(122 days)
The InnerChange™ micro-introducer catheter is intended for use in accessing the vascular system through a small gauge needle stick and for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
The InnerChange Micro-Introducer Catheter combines the function of a micro introducer and angiographic catheter. Each InnerChange Micro-Introducer Catheter consists of the following components: Stainless Steel percutaneous entry needle, Nitinol Guidewire with Stainless Steel tip, dilator, and catheter with selected tip shape and high pressure stopcock. The dilator functions to straighten the catheter tip during vascular access. When the dilator is removed, the catheter tip returns to the preformed configuration. The Inner-Change Micro-Introducer Catheter will be available in 4F and 5F sizes with various tip curve configurations and lengths ranging from 45 to 125cm.
This 510(k) summary describes a medical device called the InnerChange™ Micro-Introducer Catheter. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing, as no clinical evaluations were conducted. Therefore, the device meets acceptance criteria primarily through engineering and laboratory performance.
Here's an analysis of the provided information based on your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test Description | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Catheter Curve Retention | Met specified design and performance requirements. |
| Catheter - Dilator Passage | Met specified design and performance requirements. | |
| Taper & Length | Met specified design and performance requirements. | |
| Catheter Tortuosity | Met specified design and performance requirements. | |
| Bond Strength: Catheter, Dilator, and Guidewire | Met specified design and performance requirements. | |
| Functional Testing | Catheter Air Leakage into Hub Assembly during Aspiration | Met specified design and performance requirements. |
| Catheter Dynamic Fluid Testing | Met specified design and performance requirements. | |
| Catheter Static Pressure Testing | Met specified design and performance requirements. | |
| Catheter Flow Rate | Met specified design and performance requirements. | |
| Shelf Life Testing | Not explicitly detailed, but implied as part of "Device Verification Testing" | Met specified design and performance requirements. |
| Packaging Testing | Not explicitly detailed, but implied as part of "Device Verification Testing" | Met specified design and performance requirements. |
| Biocompatibility | ISO 10993 "Biological Evaluation of Medical Devices" | Material demonstrated to be biocompatible. |
| Intended Use Equivalence | Intended use similar to predicate devices | Stated as similar in intended use and function to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., number of catheters tested for curve retention). The testing is generally referred to as "Device Verification Testing."
The data provenance is retrospective, as it refers to testing performed on the device before seeking 510(k) clearance, for the purpose of demonstrating substantial equivalence. The document does not specify the country of origin of the data, but it can be inferred that the testing was conducted by or for Vascular Solutions, Inc. in Minneapolis, MN, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device's acceptance criteria were met through non-clinical, engineering, and laboratory testing rather than clinical studies requiring expert ground truth for interpretation of human data.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring human adjudication. The "ground truth" for non-clinical tests is established by objective measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device, not an AI-powered diagnostic tool, and no MRMC study was conducted. No clinical studies were conducted at all.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. Device performance was evaluated in isolation through engineering tests.
7. The type of ground truth used
The "ground truth" for this device's acceptance was:
- Predefined Design Specifications and Performance Requirements: This refers to the engineering and functional parameters the device was designed to meet.
- Industry Standards: Specifically, ISO 10993 for biocompatibility.
- Comparison to Predicate Devices: Performance was evaluated in the context of demonstrating equivalency to existing, legally marketed devices.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this device's non-clinical evaluation. This is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there was no training set.
§ 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).