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510(k) Data Aggregation
(56 days)
The Radical the Dude 8F Guide Catheter is indicated for the introduction of intravascular catheters into the peripheral, coronary, and neuro vasculature.
The Radical the Dude 8F Guide Catheter (Dude 8F Catheter) is an 8 French (Fr) guide catheter designed to aid the physician in accessing the target vasculature during interventional procedures. The Dude 8F Catheter has a usable length between 80 cm and 110 cm, and an outer diameter (OD) size designation of 8 Fr. The Dude 8F Catheter has variable stiffness along its length, incorporating hybrid ribbon technologies to maintain stability and vary stiffness along the device length. The distal portion of the Dude 8F Catheter has a hydrophilic coating. The Dude 8F Catheter is packaged with a rotating hemostasis valve (RHV) and a peel-away sheath.
The provided FDA 510(k) summary (K243577) describes a medical device, the Radical the Dude 8F Guide Catheter, and its substantial equivalence to a predicate device. However, this document does not describe a study involving AI or software performance evaluation with human-in-the-loop scenarios.
Therefore, most of the questions regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typically relevant for assessing the performance of AI/software medical devices, cannot be answered based on the provided text.
The 510(k) pertains to a physical catheter device and details traditional bench testing and biocompatibility assessments to establish substantial equivalence with a previously cleared device.
Based on the provided document, here's what can be extracted, and where limitations exist:
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A table of acceptance criteria and the reported device performance
The document provides a summary of "Nonclinical Performance Testing" (Bench Testing and Biocompatibility). The acceptance "criteria" are implied by the "Pass" result for each test.
Table of Acceptance Criteria and Reported Device Performance
| Test | Test Method/Applicable Standard | Acceptance Criteria (Implied by "Pass") | Reported Device Performance |
|---|---|---|---|
| Visual Inspection | Visual inspection completed for surface defects. | No surface defects | Pass |
| Dimensional Inspection | Critical dimensions were verified. | Critical dimensions met specifications | Pass |
| Simulated Use Test | Simulated use in a bench anatomical model with femoral artery access. | Successful use in simulated anatomical model | Pass |
| PTFE Delamination | Assessed for PTFE delamination at distal tip following simulated use testing. | No PTFE delamination | Pass |
| Tensile Testing | Tensile strength measured along entire catheter length. | Tensile strength met specifications | Pass |
| Torque Strength | The distal end of the catheter was constrained from movement while the proximal end was turned until failure in a simulated anatomy model. | Torque strength met specifications | Pass |
| Kink Resistance | Resistance to kink was tested at various locations along the catheter shaft using successively smaller radii to challenge the catheter. | Acceptable kink resistance | Pass |
| Catheter Burst | Catheter burst tested per ISO 10555-1. | Met ISO 10555-1 burst requirements | Pass |
| Liquid Leak Test | Liquid leak tested per ISO 10555-1. | Met ISO 10555-1 liquid leak requirements | Pass |
| Air Leak Test | Air leak tested per ISO 10555-1. | Met ISO 10555-1 air leak requirements | Pass |
| Hydrophilic Coating Integrity | The integrity of the hydrophilic coating was inspected before and after simulated use testing in an in vitro model. | Hydrophilic coating integrity maintained | Pass |
| Particulate Testing | During simulated use testing in an in vitro model the particle size and count were analyzed using light obscuration method and compared to the reference device. | Particle size and count comparable to reference device | Pass |
| Tip Stiffness | Compared the tip stiffness of the Dude 8F Catheter with the reference device. | Tip stiffness comparable to reference device | Pass |
| Biocompatibility: | |||
| Hemocompatibility: Partial Thromboplastin Time (PTT) | The test article average clotting time was higher and was not statistically significant when compared to the negative control. The test article average clotting time was lower and was not statistically significant when compared to the vehicle control. | PTT similar to the reference device | Pass |
| Thrombogenicity in Canine Model | An in vivo canine test to evaluate the thrombogenic potential of the subject device compared to a comparator device. | Thrombogenicity similar to reference device | Pass |
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document describes bench testing and biocompatibility testing. Specific sample sizes for each bench test are not specified in this summary.
- For the "Thrombogenicity in Canine Model", it used an in vivo canine test, implying an animal study. The exact number of animals or the test setup details are not provided in this summary.
- There is no mention of "test sets" in the context of clinical data or patient data, as this is a device for physical performance and biocompatibility.
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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)
- Not applicable. The tests are physical or chemical evaluations (e.g., visual inspection, dimensional inspection, tensile strength, PTT). "Ground truth" in the context of expert review for diagnostic accuracy is not relevant here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring adjudication of expert opinions for a test set.
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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 study was not done, as this is neither an AI device nor does it involve human readers interpreting images.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For bench testing, the "ground truth" is established by adherence to engineering specifications, relevant ISO standards (e.g., ISO 10555-1), and comparison to the predicate/reference device's performance. For biocompatibility, it's based on standard biological evaluation methods and comparison to controls or reference devices.
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The sample size for the training set
- Not applicable. This is not an AI/ML device employing a training set.
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How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
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(25 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 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 Select+ Catheter is an accessory within kitted configurations of the INDIGO Lightning Flash Aspiration System. The Select+ Catheter is used to aide in access to the site of occlusion and is removed prior to initiating aspiration with the aspiration catheter. The use of the Select+ Catheter to facilitate access to the site of the occlusion is an optional procedural step for INDIGO Lightning Flash Aspiration Catheters. The device is provided sterile and intended for single use only.
The provided text is a 510(k) summary for the Indigo® Lightning Flash Aspiration System - Select+™ Catheter. It does not describe a study involving an AI device or software, nor does it provide the detailed information requested in the prompt regarding acceptance criteria and performance of an AI-powered device.
Instead, this document focuses on establishing substantial equivalence of a new catheter (Select+™ Catheter) to a previously cleared predicate device (Indigo Aspiration System – Lightning Flash Select Catheter) and a reference device (Neuron Max System - Select Catheter).
Therefore, I cannot provide the requested information from the given text. The text does not contain:
- A table of acceptance criteria and reported device performance for an AI device.
- Sample size used for a test set for an AI device or data provenance.
- Number and qualifications of experts for ground truth establishment for an AI device.
- Adjudication method for an AI device.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study for an AI device.
- Standalone performance details for an AI algorithm.
- Type of ground truth used for an AI device.
- Sample size for the training set of an AI device.
- How ground truth for the training set of an AI device was established.
The document states, under "7.5 Summary of Performance Data – Animal, Clinical", that "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." This further confirms that the information requested for an AI-based study is not present.
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(60 days)
The Paragon 8F Balloon Guide Catheter is in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Paragon 8F Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.
The Paragon™ 8F Balloon Guide Catheter (BGC) is a multi-lumen, braid-reinforced, variable stiffness catheter with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. Balloon inflation can be facilitated through the side port of the bifurcated luer hub. The 10 mm long balloon can be inflated up to a maximum volume of 0.6 mL. At this volume, the balloon diameter is 10 mm. The through-lumen extends from the center port of the bifurcated luer hub to the distal tip. The external distal segment of the catheter shaft has hydrophilic coating to reduce friction during use. The coating starts from the proximal balloon bond and extends proximally for 19 cm in length. There are two Paragon 8F BGC configurations which have working lengths of 85 cm. The difference in device length resides in the proximal shaft segment only. The 16 cm distal flexible segment and the balloon are identical for both configurations.
The Paragon 8F Balloon Guide Catheter is compatible with minimum 0.110 inch inner diameter (ID) introducer sheaths, guidewires up to 0.038 inch outer diameter (OD), and 6F catheters up to 0.085 inch OD. The Paragon 8F Balloon Guide Catheter is sterile, non-pyrogenic, and intended for single use only.
The provided text describes the acceptance criteria and the study proving the device meets these criteria for the Wallaby Medical Paragon 8F Balloon Guide Catheter (K232437). However, it focuses on the physical and biological performance of the catheter, not on an AI/ML-based medical device. Therefore, many of the requested fields related to AI/ML device validation (e.g., sample sizes for training/test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance) are not applicable to this submission.
Here's a breakdown of the available information based on the provided text, adapted to the context of a physical medical device.
Acceptance Criteria and Device Performance (for a Physical Medical Device)
| Acceptance Criteria Category | Specific Test / Requirement | Reported Device Performance (Table 2 & 3 summary) |
|---|---|---|
| Design Verification (Bench) | Visual Inspection: Verify visual surface requirements. | Pass – all samples met the pre-determined acceptance criteria. |
| Dimensional Inspection: Verify dimensional specifications. | Pass – all samples met the pre-determined acceptance criteria. | |
| Simulated Use: Evaluate device performance and accessories in a simulated anatomy model. | Pass – all samples met the pre-determined acceptance criteria. | |
| Kink Resistance: Evaluate device around clinically relevant radii and verify kink resistance. | Pass – all samples met the pre-determined acceptance criteria. | |
| Coating Lubricity: Evaluate frictional forces and verify coating lubricity. | Pass – all samples met the pre-determined acceptance criteria. | |
| Radiopacity: Evaluate marker band visibility under fluoroscopy. | Pass – all samples met the pre-determined acceptance criteria. | |
| Delivery/Retrieval: Evaluate device in an anatomical model and verify frictional force. | Pass – all samples met the pre-determined acceptance criteria. | |
| Balloon Inflation Time: Verify balloon inflation time. | Pass – all samples met the pre-determined acceptance criteria. | |
| Balloon Deflation Time: Verify balloon deflation time. | Pass – all samples met the pre-determined acceptance criteria. | |
| Distal Tip Stiffness: Evaluate distal tip deflection force and verify stiffness. | Pass – all samples met the pre-determined acceptance criteria. | |
| Coating Integrity: Evaluate device pre- and post-insertion/retrieval through a simulated vascular model and verify coating integrity. | Pass – all samples met the pre-determined acceptance criteria. | |
| Torque Strength: Evaluate device integrity after applied hub rotations with distal end held stationary and verify torque strength. | Pass – all samples met the pre-determined acceptance criteria. | |
| Shaft & Hub Tensile: Verify tensile strength. | Pass – all samples met the pre-determined acceptance criteria. | |
| Liquid Leak: Verify liquid leak requirements per ISO 10555-1. | Pass – all samples met the pre-determined acceptance criteria. | |
| Air Leak: Verify air leak requirements per ISO 10555-1. | Pass – all samples met the pre-determined acceptance criteria. | |
| Hub Compatibility: Verify BGC bifurcated luer hub requirements per ISO 80369-7. | Pass – all samples met the pre-determined acceptance criteria. | |
| RHV Luer: Verify RHV luer requirements per ISO 80369-7. | Pass – all samples met the pre-determined acceptance criteria. | |
| Static Burst: Verify static burst requirements per ISO 10555-1. | Pass – all samples met the pre-determined acceptance criteria. | |
| Dynamic Burst: Verify dynamic burst requirements per ISO 10555-1. | Pass – all samples met the pre-determined acceptance criteria. | |
| Resistance to Lumen Collapse: Demonstrate main lumen does not collapse under aspiration. | Pass – all samples met the pre-determined acceptance criteria. | |
| Corrosion Resistance: Verify corrosion resistance requirements per ISO 10555-1. | Pass – all samples met the pre-determined acceptance criteria. | |
| Extension Tubing Tensile: Verify tensile strength requirements per ISO 10555-1. | Pass – all samples met the pre-determined acceptance criteria. | |
| Particulate: Evaluate device within a simulated anatomy model and verify particulate count similar to comparator device. | Pass – all samples met the pre-determined acceptance criteria. | |
| Balloon Fatigue: Evaluate repetitive balloon inflation and deflation cycles and verify fatigue. | Pass – all samples met the pre-determined acceptance criteria. | |
| Balloon Joint Integrity: Evaluate tensile force and verify balloon joint integrity. | Pass – all samples met the pre-determined acceptance criteria. | |
| Balloon Burst Volume: Verify balloon burst volume. | Pass – all samples met the pre-determined acceptance criteria. | |
| Balloon Diameter to Inflation Volume (Compliance): Characterize balloon diameter for pre-defined inflation volumes. | All samples were characterized. | |
| Shelf Life: Verify device performance after accelerated aging. | Pass – all samples met the pre-determined acceptance criteria. | |
| Transit Testing: Subject device, accessories, and packaging to environmental conditioning and shipping simulation and verify performance. | Pass – all samples met the pre-determined acceptance criteria. | |
| Packaging - Bubble Leak: Evaluate packaging per ASTM F2096-11 and verify requirements. | Pass – all samples met the pre-determined acceptance criteria. | |
| Packaging - Pouch Seal Strength: Evaluate packaging per ASTM F88 Technique A (unsupported peel) and verify requirements. | Pass – all samples met the pre-determined acceptance criteria. | |
| Sterility: Subject device, accessories, and packaging to sterilization and verify requirements. | Pass – all samples met the pre-determined acceptance criteria (Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135:2014). | |
| Biocompatibility | MEM Elution Cytotoxicity (BGC, 3-way stopcock, extension tubing, syringe, sheath, RHV): Evaluate for cytotoxicity. | Non-cytotoxic (scores of 0, no cytotoxic potential to L-929 mouse fibroblast cells). |
| ISO Intracutaneous Irritation (BGC, 3-way stopcock, extension tubing, syringe, sheath, RHV): Evaluate for irritation. | Non-irritant / Negligible Irritant (delta between test article and vehicle control = 0.5°C). | |
| Complement Activation - SC5b-9 Assays (BGC): Evaluate potential to activate complement system. | Not a potential activator of complement system (results within acceptable range, not statistically different than activated NHS control or negative control). | |
| ASTM Hemolysis - Direct Contact and Extract Method (BGC, 3-way stopcock, extension tubing, syringe, sheath, RHV): Evaluate for hemolysis. | Non-hemolytic (blank corrected hemolytic index: 0.1 or 0.0). | |
| Thromboresistance Evaluation (BGC): Evaluate resistance to thrombus formation. | Thromboresistance of the test device is similar to control (no adverse effects or clinical signs during test period, no thrombus score >3 for test or control device). | |
| In Vitro Hemocompatibility Assay (BGC): Evaluate effects on blood components. | Test article not a risk for adversely affecting concentrations of various cellular and non-cellular components in blood (test article results were within acceptable range). | |
| Partial Thromboplastin Time (PTT) (BGC): Evaluate clotting risk. | Not at risk for clotting (test article 99.5% of negative control, not statistically different from comparison article). | |
| Chemical Characterization (BGC): Evaluate extractable and leachable chemicals. | The risk is acceptable (extractable and leachable chemical characterization and toxicological risk assessment suggest negligible adverse toxic effect during intended clinical use). |
Since this is for a physical medical device (catheter) and not an AI/ML software, the following sections are either not applicable ("N/A") or cannot be extracted from the provided text, as they pertain specifically to AI/ML software validation.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The exact number of samples for each bench test is not explicitly stated in the summary, other than "all samples" met the criteria. For biocompatibility, it refers to standard GLP (Good Laboratory Practice) animal and in vitro studies, which have their own sample size guidelines.
- Data Provenance: N/A. This applies to clinical data for AI/ML. The "data" here is the physical performance and biocompatibility of the device, typically conducted in a laboratory setting.
- Retrospective or Prospective: N/A. (Applies to AI/ML clinical data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- N/A. Ground truth in this context refers to established standards (e.g., ISO, ASTM), specified design requirements, and GLP guidelines for testing. Expert interpretation of images or other data to establish a "truth" is not relevant here.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- N/A. This is relevant for AI/ML where multiple human readers interpret data. For physical device testing, results are objective measurements against predefined criteria.
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:
- N/A. This is a physical device, not an AI/ML algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- N/A. This is a physical device, not an AI/ML algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- For bench testing: Pre-defined engineering specifications, industry standards (ISO, ASTM), and design requirements.
- For biocompatibility: Standardized biological evaluation methods and acceptance criteria defined in ISO 10993 series. Animal studies (e.g., guinea pig, rabbit) are the "ground truth" for assessing biological responses.
8. The Sample Size for the Training Set:
- N/A. This applies to AI/ML software. This device does not have a "training set."
9. How the Ground Truth for the Training Set was Established:
- N/A. This applies to AI/ML software.
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(176 days)
The ISAAC™ Neurovascular Navigation Catheter is indicated for use in facilitating advancement of catheters through the neuro and peripheral vasculature and introduction of diagnostic agents. The ISAAC™ Neurovascular Navigation Catheter is not intended for use in the coronary vasculature.
The ISAAC™ Neurovascular Navigation Catheter) is a braid-reinforced variable stiffness catheter with a pre-shaped distal segment. The distal end of the catheter is coated with a hydrophilic coating around the curve of the pre-shaped section of the Simmons (SIM) configuration. It is a single lumen catheter with a radiopaque distal coiled section and a Luer hub on the proximal end. The ISAAC Catheter is sterile, non-pyrogenic and intended for single use only.
The FDA 510(k) summary for the MicroVention, Inc. ISAAC Neurovascular Navigation Catheter (K222115) indicates that a range of performance testing was conducted to demonstrate the device's substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria / Performance Claim | Reported Device Performance |
|---|---|---|
| Physical Attributes | Measurement of usable length, proximal/distal outer diameters, distal length, and inner diameters. | Pass |
| Tip Flexibility | Device shall have less force to bend at the distal tip than the comparator reference device. | Pass |
| Simulated Use | Performance rated during simulated-use testing in benchtop vessel model. | Pass |
| Radio Detectability | Catheter must be visible under X-ray fluoroscopy. | Pass |
| Kink Resistance | Kink resistance measured by subjecting the device to bending in simulated tortuous anatomy. | Pass |
| Static Burst | Fluid injected into the lumen at increasing pressure until catheter burst while distal tip occluded. | Pass |
| Liquid Leakage | Pressure maintained for 30 seconds with occluded distal tip; device inspected for leakage per ISO 10555-1. | Pass |
| Leakage and Damage Under High Static Pressure Conditions | Dyed fluid injected until rated burst pressure reached and held for 10 seconds while distal tip occluded. | Pass |
| Air Leakage | Vacuum applied; observed for air bubbles per ISO 80369-7 and ISO 10555-1. | Pass |
| Dynamic Burst | Catheter injected with fluid at a set pressure and inspected for damage. | Pass |
| Force at Break (Hub/Distal) | Hub/distal sections secured into tensile test machine; pulled until catheter broke, pull force recorded. | Pass |
| Particulate Testing | Catheter underwent simulated-use testing in a benchtop model and evaluated for particulates. | Pass |
| Surface Contamination | Device must be free from visible surface defects. | Pass |
| Corrosion Resistance | Catheter tested per ISO 10555-1 and ISO 11070. | Pass |
| Coating Durability and Lubricity | Device secured to tensile machine, hydrated, force to slide through clamp recorded (20 cycles for lubricity, 100 cycles for durability). | Pass |
| Catheter Flexural Fatigue | Tensile strength and pressure characteristics measured per ISO 10555-1. | Pass |
| Hub and Luer Connector | Luer connector tested to dimensional and performance requirements per ISO 80369-7. | Pass |
| Stiffness | Catheter stiffness profile compared to the reference device. | Pass |
| Torque Strength | Evaluated by measuring number of catheter rotations until failure after tracking through a tortuous anatomical model. | Pass |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility (Irritation Reactivity) | Non-irritant | Non-irritant |
| Biocompatibility (Maximization - Sensitization) | Non-sensitizing | Non-sensitizing |
| Biocompatibility (Systemic Toxicity) | Non-acute systemically toxic | Non-acute systemically toxic |
| Biocompatibility (Pyrogenicity) | Non-pyrogenic | Non-pyrogenic |
| Biocompatibility (Hemocompatibility In-Vitro Blood Loop Assay) | Thrombogenic risk potential similar to the predicate | Similar to predicate |
| Biocompatibility (Hemocompatibility Hemolysis Assay) | Non-hemolytic | Non-hemolytic |
| Biocompatibility (Hemocompatibility Complement Activation Assay) | Non-activator of complement system | Non-activator of complement system |
| Biocompatibility (Hemocompatibility Partial Thromboplastin Time (PTT) Assay) | No effect on the PTT | No effect on PTT |
| Biocompatibility (Hemocompatibility Heparinized Blood Platelet and Leukocyte Count Assay) | Pass | Pass |
| Animal Study (Tracking Performance, Support, Safety) | Perform comparably to the control article (Chaperon Guiding Catheter) in terms of tracking, support, and safety. | Performed comparably |
| Animal Study (Device-associated Complications) | No significant device-associated complications (dissection, perforation, embolic debris, thrombus, hemorrhage, ischemia, necrosis, fibrin deposition, IEL rupture, EEL rupture, mineralization, neointimal maturation, medial/adventitial injury/fibrosis). | No significant complications |
2. Sample Size Used for the Test Set and Data Provenance:
- Benchtop and Biocompatibility Testing: The specific sample sizes for each individual benchtop and biocompatibility test are not explicitly detailed in this summary. However, these tests are generally conducted on a statistically significant number of device units or material samples to ensure representativeness and reproducibility.
- Animal Study: The animal study was conducted using a "porcine model." The exact number of animals involved is not specified, but it's referred to as an "acute animal testing" in a "porcine model."
- Data Provenance:
- Benchtop Testing: Likely laboratory-generated data from MicroVention, Inc., performed under controlled conditions.
- Biocompatibility Testing: Performed on material extracts or the device itself, likely by specialized laboratories following ISO standards.
- Animal Study: Conducted in accordance with FDA Good Laboratory Practice (GLP) Regulation (21 CFR Part 58), indicating a prospective study specifically designed to assess the device. The provenance is internal to the controlled study environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Benchtop and Biocompatibility Testing: The summary does not specify the use of "experts" to establish a ground truth in the traditional sense (e.g., for image interpretation). Instead, these tests rely on objective, measurable criteria defined by established international standards (e.g., ISO, ASTM). The "ground truth" would be the direct measurement or observation of the device's physical, mechanical, and biological properties against predefined limits or comparison with a predicate.
- Animal Study: The evaluation of the animal study results regarding complications and performance comparability would involve veterinarians and potentially pathologists who are experts in animal physiology and disease interpretation. Their specific number and qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set Without Explanation:
- Benchtop and Biocompatibility Testing: An "adjudication method" in the sense of resolving discrepancies between multiple expert interpretations is generally not applicable to the objective measurements performed in these tests. Results are typically pass/fail based on predetermined specifications or direct comparison to controls/predicates.
- Animal Study: While not explicitly stated, observations in animal studies, especially pathological findings, often involve review by multiple experts (e.g., veterinary pathologists). If discrepancies occur, an adjudication process involving consensus or a tie-breaking expert would likely be in place, though this is not detailed in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- Not Applicable. The ISAAC Neurovascular Navigation Catheter is a physical medical device (catheter) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not Applicable. As mentioned above, this is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used:
- Benchtop Testing: Objective physical and mechanical measurements, adherence to industry standards, and comparison to predicate device characteristics.
- Biocompatibility Testing: Results obtained from standardized biological assays (e.g., cell cultures, animal models for irritation/sensitization) providing objective data on biological reactions, evaluated against established acceptance criteria (e.g., "non-cytotoxic," "non-irritant").
- Animal Study: Direct observation of device performance (tracking, support) and histological/pathological assessment for complications (e.g., dissection, thrombus, tissue injury) in a living porcine model, compared against the control article.
8. The Sample Size for the Training Set:
- Not Applicable. This is a physical medical device, and the concept of a "training set" for an AI algorithm is not relevant here. The device design and manufacturing process would involve extensive engineering development and iterative testing (developmental testing) which is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no "training set" in the context of an AI algorithm for this device, a method for establishing its ground truth is not relevant. The device development relies on engineering principles, material science, and performance testing against established standards and predicate device characteristics.
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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 | 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: 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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