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510(k) Data Aggregation
(330 days)
Esperance Distal Access Catheter
The Esperance Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
The Esperance® Distal Access Catheter is a single-use, single lumen, variable stiffness, composite catheter. The device includes 5F and 6F catheters with inner diameters of 0.055" and 0.071", respectively, designed with three different working lengths for both sizes: 115 cm, and 131 cm. The device is supplied with a peelable introducer and shaping mandrel. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.
The Esperance® Distal Access Catheter is a non-active, surgically invasive device intended for short term use within the vasculature.
The provided document is a 510(k) Substantial Equivalence Determination letter from the FDA for a medical device called the "Esperance Distal Access Catheter." It details non-clinical performance testing but does not include information about a study proving device performance against acceptance criteria in the context of an AI/ML-driven device or human-in-the-loop performance.
Specifically, the document states:
- "Animal data were not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical bench testing."
- "A clinical study was not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical bench testing."
Therefore, I cannot extract the requested information points related to a study proving the device meets acceptance criteria for an AI/ML device, as such a study was not performed or detailed in this submission. The tests listed are primarily engineering bench tests for a physical catheter, not AI model validation.
However, I can extract the acceptance criteria for the physical device's performance from the "NON-CLINICAL PERFORMANCE DATA" section.
Here's what I can provide based on the document:
1. A table of acceptance criteria and the reported device performance (for non-clinical bench tests):
| Test | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| Visual Inspection* | Requirements were met. | The device met all pre-defined acceptance criteria. |
| Dimensional Inspection* (ID, OD, Overall Length, Working Length, Coating Length, Distal Tip to Marker Band, Hub/Strain Relief Length) | Requirements were met. | The device met all pre-defined acceptance criteria. |
| Simulated Use | Performs as intended, meets pre-defined acceptance criteria for: preparation/ease of assembly, introducer sheath interaction, introducer peel away, compatibility with guidewire/microcatheter, lubricity and durability of hydrophilic coating, and kink resistance. | Device performs as intended and met all pre-defined acceptance criteria under simulated use conditions. (Supplemented by additional testing beyond reference device, K211697) |
| Physician Validation* | Performs as intended under simulated use conditions. | Device performs as intended under simulated use conditions. |
| Delivery and Retrieval Forces | Meets pre-defined acceptance criteria in a vascular model under simulated use conditions. | Met all pre-defined acceptance criteria. (Supplemented by additional testing beyond reference device, K211697) |
| Tip Stiffness* | Meets acceptance criteria when deflected on a universal testing machine. | Met acceptance criteria. |
| Tip Shaping* | Meets pre-defined acceptance criteria when shaped with shaping mandrel and steam. | Met the pre-defined acceptance criteria. |
| System Tensile* (Hub, Shaft, Tip) | Meets the minimum tensile requirement. | The device met all predefined acceptance criteria. |
| Elongation to Failure* | Met all pre-defined acceptance criteria, obtained from shaft tensile testing data. | The device met all pre-defined acceptance criteria. |
| Torque Strength* | Meets the predefined acceptance criteria in a vascular model. | Met the predefined acceptance criteria. |
| Coating Integrity (after particulate testing) | Meets all pre-defined acceptance criteria (inspected pre- and post-insertion and retrieval through a vascular model). | The device coating integrity was inspected pre- and post-insertion and retrieval through a vascular model and met all pre-defined acceptance criteria. (Supplemented by additional testing beyond reference device, K211697) |
| Coating Lubricity* | Meets all pre-defined acceptance criteria from frictional forces on a universal testing machine. | Met all pre-defined acceptance criteria. |
| Catheter Burst, Leak (Liquid and Air) | Does not leak, burst, and is compatible with accessories per ISO 10555-1 and meets acceptance criteria. | Met acceptance criteria. (Supplemented by additional testing beyond reference device, K211697) |
| Kink Resistance* | Meets acceptance criteria for resistance to kinking around bends with clinically relevant radii. | Met acceptance criteria. |
| Particulate | Any particulate generated is comparable to cleared comparator devices and meets acceptance criteria. | The device met acceptance criteria. (Supplemented by additional testing beyond reference device, K211697) |
| Corrosion Resistance* | Is corrosion resistant per ISO 10555-1. | The catheter is corrosion resistant per ISO 10555-1. |
| Radiopacity* | Meets the pre-defined acceptance criteria for marker band visibility under fluoroscopy. | Met the pre-defined acceptance criteria. |
| Luer Hub Testing* | Meets the pre-defined specifications per ISO 80369-7 and ISO 80369-20. | Met the pre-defined specifications. |
For the remaining points, the document explicitly states that clinical or animal studies were not deemed necessary beyond the non-clinical bench testing for this specific device (a physical catheter). Therefore, the following information cannot be provided from the given text:
- Sample sized used for the test set and the data provenance: Not applicable for an AI/ML context, as no such test set was described. Bench tests were performed on physical units, but specific sample sizes for each test are not listed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML system is not relevant to this physical device's non-clinical bench testing. "Physician Validation" was mentioned, but no details on the number or qualifications of physicians, nor their role in establishing a ground truth for an AI system.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for an AI/ML system. Ground truth in this context would refer to the reference standards for the physical tests (e.g., precise measurements, material specifications, functional performance during simulated use).
- The sample size for the training set: Not applicable, as there is no AI/ML training set.
- How the ground truth for the training set was established: Not applicable, as there is no AI/ML training set.
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