(248 days)
The Odyssey Micro Catheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guide wire for another. The Odyssey Micro Catheter is also intended to assist in the infusion of contrast media. The micro catheter is not intended to be used in the neurovasculature.
The Odyssey Micro Catheter is a single lumen catheter constructed using a PTFE liner inside of metallic coil and a polymer outer layer. The distal tip is a radiopaque polymer material and the distal 30 cm to 60 cm of the micro catheter has a hydrophilic coating. The key components of the catheter are the core, coil(s), tip, and coatings.
The provided text describes a 510(k) premarket notification for a medical device called the Odyssey Micro Catheter. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study in the typical sense of a novel AI/software medical device.
Therefore, the information requested for AI/software-centric studies (like sample sizes for test/training sets, data provenance, number/qualification of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this submission, as it concerns a physical medical device and its performance in in vitro bench tests.
However, I can extract the acceptance criteria (inferred from the tests performed) and summarize the study's findings:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list numerical acceptance criteria values for each test but states that the Odyssey Micro Catheter "met all predetermined acceptance criteria." The "reported device performance" is essentially that the device performed comparably or favorably to the predicate and met established standards.
| Acceptance Criteria (Inferred from Tests) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: | Met all predetermined acceptance criteria |
| - Cytotoxicity | Conducted in compliance with ISO10993-1:2009 and G95-1 |
| - Sensitization | |
| - Intracutaneous Reactivity | |
| - Acute Systemic Toxicity | |
| - Pyrogenicity Testing | |
| - Hemolysis | |
| - Complement Activation | |
| - In-Vivo Thrombogenicity | |
| - Chemical Characterization | |
| Particulate testing | Met all predetermined acceptance criteria |
| Corrosion resistance | Met all predetermined acceptance criteria |
| Dimensional inspection | Met all predetermined acceptance criteria |
| Sterile package integrity testing | Met all predetermined acceptance criteria |
| Tensile strength | Met all predetermined acceptance criteria |
| Torque strength | Met all predetermined acceptance criteria |
| Kink resistance | Met all predetermined acceptance criteria |
| Radiopacity | Met all predetermined acceptance criteria |
| Flow rate | Met all predetermined acceptance criteria |
| Burst pressure/freedom from leakage | Met all predetermined acceptance criteria |
| Equivalency to Predicate Device | Compared favorably with the predicate device (ASAHI Corsair Microcatheter - K151103) |
| Functional Specifications | Met |
| Shelf Life | Met |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a "test set" in the context of clinical data. The testing involved in vitro bench tests on the device itself. The number of units tested for each specific bench test is not detailed.
- Data Provenance: Not applicable in the context of human data. The "study" here refers to "Performance in vitro bench tests" conducted by the manufacturer, Heraeus Medical Components, LLC.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in this context, would refer to the validated methods and standards used for in vitro testing (e.g., ISO standards, internal validation of test equipment). This isn't about expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for human interpretation of data, typically in clinical studies or when establishing ground truth from expert readings. This was in vitro bench 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
- Not Applicable. This is a physical micro catheter, not an AI/software device that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device. "Standalone performance" in this context refers to the device's functional performance against engineering and safety specifications in vitro.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance "study" was established by validated international standards (ISO 10555-1:2013, ISO10993-1:2009) and FDA guidance (G95-1) for in vitro functional performance and biocompatibility. The specific outcomes were measurements of physical and biological properties.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set."
Summary of the Study:
The "study" described in the 510(k) summary involves a series of in vitro bench tests designed to demonstrate the safety and effectiveness of the Odyssey Micro Catheter by proving its substantial equivalence to a legally marketed predicate device (ASAHI Corsair Microcatheter, K151103).
The key aspects of the study include:
- Tests Conducted: Biocompatibility testing (cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, hemolysis, complement activation, in-vivo thrombogenicity, chemical characterization), particulate testing, corrosion resistance, dimensional inspection, sterile package integrity, tensile strength, torque strength, kink resistance, radiopacity, flow rate, and burst pressure/freedom from leakage.
- Standards Followed: ISO 10555-1:2013 (Intravascular catheters - sterile and single-use catheters - Part 1: General requirements) for functional testing, and ISO10993-1:2009 and G95-1 (FDA guidance) for biocompatibility testing.
- Outcome: The Odyssey Micro Catheter "met all predetermined acceptance criteria and compared favorably with the predicate device." The study supported claims of substantial equivalence based on indications for use, physical and technological characteristics, and comparative device testing, without raising new questions of safety and effectiveness.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).