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 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 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 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 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 Lightning Bolt Aspiration Tubing (INDIGO Aspiration Tubing) is designed to serve as a conduit to assist in thrombus removal, facilitating transfer of vacuum between the Penumbra Aspiration Pump and the INDIGO Aspiration Catheter while providing intermittent, continuous, or modulated aspiration. Modulated aspiration is provided when the Lightning Bolt Aspiration Tubing alternates between connecting the INDIGO Aspiration Catheter to the Penumbra Aspiration Pump and a sterile saline intravenous (IV) bag at ambient pressure.

The provided text is a 510(k) summary for the Penumbra Indigo® Aspiration System - Lightning Bolt Aspiration Tubing (K242075). It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device (K223186).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the subject device meets specific clinical performance acceptance criteria in a standalone study against a predefined clinical benchmark. The studies described are primarily bench-top (non-clinical) tests to verify that the subject device performs similarly to the predicate device and functions as intended.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests performed, stating that the subject device met all acceptance criteria. However, it does not provide a table detailing specific quantitative acceptance criteria or corresponding device performance values for most tests. Instead, it offers general statements of compliance or similarity to the predicate device.

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

The document does not explicitly provide the sample sizes (number of units or test iterations) for each specific bench-top test. It generally references "testing performed on the subject Lightning Bolt Aspiration Tubing device."

The data provenance is non-clinical bench testing, conducted by the manufacturer, Penumbra, Inc. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence. There is no information about country of origin of the data beyond implicitly being from testing conducted by the US-based manufacturer.

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

For the non-clinical bench-top tests described, the concept of "ground truth" as established by medical experts (e.g., radiologists) is not applicable. These tests evaluate engineering and material performance against predefined specifications, often based on industry standards or internal design requirements. The "ground truth" for these tests would be the physical properties and performance of the device as measured in the lab.

4. Adjudication Method for the Test Set

Since the tests are non-clinical bench tests evaluating engineering performance, an adjudication method (like 2+1, 3+1 for clinical endpoints) is not relevant. Test results are typically objective measurements against a Pass/Fail criterion.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." Therefore, there is no information on the effect size of human readers improving with or without AI assistance, as this is not an AI device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone study was not done. This device is physical medical tubing, not an AI algorithm.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" is based on:

• Engineering specifications and design requirements for mechanical, dimensional, and material properties.
• Industry standards (e.g., ISO for sterility, various IEC standards for electrical safety).
• Performance of the predicate device as a benchmark for comparison (e.g., "performed similarly to the predicate device").

8. Sample Size for the Training Set

Not Applicable. This is a physical medical device (tubing), not a machine learning algorithm. Therefore, there is no "training set."

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

Not Applicable. There is no training set for this device.

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 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