(129 days)
No
The device description and performance studies focus on mechanical aspects of the device and do not mention any AI/ML components or algorithms.
Yes
The "Intended Use / Indications for Use" states that the device is for "The non-surgical removal of emboli and thrombi from blood vessels," which is a treatment for a medical condition. The "Device Description" further clarifies it for "the minimally invasive treatment of thromboemboli."
No
Explanation: The device is described as a "Thrombectomy System" indicated for the "non-surgical removal of emboli and thrombi from blood vessels" and for "injection, infusion, and/or aspiration of contrast media and other fluids." Its function is therapeutic (removing clots and fluid management), not diagnostic (identifying or characterizing a condition).
No
The device description clearly states it is a "catheter-based system" comprised of physical components (Sheath and Catheter) used for a minimally invasive procedure. The performance studies also detail testing of physical attributes like tensile strength and leak testing, indicating a hardware device.
Based on the provided information, the Mini-ClotTriever Thrombectomy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "non-surgical removal of emboli and thrombi 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 within the patient's body (in vivo), not on samples of bodily fluids or tissues outside the body (in vitro).
- Device Description: The description details a catheter-based system used for minimally invasive treatment within the peripheral vasculature. This further confirms its in vivo application.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
Therefore, the Mini-ClotTriever Thrombectomy System is a medical device used for therapeutic and procedural purposes within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mini-ClotTriever Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Mini-ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.
The Mini-ClotTriever Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.
Product codes (comma separated list FDA assigned to the subject device)
QEW
Device Description
The Mini-ClotTriever (“MCT”) Thrombectomy System is a single-use, over-the-wire, catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system is comprised of two main components packaged separately:
Mini-ClotTriever Sheath (8 Fr)
Mini-ClotTriever Catheter (8 Fr)
The MCT Sheath is placed in the target vessel, and, after its funnel is expanded, the MCT Catheter is inserted through the sheath and advanced past the thrombus. The MCT Catheter coring element is deployed to engage the clot and retracted into the MCT Sheath to capture the targeted thrombus. Additional clot may be removed by aspiration through the sheath with a syringe (not provided). After the procedure is complete, the MCT Catheter and MCT Sheath are removed from the patient.
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
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 Mini-ClotTriever. These tests included:
- Pouch Seal Visual Inspection and Dye Penetration
- Visual & Dimensional Inspection Delivery Catheter
- Visual & Dimensional Inspection Element Catheter
- Visual & Dimensional Inspection - Sheath
- Visual & Dimensional Inspection Dilator
- Guidewire Compatibility
- Coring Element Comparative Radial Force Testing
- Sheath Funnel Comparative Radial Force Testing
- Catheter Leak Testing
- Sheath Leak Testing
- Simulated Use, Pre-dilator
- Simulated Use, Sheath/Dilator
- Simulated Use, Catheter
- Simulated Use. System
- Retraction with Clot Analog
- Post Pre-Conditioning Leak Testing
- Sheath Shaft Side Loading
- Tensile Testing Sheath
- Tensile Testing Catheter
- Corrosion Testing
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Neither animal testing nor clinical testing were required for the determination of substantial equivalence.
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.
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.
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
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August 4, 2022
Inari Medical Ellen Nguyen Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618
Re: K220887
Trade/Device Name: Mini-ClotTriever Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW Dated: June 24, 2022 Received: June 27, 2022
Dear Ellen Nguyen:
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) K220887
Device Name Mini-ClotTriever Thrombectomy System
Indications for Use (Describe) The Mini-ClotTriever Thrombectomy System is indicated for:
· The non-surgical removal of emboli and thrombi from blood vessels.
· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Mini-ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.
The Mini-ClotTriever Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.
| 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
PAGE 1 OF 6
510(K) SUMMARY
| Date prepared | August 3, 2022 |
|---|---|
| Name | Inari Medical, Inc. |
| 6001 Oak Canyon, Suite 100 | |
| Irvine, CA 92618 | |
| 877.923.4747 | |
| Contact person | Ellen Nguyen |
| Regulatory Affairs Specialist | |
| Trade name | Mini-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 | Inari ClotTriever Thrombectomy System (K210689) |
| Reference device | Merit Medical Prelude Short Sheath Introducer (K082063) |
| Rex Medical Cleaner Rotational Thrombectomy System (K091029) | |
| Vesalio NeVa PV Thrombectomy Device (K201085) | |
| Description | The Mini-ClotTriever (“MCT”) Thrombectomy System is a single-use, over-the-wire, catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system is comprised of two main components packaged separately: |
| Mini-ClotTriever Sheath (8 Fr)Mini-ClotTriever Catheter (8 Fr)The MCT Sheath is placed in the target vessel, and, after its funnel is expanded, the MCT Catheter is inserted through the sheath and advanced past the thrombus. The MCT Catheter coring element is deployed to engage the clot and retracted into the MCT Sheath to capture the targeted thrombus. Additional clot may be removed by aspiration through the sheath with a syringe (not provided). After the procedure is complete, the MCT Catheter and MCT Sheath are removed from the patient. | |
| Indications for Use | The Mini-ClotTriever Thrombectomy System is indicated for: |
| The non-surgical removal of emboli and thrombi from blood vessels.Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. |
4
PAGE 2 OF 6
The Mini-ClotTriever Thrombectomy System is intended for use in the peripheral vasculature. The Mini-ClotTriever Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment. The proposed modifications to the ClotTriever Thrombectomy System include Device Modifications material, design, and dimensional changes to the sheath and catheter. The purpose for these modifications is to introduce the Mini-ClotTriever Thrombectomy System, a ClotTriever Thrombectomy System variant. The subject device and predicate device have a similar design and materials of Comparison of Technological construction. The modifications do not change the intended use or the principles of Characteristics operation from the predicate device. The ClotTriever and Mini-ClotTriever are with the both tracked over a pre-placed compatible guidewire. The Mini-ClotTriever Predicate Catheter performs mechanical thrombectomy (coring and entrapping clot and withdrawing through the sheath) following the same method as the predicate Device ClotTriever Catheter. Although the predicate and subject devices have different technological characteristics, all leveraged and performed design verification and validation tests confirm that these differences do not raise any new or different questions of safety or effectiveness. Summary of The Mini-ClotTriever System and ClotTriever System have the same indications for substantial use: both are indicated for the non-surgical removal of emboli and thrombi from blood vessels and the injection, infusion, and/or aspiration of contrast media and equivalence other fluids into or from a blood vessel. Both are intended for use in the peripheral vasculature, but unlike the predicate device, the Mini-ClotTriever is not indicated for use in treating deep vein thrombosis.
| Feature | Mini-ClotTriever
Thrombectomy System
(K220887) | ClotTriever
Thrombectomy System
Predicate (K210689) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Inari Medical | Inari Medical |
| Product code | QEW | QEW |
| Intended
use/Indications for
use | The Mini-ClotTriever
Thrombectomy System is
indicated for:
The non-surgical removal
of emboli and thrombi
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
indicated for:
The non-surgical
removal of emboli and
thrombi from blood
vessels. Injection, infusion,
and/or aspiration of
contrast media and
other fluids into or from
a blood vessel. |
| Feature | Mini-ClotTriever
Thrombectomy System
(K220887) | ClotTriever
Thrombectomy System
Predicate (K210689) |
| | The Mini-ClotTriever
Thrombectomy System is
intended for use in the peripheral
vasculature.
The Mini-ClotTriever
Thrombectomy System is not
intended for use in deep vein
thrombosis (DVT) treatment. | The ClotTriever
Thrombectomy System is
intended for use in the
peripheral vasculature
including deep vein
thrombosis (DVT). |
| Device description | The Mini-ClotTriever
Thrombectomy System consists
of the Mini-ClotTriever Sheath
and the Mini-ClotTriever
Catheter. The Mini-ClotTriever
Sheath is comprised of
reinforced polymeric coaxial
sheath shafts equipped with a
self-expanding distal mesh
funnel, a flush/aspiration port,
and a proximal hemostatic valve.
The Mini-ClotTriever Catheter
is comprised of reinforced
polymeric coaxial shafts
terminating in an expandable
nitinol coring element/collection
bag (basket). Other accessories
provided include a pre-dilator
and dilator. | The ClotTriever
Thrombectomy System
consists of the ClotTriever
Sheaths and the ClotTriever
Catheter. The ClotTriever
Sheaths are comprised of 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
accessories provided include
a pre-dilator, dilator, the
funnel loading tool, and a
Large Bore 60 cc syringe. |
| Principles of
operation | The Mini-ClotTriever Catheter
is advanced into the vessel
beyond the clot. The self-
expanding nitinol coring element
is deployed. The expanded
coring element cores, separates,
and entraps thrombus from the
vessel as it is being drawn to the
funnel opening of the Mini-
ClotTriever Sheath. The coring
element is pulled through the
Mini-ClotTriever Sheath with
the entrapped clot. A syringe
(not provided) can be used 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. |
| Feature | Mini-ClotTriever
Thrombectomy System
(K220887) | ClotTriever
Thrombectomy System
Predicate (K210689) |
| Target vessel | Peripheral vessels 4-10 mm | Peripheral vessels 6-16 mm |
| Contraindicated
vessels |