(206 days)
The IntraNovo 25 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 extremities, 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 25 Microcatheter (the "IntraNovo 25" 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 polytetraflouroethylene (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 25 Microcatheter. Depending on the model, one or two radiopaque marker bands are 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 2.7 French size on the distal end with an inner diameter of 0.025" throughout the shaft. The device is available in lengths of 110 cm, 130 cm, and 150 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 device is supplied sterile and is intended for single use.
The provided document is a 510(k) premarket notification for a medical device called the "IntraNovo 25 Microcatheter." It outlines the device's characteristics, intended use, and a comparison to a predicate device, along with a summary of testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a separate section for each test, but rather implies that individual tests passed based on internal test methods or referenced ISO/ASTM standards. The "Test Results" column for each test simply states "Pass."
Here's a table summarizing the tests and reported performance:
| Test # | Test Name | Applicable Standard or Internal Test Method | Reported Device Performance (Acceptance Criteria) |
|---|---|---|---|
| 1 | Guidewire & Guide Catheter Compatibility | Internal Test Method | T=0 Pass, T=2 Pass (Implies compatibility was demonstrated) |
| 2 | In-Vitro Track Force | Internal Test Method | T=0 Pass, T=2 Pass (Implies adequate track force) |
| 3 | Durability of Hydrophilic Coating | Internal Test Method | T=0 Pass, T=2 Pass (Implies coating remained durable) |
| 4 | Lubricity of Hydrophilic Coating | Internal Test Method | T=0 Pass, T=2 Pass (Implies coating retained lubricity) |
| 5 | Tip Shape Retention | Internal Test Method | T=0 Pass, T=2 Pass (Implies tip shape was retained) |
| 6 | Static Burst Pressure | ISO 10555 | T=0 Pass, T=2 Pass (Implies device withstood static burst pressure as per standard) |
| 7 | Dimensional & Physical Attributes | ISO 10555 | T=0 Pass, T=2 Pass (Implies dimensions and physical characteristics met standard) |
| 8 | Corrosion Resistance | ISO 10555 | T=0 Pass, T=2 Pass (Implies resistance to corrosion as per standard) |
| 9 | Dynamic Burst Pressure | Internal Test Method | T=0 Pass, T=2 Pass (Implies device withstood dynamic burst pressure) |
| 10 | Air Leak | Internal Test Method | T=0 Pass, T=2 Pass (Implies no air leakage) |
| 11 | Liquid Leakage | Internal Test Method | T=0 Pass, T=2 Pass (Implies no liquid leakage) |
| 12 | Tensile Strength | ISO 10555 | T=0 Pass, T=2 Pass (Implies adequate tensile strength as per standard) |
| 13 | Flow Rate | Internal Test Method | T=0 Pass, T=2 Pass (Implies satisfactory flow rate) |
| 14 | Kink Resistance | Internal Test Method | T=0 Pass, T=2 Pass (Implies good kink resistance) |
| 15 | Radiopacity | ASTM-F640-12 | T=0 Pass, T=2 Pass (Implies radiopacity met standard) |
| 16 | Torque to Failure | Internal Test Method | T=0 Pass, T=2 Pass (Implies adequate torque resistance) |
| 17 | Catheter Stiffness | Internal Test Method | T=0 Pass, T=2 Pass (Implies appropriate catheter stiffness) |
| 18 | Packaging Integrity | ASTM F-88-09, ASTM-1929-98 | T=0 Pass, T=2 Pass (Implies packaging integrity as per standards) |
| 19 | Therapeutic Agents | Internal Test Method | T=0 Pass, T=2 Pass (Implies compatibility with therapeutic agents) |
| 20 | Female Luer Hub Verification | ISO 594 | T=0 Pass, T=2 Pass (Implies luer hub met standard) |
| 21 | Shipping and Transportation Simulation | ISTA 3PA | T=0 Pass, T=2 Pass (Implies device integrity after shipping simulation) |
| 22 | Coating Integrity | Internal Test Method | T=0 Pass, T=2 Pass (Implies coating integrity maintained) |
| 23 | Torque Response | Internal Test Method | T=0 Pass, T=2 Pass (Implies satisfactory torque response) |
| 24 | Particulate Evaluation | USP | T=0 Pass, T=2 Pass (Implies particulate levels met USP standards) |
| Biocompatibility Tests (e.g., Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity, Hemolysis, Coagulation, Complement Activation, In vivo Thrombogenicity) | ISO 10993, ASTM, USP methods | Pass (Implies meeting biocompatibility requirements) | |
| Sterilization Process Validation (Ethylene Oxide Gas) | - | 10^-6 (Pass) (Implies sterilization achieved required SAL) |
Important Note: The document specifies that "The IntraNovo 25 Microcatheter met the predetermined acceptance criteria." However, it does not explicitly list these criteria for each test (e.g., "burst pressure must be > X psi"). The "Pass" indicates that these internal criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of devices) used for each bench test. It mentions that testing was performed on "non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2)," suggesting a comparison between fresh and aged devices. However, the number of devices in each group is not provided.
- Data Provenance: The data is generated from bench testing performed by Texas Medical Technologies, Inc. (the manufacturer). This is not human clinical data, so concepts like "country of origin of the data" and "retrospective or prospective" do not directly apply in the same way they would for clinical studies. It's pre-market, in-vitro/bench data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is bench testing of a physical device, not a diagnostic or prognostic algorithm that requires ground truth establishment by human experts reading medical images or clinical data. The "ground truth" for these tests is defined by the physical or chemical properties measured against a standard or an internal specification.
4. Adjudication Method for the Test Set
N/A. As this is bench testing, there is no adjudication by human experts in the sense of reviewing interpretations or diagnoses. The "adjudication" is inherent in whether the device's physical performance (e.g., burst pressure, flow rate, and biocompatibility) quantitatively meets the predetermined acceptance criteria for each test.
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
N/A. This document is for a microcatheter, a physical medical device, not an AI software algorithm or diagnostic tool that would typically undergo an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the IntraNovo 25 Microcatheter in this context is established by:
- Bench Test Specifications: Predetermined performance targets and limits derived from engineering specifications, industry best practices, and regulatory standards (ISO, ASTM, USP).
- Referenced Standards: Adherence to established international and national standards (e.g., ISO 10555 for catheters, ISO 10993 for biocompatibility, ASTM for materials, USP for particulates). The acceptance criteria for many of these tests are defined within these standards.
8. The Sample Size for the Training Set
N/A. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
N/A. This is a physical medical device, not a machine learning model, so there is no "training set" or ground truth establishment for such a 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).