance of the device's safety mechanism by itself. While clinicians perform the insertion, the evaluation is of the device's inherent safety feature (activation and prevention of sharps injuries), not of the human-device interaction as a human-in-the-loop system for diagnostic or interpretive tasks. The device itself (the safety mechanism) acts autonomously upon removal.
7. Type of Ground Truth Used
- The ground truth in this study is based on direct observation and objective outcome of the device's mechanical function: successful activation of the safety mechanism and the absence of actual sharps injuries during simulated removal. This is a physical, measurable outcome.
8. Sample Size for the Training Set
- Not applicable. The document describes a performance test for a mechanical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML algorithm, there is no training set and thus no ground truth established for one.
§ 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.