(91 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, coil-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) Summary for a medical device called the Millipede 088 Access Catheter. It's a submission to the FDA for market clearance, asserting that the "subject device" (new version) is substantially equivalent to a "predicate device" (previously cleared version).
Here's the breakdown of acceptance criteria and the study proving the device meets them, based on the provided text:
Important Note: This document describes a medical device, not an AI/Software as a Medical Device (SaMD). Therefore, questions related to AI-specific metrics like human reader improvement with AI assistance, training sets, and expert qualifications for ground truth establishment for AI models are not applicable in this context. The "acceptance criteria" here refer to engineering and performance specifications for the physical catheter and its accessories.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a direct "acceptance criteria" column with specific numerical targets. Instead, it lists various performance tests and then states whether the device "met established specifications" or if the characteristics are "suitable for its intended use." I will infer the acceptance criteria from these conclusions.
| Test / Attribute | Acceptance Criteria (Inferred from Conclusion) | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| Dimensional Inspection | Conformance to specifications. | The device met established specifications. |
| Visual Inspection | Freedom from defects; surface characteristics suitable for intended use. | The device surface characteristics are suitable for its intended use. |
| Simulated Use Testing | Deliverability and compatibility with accessory devices in a neurovascular model. | The device performs as intended under simulated use conditions. |
| Hydrophilic Coating Integrity | Coating integrity suitable for intended use after multiple cycles. | The hydrophilic coating integrity is suitable for its intended use. |
| Particulate Recovery | Particulate size and count similar to control devices. | The particulate size and count was similar to control devices. |
| Kink Resistance | Met established specifications when formed into a defined bend diameter. | The device met established specifications. |
| Air Leakage | Device integrity suitable for intended use (per ISO 10555-1:2013 Annex D). | The device integrity is suitable for its intended use. |
| Liquid Leakage | Device integrity suitable for intended use (per ISO 10555-1:2013 Annex C). | The device integrity is suitable for its intended use. |
| Static Burst | Device integrity suitable for intended use (per ISO 10555-1 Annex F). | The device integrity is suitable for its intended use. |
| Catheter Joint Tensile Testing | Tensile strength of bonds between catheter sections met specifications. | The device met established specifications. |
| Torque Strength | Integrity maintained after rotation in a simulated use model. | The device met established specifications. |
| Flow Rate Characterization | Flow rate characterized for saline and contrast-saline solution. | The flow rate was characterized. |
| Biocompatibility | ||
| Cytotoxicity (ISO MEM Elution) | Non-cytotoxic. | The test article is non-cytotoxic. |
| Sensitization (ISO Guinea Pig Maximization) | No sensitization response. | The test article did not elicit a sensitization response. |
| Irritation (ISO Intracutaneous Reactivity) | Requirements of ISO intracutaneous reactivity test met. | Requirements of the ISO intracutaneous reactivity test were met for the test article. |
| Acute Systemic Toxicity (ISO Acute Systemic Injection) | Requirements of ISO acute systemic injection test met. | Requirements of the ISO acute systemic injection test were met for the test article. |
| Material-Medicated Pyrogenicity | Non-pyrogenic. | The test article is non-pyrogenic. |
| Hemocompatibility (ASTM Hemolysis) | Non-hemolytic. | The test article is considered non-hemolytic. |
| Sterilization | ||
| EO Residual Testing | EO residuals within limits specified in ISO 10993-7. | Confirmed that EO residuals were within the limits specified in ISO 10993-7. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for each test in the "Performance Testing (Bench)" section. For bench tests, it typically involves a certain number of devices tested to ensure reproducibility and statistical significance. However, this specific summary does not offer those details. The testing is bench-top testing, meaning it's performed in a laboratory setting, not on patient data. There is no 'data provenance' in terms of country of origin or retrospective/prospective for this type of physical device testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable. This is a physical medical device. "Ground truth" in the context of expert review is for evaluating the performance of diagnostic algorithms or imaging interpretations, which is not what this document is about. The "ground truth" for the device's performance is established by standardized engineering measurements and tests.
4. Adjudication Method for the Test Set
This question is not applicable. As stated above, this is about physical device performance, not interpretive tasks requiring expert adjudication.
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
This question is not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an algorithm or software device.
7. The type of ground truth used
For the performance testing, the "ground truth" is derived from established engineering specifications, industry standards (e.g., ISO, ASTM), and simulated use conditions designed to mimic real-world scenarios. For biocompatibility, the ground truth is defined by the Pass/Fail criteria outlined in the relevant ISO 10993 standards.
8. The sample size for the training set
This question is not applicable. 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
This question is not applicable, as there is no training set for this type of 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).