(30 days)
The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.
The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO).
The Millipede 088 Access Catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "Millipede 088 Access Catheter." It is a submission for a new version of an existing device (K231802). The document focuses on demonstrating that the new subject device (K233648) is "substantially equivalent" to this predicate device. This means the primary goal is to show the new device is as safe and effective as the previously cleared one, not to prove its efficacy from scratch through a clinical trial.
Therefore, the requested information about device performance, particularly related to clinical acceptance criteria, expert ground truth, MRMC studies, standalone algorithm performance, and training/test sets, does not directly apply to this type of device submission. This document describes a physical medical device (catheter), not a software algorithm or an AI-powered diagnostic tool. The "performance testing" described refers to mechanical, material, and functional bench tests, not clinical performance metrics in the way one would evaluate an AI diagnostic tool.
The "acceptance criteria" for this device are met by demonstrating substantial equivalence to the predicate device through:
- Identical Indications for Use.
- Similar technological characteristics.
- Successful completion of non-clinical (bench) performance testing and biocompatibility testing.
Here's a breakdown of the closest applicable information from the provided text, while acknowledging that many of the original prompt's requests are not relevant to a physical catheter's 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are design specifications and regulatory standards for the physical and biological properties of the catheter. The "reported device performance" indicates whether the device met these specifications and standards.
| Test (Acceptance Criteria Category) | Test Method | Reported Device Performance (Conclusion) |
|---|---|---|
| Dimensional Inspection | The device dimensions were measured to confirm conformance to the specifications. | The device met established specifications. |
| Visual Inspection | Device surface characteristics were assessed to confirm freedom from defects that could affect clinical use. | The device surface characteristics are suitable for its intended use. |
| Simulated Use Testing | Deliverability and compatibility with accessory devices were evaluated in a neurovascular model. | The device performs as intended under simulated use conditions. |
| Hydrophilic Coating Integrity | The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles. | The hydrophilic coating integrity is suitable for its intended use. |
| Particulate Recovery | The purpose of this test was to quantify the particulate sizes and counts generated during simulated use of the test article. | The particulate generation was similar to control devices. |
| Kink Resistance | Test specimen segments were formed into a defined bend diameter to evaluate kink resistance. | The device met established specifications. |
| Tip Stiffness | The bending stiffness of the catheter tip was measured to confirm conformance to the specification derived from comparator devices. | The device met established specifications. |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | The device integrity is suitable for its intended use. |
| Liquid Leakage | Tested as per ISO 10555-1:2013 Annex C. | The device integrity is suitable for its intended use. |
| Static Burst | Tested as per ISO 10555-1 Annex F. | The device integrity is suitable for its intended use. |
| Catheter Joint Tensile Testing | The tensile strength was evaluated for the bonds between sections of the catheter. | The device met established specifications. |
| Torque Strength | The test specimens were rotated with the distal end constrained from movement to evaluate integrity after rotation. | The device met established specifications. |
| Flow Rate Characterization | The flow rate of saline and a contrast-saline solution was characterized when injected through the catheter. | The flow rate was characterized. (Implies it met acceptable ranges/expectations) |
| Biocompatibility | Cytotoxicity (ISO MEM Elution), Sensitization (ISO Guinea Pig Maximization), Irritation (ISO Intracutaneous Reactivity), Acute Systemic Toxicity (ISO Acute Systemic Injection), Material-Mediated Pyrogenicity, Hemocompatibility (Complement Activation, Partial Thromboplastin Time, ASTM Hemolysis, Thromboresistance) based on ISO 10993-1:2018. | All tests passed; suitable for intended use, non-cytotoxic, non-sensitizing, non-irritating, non-pyrogenic, non-hemolytic, similar thromboresistance to control. |
| Shelf Life | Functional and performance testing after 12-month accelerated aging according to ASTM F1980. | Device performance verified after 12-month accelerated aging. |
| Sterilization | Confirmatory EO residual testing. | EO residuals were within limits specified in ISO 10993-7. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each bench test (e.g., how many catheters were kink-tested or burst-tested). It refers to standard "test specimens" and "device dimensions."
Data Provenance: The testing was conducted by Perfuze Ltd., which is based in Ireland, suggesting the provenance of the bench test data is from their internal testing or accredited labs they contracted. The tests are "bench" tests, meaning they are performed in a lab setting, not on patient data.
Retrospective or Prospective: These are laboratory bench tests, so the concept of retrospective or prospective data collection doesn't apply as it would for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is irrelevant for a physical device's bench testing. Ground truth for these tests is established by objective physical measurements against engineering specifications (e.g., using calipers for dimensional inspection, pressure sensors for burst tests, standardized biological assays for biocompatibility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Bench tests follow predefined protocols and objective measurements.
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 for a physical medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical device, not an AI diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the bench tests is based on engineering specifications, industry standards (e.g., ISO, ASTM), and validated test methods. For biocompatibility, it's based on biological responses in standardized assays.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model that undergoes "training."
9. How the ground truth for the training set was established
Not applicable.
§ 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).