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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.

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The Clari Vein IC is indicated for infusion of physician specified agents in the peripheral vasculature.

The ClariVein IC is a specialty infusion catheter with 360°rotatable fluid dispersion wire connected to a proximally located integral battery powered motor drive unit (MDU). The MDU includes the speed selector, handle grip and syringe support features which facilitate physician-controlled infusion of the selected agent. The ClariVein IC is introduced through a microintroducer. Utilizing vascular imaging, the coaxial catheter sheath with dispersion wire is navigated through the vasculature to the treatment site. Fluid delivered through the catheter assembly's infusion port, surrounds the dispersion wire and exits via an opening at the distal end of the catheter. The Clari Vein IC has no user serviceable parts or capital equipment. It is provided to the user sterile, for single patient use and is fully disposable.

The provided document is a 510(k) Premarket Notification for the ClariVein IC device. This type of FDA submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials.

The document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML-driven medical device, which would typically involve performance metrics like sensitivity, specificity, AUC, etc., on a clinical dataset. Instead, it describes non-clinical testing to demonstrate that the device functions as intended and is safe for its indicated use, relying heavily on its similarity to a predicate device.

Therefore, I cannot populate the requested table and answer the questions related to acceptance criteria, AI/ML performance, sample size, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the information provided for this specific device's 510(k) submission.

The document explicitly states:
"H. Clinical Testing: Not applicable."
"I. Animal Testing: Not applicable."

This signifies that the FDA's substantial equivalence determination for this device did not require human or animal clinical studies to demonstrate its performance against specific clinical acceptance criteria in the way you've outlined for an AI/ML device.

The "Performance Data" section (G) focuses on:

• Compliance with Industry Standards: (ISO, ISTA, IEC) related to the physical characteristics, safety, and manufacturing processes of medical devices.
• Biocompatibility Testing: To ensure the materials used in the device are safe for contact with human tissue.
• Nonclinical Performance Testing: Mechanical and functional tests (e.g., tensile strength, leak tests, wire rotation speed, torque force, simulated use) to verify the device's physical integrity and functional parameters.

Summary of Device Performance (based on provided text, not an AI/ML context):

Reasons why the other requested information cannot be provided from this document:

• Sample sized used for the test set and data provenance: No clinical test set. The non-clinical tests typically involve a sample of devices tested under laboratory conditions, but specific sample sizes for these engineering tests are not detailed here. Data provenance (country, retrospective/prospective) is not relevant for non-clinical lab tests.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no clinical test set requiring expert ground truth for diagnostic or prognostic performance.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable (no clinical test set).
• 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 (not an AI/ML device; no MRMC study).
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI/ML device).
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable (no clinical ground truth established for performance metrics). The "ground truth" for the non-clinical tests would be the pre-defined engineering specifications and standards.
• The sample size for the training set: Not applicable (not an AI/ML device).
• How the ground truth for the training set was established: Not applicable (not an AI/ML device).

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