(28 days)
The ClariVein IC is indicated for the infusion of physician-specified agents in the peripheral vasculature (e.g., superficial veins, saphenous veins).
The ClariVein IC is a specialty infusion catheter available in multiple lengths (45cm, 65cm, 85cm). The catheter assembly, including the catheter shaft, infusion port, and rotatable wire, is connected by means of a cartridge to an integral self-contained motor drive unit (MDU). The MDU includes the syringe support, handle grip, wire rotation speed selectors, and trigger features for physician-controlled infusion of a physician-specified agent. The .035" (2.7F) outside diameter of the ClariVein IC catheter is compatible with an 18 gauge or greater short peripheral catheter or a 4Fr or greater introducer to gain vascular access. The ClariVein IC is labeled sterile for single use and is provided with instruction for its safe and effective use. It has no serviceable or reusable parts. It is entirely disposable post procedure. The ClariVein IC does not include medicants or agents. The ClariVein IC is not made of phthalate or latex material manufactured parts. It has been determined to be biocompatible for its intended use. The associated accessory includes a 5mL piston style, luer syringe as a convenience for the user.
The provided document is a 510(k) summary for the ClariVein IC device, which is a medical device for infusing agents into the peripheral vasculature. As such, it does not detail acceptance criteria or a study proving that the device meets acceptance criteria in the way that an AI/ML device submission would. Instead, the document focuses on demonstrating substantial equivalence to a predicate device.
However, I can extract information related to "performance data" which, in the context of a 510(k) for a non-AI/ML device, refers to safety and effectiveness comparisons to an existing device rather than a new performance study.
Here's a breakdown based on the categories you provided, adapted to the context of this document:
1. Table of Acceptance Criteria and Reported Device Performance
This type of table is not present in the document because it's a 510(k) submission showing substantial equivalence, not a de novo clearance or an AI/ML device performance study. The "performance" assessment here is about the device being fundamentally similar to a previously cleared device, not meeting specific quantitative performance metrics against a medical condition for which an AI/ML system would be evaluated.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of an AI/ML performance study as described. The document states:
- "No new performance testing was required to be conducted for the subject ClariVein IC."
- "Clinical safety and performance information found in the literature, supplemented with post-market customer reported data, support the addition of examples of peripheral vasculature to the Indications for Use statement."
This indicates that any "data" considered for the change in indications for use was derived from existing literature and post-market surveillance of the predicate device, not a dedicated "test set" for a new device's performance. The document does not specify sample sizes or countries of origin for this supplementary data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. There was no test set for a new performance evaluation that required expert ground truth establishment.
4. Adjudication Method
Not applicable. There was no test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a 510(k) for a physical medical catheter, not an AI/ML medical device. Therefore, an MRMC study is not relevant to this submission.
6. Standalone (Algorithm Only) Performance Study
No. This device is not an algorithm or AI system.
7. Type of Ground Truth Used
Not applicable in the AI/ML sense. The "ground truth" for this submission revolves around demonstrating that the modified device (with updated indications for use) is still safe and effective and substantially equivalent to the predicate. This is supported by:
- "fundamental scientific characteristics... are the same as the predicate device."
- "All materials of the subject device are used in the legally marketed predicate ClariVein IC with the same intended use, patient contact, processing and sterilization methods."
- "Clinical safety and performance information found in the literature, supplemented with post-market customer reported data."
8. Sample Size for the Training Set
Not applicable. There is no AI/ML component to this device, so no training set was used.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI/ML component to this device, so no training set or its ground truth was established.
§ 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).