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The Excipio SV Thrombectory Device is indicated for the non-surgical removal of soft emboli and thrombi from peripheral blood vessels.

The Excipio SV Thrombectomy Device consists of a Thrombectomy Catheter to mechanically displace thrombus when used with an aspiration catheter. The Device will be sold as a sterile, single use device.

Thrombectomy Catheter
The Thrombectomy Catheter is a mechanical thrombus displacement device with a nitinol braided component (basket) at the distal end that can be opened and closed via an activation wire that attaches to the distal end of the braid and attaches to a proximal handle. The operator can open the braided component to a diameter that best matches the target vessel (4-8mm in diameter). Proximal and distal marker bands delineate the ends of the basket component, and 4 radiopaque markers delineate the circumference of the basket component to facilitate visualization under fluoroscopy.

The provided document describes the Excipio SV Thrombectomy Device and its substantial equivalence to predicate devices, but it does not contain information about the acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for a physical medical device (a thrombectomy device), and the testing described is standard for such a device (e.g., visual inspection, dimensional inspection, biocompatibility, animal study for thrombogenicity).

Therefore, I cannot provide the requested information for the following points as they are not applicable to this physical medical device submission:

1. A table of acceptance criteria and the reported device performance: This document refers to meeting acceptance criteria for non-clinical lab tests (e.g., kink resistance, tensile testing) and biocompatibility, but it doesn't provide specific quantitative acceptance criteria or detailed reported performance values for these tests in a table format that would be typical for an AI/ML device. It merely states that the device "met all acceptance criteria."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable to this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Cleaner Plus™ Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids. including thrombolytics, in the peripheral venous vasculature.

The Cleaner Plus™ Thrombectomy System is a single use device used to provide thrombectomy in the peripheral venous vasculature. The device provides additional features, such as aspiration and over-the-wire device placement.

The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes system controls, and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the Aspiration Canister.

The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the therapeutic site. The dilator and guidewire are removed, and the Maceration Wire, using the Peel-Away introducer is advanced through the hemostasis valve of the Aspiration Catheter to the therapeutic site and connected to the handpiece. To complete the system, the provided Aspiration Canister is connected to the handpiece to provide aspiration. The Handpiece provides controls to turn on/off maceration and/or the application of suction. Like the current Cleaner15/CleanerXT devices, mechanical thrombectomy will be achieved by rotating a flexible stainless-steel maceration wire powered by a motor inside the handpiece. The aspiration source is provided to aspirate macerated clot from the distal portion of the device through the handpiece and captures the macerated clot in the Aspiration Canister reservoir. The Aspiration Canister includes a switch to initiate the pump, and LEDs that indicate the level of the vacuum.

The provided text describes the evaluation of a medical device, the Cleaner Plus™ Thrombectomy System, for substantial equivalence to predicate devices, as part of an FDA 510(k) submission. This document is a regulatory submission, and as such, it focuses on non-clinical data (bench-top and animal studies) rather than clinical study data involving human patients or complex AI performance metrics.

Therefore, many of the requested points related to AI performance, human reader studies (MRMC), data provenance, expert consensus on ground truth, and training data for AI models are not applicable to this type of medical device submission.

Here's an analysis of the acceptance criteria and study information provided, focusing on what is relevant in this context:

1. Table of Acceptance Criteria and Reported Device Performance

The document details non-clinical performance tests that were conducted and states that the device "were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not explicitly list quantified acceptance criteria for each test or detailed performance results in a table format. Instead, it lists the types of tests performed.

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INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems.

INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.

Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The Aspiration Catheter, Separator and Aspiration Tubing are available in multiple configurations. The devices are provided sterile, nonpyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional techniques.

The INDIGO® Aspiration System is comprised of several devices:

• . INDIGO Aspiration Catheter
• Penumbra Aspiration Pump ●
• INDIGO Aspiration Pump Canister .
• INDIGO Aspiration Tubing ●
• . INDIGO Separator™

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device.

The Penumbra, Inc. Indigo Aspiration System, specifically the Aspiration Catheter 7 and Separator 7, underwent various non-clinical tests to demonstrate its substantial equivalence to predicate devices. The following information summarizes the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes used for each individual test within the "Design Verification (Bench-top Testing)" section. It generally states that "units used in this Design Verification testing" were evaluated. The data provenance is not explicitly stated as country of origin, but it is implied to be from Penumbra, Inc. in Alameda, CA, USA, where the device manufacturer is located. The studies are non-clinical (bench-top and laboratory testing), not human or animal studies, so the terms "retrospective" or "prospective" are not directly applicable in the same way they would be for clinical data.

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 applicable. The studies described are non-clinical engineering and laboratory tests (biocompatibility, mechanical performance, etc.). Ground truth in this context refers to established engineering specifications and international standards, not expert medical opinion on diagnostic images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies where multiple human readers are involved. The studies described here are objective, quantifiable engineering and laboratory tests with predetermined specifications.

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:

This information is not applicable. The device described (Indigo Aspiration System - Aspiration Catheter 7 and Separator 7) is a physical medical device (catheter and separator for thrombus removal), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

This information is not applicable. As stated above, the device is a physical medical device, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the non-clinical tests was based on pre-determined product specifications, engineering standards, and international regulations/guidelines. For example:

• Biocompatibility: ISO 10993-1, USP standards, FDA GLP, BS EN ISO 10993-4.
• Mechanical and Physical Properties: Specific maximum/minimum values, visual criteria (e.g., "no air leaks," "no visible corrosion," "must be Diamond shape"), and adherence to accepted test methods.
• Sterilization: BS EN ISO 11135.
• Shelf Life & Packaging: Acceptance criteria established for stability and integrity.

8. The sample size for the training set:

This information is not applicable. There is no mention of an algorithm or AI model requiring a training set. The device is a physical medical instrument.

9. How the ground truth for the training set was established:

This information is not applicable, as there is no training set for a physical medical device.

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INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.
INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Indigo Aspiration System ("Indigo System") is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems using the Indigo Aspiration Catheter, Indigo Separator, Indigo Aspiration Tubing, and Penumbra Aspiration Pump. The Indigo System was most recently cleared under K180939.
The INDIGO® Aspiration System is comprised of the several devices:

• · INDIGO Aspiration Catheter
• Penumbra Aspiration Pump
• INDIGO Pump/Canister Tubing
• INDIGO Aspiration Tubing
• INDIGO Separator
  The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device.
  Lightning Aspiration Tubing: The Lightning Aspiration Tubing is a component to the currently available Indigo Aspiration System. The Lightning Aspiration Tubing facilitates the transfer of vacuum between the INDIGO Aspiration Catheter and the Penumbra Aspiration Pump while providing aspiration.

This document is a 510(k) Pre-market Notification for a medical device (Indigo Aspiration System - Lightning Aspiration Tubing) and as such, it focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through a comparative effectiveness study with human readers assisting AI or an AI standalone system. The concepts of AI assistance, multi-reader multi-case studies, and specific performance metrics like sensitivity/specificity for AI are not applicable here.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance testing conducted to ensure the new device functions as intended and is equivalent to the predicate device. The prompt's request for information largely aligns with the type of evaluation performed for an AI-powered diagnostic device, which is not what this document describes.

Therefore, providing a direct answer to all points of the prompt as though the document describes an AI diagnostic or assistive device study would be factually incorrect and misleading.

However, I can extract the relevant information regarding the engineering/performance acceptance criteria and the supporting studies from the provided document as it pertains to the device's substantial equivalence.

Here's how the information can be broken down based on the document's content, focusing on what is present:

Device: Indigo Aspiration System - Lightning Aspiration Tubing

Regulatory Class: Class II

Product Code: QEW (Embolectomy Catheter)

Purpose of Submission: Demonstrate substantial equivalence to a predicate device (K180939, 110 Aspiration Tubing, modified).

1. Table of Acceptance Criteria and Reported Device Performance

The document details various non-clinical tests performed to demonstrate the device meets its design specifications and is substantially equivalent to the predicate. These are more akin to engineering and material acceptance criteria rather than diagnostic performance metrics.

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

• Test Set Sample Size: Not explicitly stated as a single "test set" in the context of an AI study. The "test sets" for each specific engineering/performance test (e.g., biocompatibility, tensile strength, simulated use) would vary, but the document does not provide the exact sample sizes for each. It generally states that "units" or "the subject device" were tested.
• Data Provenance: The tests are non-clinical (bench-top, laboratory testing) and focused on device performance, not clinical patient data. The provenance is internal to Penumbra, Inc. (Alameda, CA, USA). The document does not specify if any retrospective or prospective patient data was used, as it explicitly states "Clinical Testing was not required".

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

This concept is not applicable to this 510(k) submission. "Ground truth" in the context of AI diagnostic performance is typically established by medical experts (e.g., radiologists, pathologists). Here, the "ground truth" for each test is its defined engineering specification or a generally accepted laboratory standard (e.g., ISO guidelines for biocompatibility). The experts would be engineers, chemists, and quality control professionals, but their number and specific qualifications are not detailed in this regulatory summary.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used for resolving disagreements among human readers or between human readers and AI outputs in diagnostic studies. For engineering tests, results are typically binary (pass/fail) based on objective measurements against pre-defined specifications.

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 not an AI-powered diagnostic or assistive tool for human readers. It's a medical device (aspiration tubing) used in a non-AI surgical/interventional procedure. Therefore, no MRMC study with human readers and AI assistance was conducted or described.

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

Not applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the various non-clinical tests were:

• Pre-defined engineering specifications (e.g., dimensional requirements, tensile strength minimums).
• International and national standards (e.g., ISO 10993-1 for biocompatibility, IEC/EN 60601 series for electrical safety).
• Results from previously cleared predicate devices for comparison.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

Not applicable, as no training set exists for this device.

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The WOLF Thrombectorny Device is indicated for the nonsurgical removal of emboli and thrombi from arterial blood vessels in the peripheral vasculature.

The WOLF Thrombectomy Device is comprised of two single lumen variable stiffness catheters (WOLF Inner & Outer) designed for use in removing clot from arterial peripheral vessels. The WOLF inner catheter is attached to the weave which when pulled, inqests the clot into the WOLF outer catheter. The WOLF device is delivered through a quide catheter that has an inner diameter of at least 0.068″. Both WOLF catheters have hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot.

The WOLF inner catheter has two radiopague marker bands. The distal marker is used to indicate the tip of the catheter during tracking. The proximal marker is used to indicate how far the physician should pull back the GC prior to pulling. The outer catheter has a distal radiopaque marker band to indicate its distal tip during tracking and pulling. The weave also has a radiopaque polymer cuff that allows for visualization of the weave movement.

I am sorry, but the provided text does not contain the specific information required to complete the table and answer the questions related to the acceptance criteria and study details for the WOLF Thrombectomy Device. The document is primarily an FDA 510(k) clearance letter and summary, which confirms the device's substantial equivalence to predicate devices but does not elaborate on specific acceptance criteria and detailed study results in the structured format requested.

The text mentions that "The objectives, as well as the acceptance criteria for success, were met" in the Animal Testing section, but it does not specify what those criteria were. It also describes that "Bench studies indicate that the 880 Medical WOLF Thrombectomy Device performs as intended" and lists various types of performance testing, but it does not provide the quantitative results or acceptance criteria for each test.

Therefore, I cannot provide the requested table and detailed answers based solely on the input provided.

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Penumbra Aspiration Catheters and Separators: As part of the Penumbra Aspiration System, the Penumbra Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Penumbra Aspiration Tubing: As part of the Penumbra Aspiration System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Aspiration Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the coronary and peripheral vasculature. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional radiology. The Penumbra Aspiration System is designed to remove thrombus from the coronary and peripheral vasculature using continuous aspiration. The Aspiration Catheter targets aspiration from the pump directly to the thrombus. The Separator may be used to clear the lumen of the Aspiration Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using an Aspiration Catheter with an I.D. of 0.054 in or larger. The Aspiration Catheter is introduced through a guide catheter or long introducer sheath and into the coronary or peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The Aspiration Catheter is used with the Penumbra Pump MAX to aspirate thrombus from an occluded vessel. As needed, the Separator may be deployed from the Aspiration Catheter to assist with thrombus removal. The Separator is advanced and retracted through the Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Aspiration Catheter tip. For the aspiration source, the Aspiration Catheter is used in conjunction with the Penumbra Pump MAX, which is connected using the Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Separator is provided with an introducer and torque device. The Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and a peelable sheath. The Separator is provided with an introducer and torque device. The Aspiration Catheter and Separator are visible under fluoroscopy. The Penumbra Pump MAX is the aspiration source for the Penumbra Aspiration System. The Penumbra Pump MAX operates using AC power and is designed to be portable if needed. The Penumbra Pump MAX provides vacuum of up to 29 inHg. The pump is available in both 110Vac and 230Vac versions. The front face of the pump has a display panel with a vacuum gauge, vacuum regulator dial, and power switch. The pump connects to the canister reservoir with a tubing assembly (Penumbra Pump/Canister Tubing), which is provided as an accessory. The Penumbra Pump/Canister Tubing consists of a short tubing segment with an inline filter and connectors on each end to facilitate attachment to the pump's vacuum port. The tubing is provided pre-attached to the canister reservoir lid. The Penumbra Pump/Canister Tubing is provided non-sterile and is used outside the sterile field.

The provided document is a 510(k) premarket notification for the Penumbra Aspiration System. It details the device's indications for use, its classification, and a comparison to predicate and reference devices. However, the document primarily focuses on demonstrating substantial equivalence through non-clinical (benchtop) and animal study data, largely leveraging existing data from previously cleared similar devices.

Crucially, this document does NOT contain information about specific "acceptance criteria" or "device performance" in terms of clinical outcomes, nor does it describe a study involving human subjects or experts for establishing ground truth for AI/algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the specified sub-points (table of acceptance criteria/performance, sample size, experts, adjudication, MRMC study, standalone performance, type of ground truth, training set details) because this information is not present in the provided text.

The document discusses:

• Leveraged Non-Clinical Data (Section 1.10): This section lists benchtop tests (Friction, Visual & Dimensional, Pouch Seal Strength, Flow Rate, Tensile, Elongation, Bond Strength, Hub Air Aspiration, Torsion, Burst, Simulated Use, Particulate, Flexibility, Packaging, Corrosion). It states that "all established requirements and acceptance criteria were met," but it does not specify what those acceptance criteria were in measurable terms (e.g., "flow rate X L/min," "tensile strength Y N"). It also does not define "device performance" in the way requested (e.g., diagnostic accuracy, sensitivity, specificity).
• Leveraged Animal Studies (Section 1.11): This section summarizes findings from design validation in GLP animal testing, noting "No vessel injury," "No abnormal gross or histology findings," and "no significant vascular response." This is performance data in an animal model, but not clinical performance in humans, nor does it relate to acceptance criteria for an AI/algorithm-driven device.

In summary, the provided text describes the regulatory clearance process for a medical device (an aspiration system) based on substantial equivalence to existing devices, supported by benchtop testing and animal studies. It does not contain the kind of information typically found in a study proving an AI/algorithm-driven device meets specific clinical acceptance criteria, which would involve human data, expert review, and metrics like accuracy, sensitivity, or specificity.

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