(62 days)
No
The device description and performance studies focus on mechanical aspects of clot removal and fluid management, with no mention of AI/ML algorithms for image analysis, decision support, or other functions.
Yes.
The device is used for the non-surgical removal of soft thrombi and emboli from blood vessels in the peripheral vasculature. This direct therapeutic action to treat a medical condition qualifies it as a therapeutic device.
No
The ClotTriever Thrombectomy System is designed for the "non-surgical removal of soft thrombi and emboli from blood vessels" and for "injection, infusion, and/or aspiration of contrast media and other fluids." These are interventional and therapeutic functions, not diagnostic ones.
No
The device description explicitly details physical components like catheters, sheaths, ports, valves, and accessories, indicating it is a hardware-based medical device system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The ClotTriever Thrombectomy System is a device used inside the body (in the peripheral vasculature) to physically remove blood clots. It is an interventional device, not a diagnostic one.
- Intended Use: The intended use clearly states "non-surgical removal of soft thrombi and emboli from blood vessels" and "Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel." These are therapeutic and procedural actions, not diagnostic tests on samples.
- Device Description: The description details the physical components used for insertion, manipulation within blood vessels, and clot removal. It does not describe components for analyzing biological samples.
Therefore, the ClotTriever Thrombectomy System is a medical device used for treatment and procedures within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
To aid in fluoroscopic visualization, the dilator and ClotTriever Catheter distal tips are radiopaque.
Anatomical Site
peripheral vasculature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: In accordance with the Design Failure Modes and Effects Analysis, verification and validation testing were identified to support the substantial equivalence of the modified ClotTriever Thrombectomy System to the predicate device. This testing demonstrated compliance with relevant product specifications. These tests included:
- Pouch Seal Inspection
- Dye Penetration Inspection
- Pouch Peel Test
- Visual & Dimensional Inspections: ClotTriever Sheath, Dilator, Clot Reservoir & Loading Tool
- Guidewire Compatibility Verification
- Insertion Force - ClotTriever Dilator Handle into Sheath Hub
- Retraction Force Dilator Handle from Sheath Hub
- Deployment Force - ClotTriever Sheath from Dilator
- Engagement Force - Dilator Handle
- Retraction Force – Dilator Thru ClotTriever Sheath
- Retraction Force – Dilator Handle
- Insertion Verification ClotTriever Delivery Catheter thru Sheath
- Retraction of the ClotTriever Catheter Thru ClotTriever Sheath
- Kink Resistance/ Radius Verification ClotTriever Sheath & Dilator
- Leakage Verification, ClotTriever Sheath
- Leakage Verification, ClotTriever Dilator
- Leakage Verification, Clot Reservoir
- Air Leakage, ClotTriever Sheath
- Clot Reservoir Check Valve Cracking Pressure
- Vacuum Testing, ClotTriever Sheath
- Vacuum Testing, ClotTriever Clot Reservoir
- Push-Button Force Testing Garrote Valve
- Fluid Test Thru ClotTriever Sheath/Dilator
- . Corrosion Resistance
- ClotTriever Dilator Retraction in Clot Analog
- Simulated Use, Track and Tensile ClotTriever Dilator
- . Simulated Use, Track and Tensile - ClotTriever Sheath
- Simulated Use, Tensile – ClotTriever Clot Reservoir
- Simulated Use Track and Turn-to-Failure, ClotTriever Sheath
- Torque Testing - Dilator
- Torque Testing Garrote Valve
- Torque Testing - Flushing Stopcock
- Burst Testing Garrote Valve
- Burst Testing Flushing Stopcock
- . Particulate Evaluation
Clinical testing was not required for the determination of substantial equivalence.
Conclusion: Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use. Based upon the same intended use and principle of operation, technology, and nonclinical testing it is concluded that the modified ClotTriever Thrombectomy System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Inari Medical's ClotTriever Thrombectomy System (K173470)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Inari Medical's FlowTriever Retrieval/Aspiration System (K173672), Inari Medical's Infusion Aspiration Catheter System (K143563), Merit Medical Systems' VacLok Vacuum Syringe (K163597)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 9, 2018
Inari Medical Eben Gordon Vice President, RA/QA 9272 Jeronimo Rd., Suite 124 Irvine, California 92618
Re: K180329
Trade/Device Name: ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: March 12, 2018 Received: March 13, 2018
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Eben Gordon
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K180329
Device Name ClotTriever Thrombectomy System
Indications for Use (Describe)
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.
X | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
| Date prepared | February 5, 2018 |
|---|---|
| Name | Inari Medical, Inc. |
| 9272 Jeronimo Road, Suite 124 | |
| 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 | DXE |
| Regulatory class | II |
| Predicate device | Inari Medical's ClotTriever Thrombectomy System (K173470) |
| Reference | |
| devices | Inari Medical's FlowTriever Retrieval/Aspiration System (K173672) |
| Inari Medical's Infusion Aspiration Catheter System (K143563) | |
| Merit Medical Systems' VacLok Vacuum Syringe (K163597) | |
| Description | 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. | |
| Indications for | |
| Use | 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. |
4
The changes to the ClotTriever Thrombectomy System are:
- modifications
equivalence
Device
- Reduction in the length of the ClotTriever Sheath from 26 cm to 15 cm.
- Reduction in the length of the Dilator to match the Sheath change.
- An outer shaft has been added to the Dilator to aid in its removal from the ClotTriever Sheath after the funnel has been deployed.
- Decrease in the Dilator tip taper and hardness. ●
- Pre-loading of the Dilator into ClotTriever Sheath prior to final packaging.
- . Replacement of the hemostasis valve with a user actuated hemostasis valve in the ClotTriever Sheath's proximal hub.
- Addition of a stopcock in the sideport tubing.
- Elimination of the Valve Dilator, Aspiration Insert, Flush Port Adapter, ● and tubing clamp components.
- Replacement of the 60 cc Monoject Syringe with the 60 cc VacLok . Vacuum Syringe.
Summary of There is no change of intended use or fundamental scientific technology between substantial the modified and predicate devices.
Non-Clinical Testing
In accordance with the Design Failure Modes and Effects Analysis, verification and validation testing were identified to support the substantial equivalence of the modified ClotTriever Thrombectomy System to the predicate device. This testing demonstrated compliance with relevant product specifications. These tests included:
- Pouch Seal Inspection
- Dye Penetration Inspection ●
- Pouch Peel Test ●
- Visual & Dimensional Inspections: ClotTriever Sheath, Dilator, Clot ● Reservoir & Loading Tool
- Guidewire Compatibility Verification ●
- Insertion Force - ClotTriever Dilator Handle into Sheath Hub
- Retraction Force Dilator Handle from Sheath Hub ●
- Deployment Force - ClotTriever Sheath from Dilator
- Engagement Force - Dilator Handle
- Retraction Force – Dilator Thru ClotTriever Sheath
- Retraction Force – Dilator Handle
- Insertion Verification ClotTriever Delivery Catheter thru Sheath ●
- Retraction of the ClotTriever Catheter Thru ClotTriever Sheath ●
- Kink Resistance/ Radius Verification ClotTriever Sheath & Dilator ●
- Leakage Verification, ClotTriever Sheath
- Leakage Verification, ClotTriever Dilator ●
- Leakage Verification, Clot Reservoir ●
- Air Leakage, ClotTriever Sheath ●
- Clot Reservoir Check Valve Cracking Pressure ●
5
- Vacuum Testing, ClotTriever Sheath ●
- Vacuum Testing, ClotTriever Clot Reservoir ●
- Push-Button Force Testing Garrote Valve ●
- Fluid Test Thru ClotTriever Sheath/Dilator ●
- . Corrosion Resistance
- ClotTriever Dilator Retraction in Clot Analog
- Simulated Use, Track and Tensile ClotTriever Dilator ●
- . Simulated Use, Track and Tensile - ClotTriever Sheath
- Simulated Use, Tensile – ClotTriever Clot Reservoir
- Simulated Use Track and Turn-to-Failure, ClotTriever Sheath ●
- Torque Testing - Dilator
- Torque Testing Garrote Valve ●
- Torque Testing - Flushing Stopcock
- Burst Testing Garrote Valve ●
- Burst Testing Flushing Stopcock ●
- . Particulate Evaluation
Clinical testing was not required for the determination of substantial equivalence.
Conclusion
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use. Based upon the same intended use and principle of operation, technology, and nonclinical testing it is concluded that the modified ClotTriever Thrombectomy System is substantially equivalent to the predicate device.