(107 days)
The Sublime™ Microcatheter is intended to access the peripheral vasculature in order to facilitate the placement and/or the exchange of guidewires. The Sublime Microcatheter is also intended to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The Sublime Microcatheter is a sterile, single-use, disposable intravascular catheter with an atraumatic distal tip and a proximal hub with a luer fitting. The Sublime Microcatheter is a single lumen support catheter, compatible with 014", 018", and 035" guide wire platforms and a 4F guide catheter. It has a working length of up to 200 cm, and both straight and angled tip configurations. The catheter has a stainless-steel braid supported construction with hydrophilic coating. The distal end of the catheter includes a radiopaque markerband to facilitate visualization under fluoroscopy.
This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the Sublime™ Microcatheter. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Important Note: This document pertains to a medical device (Microcatheter), not an AI/software device. Therefore, many of the typical questions for AI/software such as "Number of experts used to establish ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Training set sample size," and "How ground truth for training set was established" are not applicable in this context. The acceptance criteria and studies are for a physical medical device's performance characteristics.
Acceptance Criteria and Reported Device Performance
The document states that "All test results met documented acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed, implying that specific criteria were defined and met internally by the manufacturer.
Table 1: Acceptance Criteria and Reported Device Performance (as inferred from the text)
| Performance Characteristic/Test | Acceptance Criteria (Not explicitly stated in document, but implied meeting criteria) | Reported Device Performance (Not explicitly quantified, but stated as "met documented acceptance criteria") |
|---|---|---|
| Flow Rate | Must meet intended flow rates for saline/contrast delivery | Met documented acceptance criteria |
| Dimensional Evaluations | Must conform to specified dimensions (e.g., ID, OD, length) | Met documented acceptance criteria |
| Radiopacity | Must be sufficiently visible under fluoroscopy | Met documented acceptance criteria |
| Tensile Strength | Must withstand specified tensile forces without failure | Met documented acceptance criteria |
| Freedom from Leakage | Must not leak under specified pressure/conditions | Met documented acceptance criteria |
| Hub/Luer connector compatibility | Must be compatible with standard luer fittings | Met documented acceptance criteria |
| Guidewire Movement | Must allow smooth guidewire placement and exchange | Met documented acceptance criteria |
| Burst Testing | Must withstand specified internal pressures without bursting | Met documented acceptance criteria |
| Flexibility and Kink Resistance | Must exhibit appropriate flexibility and resist kinking during insertion/maneuvering | Met documented acceptance criteria |
| Track Force | Must achieve specified trackability over a guidewire | Met documented acceptance criteria |
| Torque Strength | Must withstand specified torque forces without failure | Met documented acceptance criteria |
| Hydrophilic Coating | Must maintain lubricity and integrity as specified | Met documented acceptance criteria |
| Particulate Testing | Must demonstrate minimal particulate release | Met documented acceptance criteria |
| Atraumatic Surfaces | Must have smooth surfaces to prevent vessel damage | Met documented acceptance criteria |
| Simulated Use Testing | Must perform acceptably in simulated clinical scenarios | Met documented acceptance criteria |
| Biocompatibility | ||
| - Cytotoxicity | Non-cytotoxic | Met documented acceptance criteria |
| - Hemocompatibility | Hemocompatible | Met documented acceptance criteria |
| - Sensitization | Non-sensitizing | Met documented acceptance criteria |
| - Acute System Toxicity | Non-toxic acute system response | Met documented acceptance criteria |
| - Irritation/Reactivity | Non-irritating/non-reactive | Met documented acceptance criteria |
| - Pyrogenicity | Non-pyrogenic | Met documented acceptance criteria |
Study Details
As this is a physical medical device, the "study" primarily consists of design verification testing rather than clinical performance studies typically seen with diagnostic or AI devices. The goal is to demonstrate "substantial equivalence" to a predicate device based on performance characteristics.
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Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not specify the sample sizes used for each of the listed tests (e.g., number of catheters tested for flow rate, tensile strength, etc.).
- Data Provenance: This would typically be from laboratory bench testing and simulated use, conducted by the manufacturer (Surmodics Inc.). The country of origin is implied to be the USA, as the company is based in Eden Prairie, Minnesota, and submitting to the US FDA. The testing is prospective in nature, as it's part of the premarket notification process for a new device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable for this type of medical device clearance. "Ground truth" in this context refers to engineering specifications and performance standards established by the manufacturer and recognized industry standards (e.g., ISO standards for medical devices). The expertise would be in materials science, mechanical engineering, and quality control, rather than medical interpretation by radiologists.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable for engineering bench testing. Adjudication methods are typically for human interpretation of medical images or clinical outcomes. Deviations from expected test results would be handled through a non-conformance process and investigation by engineers and quality personnel.
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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:
- This is not applicable. This is a physical microcatheter, not an AI software. No human reader studies (MRMC) were conducted or required for this type of device clearance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or more appropriately, the reference standard) for these tests is based on defined engineering specifications, performance standards (e.g., ISO standards for catheters), and validation methods for each physical characteristic (e.g., a calibrated flow meter for flow rate, a universal testing machine for tensile strength, a pressure gauge for burst testing). Biocompatibility is assessed against established biological safety standards.
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The sample size for the training set:
- This is not applicable. This is a physical medical device, not a machine learning model that requires a training set.
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How the ground truth for the training set was established:
- This is not applicable for the same reason as above.
§ 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).