(26 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI or ML.
Yes
The device is indicated for the "non-surgical removal of soft thrombi and emboli from blood vessels," which directly addresses and treats a medical condition (thrombi and emboli), thus fulfilling the definition of a therapeutic device.
No
The device is described as a thrombectomy system designed for the non-surgical removal of thrombi and emboli, and for injection/aspiration of fluids/contrast, which are therapeutic and interventional functions, not diagnostic ones.
No
The device description clearly details physical components such as catheters, sheaths, ports, and a handle, indicating it is a hardware-based medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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 into or from a blood vessel." These are procedures performed on the patient's body, not on samples from the body for diagnostic purposes.
- Device Description: The description details a system of catheters, sheaths, and accessories designed for physical intervention within blood vessels. This aligns with a therapeutic or interventional device, not a diagnostic one that analyzes biological samples.
- Lack of Diagnostic Function: There is no mention of the device analyzing blood, tissue, or other biological samples to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to physically remove clots and manage fluids within the vascular system, which is a therapeutic intervention.
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
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
- Packaging Inspection
- Visual & Dimensional Inspections
- Guidewire Compatibility Verification
- Deployment Force Net/Coring Element from Delivery Catheter
- Retraction Force - Net/Coring Element into Delivery Catheter
- Retraction Force ClotTriever Catheter Thru ClotTriever Sheath
- Kink Resistance/ Radius Verification - ClotTriever Catheter
- Leakage Verification, ClotTriever Catheter
- Leakage Verification, ClotTriever Catheter ID with Guidewire in Place
- Simulated Use Track and Tensile ClotTriever Catheter
- Clot Burden Removal Test
- Performance Test - Thrombus Removal Characterization
Clinical testing was not required for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Inari ClotTriever Thrombectomy System (K163549)
Reference Device(s)
Not Found
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.
December 4, 2017
Inari Medical, Inc. Mr. Eben Gordon Vice President, Regulatory Affairs and Quality Assurance 9272 Jeronimo Road, Suite 124 Irvine, California 92618
Re: K173470
Trade/Device Name: ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: November 7, 2017 Received: November 8, 2017
Dear Mr. 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. Iisting 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
M. G. Hillemann
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) K173470
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.
| 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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3
510(K) SUMMARY
| Date prepared | November 7, 2017 |
|---|---|
| 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 devices | Inari ClotTriever Thrombectomy System (K163549) |
| 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 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. | |
| 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
Device modifications
The changes to the ClotTriever Thrombectomy System are:
- . Implement a collapsible clot collection bag
- Shortening the handle from approximately 23.5 cm to approximately 12.7 ● cm
- Switch to a 0.018" guidewire compatibility for the ClotTriever Catheter ●
There is no change of intended use or fundamental scientific technology between Summary of substantial equivalence the proposed 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
- Packaging Inspection ●
- Visual & Dimensional Inspections ●
- Guidewire Compatibility Verification ●
- Deployment Force Net/Coring Element from Delivery Catheter ●
- Retraction Force - Net/Coring Element into Delivery Catheter
- Retraction Force ClotTriever Catheter Thru ClotTriever Sheath ●
- Kink Resistance/ Radius Verification - ClotTriever Catheter
- Leakage Verification, ClotTriever Catheter ●
- Leakage Verification, ClotTriever Catheter ID with Guidewire in Place
- Simulated Use Track and Tensile ClotTriever Catheter ●
- Clot Burden Removal Test ●
- . Performance Test - Thrombus Removal Characterization
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.