(70 days)
The intended use for the SmartSite Access Pin is to allow access to IV administration sets, medication vials, blood tubes, and solution bags with one convenient device without the use of needles or blunt cannulas.
The SmartSite Access Pin is a stand alone accessory and is the same device as the currently marketed /VAC Needle Free Valve (K960280) with the exception of a modified housing. The housing for the SmartSite Access Pin has been modified to accommodate the needs of an access pin by adding a protected spike and finger grips. Functionally, the SmartSite Access Pin is the same as the currently marketed /VAC Needle Free Valve in that it allows access to IV administration sets. As an access pin device, the SmartSite Access Pin also allows access to medication vials, blood tubes, and solution bags without the use of needles or blunt cannulas.
This is a medical device 510(k) premarket notification, not a study evaluating an AI algorithm or diagnostic device. Therefore, most of the requested information regarding acceptance criteria for device performance in a study setting, sample sizes for test/training sets, expert involvement, and ground truth establishment, is not applicable.
Instead, this document describes a conventional medical device (SmartSite™ Access Pin) and its substantial equivalence to previously cleared devices. The "acceptance criteria" here would refer to the regulatory requirements for substantial equivalence, rather than statistical performance metrics of a diagnostic algorithm.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Regulatory) | Reported Device Performance (Substantial Equivalence) |
|---|---|
| Safety and Effectiveness (no new questions raised) | SmartSite™ Access Pin is functionally the same as the currently marketed IVAC Needle Free Valve (K960280) and performs the access pin application similarly to the ICU Medical Inc. Piggy Lock Needle Housing (K910546) and Acacia, Inc., Luer Lock Transfer Pin (K901063). |
| Intended Use (consistent with predicate devices) | Allows access to IV administration sets, medication vials, blood tubes, and solution bags without needles or blunt cannulas. This is consistent with the functions of the predicate devices. |
| Technological Characteristics (similar design and materials) | Consists of components with the same method of manufacture and similar standard materials as the IVAC Needle Free Valve (K960280). The primary function is the same, with the addition of the access pin application. |
| Device Description (minor modifications, same core function) | The SmartSite Access Pin is the same device as the IVAC Needle Free Valve (K960280) with a modified housing (added protected spike and finger grips) to accommodate access pin needs. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) premarket notification for a traditional medical device, not a study involving a test set of data for an algorithm. The "testing" involved would be engineering and functional testing to ensure the device meets its specifications and is safe, but not in the context of diagnostic performance on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth and expert adjudication are not relevant for this type of medical device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
Not applicable. This device is not an AI algorithm and does not involve human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
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.