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510(k) Data Aggregation
(22 days)
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.
| Acceptance Criterion Type | Reported Device Performance |
|---|---|
| Bench-top performance (physical and mechanical properties) | "met all specifications and testing requirements" |
| Electrical Safety and Suction Equipment Testing (IEC 60601-1, IEC 60601-1-2 & -6) | "successfully met all applicable requirements" |
| Biocompatibility | Equivalent to predicate (due to equivalent materials) |
| Sterilization | Maintained from predicate |
| Packaging Characteristics | Maintained from predicate |
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.
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(240 days)
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:
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Biological safety in accordance with ISO 10993-1, USP standards, and FDA Good Laboratory Practices (GLP) for cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility (per BS EN ISO 10993-4 requirements). | Passed |
| Design Verification (Bench-top Testing) - CAT7 | ||
| Dimensional/Visual Inspection | Meet all product specifications. | Pass |
| Simulated Use (Peripheral Access, Vessel Access Entry Performance, Delivery/Retrieval & Clot Removal) | Effectiveness of devices to remove clots and Aspiration Catheter not collapsing under vacuum when simulated in an anatomical vascular flow model with accessory devices. | Pass |
| Aspiration Catheter/7F Sheath compatibility (Friction Force) | Maximum value per specification. | Pass |
| Aspiration Catheter/0.038" Guidewire compatibility (Friction Force) | Maximum value per specification. | Pass |
| Coating Integrity (Pre-Inspection/Post-Inspection) | Coating has not delaminated, peeled, or flaked prior to and after simulated use particulate testing. | Pass |
| Particulate Testing | < 10 µm will be ≤ 6000 particles; < 25 µm will be ≤ 600 particles. (> 75 µm and > 125 µm particles recorded for informational purposes only). | Pass |
| Hub Air Aspiration | No air leaks. | Pass |
| Catheter Pressure (Lumen Burst Pressure) | Minimum value per specification. | Pass |
| Hub / Shaft Tensile Strength | Minimum value per specification. | Pass |
| Catheter Shaft Tensile (all joints) | Minimum value per specification. | Pass |
| Elongation to Failure | Minimum value per specification. | Pass |
| Corrosion | No visible corrosion on Cathether immediately after Corrosion Testing procedure. | Pass |
| Design Verification (Bench-top Testing) - SEP7 | ||
| Dimensional/Visual Inspection | Meet all product specifications. | Pass |
| Separator Cone Shape | Must be Diamond shape. | Pass |
| Coating Integrity (Pre-Inspection/Post-Inspection) | Coating has not delaminated, peeled, or flaked prior to or after simulated use particulate testing. | Pass |
| Particulate Testing | The maximum number of particles: < 10 µm will be ≤ 6000 particles; < 25 µm will be ≤ 600 particles. (> 75 µm and > 125 µm particles recorded for informational purposes only). | Pass |
| Separator 7 Break Force (Cone/Wire) | Minimum value per specification. | Pass |
| Shelf Life | CAT7: 12-month shelf life (based on accelerated aging). SEP7: 36-month shelf life (leveraged from predicate device). | Met |
| Sterilization | Sterilized in accordance with BS EN ISO 11135 (Ethylene Oxide gas exposure). | Met |
| Packaging | All acceptance criteria for packaging validation. (CAT7: Packaging Validation Testing completed. SEP7: Packaging Validation Testing leveraged). | Met |
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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(217 days)
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.
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(79 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Efficacy Endpoint: Lower limit of the 95% confidence interval (CI) of the change in RV/LV ratio from baseline to 48 hours for acute PE patients (assessed by CTA) must be > 0.20 (indicating reduction in right ventricular dilation). | Absolute reduction in RV/LV ratio of 0.42 ± 0.25 (95% CI 0.37, 0.46). The lower limit of the 95% CI (0.37) is > 0.20. (26.9% reduction, p<0.0001) |
| Primary Safety Endpoint: 48-hour rate of major adverse events (composite of device-related death, major bleeding, and device-related SAEs including clinical deterioration, pulmonary vascular injury, and cardiac injury) should not be equal to 40%. | The 48-hour rate of major adverse events was 1.7% (95% CI 0.0%, 4.0%), p<0.0001. This is significantly lower than 40%. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- ITT (Intent-To-Treat) analysis population: 119 subjects
- mITT (Modified ITT) population (primary for efficacy): 110 subjects (excluded subjects who received adjunctive treatments or thrombolytics intra-procedure through 48 hours post-procedure).
- Safety endpoints: Evaluated based on the ITT population (119 subjects).
- Data Provenance: The Penumbra EXTRACT-PE trial was a prospective, multicenter, single-arm trial conducted at 22 centers in the U.S.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document states: "An independent imaging core lab and a clinical events committee (CEC) reviewed safety endpoints data." It does not specify the exact number of experts or their detailed qualifications (e.g., "radiologist with 10 years of experience"). However, the involvement of an "independent imaging core lab" implies that imaging specialists (e.g., radiologists) were involved in assessing the imaging data for the RV/LV ratio, and a "clinical events committee" suggests physicians or clinical experts were involved in assessing safety events.
4. Adjudication Method for the Test Set
The document mentions an "independent imaging core lab" and a "clinical events committee (CEC)" reviewed endpoints data. This implies a form of expert review and consensus, but the specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The EXTRACT-PE trial was a single-arm trial, evaluating the device's performance without direct comparison to human readers or another treatment arm within the study design (though it established substantial equivalence to a predicate device based on its performance). Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable here, as this device itself is a mechanical aspiration system, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, in a sense. The "device performance" in this context refers to the Indigo Aspiration System as a standalone therapeutic device. The clinical trial evaluated the device's ability to achieve specific physiological outcomes (RV/LV ratio reduction) and safety outcomes when used by clinicians. Since it's a therapeutic device for mechanical thrombectomy, its performance is its standalone performance in treating patients. There isn't an "algorithm" being evaluated in the AI sense; rather, the mechanical system's efficacy is being assessed.
7. Type of Ground Truth Used
- The ground truth for efficacy (reduction in RV/LV ratio) was established by CTA (Computed Tomography Angiography) images assessed by an independent imaging core laboratory.
- The ground truth for safety (major adverse events) was established by clinical evaluation and review by a clinical events committee (CEC). This would incorporate clinical diagnoses, patient outcomes, and potentially imaging findings.
8. Sample Size for the Training Set
- Not applicable / Not explicitly stated for this submission. The Indigo Aspiration System is a mechanical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's design and functionality are based on engineering principles and prior validated devices. The clinical study (EXTRACT-PE) served as a validation study for the expanded indication.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As explained above, this device does not involve an AI/ML algorithm that requires a "training set" with established ground truth. The development and validation of this mechanical device rely on engineering design, bench testing, animal studies, and then human clinical trials to demonstrate safety and efficacy. The prior versions of the device (predicate and reference devices) would have undergone similar developmental and validation processes.
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(29 days)
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA ) or who fail IV t-PA therapy are candidates for treatment.
Penumbra 3D Revascularization Device
As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion 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 System is intended for the removal of thrombus from the neuro vasculature using continuous aspiration. Intended users for this device are physicians who have received appropriate training in interventional neuroradiology and the treatment of acute ischemic stroke.
The Penumbra System is designed to remove thrombus from the vasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an I.D. of 0.054in or largerfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the primary occlusion. The Penumbra Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the Penumbra Reperfusion Catheter is used in conjunction with the Aspiration Pump, which is connected using the Penumbra Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The Penumbra Reperfusion Catheters, 3D Revascularization Device and Separators are visible under fluoroscopy.
The Penumbra Aspiration Tubing connects the Penumbra Aspiration Pump Canister to the Penumbra Reperfusion Catheter within the sterile field, providing a means for introducing vacuum during procedures. The Aspiration Tubing has a flow switch that allows the physician to start and stop the flow of aspiration. The Aspiration Tubing is available in three inner diameters: 0.071 in [1.80mm] for PST1, 0.088 in [2.24mm] for PST2, and 0.110 in [2.79mm] for PST3 and PST4. The Aspiration Tubing is designed and composed of materials which are commonly used in interventional devices. The Modified 110 Aspiration Tubing (PST4) is the subject device for this submission (K182522).
The provided text describes the acceptance criteria and the study for the Penumbra System (Modified 110 Aspiration Tubing), regulated under K182522.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Subject | Attribute | Acceptance Criteria | Reported Device Performance | Pass / Fail |
|---|---|---|---|---|
| Biocompatibility | ||||
| Cytotoxicity (MEM Elution) | Cell lysis grade | Sample extracts must yield a cell lysis grade of 2 or lower | Grade 2: Mild | Pass |
| Sensitization | Test Group score on Magnusson and Kligman scale (provided Control Grade < 1) | Test Group shall yield Grade < 1 score | Grade 0: No visible change | Pass |
| Irritation (Intracutaneous) | Difference in the mean test article and mean control score | The difference in the mean test article and mean control score must be grade 1.0 or lower | Grade 0.0 difference (saline extract) and Grade 0.1 difference (sesame oil extract) | Pass |
| Bench-top Testing | ||||
| Dimensional/Visual Inspection | Conformance to dimensional and visual specifications | 100% Must meet Specification | Pass | Pass |
| Suction Connector/Canister Lid Compatibility | Secure attachment of Suction Connector to Pump Canister lid | 100% Must meet Specification | Pass | Pass |
| Rotating Luer/RHV Compatibility | Secure connection of Rotating Luer to RHV port | 100% Must meet Specification | Pass | Pass |
| Aspiration Tubing Lumen Ovalization under Vacuum | Maintenance of functionality and open lumen at vacuum pressure | 100% Must meet Specification | Pass | Pass |
| Aspiration Tubing Joint Leak under Vacuum | Maintenance of functionality with no leaks at vacuum pressure | 100% Must meet Specification | Pass | Pass |
| Flow Control Switch Function | Complete and immediate fluid flow cessation after specified ON/OFF cycles | 100% Must meet Specification | Pass | Pass |
| Penumbra Aspiration System Compatibility with Aspiration Catheter and Separator | Clot removal under minimum vacuum pressure | 100% Must meet Specification | Pass | Pass |
| Penumbra Aspiration System Compatibility with Aspiration Catheter | Clot removal under minimum vacuum pressure | 100% Must meet Specification | Pass | Pass |
| Suction Connector/Tubing Joint Tensile | Break force per product specification. | 100% Must meet Specification | Pass | Pass |
| Rotating Male Luer/Tubing Joint Tensile | Break force per product specification. | 100% Must meet Specification | Pass | Pass |
| Shelf Life | Device stability for 36 months | Demonstrated device stability for 36 months based on accelerated aging | The modified 110 Aspiration Tubing has demonstrated device stability for 36 months based on accelerated aging. | Pass |
| Sterilization | Sterility by EO, EO residual testing, Comparative Resistance Testing, Endotoxin (LAL) Testing | Met acceptance criteria for EO residual testing per EN ISO 10993-7, Comparative Resistance Testing per AAMI TIR 28, and Endotoxin (LAL) Testing per ANSI/AAMI ST72. | The modified 110 Aspiration Tubing has demonstrated sterility by EO in accordance with EN ISO 11135. All test samples met the specified acceptance criteria. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state specific sample sizes for each test within the "Bench-top Testing" summary. However, it indicates that "All bench-top studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures." The data provenance is not specified, but the context implies it is generated internally by Penumbra, Inc. (Alameda, CA, USA) as part of their design verification process. The studies are non-clinical (bench-top and laboratory tests).
For Biocompatibility, the studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP).
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, involving laboratory and bench-top testing, and thus do not involve human expert interpretation for establishing ground truth in the way a medical imaging study might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The studies described are non-clinical, involving objective measurements and established laboratory procedures, which do not typically involve human adjudication for ground truth.
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
A multi-reader, multi-case comparative effectiveness study was not done. The submission focuses on the modified aspiration tubing and its physical and mechanical properties, not on diagnostic performance or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not done. The device is a physical medical device (aspiration tubing), not a software or AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical studies:
- Biocompatibility: Ground truth was established by adherence to recognized standards (EN ISO 10993-1, EN ISO 10993-5, EN ISO 10993-10) and specific acceptance criteria determined by these standards and GLP.
- Bench-top Testing: Ground truth was based on pre-defined design specifications, risk analysis, and performance standards.
- Shelf Life & Sterilization: Ground truth was established by adherence to recognized standards (ASTM D4169, EN ISO 11135, EN ISO 10993-7, AAMI TIR 28, ANSI/AAMI ST72) and specific acceptance criteria.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set for a machine learning model, no ground truth needed to be established for it.
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