(64 days)
The V3 Valve is a passive anti-needlestick device designed to provide aspiration, injection, or gravity flow of fluids upon insertion of a mate luer-lock fitting.
The V3 Valve is a passive anti-needlestick device designed to provide aspiration, injection, or gravity flow of fluids upon insertion of a male luer-lock fitting.
The provided text describes a 510(k) submission for the "V3 Valve," an intravascular administration set. This submission aims to demonstrate substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance data in the typical sense of a clinical trial for an AI/diagnostic device.
Therefore, many of the requested elements (like acceptance criteria for a study, sample sizes, expert qualifications, MRMC studies, standalone performance, training sets, etc.) are not applicable or not provided in this type of regulatory document.
However, I can extract information related to the device and its intended use, as well as the basis for its safety and effectiveness claims within the context of substantial equivalence.
Here's a breakdown of the available information:
Acceptance Criteria and Device Performance
Since this is a 510(k) submission for a non-AI/diagnostic device, the concept of "acceptance criteria" and "reported device performance" in the typical sense of metrics like sensitivity, specificity, or AUC is not applicable. Instead, the "acceptance criteria" are compliance with established testing procedures and parameters that conform to product design specifications, as detailed for safety and effectiveness.
| Acceptance Criteria (related to device requirements) | Reported Device Performance (as claimed by manufacturer) |
|---|---|
| Material suitability (in accordance with ISO 10993) | Determined to be suitable for intended use |
| Conformity to product design specifications | Met all required release specifications |
| Compliance with Quality Control Test Procedure documents | All finished products tested and meet specifications |
| Physical testing requirements | Satisfied through established testing procedures |
| Visual examination (in-process and finished product) | Performed |
| Substantial equivalence to predicate devices (K941679, K955585) | V3 Valve is equivalent in materials, form, and intended use; no new issues of safety or effectiveness raised. |
| Compliance with general control provisions of the Act (e.g., annual registration, listing, GMP, labeling) | Assumed for marketing approval |
Study Information (Not Applicable/Provided for AI/Diagnostic Devices)
- Sample size used for the test set and the data provenance: Not applicable. This document describes a medical device (valve), not an AI/diagnostic algorithm that would have test sets. The "testing" refers to manufacturing quality control.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the clinical diagnostic sense is established for this device.
- Adjudication method for the test set: Not applicable.
- 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 not an AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" refers to product design specifications, material standards (ISO 10993), and quality control procedures.
- The sample size for the training set: Not applicable. No training set is involved.
- How the ground truth for the training set was established: Not applicable.
Additional Context from the Document:
- Device Name: V3 Valve
- Trade Name: Intravascular Administration Set
- Classification: General Hospital Class II, 80 FPA, Intravascular Administration Set (21 CFR 880.5860)
- Intended Use: "The V3 Valve is a passive anti-needlestick device designed to provide aspiration, injection, or gravity flow of fluids upon insertion of a male luer-lock fitting."
- Predicate Devices:
- Basis for Safety and Effectiveness (as claimed by manufacturer):
- Materials tested in accordance with ISO 10993.
- All finished products are tested against required release specifications, including physical testing and visual examination.
- Physical testing is defined by Quality Control Test Procedure documents that conform to product design specifications.
- Substantial equivalence in materials, form, and intended use to predicate devices, with no new issues of safety or effectiveness raised.
The FDA's letter (JAN - 6 1998) confirms that the device was found "substantially equivalent" for the stated indications for use, allowing it to be marketed. This determination implies that the provided information (including the safety and effectiveness claims based on material testing and quality control) was sufficient for regulatory approval under the 510(k) pathway.
§ 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.