(268 days)
No
The device description and performance studies focus on mechanical thrombus removal and do not mention any AI/ML components or capabilities.
Yes
The device is indicated for the non-surgical removal of thrombi and emboli from blood vessels, which is a therapeutic intervention aimed at treating medical conditions like deep vein thrombosis (DVT) by removing clots.
No
The device is designed for the non-surgical removal of thrombi and emboli from blood vessels and for injection/aspiration of fluids, which are therapeutic interventions, not diagnostic functions.
No
The device description explicitly details physical components like a sheath, catheter, dilator, syringe, and ports, indicating it is a hardware-based medical device.
Based on the provided information, the ClotTriever Thrombectomy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "non-surgical removal of thrombi and emboli from blood vessels" and "Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel." This describes a therapeutic and interventional procedure performed within the patient's body.
- Device Description: The description details a system of sheaths, catheters, and accessories designed for mechanical removal of clots from blood vessels. This is consistent with an in-vivo medical device.
- Anatomical Site: The device is used in the "peripheral vasculature including deep vein thrombosis (DVT)," which is an anatomical location within the body.
- Performance Studies: The clinical testing describes outcomes related to thrombus removal and patient symptoms, which are results of an in-vivo intervention.
In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The ClotTriever Thrombectomy System operates directly within the patient's circulatory system.
N/A
Intended Use / 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 in the peripheral vasculature including deep vein thrombosis (DVT).
Product codes
QEW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature including deep vein thrombosis (DVT)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 greater than or equal to 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
§ 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).
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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
1
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 100 | |
| Irvine, CA 92618 | |
| 949.600.8433 x114 | |
| Contact person | Eben Gordon |
| Vice 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 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. | |
| 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