(104 days)
The DermaTech IV Holder is intended as an intravascular administration set to administer fluids through a catheter or needle inserted into a patients artery or vein.
The DermaTech Sterile IV Holder is a sterile tape-less anchoring system comprising of Non-pyrogenic, PVC tubing with ABS male and female luer locks at each end, two Low Density Polyethylene Clam Shell tubing holders with a Polypropylene Hybrid Stretch Bonded Laminate Velcro strap. Once a needle or catheter is inserted into the artery or vein the DermaTech Sterile IV Holder is attached and provides a app-lecs a securing method to administer IV fluids.
The provided document describes a 510(k) premarket notification for the DermaTech Medical Sterile IV Holder, asserting its substantial equivalence to predicate devices. The study conducted focuses on non-clinical tests to support this claim, rather than human-in-the-loop performance or diagnostic accuracy studies typical for AI/ML devices.
Here's an analysis of the acceptance criteria and study as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Substantial Equivalence (Based on Non-Clinical Testing):
| Requirement | Acceptance Criteria (Predicate Match) | Reported Device Performance (DermaTech IV Holder) |
|---|---|---|
| Flow Rate | Comparable to predicate devices | Verified to be substantially equivalent |
| Backpressure | Comparable to predicate devices (no leakage under backpressure) | Verified to be substantially equivalent |
| Vacuum Leakage | Comparable to predicate devices (no leakage under vacuum) | Verified to be substantially equivalent |
| Materials | Similar to predicate devices (PVC, ABS, LDPE, Polypropylene) | All materials similar to predicate devices |
| Intended Use | Same as predicate devices | Same as predicate devices |
Note: The document explicitly states "The comparison test verifies the predicate devices and the DermaTech IV Holder are substantially Equivalent." This is the reported performance for all criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size Used for Test Set: The document does not specify the sample size for the non-clinical tests (flow rate, backpressure, vacuum leakage). It only states "The current devices were compared..."
- Data Provenance: The data provenance is not specified beyond being "non-clinical tests." It is implicit that these tests would have been conducted by DermaTech Medical or a contract testing lab. There is no information about country of origin, nor whether the tests were retrospective or prospective, though non-clinical tests are generally considered prospective in their execution.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is not applicable to this submission. The DermaTech IV Holder is a medical device, not an AI/ML diagnostic or prognostic tool that would require expert-established ground truth for a test set. The "ground truth" for this device's performance is derived from physical test measurements compared against predicate devices' specifications or performance.
4. Adjudication Method for the Test Set
This question is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic studies, not for non-clinical device performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This question is not applicable to this submission. The document describes a non-clinical study for a physical medical device (IV holder), not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable to this submission. This device is a physical IV holder and does not involve an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for this submission's non-clinical tests was established by measurable physical properties and performance characteristics (flow rate, backpressure leakage, vacuum leakage) of the predicate devices. The aim was to show that the DermaTech IV Holder matched these characteristics.
8. Sample Size for the Training Set
This question is not applicable to this submission. There is no AI/ML model or "training set" for this physical device.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable to this submission. There is no AI/ML model or "training set," and therefore no ground truth was established for such a 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.