(164 days)
Single use, sterile device for preparation of drugs in a standard luer syringe to transfer the prepared drug back into the syringe for delivery.
The E-Z-Link device is a sterile, single use device that, through the use of a stainless steel cannula (needle), facilitates creation of a sterile fluid path to transfer liquid from a standard luer lock syringe to a standard pharmaceutical 13 mm vial containing a drug, in order to mix or reconstitute the drug and aspirate and transfer the prepared drug back into the luer lock syringe for delivery. The product line will include devices with different gauge transfer needles (20 and 27 Gauge).
The E-Z-Link device is a sterile, single-use vial adapter/reconstitution device. The provided text primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and performance testing. It does not describe a study involving a test set, ground truth, or expert readers in the context of typical AI/diagnostic device evaluation.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The regulatory submission for the E-Z-Link device focuses on demonstrating that its performance characteristics meet established standards for similar devices. The "acceptance criteria" are implied by the successful completion of the listed tests, indicating the device meets the functional, safety, and quality requirements.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet standards for needle patency | Data generated verifying design for needle patency |
| Meet leak testing requirements per ISO 594-1 | Data generated verifying design for leak testing |
| Meet needle attachment force requirements per ISO 7864:1993(E) | Data generated verifying design for needle attachment force |
| Meet transfer holdup volume specifications | Data generated verifying design for transfer holdup volume |
| Meet force to transfer liquid to vial specifications | Data generated verifying design for force to transfer liquid to vial |
| Meet vial attachment force specifications | Data generated verifying design for vial attachment force |
| Meet vial detachment force specifications | Data generated verifying design for vial detachment force |
| Meet packaging removal force specifications | Data generated verifying design for packaging removal force |
| Meet force to attach/detach luer lock syringe specifications | Data generated verifying design for force to attach/detach luer lock syringe |
| Meet needle shield override force specifications | Data generated verifying design for needle shield override force |
| Meet coring/fragmentation requirements | Data generated verifying design for coring/fragmentation |
| Meet biocompatibility standards per ISO 10993-1 | Data generated verifying design for biocompatibility |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of evaluating an AI or diagnostic algorithm on a specific dataset of cases. The performance data refers to physical and biological testing of the device itself. Therefore, information about sample size and data provenance for a test set is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes physical device testing, not a study evaluating human or AI performance against a ground truth from experts.
4. Adjudication Method for the Test Set
This information is not applicable.
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
An MRMC study is not applicable to this type of device (a mechanical vial adapter). The document does not describe any human reader performance evaluation or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The E-Z-Link is a manually operated mechanical device, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The concept of "ground truth" as typically used in diagnostic imaging or AI studies is not applicable here. For mechanical devices like E-Z-Link, the "ground truth" is defined by adherence to engineering specifications, international standards (e.g., ISO), and accepted medical device performance parameters for safety and functionality. For example, for "Leak Testing of connections per ISO 594-1," the "ground truth" is the specified leak rate threshold outlined in the ISO standard.
8. The Sample Size for the Training Set
This information is not applicable. The E-Z-Link is a mechanical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable.
§ 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.