(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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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 9, 2020
Inari Medical Eben Gordon Vice President, RA/QA 9 Parker. Suite 100 Irvine, California 92618
Re: K193462
Trade/Device Name: ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: July 29, 2020 Received: August 3, 2020
Dear Eben Gordon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193462
Device Name ClotTriever Thrombectomy System
Indications for Use (Describe)
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).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
| Date prepared | September 9, 2020 |
|---|---|
| Name | Inari Medical, Inc.9 Parker, Suite 100Irvine, CA 92618949.600.8433 x114 |
| Contact person | Eben GordonVice President, Regulatory Affairs & Quality Assurance |
| Trade name | ClotTriever Thrombectomy System |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Product code | QEW |
| Regulatory class | II |
| Predicate device | ZelanteDVT Thrombectomy Set (K151313) |
| Reference device | ClotTriever Thrombectomy System (K192332) |
| Description | The ClotTriever Thrombectomy System is a single-use, sterile medical devicedesigned for use in the peripheral vasculature. The ClotTrieverThrombectomy System consists of the ClotTriever Sheath and the ClotTrieverCatheter. The ClotTriever Sheath comprises a reinforced polymeric sheathequipped with a self-expanding distal mesh funnel, a flush/aspiration port, anda proximal hemostatic valve. A dilator is provided to aid insertion. Otherprovided accessories include the funnel loading tool and a Large Bore 60 ccsyringe. The ClotTriever Catheter comprises reinforced polymeric coaxialshafts terminating in an expandable coring element and thrombus collectionbag. Two ports terminating in stopcocks are provided for de-airing thecatheter shafts. To aid in fluoroscopic visualization, the Sheath dilator andClotTriever Catheter distal tips are radiopaque. |
| Indications for Use | 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). | |
| Device modification | The Indications for Use has been changed to include the treatment of DVT and removal of the soft thrombi and emboli limitation. |
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Summary of substantial equivalence
The ClotTriever Thrombectomy System, predicate and reference devices have the same intended use: removal of thrombus and emboli from and infusion of fluids into the peripheral vasculature.
Non-Clinical Testing
Non-clinical testing was not required to support the change to the Indications for Use.
Clinical Testing
The ClotTriever Outcomes (CLOUT) Registry has generated real-world patient outcome information following treatment of acute and non-acute lower extremity proximal deep vein thrombosis (DVT) with the ClotTriever System. Procedural and acute data of 133 patients across 16 sites and 30-day follow-up data of 98 patients was assessed. 99.2% of patients were treated in a single session. Thrombus removal of ≥75% via core lab Marder scores was achieved in 75.2% of treated limbs, including those with chronic disease. There were 9 (6.8%) major adverse events through 30 days, none of which were device related, one (0.8%) access-site hematoma, and no acute renal injuries. At 30-day follow-up, compared to baseline, the number of patients with post-thrombotic syndrome (PTS) as well as moderate or severe PTS had both significantly decreased (p<0.0001). Additionally, quality of life scores, including Villalta, revised venous clinical severity score (rVCSS), EO-5D. and numeric pain rating scale (NPRS), all showed statistically significant improvement at 30 days.
Conclusion
The specific use of treating DVT falls within the current cleared general use and real world clinical data supports the including the treatment of DVT and the removal of the soft thrombi and emboli limitation in the Indications for Use. The proposed changes to the Indications for Use do not raise new or different questions of safety and effectiveness, therefore, it can be concluded that the modified ClotTriever Catheter is substantially equivalent to the predicate device.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).