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510(k) Data Aggregation
(267 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.
The provided document is a 510(k) summary for the Millipede 088 Access Catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a standalone clinical study to prove the device meets those criteria.
Therefore, the document does not contain the information requested in points 2, 3, 4, 5, 8, and 9, and only partially addresses points 1, 6, and 7.
Here's a breakdown of what can be extracted:
1. Acceptance Criteria and Reported Device Performance
The document lists various performance tests and their conclusions, indicating that the device met "established specifications" or was "suitable for its intended use." However, the specific quantitative acceptance criteria for each test are not provided. The reported device performance is qualitative rather than quantitative in most cases.
| Test | Test Method | Reported Device Performance (Conclusions) |
|---|---|---|
| Dimensional Inspection | Device dimensions were measured to confirm conformance to the specifications. | The device met established specifications. |
| Tip Stiffness | Test specimens were tested for tip flexibility and compared to predicate and reference devices. | The device met established specifications. |
| Visual Inspection | Device surface characteristics were assessed to confirm freedom from defects. | 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 | Quantify the particulate size and count generated by simulated use of the test article. | The particulate size and count were similar to control devices. |
| Tensile Strength | The tensile strength was evaluated for the bonds between sections of the catheter. | 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 per ISO 10555-1:2013 Annex C. | The device integrity is suitable for its intended use. |
| Static Burst | Tested per ISO 10555-1:2013 Annex F. | The device integrity is suitable for its intended use. |
| Luer Integrity | The luers were evaluated for compliance to relevant standards. | The luers on the device are suitable for their intended use. |
| Kink Resistance | Test specimen segments were formed into a defined bend diameter to evaluate kink resistance. | The device met established specifications. |
| Torque Strength | The test specimens were rotated in a simulated use model 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. |
| Radiopacity | Radiopacity of the device was evaluated in an animal model under fluoroscopy. | The radiopacity of the Millipede 088 Access Catheter was similar to a control device. |
| Biocompatibility (various tests) | ISO 10993-1, 10993-4 (Hemocompatibility), 10993-5 (Cytotoxicity), 10993-10 (Irritation, Sensitization), 10993-11 (Systemic Toxicity, Pyrogenicity) | Non-cytotoxic, no sensitization response, met intracutaneous reactivity, met acute systemic injection, non-pyrogenic, not a complement activator, not an intrinsic coagulation pathway activator, non-hemolytic, similar thromboresistance to controls. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the individual performance tests beyond implicitly suggesting multiple samples were tested (e.g., "test specimens," "test articles"). For the Animal Testing, it states "two studies in a porcine model."
The data provenance for the in vitro and animal studies isn't explicitly stated beyond "Good Laboratory Practices" for the animal studies, which is a standard of conduct rather than a geographic origin. No human data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as the submission relies on objective performance testing, biocompatibility studies, and animal studies rather than expert-derived ground truth from human data for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The evaluation methods described are objective performance tests and animal studies, not human data 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
Not applicable. This device is an access catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance testing described (mechanical, dimensional, coating integrity, etc.) and the animal studies represent "standalone" evaluations of the device's physical and functional properties without human interpretation of data in a clinical context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance and biocompatibility tests, the "ground truth" is defined by the established specifications, relevant ISO standards, and comparison to control devices or predicate devices. For example:
- "The device met established specifications."
- "The test article is non-cytotoxic."
- "The particulate size and count were similar to control devices."
- "The radiopacity of the Millipede 088 Access Catheter was similar to a control device."
- For animal testing, "Usability, radiopacity, thromboresistance, and vessel injury were assessed," and "The results for the subject device were comparable to a control device."
8. The sample size for the training set
Not applicable. This device is a medical catheter and does not involve a "training set" in the context of machine learning or AI. Its performance is evaluated through engineering and biological testing.
9. How the ground truth for the training set was established
Not applicable (as above).
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