(65 days)
ClotTriever Thrombectomy System (K210190)
No
The description focuses on the mechanical components and function of the device for thrombus removal. There is no mention of AI/ML, image processing, or data-driven analysis.
Yes
The device is intended for the non-surgical removal of thrombi and emboli from blood vessels, which is a therapeutic intervention to treat a medical condition (e.g., deep vein thrombosis).
No
The device is described as a thrombectomy system intended for the non-surgical removal of thrombi and emboli from blood vessels, which is a therapeutic function, not a diagnostic one. While it uses fluoroscopic visualization, this is for guidance during the procedure, not for diagnosing a condition.
No
The device description clearly outlines physical components such as a sheath, catheter, ports, and accessories, indicating it is a hardware-based medical device.
Based on the provided information, the ClotTriever Thrombectomy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use 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 involves direct interaction with the patient's circulatory system for therapeutic and diagnostic imaging purposes, not for testing samples in vitro (outside the body).
- Device Description: The device is described as a system of catheters and sheaths designed for insertion into blood vessels to physically remove clots or deliver/remove fluids. This is consistent with an interventional medical device used in vivo.
- Anatomical Site: The device is used in the peripheral vasculature, which is within the patient's body.
- Input Imaging Modality: Fluoroscopic visualization is used to guide the device within the body.
- Performance Studies: The non-clinical testing described focuses on the physical properties and functionality of the device itself (e.g., leak testing, tensile testing, in vivo functional testing), not on the performance of a diagnostic test on biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The ClotTriever Thrombectomy System operates directly within the patient's body for therapeutic and procedural purposes.
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 intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
Product codes (comma separated list FDA assigned to the subject device)
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. 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
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 (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 pre-dilator. This testing demonstrated compliance with relevant product specifications. These tests included: Visual and Dimensional Inspection Guidewire Compatibility Leak Testing Simulated Use Insertion/Kink Radius Testing Tensile Testing In Vivo Functional Testing/Radiopacity Verification The following testing was leveraged from K163549: Pouch Seal Visual Inspection and Dye Penetration Pouch, Peel, Seal Strength Sterilization Validation Clinical testing was not required for the determination of substantial equivalence. Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
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.
ClotTriever Thrombectomy System (K210190)
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.
Cook Incorporated Dilator Sets (K183036)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 12, 2021
Inari Medical, Inc. Larry Boucher Regulatory Affairs Manager 9 Parker. Suite 100 Irvine, California 92618
Re: K210689
Trade/Device Name: ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: March 15, 2021 Received: March 16, 2021
Dear Larry Boucher:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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
2
Indications for Use
510(k) Number (if known) K210689
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 intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
|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 | March 15, 2021 |
|---|---|
| Name | Inari Medical, Inc. |
| 9 Parker, Suite 100 | |
| Irvine, CA 92618 | |
| 949.600.8433 x114 | |
| Contact person | Larry Boucher |
| Regulatory Affairs Manager | |
| 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 | ClotTriever Thrombectomy System (K210190) |
| Reference Device | Cook Incorporated Dilator Sets (K183036) |
| 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. 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 | |
| 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 | A pre-dilator that can be inserted into and dilate the target vessel prior to |
| the insertion of the ClotTriever Sheath will be provided with the ClotTriever system: | |
| A 16 Fr pre-dilator will be included with the 13 Fr ClotTriever Sheath A 19 Fr pre-dilator will be included with the 16 Fr ClotTriever Sheath The purpose for providing the pre-dilator is to assure its availability for the ClotTriever thrombectomy procedure. | |
| Summary of | |
| substantial | |
| equivalence | The ClotTriever pre-dilator and the predicate device have the same intended use: To be used for dilating puncture sites or catheter tracts for percutaneous placement of devices. |
The addition of the pre-dilator does not change the intended use of the ClotTriever Thrombectomy System: removal of thrombus and emboli from and infusion of fluids into the peripheral vasculature. |
| | 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 pre-dilator. This testing demonstrated compliance with relevant product specifications. These tests included: Visual and Dimensional Inspection Guidewire Compatibility Leak Testing Simulated Use Insertion/Kink Radius Testing Tensile Testing In Vivo Functional Testing/Radiopacity Verification The following testing was leveraged from K163549: Pouch Seal Visual Inspection and Dye Penetration Pouch, Peel, Seal Strength Sterilization Validation Clinical testing was not required for the determination of substantial equivalence.
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications. |
| | Conclusion
The proposed device modification to the ClotTriever Thrombectomy System does not change its intended use nor does it change the principles of operation. With consideration of the results of the testing, it can be concluded that the proposed pre-dilator is substantially equivalent to the predicate device. |
4
5
| Device | ClotTriever Thrombectomy System
Proposed (TBD) | ClotTriever Thrombectomy System
Predicate (K210190) | Cook Inc. Dilator Sets
Reference (K183036) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Inari Medical | Inari Medical | Cook Inc. |
| Product code | QEW, DRE | QEW | DRE |
| Intended use | Removal of thrombus and emboli from, and infusion of
fluids into, the peripheral vasculature. | Removal of thrombus and emboli from, and infusion of
fluids into, the peripheral vasculature. | Intended to be used for dilating puncture sites or
catheter tracts for percutaneous placement of devices
for vascular and non-vascular applications such as in
the venous, arterial, biliary and renal systems. |
| 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). | 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). | Intended to be used for dilating puncture sites or
catheter tracts for percutaneous placement of devices
for vascular and non-vascular applications such as in
the venous, arterial, biliary and renal systems. |
| Device Description | 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. Other provided accessories
include a pre-dilator, the funnel loading tool and a Large
Bore 60 cc syringe | 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. Other provided accessories
include the funnel loading tool and a Large Bore 60 cc
syringe | Cook Dilator Sets are used percutaneously to dilate
puncture sites or catheter tracts, thereby facilitating
the placement of other therapeutic or diagnostic
devices into a natural body space (e.g., the peritoneal
cavity, an artery or vein) for various vascular or non-
vascular clinical applications. The dilator component of
the Dilator Sets is available in diameters ranging from
3.0 to 26.0 French and in lengths ranging from 6 to 65
cm. The broad range of dilator sizes accommodates the
variation in the size of the K183036 devices that could
be inserted through the initial access site. |
6
| Device | ClotTriever Thrombectomy System
Proposed (TBD) | ClotTriever Thrombectomy System
Predicate (K210190) | Cook Inc. Dilator Sets
Reference (K183036) |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Principles of operation | The ClotTriever Catheter is advanced into the vessel and
beyond the clot. The self-expanding braided nitinol wire net
is deployed. The expanded net cores, separates, and entraps
thrombus from the vessel as it is being drawn to the funnel
opening of the ClotTriever Sheath. The net is collapsed and
pulled into and through the ClotTriever Sheath with the
entrapped clot. A 60 cc syringe is provided for the aspiration
of clot in the sheath and the infusion of contrast media and
other fluids. | The ClotTriever Catheter is advanced into the vessel and
beyond the clot. The self-expanding braided nitinol wire net
is deployed. The expanded net cores, separates, and entraps
thrombus from the vessel as it is being drawn to the funnel
opening of the ClotTriever Sheath. The net is collapsed and
pulled into and through the ClotTriever Sheath with the
entrapped clot. A 60 cc syringe is provided for the aspiration
of clot in the sheath and the infusion of contrast media and
other fluids. | The dilator is advanced over a standard 0.035"
guidewire into the access site prior to placement of a
therapeutic or diagnostic device. |
| Guidewire compatibility | 0.035" | 0.035" | 0.035" |
| How provided | Sterile, single use | Sterile, single use | Sterile, single use |
| Pre-dilator | 13 Fr ClotTriever Sheath: 16 Fr Pre-dilator
16 Fr ClotTriever Sheath: 19 Fr Pre-dilator | Recommended accessory | 3 Fr to 26 Fr |
| Pre-dilator material | LDPE/HDPE | Not provided | LDPE/HDPE |