(402 days)
The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region.
The device also has the ability to deliver physician specified fluids out the distal tip with or without inflation of the balloons.
The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region. The exterior surface of the distal 120cm catheter length is treated with a hydrophilic coating.
The 2.4F IsoFlow™ Infusion Catheter System is intended to be used with guide catheters 4F (0.050") and larger, along with a 0.010" guide wire for positioning the catheter in the desired region. A standard Y-adaptor RHV provides for guide wire entry and saline flush into the main guide wire / bypass lumen of the catheter. Radiopaque markers at the distal tip and between the two balloons allow for final position adjustment under fluoroscopy guidance.
The two compliant balloons are inflated simultaneously using radiopaque fluid delivered via a single inflation lumen.
Physician specified infusion fluid through either the labeled infusion lumen or the labeled guidewire lumen is delivered via the 1-way stopcock connection. The mixture of infusion and radiopaque agents is delivered directly to the target region between the balloons, or out the distal tip respectively.
For infusion out of the sideport holes, retracting the guide wire to the radiopaque marker band proximal to both balloons allows blood to bypass the isolated tarqet region via holes connecting the guide wire / bypass lumen with the catheter exterior. Complete removal of the guidewire allows delivery from the distal tip.
All components of the catheter system are provided sterile. Each device is intended for single use. Do not reuse or attempt to resterilize any component of the system.
The provided text does not contain detailed information about acceptance criteria, device performance,
or a study comparing the device against specific criteria in the way typically found for AI/ML-based
medical devices. The document is a 510(k) summary for a physical medical device—the IsoFlow™
Infusion Catheter—seeking substantial equivalence to predicate devices.
Therefore, many of the requested categories (such as sample size for test set, number of experts,
adjudication method, MRMC study, standalone performance, training set details) are not applicable
to this type of submission and are not present in the provided text.
However, I can extract the information that is present concerning the device's characteristics and its
comparison to predicate devices, which forms the basis for its acceptance (i.e., substantial
equivalence) by the FDA.
Here's a summary based on the provided text, addressing the applicable points:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like the IsoFlow™ Infusion Catheter, "acceptance criteria" are
typically demonstrated through substantial equivalence to legally marketed predicate devices, along
with adherence to performance standards and safety testing (which are summarized, but not detailed
in a quantitative study in this specific 510(k) summary). The performance is shown by demonstrating
that the device's characteristics are "Substantially Equivalent" to the predicates.
| Category | Acceptance Criteria (Demonstrated by Substantial Equivalence to Predicate Devices) | Reported Device Performance (IsoFlow™ Infusion Catheter) |
|---|---|---|
| Intended Use | Substantially Equivalent to predicate devices (K932616, K913517) | Substantially Equivalent |
| Physical Description | Substantially Equivalent to predicate devices (K932616, K913517) | Substantially Equivalent |
| Anatomical Sites | Substantially Equivalent to predicate devices (K932616, K913517) | Substantially Equivalent |
| Design | Substantially Equivalent to predicate devices (K932616, K913517) | Substantially Equivalent |
| Materials | Substantially Equivalent to predicate devices (K932616, K913517) | Substantially Equivalent |
| Primary Indication | Isolate a specific treatment region from blood flow while allowing infusion/perfusion. | Functionally meets this indication as stated. |
| Secondary Indication | Deliver physician specified fluids out the distal tip with or without inflation. | Functionally meets this indication as stated. |
2. Sample size used for the test set and the data provenance
Not applicable. The document describes a 510(k) submission for a physical medical device (infusion
catheter), not an AI/ML device relying on a test set of data. The "study" here is the comparison of
the device's characteristics to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of
those experts
Not applicable. This information is typically relevant for AI/ML device evaluations. For this traditional
medical device, "ground truth" mainly refers to the functional and material specifications meeting
established medical device standards and being comparable to legally marketed devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not relevant for the type of device and submission described.
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
Not applicable. This type of study is for AI/ML-assisted diagnostic or therapeutic devices, not for
a physical infusion catheter.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is for AI/ML devices. The IsoFlow™ Infusion Catheter is a physical device
used by a physician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of an AI/ML device. For this physical catheter, the "ground truth" for
its acceptance is established through:
- Engineering design specifications and material science: Ensuring the catheter is constructed
from biocompatible materials and designed to safely perform its intended functions. - Comparison to predicate devices: Demonstration of substantial equivalence in intended use,
technological characteristics (physical description, anatomical sites, design, materials), and
performance. This implies that the predicate devices themselves have a history of safe and
effective use. - Performance testing: While not detailed in this summary, a 510(k) submission typically
includes bench testing (e.g., burst pressure, tensile strength, flow rates, balloon integrity),
biocompatibility testing, and sterilization validation to ensure safety and performance.
8. The sample size for the training set
Not applicable. There is no AI/ML model to train for this device.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model to train for this device.
§ 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).