(85 days)
The proposed adapter will be used to convert a conventional needle-accessed vinjection site on a Baxter or competitive solution administration set to an InterLink® injection site. This device, like other products containing the InterLink® injection site is designed to reduce the risk of accidental needle sticks when used in conjunction with the InterLink® cannula, as part of a "needleless" IV access system.
The proposed InterLink® Adapter for Conventional Y-Site is designed to convert a conventional (needle-accessed) y-injection site to an InterLink® injection site (needleless access). The InterLink® injection site is incorporated into the top of the adapter to allow access to conventional injection sites with InterLink® cannulae. The adapter contains a plastic spike to pierce the conventional Y-site septum and a slot which connects to the arm of the Y-site. There are no new materials involved in the proposed adapter. All plastic and rubber materials used have been previously tested and used in other Baxter devices for similar I.V. solution administration applications.
This document is a 510(k) summary for a medical device (InterLink® Adapter for Conventional Y-Site), which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies or rigorous acceptance criteria with reported performance in a format suitable for the requested table.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions functional performance testing but does not provide specific quantitative acceptance criteria or detailed reported performance values in a table format. It states: "The data indicate that the proposed adapter meets or exceeds all functional requirements and support its suitability for use with the intended sets." This is a general statement of success rather than specific quantitative results against defined criteria.
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Seal Integrity | Not explicitly stated (e.g., "no leaks at X pressure for Y duration") | "meets or exceeds all functional requirements and support its suitability for use with the intended sets" |
| Adapter Security on Y-Site | Not explicitly stated (e.g., "withstands X force without dislodgement") | "meets or exceeds all functional requirements and support its suitability for use with the intended sets" |
| Material Compatibility | Assumed: Materials are compatible and safe for intended use. | "All plastic and rubber materials used have been previously tested and used in other Baxter devices for similar I.V. solution administration applications." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The text mentions "Testing was performed with Baxter and competitive sets including Abbott, IMED. IVAC, Burron Medical and McGaw sets," but no number of samples or tests is provided.
- Data Provenance: Not explicitly stated. The testing was "generated" regarding the functional performance. No country of origin is mentioned, and it is a prospective functional test rather than a retrospective analysis of 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)
This type of information is not relevant or present in this 510(k) summary. The study described is a functional performance test of a physical device, not an assessment of diagnostic accuracy requiring expert image interpretation or clinical judgment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, not for objective functional device testing.
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 is a functional device test, not a comparative effectiveness study involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a physical adapter, not an algorithm. The "standalone" performance here would refer to the device's functional performance on its own, which is what the non-clinical tests aimed to assess.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For functional testing of a physical device, the "ground truth" is typically defined by objective physical measurements and engineering specifications. For example, "no leakage" at a certain pressure or "no dislodgement" under a certain force. The text implies these types of objective criteria were used, although they are not explicitly detailed.
8. The sample size for the training set
Not applicable. This device is a physical product, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
§ 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.