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510(k) Data Aggregation
(276 days)
The Fountain ValveTip Infusion System is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
The Fountain ValveTip Infusion Catheter is intended to administer infusions of various therapeutic solutions into peripheral vasculature of a patient. The Fountain ValveTip Infusion Catheter has infusion holes at the distal end. These infusion holes allow for passage of thrombolytic fluid. The infusion segment of the catheter is indicated by two radiopaque marker bands. These marker bands can provide the user the means for positioning the infusion length at a desired location with the blood vessel.
The Fountain ValveTip Infusion Catheter uses a valve at the distal tip to seal the catheter to facilitate flow through the catheter and spray distribution through the infusion holes. The valve allows the catheter to track over a 0.035" guide wire to facilitate placement of the catheter. The Fountain ValveTip Catheter is available in 4 and 5 French including usable lengths from 45 cm to 135 cm and infusion segments length from 5cm to 50 cm. The usable length and Infusion lengths are the same as the predicate device configuration and will have same functional infusing characteristics.
This device is provided with the following Merit device which is already marketed in the US (Class II Exempt):
• AccessPLUS™ Hemostasis Valve
Here's an analysis of the provided text regarding the acceptance criteria and study for the Fountain ValveTip Infusion Catheter, structured according to your request.
Important Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a clinical trial or AI model validation. As such, some of the information you requested (especially regarding AI model performance, human reader studies, and detailed ground truth adjudication for an AI device) is not present in this type of document because the device described is a physical medical catheter, not an AI/software as a medical device (SaMD).
Therefore, many sections of your request will be answered with "Not Applicable (N/A)" or "Not specified in the provided document" because the context is a physical device, not an AI system.
Device: Fountain ValveTip Infusion Catheter
1. A table of acceptance criteria and the reported device performance
For a physical medical device like a catheter, "acceptance criteria" and "performance" are typically related to engineering specifications and conformity to standards rather than AI model metrics. The document references various ISO and ASTM standards and internal bench testing.
| Criterion Type / Test | Acceptance Criteria (Implicitly Met by Standards Compliance) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Conforms to ISO 10993 series and FDA guidance | Battery of tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemolysis, Thrombogenicity, Complement Activation, Subacute/Subchronic Toxicity, Implantation) met the requirements. |
| Material Properties | Conformity to relevant standards (e.g., sterilization residuals, radiopacity) | Not explicitly detailed for each, but overall compliance with standards (e.g., ISO 11135-1, ISO 10993-7, ASTM F640-12) indicated. |
| Physical/Mechanical (Bench Tests) | Implicitly met by standards (e.g., ISO 10555-1, ISO 10555-3, ISO 594 series) and internal design specifications. "The subject Fountain ValveTip Infusion Catheter met the predetermined acceptance criteria." | French size, Usable length, Surface, Compatible Guide Wire, Valve not damaging guide wire, Guide wire not damaging valve, Valve penetration and drag force, Valve leak test, Kink test, Radio-detectability, Tensile force (tip attachment), ISO-594-2 tests (Gauge, Liquid leakage, Air leakage, Separation force, Unscrewing Torque, Ease of assembly, Resisting overriding, Stress Cracking), Simulated use testing (Penetration force, Drag force, Trackability, Tip stiffness, Leakage out of tip). |
| All specified tests demonstrated that the device met the predetermined acceptance criteria. |
2. Sample sized used for the test set and the data provenance
For a physical device, "test set" refers to the physical samples tested.
- Sample Size: Not specified quantitatively for each test in the provided summary. It states "Performance testing... was conducted." Typically, engineering tests involve a sufficient number of units to demonstrate statistical confidence or meet regulatory batch release requirements, but exact numbers are not detailed here.
- Data Provenance: N/A for data provenance in the context of a dataset for an AI model. For a physical device, the "data" comes from bench tests and biocompatibility studies performed on manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical medical device (catheter), not an AI/SaMD. "Ground truth" for a physical device is established through validated laboratory tests, engineering measurements, and standardized biological assessments, not expert consensus on images or diagnostic outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Not applicable to physical 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
N/A. This device is not an AI/SaMD. No MRMC study was performed or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is a catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical medical device, "ground truth" for performance is defined by:
- Established ASTM/ISO standards: Compliance with predefined physical, mechanical, chemical, and biological properties.
- Engineering specifications: The device's design parameters (e.g., French size, usable length, valve performance) must meet internal specifications.
- Biocompatibility testing against a predicate device or historical data: Bio-reactions are assessed against known safe limits or compared to predicate device performance.
8. The sample size for the training set
N/A. There is no "training set" in the context of a physical medical device that isn't incorporating machine learning.
9. How the ground truth for the training set was established
N/A. Not applicable as there is no training set for this device.
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