(76 days)
The IntraNovo Microcatheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremittes, and all coronary vessels. The Microcatheter is also intended for drug infusion in intra-arterial therapy and infusion of embolic materials for hemostasis. The Microcatheter should not be used in cerebral vessels.
The IntraNovo Microcatheter (the "IntraNovo 21" or the "Microcatheter") is an infusion catheter intended for intravascular use. The Microcatheter consists of a single lumen. The shaft consists of a lubricous inner liner made from polytetrafluoroethylene (PTFE) with a stainless steel coil over the inner liner. The outer liner consists of different lengths of colored polyether block amide with varying durometers hardness. A lubricious hydrophilic coating covers the distal end of the IntraNovo Microcatheter. One radiopaque marker band is placed at the distal end of the Microcatheter and above the stainless steel coil. A polycarbonate hub is attached to the proximal end of the Microcatheter with a strain relief placed over the distal end of the hub. The device shaft has an outer diameter of 2.9 French size on the proximal end and 2.4 French size on the distal end with an inner diameter of 0.021" throughout the shaft. The device is available in lengths of 110 cm and 130 cm. The following accessories are included with the Microcatheter: a stainless steel steam shaping mandrel to allow for manual shaping of the distal tip and a 3.0 mL syringe.
The provided text describes a 510(k) premarket notification for the IntraNovo Microcatheter, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing. It does not contain information about clinical studies with human participants or a multi-reader, multi-case comparative effectiveness study. Therefore, several aspects of the requested information, such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC study details, and standalone algorithm performance, are not applicable or cannot be extracted from this document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the IntraNovo Microcatheter "met the predetermined acceptance criteria" for all tests. However, the specific quantitative acceptance criteria for each test are not provided in the table. Only the "Test Results (T=0) and (T=2)" which uniformly indicate "Pass" are given.
| Test # | Test Name | Applicable Standard or Internal Test Method | Acceptance Criteria (Not Explicitly Stated in Document, only "Pass" is reported for all) | Reported Device Performance (T=0 and T=2) |
|---|---|---|---|---|
| 1 | Guidewire & Guide Catheter Compatibility | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 2 | In-Vitro Track Force | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 3 | Durability of Hydrophilic Coating | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 4 | Lubricity of Hydrophilic Coating | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 5 | Tip Shape Retention | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 6 | Static Burst Pressure | ISO 10555 | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 7 | Dimensional & Physical Attributes | ISO 10555 | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 8 | Corrosion Resistance | ISO 10555 | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 9 | Dynamic Burst Pressure | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 10 | Air Leak | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 11 | Liquid Leakage | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 12 | Tensile Strength | ISO 10555 | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 13 | Flow Rate | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 14 | Kink Resistance | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 15 | Radiopacity | ASTM-F640-12 | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 16 | Torque to Failure | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 17 | Catheter Stiffness | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 18 | Packaging Integrity | ASTM F-88-09, ASTM-1929-98 | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 19 | Therapeutic Agents | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 20 | Female Luer Hub Verification | ISO 594 | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 21 | Shipping and Transportation Simulation | ISTA 3PA | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 22 | Coating Integrity | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 23 | Torque Response | Internal Test Method | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
| 24 | Particulate Evaluation | USP | Predetermined acceptance criteria (not detailed) | T=0 Pass, T=2 Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes bench testing of a physical device, not a study involving a test set of data. The "test sets" here refer to batches of manufactured devices used for physical and mechanical evaluations. The document does not specify the sample size for devices used in each bench test, nor does it refer to data provenance in terms of country of origin or retrospective/prospective nature, as these are concepts typically associated with clinical or imaging data sets. The testing was performed on "non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2)."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is not a study assessing diagnostic performance or requiring expert ground truth. The "ground truth" for these tests would be the measured physical and mechanical properties of the device against engineering specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As noted above, this is not a study requiring adjudication of interpretations.
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 document pertains to the 510(k) clearance of a physical medical device (microcatheter) and does not involve AI or human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to the 510(k) clearance of a physical medical device (microcatheter) and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the bench tests would be the established engineering specifications and performance requirements for the device, often derived from relevant ISO standards (e.g., ISO 10555) or internal test methods. These are objective measurements rather than subjective expert consensus or pathology.
8. The sample size for the training set
Not applicable. This document describes bench testing for device clearance, not the development or evaluation of an algorithm based on a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).