(67 days)
The VeinRx Infusion Catheter is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
The VeinRx InfusionCath Peripheral Infusion Catheter is comprised of a distal occlusion balloon, a fixed infusion length catheter body with infusion holes, and a proximal trifurcated Luer connection hub. The trifurcated hub allows connection to three main systems of the device. The distal black marker indicates the proximal edge of the infusion length. The proximal black marker is used to properly align the device with the recommended introducer. The InfusionCath is packaged inside a protective tube mounted on a card and placed in a sealed protective pouch.
Here's a breakdown of the requested information based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device (InfusionCath Peripheral Infusion Catheter) seeking substantial equivalence to a predicate device. As such, it does not contain the detailed study results, acceptance criteria for performance metrics, or information about AI/ML models typically found in submissions for novel AI/ML-powered devices. The primary goal of a 510(k) is to demonstrate that a new device is "as safe and effective as" a legally marketed predicate device, often by showing it meets similar performance specifications.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific acceptance criteria and reported device performance metrics in the context of quantitative measures (e.g., accuracy, sensitivity, specificity, F1-score) are NOT available. The document states:
- "The modified InfusionCath Peripheral Infusion Catheter was tested in the same manner as the original InfusionCath Peripheral Infusion Catheter. All components, subassemblies, and/or full devices met the required specifications for the completed tests."
This indicates that internal design and performance specifications were met, but the specific numerical values of these "specifications" are not detailed in this summary. The nature of this device (a catheter) suggests performance criteria would likely revolve around mechanical integrity, material compatibility, fluid flow rates, and safety, not diagnostic accuracy.
| Acceptance Criteria Category | Acceptance Criteria (Specifics not provided in the document) | Reported Device Performance (Specifics not provided in the document) |
|---|---|---|
| Functional/Mechanical | All required specifications for components, subassemblies, and/or full devices. | Met all required specifications. (Implies satisfactory performance against internal design specifications) |
| Biocompatibility/Material | Materials suitable for intended use. | Materials used in numerous previously cleared products. (Implies suitability and established safety profile) |
| Safety | N/A (General safety is implied) | N/A (General safety is implied) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "Testing Summary" and that "All components, subassemblies, and/or full devices met the required specifications for the completed tests." It does not provide details on how many units or components were tested.
- Data Provenance: Not applicable in the context of clinical data for an AI/ML device. For this physical medical device, the "data" would be results from engineering, bench, and potentially pre-clinical (animal) or limited human clinical compatibility testing. The country of origin of this testing is not specified, but it would have been conducted by or on behalf of VeinRx, Inc., a US-based company. The statement "The modified InfusionCath Peripheral Infusion Catheter was tested in the same manner as the original InfusionCath Peripheral Infusion Catheter" suggests a comparison to an existing product's performance profile rather than new, large-scale clinical trials.
- Retrospective or Prospective: Not applicable in the context of clinical data for AI/ML. The testing would have been conducted for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This device is a physical catheter, not a diagnostic device relying on expert interpretation of data to establish ground truth for a test set. Its performance is assessed through engineering testing, material characterization, and potentially pre-clinical studies, not clinical expert consensus for diagnostic accuracy.
4. Adjudication Method for the Test Set
- Not applicable. As above, this is not relevant for a physical medical device like a catheter.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. This is a physical medical device (catheter) and does not incorporate AI. Therefore, an MRMC study and analysis of AI assistance is not relevant or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is a physical medical device (catheter) and does not incorporate an AI algorithm. Therefore, standalone algorithm performance is not relevant or applicable.
7. The Type of Ground Truth Used
- Not applicable in the AI/ML sense. The "ground truth" for this device would be established by engineering specifications, material standards (e.g., ISO, ASTM, USP), and established biological compatibility requirements. For example, a "ground truth" for a material test would be whether a material passes a specific cytotoxicity test or particulate matter release limit.
8. The Sample Size for the Training Set
- Not applicable. This device does not use AI/ML, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set (no AI/ML), this question is not relevant.
In summary, the provided document is a 510(k) Pre-Market Notification for a conventional medical device (a catheter). It focuses on demonstrating substantial equivalence to a predicate device through manufacturing similarities and meeting established design specifications. It does not involve AI/ML technology, and therefore, many of the questions asked, which are relevant to AI/ML device submissions, are not applicable to this document.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).