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510(k) Data Aggregation
(88 days)
The APRO 70 Swift Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 70 Swift Catheter is also indicated for use as a conduit for retrieval devices.
The APRO 70 Swift Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Swift Catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 70 Swift Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The APRO 70 Swift Catheter is provided with an Introducer Sheath.
This document is a 510(k) Premarket Notification from the FDA regarding the APRO 70 Swift Catheter. It focuses on demonstrating the device's substantial equivalence to a predicate device, primarily through non-clinical performance data.
Here's a breakdown of the information requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| Visual and Dimensional Characteristics | Catheter meets the visual and dimensional specifications. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Particulate | Catheter meets the acceptance criteria. Subject device was evaluated with a predicate device under the same test conditions. | The APRO 70 Swift Catheter particulates were comparable to the predicate device. |
| Kink Resistance | Catheter shaft shall not kink at clinically relevant radii. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Hub Air Leakage | Catheter does not leak air into hub assembly with methods specified in ISO 10555-1, Annex D. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Hub Compatibility | Catheter meets the requirements specified in ISO 80369-7. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Torque Strength | Catheter must withstand the minimum required number of rotations without breakage and without kinking compared to legally marketed devices. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Dynamic Burst Pressure | No damage to catheter with dynamic pressure. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Liquid Leakage | Catheter must withstand pressure with methods specified in ISO 10555-1, Annex C. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Static Burst | Catheter must withstand pressures anticipated for clinical use. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Hub and Shaft Tensile Strength | Catheter hub and shaft must meet tensile strength specification. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Tip Tensile Strength | Catheter tip must meet tip tensile strength specification. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Tip Buckling Force | Catheter tip buckling force must be acceptable. Forces were compared to a predicate. | The APRO 70 Swift Catheter was comparable to the predicate device. |
| Delivery and Retrieval Force | Catheter delivery and retrieval force must be acceptable. Forces were compared to a predicate. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Simulated Use | When used per the Instructions for Use with accessory devices in an anatomical neurovascular model and during simulated clot retrieval, the Catheter must meet functionality specifications including compatibility with a stent retriever. | The APRO 70 Swift Catheter met the acceptance criteria. |
| Sterilization (Ethylene Oxide) | Sterility assurance level of 1 x 10^-6 in accordance with ISO 11135. | Verified to a sterility assurance level of 1 x 10^-6. |
| Shelf-Life (Aging Studies) | Subject device and packaging remain functional for the labeled expiration date; packaging integrity, seal strength, and device functionality meet acceptance criteria. | Met the acceptance criteria. |
| Sensitization (Guinea Pig Maximization) | Not elicit a sensitization response. | Non-sensitizing. |
| Irritation/Intracutaneous Reactivity | No evidence of irritation. | Non-irritant. |
| Cytotoxicity (MEM Elution, L929 cells) | Not elicit a cytotoxic response at 24 hours and 48 hours. | Non-cytotoxic. |
| Hemolysis - Indirect | No significant differences between the test article extract and negative control. | Non-hemolytic. |
| Hemolysis - Direct | No differences between the hemolytic index of the test article and the negative control. | Non-hemolytic. |
| Thrombogenicity - Partial Thromboplastin Time (PTT) | Acceptable clotting times (average clotting time of test article greater than vehicle control and negative control). | Acceptable clotting times. |
| Thrombogenicity - Platelet Leukocyte Count | Performed similar to comparator and negative controls. | Non-thrombogenic. |
| Thrombogenicity - Comparative Surface and Geometry Assessment | No differences in roughness or presence of any defects compared to reference device. Same geometry as reference device. | Acceptable results. |
| SC5b9 Complement Activation | Sc5b9 concentration statistically less than positive control and not statistically higher than negative control. | Acceptable. |
| Acute Systemic Toxicity | No weight loss, mortality, or evidence of systemic toxicity. | Non-toxic. |
| Material-Mediated Pyrogenicity | Total rise in temperature of < 0.5 °C for all individual rabbits. | Non-pyrogenic. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document extensively details non-clinical bench testing, sterility testing, shelf-life testing, and biocompatibility testing. It does not specify sample sizes for each individual test or the data provenance in terms of country of origin or retrospective/prospective data collection. The general statement "Alembic performed non-clinical bench, sterility, shelf-life, and biocompatibility testing" implies these tests were conducted by the manufacturer for this submission. Given that these are bench and lab tests for a medical device, they would be considered prospective in nature, as they are experiments conducted specifically to evaluate the device. The location of these tests (country of origin of the data) is not specified.
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 is not applicable as the entire study described is based on non-clinical bench, sterility, shelf-life, and biocompatibility testing. There is no "ground truth" derived from expert review of clinical data (like medical images) as there are no human studies or AI components described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this study is based on non-clinical testing, not human expert evaluations of a test set, so no adjudication method for establishing ground truth is relevant.
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
No. This is a 510(k) submission for a physical medical device (catheter), not an AI/Software as a Medical Device (SaMD). Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI/SaMD device, so no standalone algorithm performance testing was conducted.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance evaluation is established through:
- Predefined engineering specifications and standards: For bench tests like dimensions, tensile strength, burst pressure, kink resistance, etc.
- Industry consensus standards (e.g., ISO): For tests like hub air leakage (ISO 10555-1), hub compatibility (ISO 80369-7), sterilization (ISO 11135), and biocompatibility (ISO 10993-1).
- Comparative data to a predicate device: For certain performance aspects like particulate levels, tip buckling force, and delivery/retrieval force, where the device must be "comparable."
There is no "expert consensus," "pathology," or "outcomes data" as ground truth because this is a physical device submission without clinical data.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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