Search Results

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, and for the treatment of pulmonary embolism.

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 the Penumbra Aspiration Systems.

The INDIGO® Aspiration System is comprised of the 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, Select Catheter, and introducer. The INDIGO Separator may be provided with an introducer and torque device.

The provided text is a compilation of FDA documents related to the 510(k) clearance for the Penumbra, Inc. Indigo® Aspiration System – Lightning® Flash. It describes the device, its indications for use, and a comparison to predicate devices, along with summaries of non-clinical data (biocompatibility and bench-top testing).

Based on the information provided, here's an analysis regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in a quantitative manner as one might expect for an AI/ML device. Instead, it describes general compliance and qualitative outcomes for various tests.

The reported performance is described in a narrative format, indicating that tests "met all acceptance criteria" and "performed similarly to the predicate devices."

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

The document does not provide details on the specific sample sizes used for each non-clinical (bench-top) test or biocompatibility test. It mentions "testing was conducted" and "tests were performed" without quantifying the number of units or replicates involved.

Data provenance (e.g., country of origin, retrospective/prospective) is not applicable as the studies described are non-clinical bench-top tests and biocompatibility assessments, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The device is an embolectomy catheter system, which is a physical medical device, not an AI/ML diagnostic or prognostic tool that requires expert interpretation to establish ground truth for a test set. The "ground truth" for its performance is established through measurable physical and biological parameters in laboratory settings (e.g., tensile strength, aspiration efficacy in simulated models, biocompatibility of materials).

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

This information is not applicable for the reasons stated in point 3. The studies are technical verification and validation, not studies requiring adjudication of image interpretations or clinical outcomes by multiple experts.

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. An MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-driven diagnostic tools, not for a mechanical medical device like an aspiration system. The document explicitly states: "No clinical study was conducted as bench and previously performed animal testing was determined sufficient for verification and validation purposes."

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

No. This concept is not applicable as the Indigo® Aspiration System – Lightning® Flash is a mechanical medical device, not an algorithm or AI system.

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

The "ground truth" for this device's performance is based on well-established engineering standards, material science principles, and biological safety assessments. This includes:

• Quantitative measurements from bench-top tests (e.g., dimensions, tensile strength, vacuum pressure).
• Adherence to recognized standards (e.g., ISO, ASTM for materials and performance, IEC for electrical safety).
• Biocompatibility testing results (e.g., lack of cytotoxicity, sensitization).
• Functional performance in simulated use models (e.g., removal of simulated thrombi).

8. The sample size for the training set:

Not applicable. This device is not an AI/ML product that undergoes a "training set" for model development. The development process involves engineering design, prototyping, and testing of physical units.

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

Not applicable, as there is no "training set" in the context of this mechanical medical device.

Ask a specific question about this device

The INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4 As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The INDIGO Aspiration Tubing As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX 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 comprised of several devices: - INDIGO CAT RX Aspiration Catheter . - INDIGO Separator 4 ● - . INDIGO Aspiration Tubing - . INDIGO Pump Canister/Tubing - . Penumbra Aspiration Pump The INDIGO Aspiration System is designed to remove thrombus from the vasculature using continuous aspiration. The INDIGO CAT RX Aspiration Catheter is a dual lumen rapid exchange catheter that targets aspiration from the Pump directly to the thrombus, removing it via the INDIGO Aspiration Tubing and depositing it in the Pump Canister. The INDIGO Separator 4 may be used, if needed, to clear the lumen of the INDIGO CAT RX Aspiration Catheter should it become blocked with thrombus. The INDIGO CAT RX 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 INDIGO CAT RX Aspiration Catheter may be provided with a rotating hemostasis valve and a peelable sheath. The INDIGO Separator 4 is provided with an introducer and torque device. The INDIGO CAT RX Aspiration Catheter and INDIGO Separator 4 are visible under fluoroscopy.

The provided text is a 510(k) summary for the Penumbra INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4). It is a submission to the FDA for market clearance, asserting substantial equivalence to a previously cleared predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI/ML perspective. The device in question is a medical aspiration system, not an AI/ML diagnostic or therapeutic device.

The "Performance Data - Non-Clinical" and "Performance Data - Clinical" sections explicitly state:

• "The subject and predicate Indigo System (CAT RX Aspiration Catheter and Separator 4) devices are identical. Therefore, previous device performance data regarding substantial equivalence described below remain unchanged." (Section 1.10)
• "No clinical study was conducted as previously performed bench and animal testing was determined sufficient for verification and validation purposes for substantial equivalence determination." (Section 1.16)

The submission leverages prior testing and clearance of an identical predicate device. Therefore, there are no new studies or acceptance criteria specifically for this 510(k) submission to describe. The original predicate device (K180412 and reference K163618) would have had its own performance data and acceptance criteria, but those are not detailed in this document.

Therefore, it is not possible to answer the requested questions based on the provided text. The text does not describe an AI/ML device, nor does it present new performance data or acceptance criteria for a study demonstrating adherence to such criteria. The entire premise of the 510(k) is that the device is identical to a predicate and thus no new performance testing is required for this submission.

Ask a specific question about this device

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, and for the treatment of pulmonary embolism.

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 comprised of the 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 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. Intended users for this device are physicians who have received appropriate training in surgical procedures and/or interventional techniques. The device is provided sterile, non-pyrogenic, and intended for single use only.

This document is a 510(k) premarket notification for the Penumbra, Inc. Indigo® Aspiration System - Lightning™ Aspiration Tubing (K210323). It claims substantial equivalence to a predicate device (K193244).

Here's an analysis of the acceptance criteria and study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the subject device "met all specifications and testing requirements under the previously established test methods" for the predicate device. However, it does not provide a specific table of quantitative acceptance criteria or detailed reported device performance values. Instead, it makes general statements about meeting requirements.

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

The document mentions "Bench-top performance (design verification)" and "Electrical Safety and Suction Equipment Testing." However, it does not specify the sample sizes used for these tests. The data provenance is also not explicitly stated in terms of country of origin or whether it's retrospective/prospective, but the nature of the testing (bench-top, electrical safety) implies internal laboratory testing, which is typically prospective for verification.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable and not provided. The testing described relates to the physical and electrical properties of medical device components, not diagnostic accuracy or clinical outcomes that would require expert ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As with point 3, adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for bench-top or electrical safety testing of device components.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for assessing the impact of AI on human reader performance, and the subject device (Lightning Aspiration Tubing) is a physical component, not an AI or imaging diagnostic tool.

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

No, a standalone algorithm performance study was not done. This is not an AI-powered device. The testing described focuses on the physical and electrical performance of the aspiration tubing.

7. The Type of Ground Truth Used:

For the bench-top performance and electrical safety testing, the "ground truth" would be the established engineering specifications and regulatory standards (e.g., IEC 60601 series). The device's performance was compared against these predefined requirements.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This is not an AI/machine learning device that requires a training set.

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

This information is not applicable and not provided. As mentioned, there is no training set for this type of device.

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence of a medical device component (aspiration tubing) through bench-top and electrical safety testing. The criteria for acceptance are compliance with established engineering specifications and regulatory standards. The document asserts that these criteria were met but does not provide the granular data or specific acceptance thresholds that would be found in a detailed test report. It is not an AI-enabled device, and therefore many of the requested data points (like expert ground truth, MRMC studies, training sets) are not relevant to this submission.

Ask a specific question about this device

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, and for the treatment of pulmonary embolism.

The INDIGO® Aspiration System is comprised of:

• 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 and into the peripheral vasculature and guided over a guidewire to 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.

This appears to be an FDA 510(k) summary for a medical device (Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7) and not for a software or AI/ML device requiring complex performance criteria based on imaging analysis.

Therefore, the request to describe acceptance criteria and a study proving a device meets these criteria in the context of AI/ML evaluation (e.g., expert reads, ground truth, MRMC studies) is not applicable to this document.

The document states:

• "There are no differences in the technological characteristics between the subject devices and predicate devices."
• "There are no differences in performance data between the subject and predicate devices and therefore no verification and validation studies were required."
• "The Indigo System, clinical study (EXTRACT-PE) was cleared in K192833 (reference device). A review of the technological characteristics of the subject and reference devices supported leveraging the clinical outcomes of the EXTRACT-PE clinical study for the subject devices."

This 510(k) is based on substantial equivalence to a predicate device, noting no changes in technology or performance that would necessitate new performance studies. The previous clinical study (EXTRACT-PE) mentioned relates to the reference device's clinical outcomes, not a new study on the current subject device.

Therefore, I cannot fulfill your request as it pertains to a different type of device evaluation (AI/ML software) than what is presented in this FDA 510(k) summary.

Ask a specific question about this device

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, and for the treatment of pulmonary embolism.

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 comprised of:

• 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 and 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.

This FDA 510(k) Premarket Notification is for the Indigo Aspiration System - Aspiration Catheter 12 and Separator 12. The document states that the subject device is identical to the predicate device (K192981) and leverages clinical data from a reference device (K192833). Therefore, the information below focuses on the clinical study (EXTRACT-PE) mentioned as supporting the substantial equivalence for the subject device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance for the subject device. Instead, it states that the EXTRACT-PE trial (for the reference device K192833) "demonstrated that the Indigo Aspiration System showed substantially equivalent safety and effectiveness outcomes for acute PE. The primary efficacy and safety endpoints were met."

• Acceptance Criteria (Implied from the statement): Meeting primary efficacy and safety endpoints for acute Pulmonary Embolism (PE) treatment, demonstrating substantial equivalence to existing treatments. Specific numerical acceptance criteria are not provided in this document.
• Reported Device Performance: Achieved substantially equivalent safety and effectiveness outcomes for acute PE, and met primary efficacy and safety endpoints.

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

The document refers to the EXTRACT-PE clinical study for the reference device (K192833). However, it does not provide the specific sample size used for this trial nor the data provenance (country of origin, retrospective/prospective) within this 510(k) summary. Further documentation would be needed to extract this detail.

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

This information is not provided in the given document. The summary only mentions "primary efficacy and safety endpoints were met," implying clinical assessment, but not the specifics of ground truth establishment by experts.

4. Adjudication Method for the Test Set:

This information is not provided in the given document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device described is an aspiration system (a medical device used for removing emboli and thrombi), not an AI-based diagnostic or imaging device that would involve human readers interpreting output with or without AI assistance.

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

This is not applicable. The device is a physical medical device, not an algorithm. Performance is assessed through its use in a clinical setting by medical professionals.

7. The Type of Ground Truth Used:

For the EXTRACT-PE study, the ground truth would have been established through clinical outcomes data related to the efficacy (e.g., successful removal of thrombi, resolution of PE symptoms, improvements in relevant physiological parameters) and safety (e.g., adverse events, complications) of the device in treating acute PE.

8. The Sample Size for the Training Set:

This information is not provided in the given document. As it is a non-AI medical device, the concept of a "training set" in the context of machine learning does not directly apply. The clinical study for the reference device would have involved a patient cohort, but the specific number is not stated.

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

As above, the concept of a "training set" is not directly applicable. For the clinical study that demonstrated the device's performance, the "ground truth" (clinical outcomes, safety events, etc.) would have been established through standard clinical trial methodologies, including objective measurements, physician assessments, and follow-up data collection on patients enrolled in the trial.

Ask a specific question about this device

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.

Ask a specific question about this device

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, non-pyrogenic, 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 provided text describes the submission of a 510(k) premarket notification for the "Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12." This specific document is a summary of non-clinical data and does not contain information about a study based on the performance of an AI/ML powered medical device.

Therefore, I cannot answer questions 1 through 9. The information provided in the document focuses on the physical and material properties of a medical device (a catheter and separator for aspiration), its biocompatibility, shelf life, sterilization, and packaging, rather than the performance of an AI/ML algorithm.

The "Acceptance Criteria" table in this document refers to engineering specifications (e.g., maximum friction force, minimum burst pressure, particle limits) for the physical device, not performance metrics for an AI/ML model.

Ask a specific question about this device

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, and for the treatment of pulmonary embolism.

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 comprised of several devices:

• INDIGO Aspiration Catheter ●
• Penumbra Aspiration Pump ●
• INDIGO Aspiration Pump Canister
• INDIGO Aspiration Tubing ●
• . INDIGO SeparatorTM

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 and 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.

This document outlines the substantial equivalence of the "Indigo Aspiration System Lightning Aspiration Tubing" (subject device) to a predicate device (K193244) and a reference device (K192833). The review primarily focuses on demonstrating that the subject device is identical to the predicate device and that prior performance data for similar devices within the Indigo Aspiration System remain applicable.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The subject and predicate Indigo System devices are identical. Therefore, previous device performance data regarding substantial equivalence described below remain unchanged." This implies that the acceptance criteria for the subject device are met by virtue of it being identical to a previously cleared predicate device that had already satisfied those criteria.

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

• Biocompatibility & Bench-Top Performance: Not explicitly stated for the subject device, as these tests were not re-performed. The document refers to data from the predicate device (K193244). The specific sample sizes and provenance for those original tests are not detailed in this document.
• Clinical Performance (EXTRACT-PE Trial): The sample size for the clinical study (EXTRACT-PE) is not specified in this document. The data provenance is also not specified (e.g., country of origin). It is stated as a "clinical study" and "trial," suggesting it was prospective. The document refers to the data from the reference device (K192833).

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

This information is not available in the provided document. The document refers to previous clearances (K193244 and K192833) for performance data, but does not detail how ground truth was established for those studies.

4. Adjudication Method for the Test Set

This information is not available in the provided document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

An MRMC study was not mentioned or implied. The clinical data cited (EXTRACT-PE) appears to focus on device efficacy and safety outcomes rather than reader performance with or without AI assistance.

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

This is not applicable. The device (Indigo Aspiration System Lightning Aspiration Tubing) is a physical medical device, not an algorithm or AI system. Therefore, standalone performance in the context of AI is not relevant here.

7. The Type of Ground Truth Used

For the clinical study (EXTRACT-PE) related to the reference device, the document states it "demonstrated that the Indigo Aspiration System showed substantially equivalent safety and effectiveness outcomes for acute PE. The primary efficacy and safety endpoints were met." This implies that the ground truth was based on clinical outcomes data related to the efficacy of thrombus removal and patient safety in acute pulmonary embolism settings. Specific methods for establishing definitive "ground truth" for patient outcomes (e.g., imaging confirmation, pathology reports, adjudicated clinical events) are not detailed.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This is not applicable. The device is a physical medical device, not an AI model.

Ask a specific question about this device

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.

Ask a specific question about this device

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, and for the treatment of pulmonary embolism.

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 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 and 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 provided text describes the 510(k) summary for the Penumbra Indigo Aspiration System. The core of this submission is to demonstrate substantial equivalence to a predicate device, with an expanded indication for the treatment of pulmonary embolism.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device