Search Results

The APRO 70 Swift Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

The Alembic Aspiration Tubing is intended to connect the APRO 70 Swift Catheter to the aspiration pump.

The APRO 70 Swift Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Swift Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 70 Swift Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 Swift Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 70 Swift Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 70 Swift Catheter is available in lengths of 125 cm. 132 cm, and 135 cm and is provided with an introducer sheath.

The Alembic Aspiration Tubing connects the APRO 70 Swift Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.

The provided text describes the acceptance criteria and the study results for the APRO 70 Swift Catheter and Alembic Aspiration Tubing. It is important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance data, rather than a clinical trial report. Therefore, some of the requested information, particularly regarding clinical studies, human readers, and effect sizes, is not applicable or available in this document.

Here's the breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance data are primarily from non-clinical bench testing.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state specific sample sizes for each non-clinical bench test. The testing involved various repetitions per test to demonstrate meeting acceptance criteria. The data provenance is non-clinical bench testing performed by Alembic, LLC. No human (clinical) test set is mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable (N/A) as the studies described are non-clinical bench tests and do not involve expert interpretation or ground truth establishment in the context of medical imaging or diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for non-clinical bench testing. Adjudication methods are typically relevant for human reader studies or clinical trials where expert consensus is needed to establish ground truth for complex interpretations.

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 MRMC comparative effectiveness study was done. The document states: "Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary." This device is a physical catheter, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable (N/A). This is a 510(k) submission for a physical medical device (catheter and tubing), not a software algorithm.

7. The Type of Ground Truth Used

For the non-clinical bench tests, the "ground truth" or reference for performance was established by predefined engineering specifications, international standards (e.g., ISO 10555-1, EN ISO 80369-7, ISO 11135, ISO 10993-1), and comparisons to predicate devices. For example, particulate levels were compared to predicate devices, and clot retrieval was assessed against "functionality specifications" using an anatomical neurovascular model. Biocompatibility tests followed established methodologies like those in ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable (N/A). This submission is for a physical medical device, not a machine learning or AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable (N/A). As there is no training set for an algorithm, there is no ground truth established for it in this context.

Ask a specific question about this device

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

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.

Ask a specific question about this device