(56 days)
The Surmodics Microcatheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guidewire for another. This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.
Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.
The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculature. Additionally, the microcatheter can be used for contrast media injection.
The catheter is a single-lumen microcatheter with a 1.9 Fr distal outer diameter, a 2.6 Fr proximal outer diameter and is compatible with a 0.014" guidewire. The proximal end of the catheter shaft has a larger inner diameter, outer diameter and wall thickness and tapers to the catheter is available in lengths of 135 cm and 150 cm in length to facilitate access to various target sites.
The provided text describes a 510(k) premarket notification for a medical device called the "Surmodics Microcatheter." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting effectiveness studies akin to AI/ML device studies. Therefore, many of the requested elements for AI/ML device evaluations (such as human readers, ground truth establishment, training set details, or comparative effectiveness studies with AI assistance) are not applicable or not present in this document.
However, I can extract and structure the available information regarding acceptance criteria and testing:
Acceptance Criteria and Device Performance Study for Surmodics Microcatheter (K173560)
This submission establishes substantial equivalence to a predicate device (ASAHI Caravel, K152447) based on design, intended use, principles of use, materials, sizes, and sterility. The "acceptance criteria" here refer to the performance thresholds met during design verification and biocompatibility testing. The "study" refers to the conducted design verification tests and biocompatibility assessments.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness." Specific quantitative performance values or detailed acceptance criteria are not provided in this regulatory document. The table below lists the types of tests performed.
| Acceptance Criteria Category | Specific Tests Performed |
|---|---|
| Design Verification | - Visual inspections |
| - Dimensional evaluations | |
| - Radiopacity | |
| - Tensile strength | |
| - Freedom from liquid leakage | |
| - Hub/Luer connector compatibility | |
| - Simulated use | |
| - High pressure injection | |
| - Particulate | |
| - Flow Rate | |
| - Kink resistance | |
| - Tracking forces | |
| - Torque strength | |
| - Torque transmission | |
| - Hydrophilic coating testing | |
| - Freedom from air leakage | |
| - Push transmittance | |
| - 3 point bend | |
| - Coating Integrity | |
| - Package Performance Testing | |
| Biocompatibility (ISO 10993-1) | - Cytotoxicity |
| - Sensitization | |
| - Irritation/Intracutaneous Reactivity ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| - Systemic toxicity (acute) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| - Hemocompatibility ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| - Pyrogenicity | |
| Reported Performance | "All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness." This indicates successful performance against the established criteria for each test listed above. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). These details are typically contained in the full test reports referenced in such a submission, but not in the summary provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For a 510(k) submission for a non-AI/ML device, "ground truth" as typically understood in AI/ML performance evaluation (e.g., expert consensus on medical images) is not established. Device performance is assessed against engineering specifications, material properties, and regulatory standards.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/ML device and does not involve adjudication of expert interpretations for a test set.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed. This is a 510(k) submission for a microcatheter, not an AI/ML device, and thus does not involve human readers or AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done
Not applicable. This is not an AI/ML algorithm. The device performance testing is akin to "standalone" in the sense that the device's physical and functional characteristics are tested directly without human intervention in the device's core function.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by engineering specifications, material science standards, and regulatory requirements (e.g., ISO standards) for medical devices. For example, a "tensile strength" test has a defined pass/fail criterion based on mechanical properties required for the device's intended use. Similarly, biocompatibility tests are assessed against established biological response limits.
8. The Sample Size for the Training Set
Not applicable. This is a conventional medical device; there is no "training set" in the context of machine learning. The device design is based on engineering principles and iterative development, not data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).