(24 days)
Boston Scienfitic's Excelsior™ SL-10 Pre-Shaped Microcatheter and Excelsion™ 1018" Pre-Shaped Microcatheter are intended to assist in the delivery of diagnostic agents, therapeutic agents, such as occlusion coils to the peripheral, coronary, and neuro vasculature.
The Excelsior " 1018" Pre-Shaped Microcatheter and the Excelsior" SL-10 Pre-Shaped Microcatheter are intended to assist the physician in accessing the distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semirigid proximal section aids the physician in tracking over selectively placed guidewires without displacement of the wire. A luer fitting located on the cather hub is used for the attachment of accessories. A radiopague tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces tip tachitatis nuoroscopic 75the catheters are packaged individually with a variety of Pre-Shaped tips.
This document describes the 510(k) summary for the Excelsior™ 1018™ and SL-10 Pre-Shaped Microcatheters. The core of the submission is to demonstrate substantial equivalence to predicate devices, where the primary modification is the pre-shaped tips for ease of use.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the typical quantitative sense (e.g., a specific percentage accuracy or precision). Instead, the acceptance criteria are implicitly that the modified devices (with pre-shaped tips) retain the same performance characteristics and safety profile as the predicate devices. The study performed is a "testing in support of substantial equivalence determination."
| Characteristic/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functionality | Equivalent to predicate devices | "Same as predicate device" for all listed characteristics (materials, design, dimensions, markers, coating, effective length, GDC compatibility) |
| Materials | Equivalent to predicate devices | "Same as predicate device" |
| Method of Operation | Equivalent to predicate devices | Stated as "substantially equivalent" |
| Intended Use | Equivalent to predicate devices | Stated as "substantially equivalent" |
| Indications for Use | Equivalent to predicate devices | Stated as "substantially equivalent" |
| Biological Safety | Equivalent to predicate devices | "Biological safety testing support the claim of substantial equivalence," stated as "substantially equivalent." |
| Tip configuration | Ability to offer pre-shaped tips with secondary shaping option | "Offered with Pre-Shaped Tips with the option of secondary shaping... As compared to the predicate which was cleared with straight tip, steam shapeable by physician prior to use." |
| In-vitro testing results (various) | Performance equivalent to predicate devices / safety thresholds | "The results of in-vitro testing (tip shape retention, appearance of the tip, tip dimensions, static rupture, tensile I ho reading of the worling test, and coil, guide catheter compatibility) ... support the claim of substantial equivalence." |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not specified. The document refers to "in-vitro testing" but does not detail the number of units tested for each characteristic.
- Data Provenance: The data appears to be prospective as it involves "in-vitro testing" conducted specifically for this 510(k) submission. No information is given about the country of origin of the data beyond "Boston Scientific" which is a US-based company, suggesting the testing was likely conducted in the US or by a US-affiliated entity.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This submission is for a medical device (microcatheter) and relies on engineering and biocompatibility testing, not on expert interpretations of medical images or clinical data to establish a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this isn't a study involving human interpretation of data where adjudication would be necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is typically performed for diagnostic devices where the performance of human readers, with and without AI assistance, is evaluated. This submission is for a microcatheter, which is an interventional device, not a diagnostic one.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical microcatheter, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation is based on engineering specifications, material science, and established safety standards for medical devices (e.g., biocompatibility standards, mechanical testing standards for catheters). The predicate devices serve as the reference point for equivalence.
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI/ML-driven device.
9. How Ground Truth for the Training Set was Established
Not applicable, for the same reason as point 8.
§ 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).