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510(k) Data Aggregation
(256 days)
The ClotTriever Thrombectomy System is indicated for:
· The non-surgical removal of thrombi and emboli from blood vessels.
· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath is made of a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port and a proximal hemostatic valve. A dilator is included to aid insertion. Other provided accessories include the funnel loading tool and a large bore 60 cc syringe. The ClotTriever Catheter is made of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the sheath dilator and ClotTriever Catheter distal tips are radiopaque.
The provided text describes a 510(k) premarket notification for the ClotTriever Thrombectomy System, focusing on a labeling change rather than a study proving new performance claims or AI model acceptance criteria. The document states that the change is to replace "fibrous" and "adherent" with "predominantly fibrous" and "firmly adherent" from the contraindications. It explicitly mentions that Non-Clinical Testing was not required to support the change and that Clinical Testing was originally submitted in a previous 510(k) (K193462, cleared on September 9, 2020). Therefore, the document does NOT contain the information needed to answer the prompt regarding acceptance criteria and performance studies for a device, especially not those related to an AI model.
The prompt specifically asks for details about AI model acceptance criteria and performance studies (e.g., sample size, expert ground truth, MRMC studies, standalone performance), which are not discussed in this FDA 510(k) clearance letter for a thrombectomy system.
Therefore, I must state that the requested information is not available in the provided text.
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(60 days)
The ClotTriever Thrombectomy System is indicated for:
· The non-surgical removal of thrombi and emboli from blood vessels.
- · Injection, infusion, and /or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheaths, the ClotTriever Catheter, and the ClotTriever Bold Catheter. The ClotTriever Sheaths are comprised of a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. The ClotTriever Catheter and the ClotTriever Bold Catheter are comprised of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Three ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath, ClotTriever Catheter and ClotTriever Bold Catheter distal tips are radiopaque. Other accessories provided with the ClotTriever Sheath include a pre-dilator, a funnel loading tool and a Large Bore 60 cc syringe.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
This document is a 510(k) summary for a medical device modification, specifically the "ClotTriever Thrombectomy System" with the introduction of the "ClotTriever Bold Catheter." It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K210689). Therefore, the "study" described is a set of non-clinical tests to verify that the modifications do not introduce new safety or efficacy concerns.
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly list specific quantitative acceptance criteria values alongside corresponding performance results. Instead, it states that "Test results demonstrated that all acceptance criteria were met." The acceptance criteria would be derived from the product specifications for each test listed.
| Test Performed (Proposed Device) | Reported Device Performance |
|---|---|
| Visual and Dimensional Inspection | Met all acceptance criteria |
| ClotTriever Sheath Compatibility | Met all acceptance criteria |
| Deployment/Retraction Force | Met all acceptance criteria |
| Kink Radius | Met all acceptance criteria |
| Fluid Leakage, Sheath | Met all acceptance criteria |
| Vacuum Leakage, Sheath | Met all acceptance criteria |
| Simulated Use, Track & Tensile | Met all acceptance criteria |
Tests leveraged from predicate device (K210689) also met their respective acceptance criteria, implying the performance was acceptable for those aspects as well.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any of the non-clinical tests.
The data provenance is non-clinical testing, performed to verify compliance with product specifications. It's a regulatory submission and not a clinical study involving human patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as this is a non-clinical device verification study, not a study requiring expert clinical adjudication or ground truth establishment in the traditional sense of medical image analysis or diagnostic performance. The "ground truth" here is adherence to engineering specifications and performance standards.
4. Adjudication method for the test set
This information is not applicable for the same reasons as above. There is no clinical test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader, multi-case comparative effectiveness study was not done. This device is a mechanical thrombectomy system, not an AI-powered diagnostic tool, and the submission is for a device modification, focusing on non-clinical performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an algorithm or AI system. It's a physical medical device.
7. The type of ground truth used
The "ground truth" for this device's performance is established by engineering specifications and performance standards for medical devices. This includes mechanical properties, material compatibility, and functional performance in simulated environments.
8. The sample size for the training set
This information is not applicable as this is a physical medical device and not an AI/machine learning system that requires a "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 this type of device.
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(65 days)
The ClotTriever Thrombectomy System is indicated for:
- · The non-surgical removal of thrombi and emboli from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath comprises a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. The ClotTriever Catheter is comprised of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Three ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque. Other provided accessories include a pre-dilator, the funnel loading tool and a Large Bore 60 cc syringe
The provided document is a 510(k) premarket notification for the ClotTriever Thrombectomy System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data. It does not typically involve extensive clinical studies with human subjects in the same way a PMA (Premarket Approval) submission would, especially for an AI/ML-driven device.
Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets acceptance criteria in an AI/ML context (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable to this specific document. This document focuses on the mechanical and functional performance of a medical device (a thrombectomy system with a pre-dilator) through non-clinical testing.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the types of non-clinical testing performed.
| Test Type | Acceptance Criteria (Not explicitly quantified in document) | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Inspection | Device meets specified visual and dimensional requirements. | All acceptance criteria were met. |
| Guidewire Compatibility | Device is compatible with specified guidewire. | All acceptance criteria were met. |
| Leak Testing | Device does not leak beyond acceptable limits. | All acceptance criteria were met. |
| Simulated Use | Device performs as intended during simulated use. | All acceptance criteria were met. |
| Insertion/Kink Radius Testing | Device resists kinking and can be inserted as intended. | All acceptance criteria were met. |
| Tensile Testing | Device meets specified tensile strength requirements. | All acceptance criteria were met. |
| In Vivo Functional Testing/Radiopacity Verification | Device functions as intended in vivo (animal or cadaver model implied) and is radiopaque as specified. | All acceptance criteria were met. |
| Pouch Seal Visual Inspection and Dye Penetration | Pouch seals are intact and prevent dye penetration. | All acceptance criteria were met (leveraged from K163549). |
| Pouch, Peel, Seal Strength | Pouch seals meet specified strength requirements for opening. | All acceptance criteria were met (leveraged from K163549). |
| Sterilization Validation | Device is effectively sterilized. | All acceptance criteria were met (leveraged from K163549). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each type of non-clinical test. The data provenance is internal testing performed by Inari Medical, Inc. The nature of the testing (bench, in-vitro, and potentially in vivo animal/cadaver for functional testing) indicates it's likely prospective data collection for the purpose of this submission. The origin of the data is the manufacturer's testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device submission based on non-clinical engineering and performance testing, not an AI/ML algorithm requiring expert review for ground truth establishment.
4. Adjudication method for the test set
Not applicable. This is not an AI/ML study requiring expert adjudication of outputs. The tests are typically conducted according to standardized protocols with defined acceptance 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
Not applicable. This device is a mechanical thrombectomy system, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm. The testing described is for the mechanical and functional performance of the device itself.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is defined by the product specifications and performance standards for the device, and established engineering principles for evaluating medical device safety and effectiveness. For example:
- Visual and Dimensional Inspection: Comparison against engineering drawings and design specifications.
- Leak Testing: Absence of fluid egress under specified pressure.
- Tensile Testing: Measurement against predefined force resistance requirements.
- In Vivo Functional Testing: Successful and safe operation in a relevant biological model (e.g., animal or cadaver model, though the document does not specify which was used or the exact endpoints, only that the test was conducted).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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(29 days)
The ClotTriever Thrombectomy System is indicated for :
- · The non-surgical removal of thrombi and emboli from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath comprises a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include the funnel loading tool and a Large Bore 60 cc syringe. The ClotTriever Catheter comprises reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque.
This document is a 510(k) summary for the Inari Medical ClotTriever Thrombectomy System. It outlines the FDA's determination of substantial equivalence for a modified version of the device.
Based on the provided text, the device in question is not an AI/ML powered device. It's a physical medical device designed for the non-surgical removal of thrombi and emboli. Therefore, the questions related to AI/ML device performance, such as acceptance criteria based on AI metrics, sample sizes for test/training sets for AI, expert adjudication, MRMC studies, and standalone algorithm performance, are not applicable to this document.
The document states:
- "Non-Clinical Testing: Non-clinical testing was not required to support the change to the Indications for Use."
- "Clinical Testing: The CLOUT registry clinical data supporting this labeling change was previously submitted in the ClotTriever Thrombectomy System 510(k) (K193462, cleared on September 9, 2020). No additional clinical data was deemed necessary to determine substantial equivalence of the subject and predicate devices."
This means that the current 510(k) submission (K210190) is for a labeling change (specifically, removing "chronic clot" from a contraindication) for an already cleared device, and no new performance testing (clinical or non-clinical) was conducted or required for this specific submission. The substantial equivalence determination is based on the previously submitted data for K193462.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device from this document. The document describes a traditional medical device and a submission for a minor labeling modification.
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(268 days)
The ClotTriever Thrombectomy System is indicated for:
- · The non-surgical removal of thrombi and emboli from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is in the peripheral vasculature including deep vein thrombosis (DVT).
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath comprises a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include the funnel loading tool and a Large Bore 60 cc syringe. The ClotTriever Catheter comprises reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque.
The provided text describes the ClotTriever Thrombectomy System, its indications for use, and a clinical study (CLOUT Registry) conducted to support changes to its indications. However, the document does not contain a table of acceptance criteria and the device performance against those specific criteria. It outlines the results of a clinical registry and concludes that these results support the changes to the Indications for Use.
Therefore, many of the requested details cannot be fully extracted from the provided text. I will answer based on the information available and explicitly state when information is not present.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of predefined acceptance criteria for the device's performance in a clinical study. Instead, it describes clinical outcomes observed in the CLOUT Registry, which are then used to justify the expanded Indications for Use.
| Performance Metric (Observed Outcome) | Reported Device Performance (CLOUT Registry) |
|---|---|
| Thrombus removal ≥75% (via core lab Marder scores) | 75.2% of treated limbs (including chronic disease) |
| Proportion of patients treated in a single session | 99.2% |
| Major adverse events through 30 days | 9 (6.8%) |
| Device-related major adverse events | 0 |
| Access-site hematoma | 1 (0.8%) |
| Acute renal injuries | 0 |
| Significant decrease in PTS patients (vs. baseline) | p<0.0001 (at 30-day follow-up) |
| Significant decrease in moderate/severe PTS (vs. baseline) | p<0.0001 (at 30-day follow-up) |
| Significant improvement in QoL scores (Villalta, rVCSS, EQ-5D, NPRS) | Yes (all showed statistically significant improvement at 30 days) |
Note: These are observed outcomes from a registry study, not a pre-defined set of acceptance criteria with corresponding thresholds. The document implies these results were sufficient to demonstrate substantial equivalence for the expanded indications.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set):
- 133 patients (for procedural and acute data across 16 sites).
- 98 patients (for 30-day follow-up data).
- Data Provenance:
- Study Type: Clinical Registry (CLOUT Registry). Registries are typically prospective, collecting real-world data over time. The description "real-world patient outcome information" supports this.
- Country of Origin: Not explicitly stated in the provided text, but the FDA submission suggests it was likely a multi-center study, possibly within the United States or including international sites. The absence of specific country details means it cannot be determined from this document.
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)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document only mentions "core lab Marder scores" were used for thrombus removal assessment, implying expert review by a central laboratory, but details about the experts' number or qualifications are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide details about the adjudication method used for the clinical data in the CLOUT Registry. It mentions "core lab Marder scores," which suggests a centralized assessment, but not the specific adjudication process (e.g., number of readers, conflict resolution).
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
The provided text describes a clinical study of a thrombectomy device, not an AI-assisted diagnostic or interpretative system. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable and was not performed/reported for this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is also not applicable as the device described (ClotTriever Thrombectomy System) is a physical medical device for thrombus removal, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the effectiveness and safety of the device was established primarily through:
- Clinical Outcomes Data: This includes direct patient outcomes, such as rates of thrombus removal (quantified by "core lab Marder scores"), incidence of major adverse events, changes in Post-Thrombotic Syndrome (PTS) incidence, and improvements in various quality of life scores (Villalta, rVCSS, EQ-5D, NPRS).
8. The sample size for the training set
The document describes a clinical registry (CLOUT Registry), which is an observational study collecting real-world data. It does not refer to a "training set" in the context of device development or machine learning. The 133 patients (with 98 having 30-day follow-up) represent the study population for evaluating the device's performance, not a training set for an algorithm.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of this device or study, this information is not applicable. The ground truth for the efficacy and safety of the device was established through the objective clinical data collected in the CLOUT Registry, as detailed in point 7.
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(30 days)
The ClotTriever Thrombectomy System consists of the ClotTriever Sheath. The ClotTriever Thrombectomy System is indicated for:
- · The non-surgical removal of soft thrombi and emboli from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System is comprised of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include the funnel loading tool and a Large Bore 60 cc syringe. The ClotTriever Catheter consists of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque.
The provided text describes a 510(k) premarket notification for the ClotTriever Thrombectomy System, focusing on device modifications and non-clinical testing. It explicitly states that "Clinical testing was not required for the determination of substantial equivalence." This means that the information requested regarding acceptance criteria, study details, human reader performance, ground truth establishment for a training set, and sample sizes for training and test sets in a clinical context is not applicable to this submission, as no human clinical study was performed.
The document primarily details non-clinical testing to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document broadly states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use."
While a specific table of acceptance criteria with numerical performance values is not provided, the following list represents the types of non-clinical tests conducted to meet internal specifications:
| Acceptance Criteria (Test Type) | Reported Device Performance (Implied) |
|---|---|
| Pouch Seal Inspection | Met |
| Dye Penetration Inspection | Met |
| Visual & Dimensional Inspections ClotTriever Sheath | Met |
| Visual & Dimensional Inspections ClotTriever Dilator | Met |
| Visual & Dimensional Inspections Loading Tool | Met |
| Guidewire Compatibility Verification, ClotTriever Dilator | Met |
| Deployment Force ClotTriever Sheath from Dilator | Met |
| Retraction Force Dilator Thru ClotTriever Sheath | Met |
| Insertion Verification ClotTriever Delivery Catheter thru Sheath | Met |
| Retraction of the ClotTriever Catheter Thru ClotTriever Sheath | Met |
| Kink Resistance/Radius Verification ClotTriever Sheath & Dilator | Met |
| Leakage Verification, ClotTriever Sheath | Met |
| Leakage Verification, ClotTriever Dilator | Met |
| Fluid Test Thru ClotTriever Sheath/Dilator | Met |
| ClotTriever Dilator Retraction in Clot Analog | Met |
| Simulated Use, Track and Rotation ClotTriever Sheath | Met |
| Simulated Use, Track and Tensile ClotTriever Dilator | Met |
| Simulated Use, Track and Tensile ClotTriever Sheath | Met |
| Insertion and Placement Resistance | Met |
| Corrosion Resistance | Met |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in a clinical context as no human clinical study was performed. The non-clinical tests would have used physical samples of the device components. The document does not specify the number of samples for each non-clinical test or their provenance.
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)
Not applicable, as no human clinical study was conducted, and therefore no ground truth was established by medical experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human clinical study was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a medical instrument (thrombectomy system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a medical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" would be the established engineering and performance specifications for each test (e.g., a specific force for deployment, a tolerance for dimensions, absence of leakage). These are defined internally by the manufacturer during device development.
8. The sample size for the training set
Not applicable, as no algorithm or human reader training set was required for this device's regulatory submission based on non-clinical testing.
9. How the ground truth for the training set was established
Not applicable.
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(26 days)
The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and ClotTriever Sheath. The ClotTriever Thrombectomy System is indicated for:
The non-surgical removal of soft thrombi and emboli from blood vessels.Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System is comprised of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include the funnel loading tool and a 60 cc syringe. The ClotTriever Catheter consists of polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. At the proximal end of the catheter is a handle used to enable tensioning of the coring element. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the dilator and ClotTriever Catheter distal tips are radiopaque.
The provided document is a 510(k) summary for the ClotTriever Thrombectomy System, which is a medical device for removing thrombi and emboli. It describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device, but it explicitly states that clinical testing was not required. Therefore, the document does not contain information about a study proving the device meets acceptance criteria related to clinical performance or human reader effectiveness.
However, based on the non-clinical testing section, I can provide information about the acceptance criteria and performance as described for those tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual & Dimensional Inspections | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Retraction Force of Handle | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Syringe Leak Testing | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Syringe Vacuum Testing | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Syringe Tensile Testing | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Clot burden Removal Performance Test | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Simulated Use, Tensile Test | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
2. Sample size used for the test set and the data provenance:
For the non-clinical tests listed, the sample sizes are not explicitly provided in this 510(k) summary. The data provenance is generally "non-clinical testing" conducted by the manufacturer, Inari Medical, Inc. The document does not specify country of origin for the data (as it's laboratory testing, this is typically internal to the manufacturer). It is, by definition, a prospective testing of the device prototypes/units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These are non-clinical engineering and performance tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes.
4. Adjudication method for the test set:
Not applicable for these non-clinical tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This device is a thrombectomy system (a mechanical device), not an AI-powered diagnostic tool. Clinical testing was also not performed or required for this particular submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" would be established engineering specifications, performance standards, and physical measurements/observations during the tests. For example, for "Syringe Leak Testing," the ground truth would be the absence of leaks under specified conditions.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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(62 days)
The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and ClotTriever Sheath. The ClotTriever Thrombectomy System is indicated for:
• The non-surgical removal of soft thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.
The ClotTriever Thrombectomy System is a single-use, sterile medical device system designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include a clot reservoir, a funnel loading tool, and a 60 cc syringe. The ClotTriever Catheter consists of four pre- assembled polymeric coaxial catheters terminating in an expandable coring element and thrombus collection bag. At the proximal end of the catheter is a handle used to enable tensioning of the coring element. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the dilator and ClotTriever Catheter distal tips are radiopaque.
The ClotTriever Thrombectomy System underwent non-clinical testing to demonstrate substantial equivalence to its predicate device, specifically ClotTriever Thrombectomy System (K173470). The device is used for the non-surgical removal of soft thrombi and emboli from blood vessels and for the injection/aspiration of fluids in the peripheral vasculature.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text lists numerous tests conducted to ensure the device's performance meets established specifications. For each test, the "reported device performance" is a blanket statement indicating that: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use."
Without specific numerical or qualitative results for each individual test, a detailed table with specific acceptance criteria and performance metrics cannot be generated. However, the types of tests conducted serve as proxies for the acceptance criteria for various aspects of the device's functionality and safety.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Packaging & Sterility | Pouch Seal Inspection | Seal integrity adequate to maintain sterility | All acceptance criteria met |
| Dye Penetration Inspection | No dye penetration, indicating seal integrity | All acceptance criteria met | |
| Pouch Peel Test | Appropriate peel strength for safe opening | All acceptance criteria met | |
| Physical & Dimensional | Visual & Dimensional Inspections (Sheath, Dilator, Clot Reservoir, Loading Tool) | Conformance to design specifications and tolerances | All acceptance criteria met |
| Functional - Insertion & Retraction | Guidewire Compatibility Verification | Smooth passage and compatibility with guidewires | All acceptance criteria met |
| Insertion Force - ClotTriever Dilator Handle into Sheath Hub | Within specified force limits for user ease | All acceptance criteria met | |
| Retraction Force - Dilator Handle from Sheath Hub | Within specified force limits for user ease | All acceptance criteria met | |
| Deployment Force - ClotTriever Sheath from Dilator | Within specified force limits for reliable deployment | All acceptance criteria met | |
| Engagement Force - Dilator Handle | Secure engagement | All acceptance criteria met | |
| Retraction Force - Dilator Thru ClotTriever Sheath | Within specified force limits for smooth retraction | All acceptance criteria met | |
| Retraction Force - Dilator Handle | Within specified force limits for user ease | All acceptance criteria met | |
| Insertion Verification ClotTriever Delivery Catheter thru Sheath | Smooth and unobstructed passage | All acceptance criteria met | |
| Retraction of the ClotTriever Catheter Thru ClotTriever Sheath | Smooth and unobstructed retraction | All acceptance criteria met | |
| Mechanical Integrity | Kink Resistance/Radius Verification ClotTriever Sheath & Dilator | Resistance to kinking at specified radii | All acceptance criteria met |
| Leakage Verification (ClotTriever Sheath, Dilator, Clot Reservoir) | No fluid leakage | All acceptance criteria met | |
| Air Leakage, ClotTriever Sheath | No air leakage | All acceptance criteria met | |
| Clot Reservoir Check Valve Cracking Pressure | Within specified pressure range for proper function | All acceptance criteria met | |
| Vacuum Testing (ClotTriever Sheath, Clot Reservoir) | Ability to maintain specified vacuum levels | All acceptance criteria met | |
| Push-Button Force Testing Garrote Valve | Within specified force limits for user operation | All acceptance criteria met | |
| Fluid Test Thru ClotTriever Sheath/Dilator | Unobstructed fluid flow | All acceptance criteria met | |
| Corrosion Resistance | No corrosion observed | All acceptance criteria met | |
| ClotTriever Dilator Retraction in Clot Analog | Effective retraction in a simulated clot environment | All acceptance criteria met | |
| Simulated Use, Track and Tensile (ClotTriever Dilator, Sheath) | Mechanical integrity and tracking performance in simulated use | All acceptance criteria met | |
| Simulated Use, Tensile – ClotTriever Clot Reservoir | Mechanical integrity under tensile stress | All acceptance criteria met | |
| Simulated Use Track and Turn-to-Failure, ClotTriever Sheath | Durability and functionality in simulated extreme use | All acceptance criteria met | |
| Torque Testing (Dilator, Garrote Valve, Flushing Stopcock) | Resistance to breakage or failure under torque | All acceptance criteria met | |
| Burst Testing (Garrote Valve, Flushing Stopcock) | Resistance to bursting at specified pressures | All acceptance criteria met | |
| Particulate Evaluation | Within acceptable limits for biocompatibility | All acceptance criteria met |
2. Sample Size Used for the Test Set and Data Provenance
The provided information focuses on non-clinical testing (e.g., bench testing, mechanical tests). There is no information provided regarding a "test set" in the context of patient data.
- Sample Size: Not applicable for a clinical test set as no clinical testing was performed for this submission. For the non-clinical tests, specific sample sizes are not explicitly stated for each test, but it is implied that sufficient samples were used to meet the verification and validation requirements.
- Data Provenance: Not applicable for a clinical test set. For the non-clinical tests, the data provenance is from the manufacturer's (Inari Medical) internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the submission states: "Clinical testing was not required for the determination of substantial equivalence." Therefore, no clinical ground truth was established by experts for a test set in this context.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical test set requiring expert adjudication was utilized.
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
An MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not required for the determination of substantial equivalence." This implies no human-in-the-loop performance evaluation or comparison with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The ClotTriever Thrombectomy System is a physical medical device (catheter system), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission.
7. The Type of Ground Truth Used
For the non-clinical testing conducted, the "ground truth" used was established product specifications, engineering standards, and the performance of the predicate device (K173470). In other words, the device's performance was compared against predetermined acceptance criteria derived from its design requirements and the known characteristics of equivalent devices.
8. The Sample Size for the Training Set
This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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(26 days)
The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and ClotTriever Thrombectomy System is indicated for:
- · The non-surgical removal of soft thrombi and emboli from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.
The ClotTriever Thrombectomy System is a single-use, sterile medical device system designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port with tubing clamp, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include a clot reservoir, a flush port adapter, an aspiration insert, funnel loading tool, and a 60 cc syringe. The ClotTriever Catheter consists of four pre- assembled polymeric coaxial catheters terminating in an expandable coring element and thrombus collection bag. At the proximal end of the catheter is a handle used to enable tensioning of the coring element. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the dilator and ClotTriever Catheter distal tips are radiopaque, and radiopaque marker bands are located on the coring element shaft at the proximal end of the expandable coring element, and at the distal ends of the ClotTriever Sheath and ClotTriever Catheter outer shaft.
The prompt asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text. However, the provided text does not contain details about specific acceptance criteria (e.g., numerical thresholds for performance metrics) or a study with detailed results that explicitly "prove" the device meets these criteria. Instead, it describes non-clinical testing performed to establish substantial equivalence to a predicate device.
Therefore, many of the requested details cannot be extracted directly from the provided document. I will answer based on what is available, and explicitly state when information is missing.
Here's the breakdown of what can be inferred/extracted:
1. A table of acceptance criteria and the reported device performance
The document lists various non-clinical tests conducted but does not provide a table with specific acceptance criteria (e.g., "Deployment Force < X N") or reported numerical device performance results for these criteria. It only states that "Test results demonstrated that all acceptance criteria were met," implying that such criteria and results exist internally but are not disclosed in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Pouch Seal Inspection | Met established product specifications |
| Packaging Inspection | Met established product specifications |
| Visual & Dimensional Inspections | Met established product specifications |
| Guidewire Compatibility Verification | Met established product specifications |
| Deployment Force Net/Coring Element from Delivery Catheter | Met established product specifications |
| Retraction Force - Net/Coring Element into Delivery Catheter | Met established product specifications |
| Retraction Force ClotTriever Catheter Thru ClotTriever Sheath | Met established product specifications |
| Kink Resistance/ Radius Verification - ClotTriever Catheter | Met established product specifications |
| Leakage Verification, ClotTriever Catheter | Met established product specifications |
| Leakage Verification, ClotTriever Catheter ID with Guidewire in Place | Met established product specifications |
| Simulated Use Track and Tensile ClotTriever Catheter | Met established product specifications |
| Clot Burden Removal Test | Met established product specifications |
| Performance Test - Thrombus Removal Characterization | Met established product specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. The testing described is non-clinical bench testing.
- Data Provenance: Not applicable in the context of clinical data. For non-clinical testing, the location and methods would be internal to Inari Medical, Inc. The document does not specify the country where these non-clinical tests were performed.
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 question is not applicable as the study was non-clinical bench testing and did not involve human expert assessment of outcomes or imaging, nor did it establish ground truth in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as this was non-clinical bench testing, not a clinical study requiring adjudication of clinical outcomes or interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence." Therefore, no MRMC or clinical comparative effectiveness study was conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device for physical removal of clots, not an AI algorithm. The testing described is physical, non-clinical performance testing of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical testing, the "ground truth" would be defined by the pre-established engineering specifications and performance standards for each test (e.g., a certain force measurement, a successful deployment, a specified amount of clot removed in a simulated environment). The document does not specify the exact methods for defining this "ground truth" or the criteria for success beyond stating that "all acceptance criteria were met."
8. The sample size for the training set
- Not applicable as this is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable as this is a physical medical device, not an AI model requiring a training set and associated ground truth.
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(62 days)
The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and ClotTriever Sheath. The ClotTriever Thrombectomy System is indicated for:
- The non-surgical removal of soft thrombi and emboli from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.
The ClotTriever Thrombectomy System is a single-use, sterile medical device system designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port with tubing clamp, and a proximal hemostatic valve. An obturator is provided to aid insertion. Other provided accessories include a clot reservoir, a flush port adapter, an aspiration insert and a 60 ml syringe. The ClotTriever Catheter consists of three (3) pre-assembled polymeric coaxial catheters terminating in an expandable member and tissue collection net. At the proximal end of the catheter is a handle used to enable expansion of the expandable member and net. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the ClotTriever Sheath obturator and ClotTriever Catheter distal tips are radiopaque, and radiopaque marker bands are located on the intermediate shaft at the proximal end of the expandable member, and at the distal ends of the ClotTriever Sheath shaft and ClotTriever Catheter outer shaft.
The provided text is a 510(k) premarket notification summary for the ClotTriever Thrombectomy System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and an animal study. It does not describe a study involving human subjects, AI assistance, or the establishment of ground truth by human experts for a test set in the way one would for an AI/ML medical device.
Therefore, most of the requested information regarding acceptance criteria and performance related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types, training set details) is not applicable to this document.
However, based on the non-clinical testing described, I can infer the "acceptance criteria" were successful completion of various engineering and biocompatibility tests, and the "study that proves the device meets the acceptance criteria" refers to the results of these non-clinical tests and an animal study.
Here's how I can address the prompts based on the provided text, and where I must state "Not Applicable" due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document lists various tests performed to demonstrate safety and performance. The "acceptance criteria" are implied to be the successful completion of these tests to conform to standards and product specifications. The "reported device performance" is a general statement of success.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with relevant standards (e.g., ISO 10555-1, ISO 594-1/2) | "This testing demonstrated compliance with relevant standards" |
| Conformance to product specifications | "Test results demonstrated that all acceptance criteria were met, and, therefore, the device conforms to established product specifications and intended use." |
| Successful pouch seal and dye penetration | Included in successful tests report. |
| Successful pouch peel, seal strength | Included in successful tests report. |
| Passed visual and dimensional inspections | Included in successful tests report. |
| Guidewire compatibility | Included in successful tests report. |
| Acceptable deployment force of ClotTriever Sheath from Dilator | Included in successful tests report. |
| Acceptable retraction force of Dilator through ClotTriever Sheath | Included in successful tests report. |
| Acceptable insertion of Delivery Catheter through ClotTriever Sheath | Included in successful tests report. |
| Acceptable deployment force of ClotTriever from Delivery Catheter | Included in successful tests report. |
| Acceptable retraction force of handle to Expand/Collapse ClotTriever | Included in successful tests report. |
| Acceptable retraction force of ClotTriever into Delivery Catheter | Included in successful tests report. |
| Acceptable retraction force of ClotTriever Catheter through ClotTriever Sheath | Included in successful tests report. |
| Acceptable ClotTriever Sheath/Dilator Kink Radius | Included in successful tests report. |
| Acceptable ClotTriever Device Kink Radius | Included in successful tests report. |
| Passed Leakage Testing (ClotTriever Sheath, Accessories, Flush Port, Hemostasis Valves) | Included in successful tests report. |
| Passed Air Leakage (ClotTriever Sheath) | Included in successful tests report. |
| Passed Leakage Testing (ID of ClotTriever Device w/Guidewire in Place) | Included in successful tests report. |
| Passed Vacuum Testing (ClotTriever Sheath) | Included in successful tests report. |
| Passed Test Conical Fittings with 6% Luer Taper, Dilator | Included in successful tests report. |
| Passed Flow Test Through ClotTriever Sheath/Dilator | Included in successful tests report. |
| Demonstrated Corrosion Resistance | Included in successful tests report. |
| Passed Simulated Use Track & Tensile (ClotTriever Sheath, Dilator, Clot Reservoir, ClotTriever Catheter) | Included in successful tests report. |
| Passed Simulated Use Track & Turn-to-Failure (ClotTriever Sheath and Accessories, ClotTriever Catheter) | Included in successful tests report. |
| Passed Torque Testing (ClotTriever Handle, Clot Reservoir Luer Activated Valve) | Included in successful tests report. |
| Minimal/Acceptable Particulate Matter | Included in successful tests report. |
| Biocompatibility (Cytotoxicity, Guinea pig maximization sensitization, Intracutaneous irritation, Acute systemic toxicity, Material mediated pyrogen, Bacterial mutagenicity, Hemolysis, Complement activation, Thromboresistance, USP Physicochemical) | "Biocompatibility testing in accordance with ISO 10993-1" was successfully performed. |
| Shelf life of 12 months (based on accelerated aging) | "Verification testing was conducted on sterilized (ethylene oxide), accelerated-aged devices to support the 12 months shelf life." |
| Package integrity testing (ISO 11607-1/2 guidelines) | Included in successful tests report. |
| Acute safety and performance in an animal model | "Acute evaluation of the safety and performance of the ClotTriever Thrombectomy System was successfully performed in a bovine model." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated for each test, but implied to be sufficient for engineering and biocompatibility testing of medical devices. For the animal study, it mentions "a bovine model," implying one or more bovine subjects, but no specific number is provided.
- Data Provenance: The tests were conducted by Inari Medical, Inc. (Irvine, CA, USA). The studies are non-clinical (laboratory tests and an animal study), not human clinical data, so terms like "retrospective" or "prospective" usually apply to human data collection. These would be considered prospective in the sense that the tests were designed and conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document is for a traditional medical device (thrombectomy system), not an AI/ML device that requires human expert-labeled ground truth for a test set. The "ground truth" for this device's performance is derived from physical measurements against engineering specifications and biological reactions in laboratory and animal models.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this pertains to expert review of data, which is not relevant for this type of device submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a hardware medical device and does not involve human readers, AI assistance, or imaging interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm or software component described that would have a "standalone" performance. The device is a physical thrombectomy system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is multi-faceted, based on:
- Engineering Specifications and Standards: Physical and performance characteristics measured against predetermined design requirements and compliance with international standards (e.g., ISO 10555-1, ISO 594-1/2, ISO 10993-1, ISO 11607-1/2).
- Biological Response: Results from biocompatibility tests (in vitro and in vivo models) and acute evaluation in a bovine model, indicating safety and performance in a living system.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set." The device itself is manufactured according to established processes and tested.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established in this context. The "truth" about the device's design and manufacturing is based on its specifications, material properties, and manufacturing processes, which are validated through the non-clinical tests described.
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