Mini-ClotTriever Thrombectomy System
Device Facts
| Record ID | K220887 |
|---|---|
| Device Name | Mini-ClotTriever Thrombectomy System |
| Applicant | Inari Medical |
| Product Code | QEW · Cardiovascular |
| Decision Date | Aug 4, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Single-use, over-the-wire, catheter-based system for minimally invasive peripheral thrombectomy. Comprised of 8 Fr sheath with self-expanding distal mesh funnel and 8 Fr catheter with expandable nitinol coring element. Physician advances catheter over guidewire past thrombus; deploys coring element to core, separate, and entrap clot; retracts element through sheath to capture thrombus. Aspiration via syringe through sheath removes additional clot. Used in peripheral vasculature; operated by physicians. Output is physical removal of thrombus; visual confirmation via fluoroscopy (implied by radiopaque markers). Benefits include non-surgical clot removal, reducing need for invasive procedures.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing, including simulated use, tensile testing, leak testing, and comparative radial force testing.
Technological Characteristics
Materials: Pebax, PTFE, stainless steel, nitinol. Sensing/Actuation: Mechanical coring via laser-cut nitinol element. Energy: Manual. Dimensions: 8 Fr sheath, 65 cm length. Connectivity: None. Sterilization: EtO (ISO 11135).
Indications for Use
Indicated for non-surgical removal of emboli and thrombi from peripheral blood vessels (4-10 mm diameter) and injection/aspiration of fluids/contrast media. Not indicated for deep vein thrombosis (DVT) treatment.
Regulatory Classification
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.
Predicate Devices
- Inari ClotTriever Thrombectomy System (K210689)
Reference Devices
- Merit Medical Prelude Short Sheath Introducer (K082063)
- Rex Medical Cleaner Rotational Thrombectomy System (K091029)
- Vesalio NeVa PV Thrombectomy Device (K201085)
Submission Summary (Full Text)
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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
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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
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# 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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K220887
# PAGE 1 OF 6
# 510(K) SUMMARY
| Date prepared | August 3, 2022 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Inari Medical, Inc.<br>6001 Oak Canyon, Suite 100<br>Irvine, CA 92618<br>877.923.4747 |
| Contact person | Ellen Nguyen<br>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)<br>Rex Medical Cleaner Rotational Thrombectomy System (K091029)<br>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:<br>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:<br>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. |
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## 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<br>Thrombectomy System<br>(K220887) | ClotTriever<br>Thrombectomy System<br>Predicate (K210689) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Inari Medical | Inari Medical |
| Product code | QEW | QEW |
| Intended<br>use/Indications for<br>use | The Mini-ClotTriever<br>Thrombectomy System is<br>indicated for:<br>The non-surgical removal<br>of emboli and thrombi<br>from blood vessels. Injection, infusion, and/or<br>aspiration of contrast<br>media and other fluids into<br>or from a blood vessel. | The ClotTriever<br>Thrombectomy System is<br>indicated for:<br>The non-surgical<br>removal of emboli and<br>thrombi from blood<br>vessels. Injection, infusion,<br>and/or aspiration of<br>contrast media and<br>other fluids into or from<br>a blood vessel. |
| Feature | Mini-ClotTriever<br>Thrombectomy System<br>(K220887) | ClotTriever<br>Thrombectomy System<br>Predicate (K210689) |
| | The Mini-ClotTriever<br>Thrombectomy System is<br>intended for use in the peripheral<br>vasculature.<br>The Mini-ClotTriever<br>Thrombectomy System is not<br>intended for use in deep vein<br>thrombosis (DVT) treatment. | The ClotTriever<br>Thrombectomy System is<br>intended for use in the<br>peripheral vasculature<br>including deep vein<br>thrombosis (DVT). |
| Device description | The Mini-ClotTriever<br>Thrombectomy System consists<br>of the Mini-ClotTriever Sheath<br>and the Mini-ClotTriever<br>Catheter. The Mini-ClotTriever<br>Sheath is comprised of<br>reinforced polymeric coaxial<br>sheath shafts equipped with a<br>self-expanding distal mesh<br>funnel, a flush/aspiration port,<br>and a proximal hemostatic valve.<br>The Mini-ClotTriever Catheter<br>is comprised of reinforced<br>polymeric coaxial shafts<br>terminating in an expandable<br>nitinol coring element/collection<br>bag (basket). Other accessories<br>provided include a pre-dilator<br>and dilator. | The ClotTriever<br>Thrombectomy System<br>consists of the ClotTriever<br>Sheaths and the ClotTriever<br>Catheter. The ClotTriever<br>Sheaths are comprised of a<br>reinforced polymeric sheath<br>equipped with a self-<br>expanding distal mesh<br>funnel, a flush/aspiration<br>port, and a proximal<br>hemostatic valve. The<br>ClotTriever Catheter is<br>comprised of reinforced<br>polymeric coaxial shafts<br>terminating in an expandable<br>coring element and thrombus<br>collection bag. Other<br>accessories provided include<br>a pre-dilator, dilator, the<br>funnel loading tool, and a<br>Large Bore 60 cc syringe. |
| Principles of<br>operation | The Mini-ClotTriever Catheter<br>is advanced into the vessel<br>beyond the clot. The self-<br>expanding nitinol coring element<br>is deployed. The expanded<br>coring element cores, separates,<br>and entraps thrombus from the<br>vessel as it is being drawn to the<br>funnel opening of the Mini-<br>ClotTriever Sheath. The coring<br>element is pulled through the<br>Mini-ClotTriever Sheath with<br>the entrapped clot. A syringe<br>(not provided) can be used for<br>the aspiration of clot in the<br>sheath and the infusion of<br>contrast media and other fluids. | The ClotTriever Catheter is<br>advanced into the vessel and<br>beyond the clot. The self-<br>expanding braided nitinol<br>wire net is deployed. The<br>expanded net cores,<br>separates, and entraps<br>thrombus from the vessel as<br>it is being drawn to the<br>funnel opening of the<br>ClotTriever Sheath. The net<br>is collapsed and pulled into<br>and through the ClotTriever<br>Sheath with the entrapped<br>clot. A 60 cc syringe is<br>provided for the aspiration of<br>clot in the sheath and the<br>infusion of contrast media<br>and other fluids. |
| Feature | Mini-ClotTriever<br>Thrombectomy System<br>(K220887) | ClotTriever<br>Thrombectomy System<br>Predicate (K210689) |
| Target vessel | Peripheral vessels 4-10 mm | Peripheral vessels 6-16 mm |
| Contraindicated<br>vessels | < 4 mm | < 6 mm |
| Guidewire<br>compatibility | 0.035" | 0.035" |
| Shelf-life | 6 months | 2 years |
| Sterilization | EtO | EtO |
| Single-use | Yes | Yes |
| Mini-ClotTriever Sheath | | |
| Sheath dimensions | Outer shaft: 0.154" OD/0.137"<br>ID<br>Inner shaft: 0.137" OD/0.110"<br>ID<br>Length: 6 cm | 16 Fr: 0.248" OD/0.215" ID<br>13 Fr: 0.210" OD/0.182" ID<br>Length: 15 cm |
| Shaft material | Pebax 55D, ProPell<br>PTFE Liner<br>Stainless steel coil<br>Radiopaque marker band | Pebax 72D and 63D, ProPell<br>PTFE Liner<br>Stainless steel coil<br>Radiopaque marker band |
| Outer shaft material | Pebax 40D and 25D, ProPell<br>PTFE Liner | N/A |
| Hemostasis valve | 8 Fr Garrote valve<br>Rotating swivel hub with side<br>port | 13 or 16 Fr Garrote valve<br>Rotating swivel hub with<br>side port |
| Handle | Slide actuator enclosed within<br>handle housings | N/A |
| Braided funnel | OD: 10 mm<br>Length: 0.70"<br>Nitinol #2 Wire | OD: 14 mm<br>Length: 0.90"<br>Nitinol #2 Wire |
| Side port | Tygon tubing<br>1-way stopcock with female<br>Luer connector | Tygon tubing<br>Flushing stopcock and quick-<br>connect |
| Dilator | OD: 0.110"<br>Working length: 17.8 cm<br>Tipped LDPE/HDPE extrusion<br>Dilator cap<br>Proximal flush port | OD: 0.206" (16 Fr) or 0.178"<br>(13 Fr)<br>Working length: 26 cm<br>Pebax 55D and 72D, ProPell<br>Slide actuator enclosed<br>within handle housings<br>Proximal flush port<br>Braid cover/tip |
| Pre-Dilator | OD: 0.13" (10 Fr)<br>Polypropylene, HDPE<br>Length: 10.2 cm | OD: 0.53" (16 Fr) or 0.64"<br>(19 Fr)<br>LDPE/HDPE |
| Feature | Mini-ClotTriever<br>Thrombectomy System<br>(K220887) | ClotTriever<br>Thrombectomy System<br>Predicate (K210689) |
| | | Length: 27 cm |
| | Mini-ClotTriever Catheter | |
| Delivery catheter<br>(outer) | OD: 0.111"<br>PTFE Liner<br>SS304V Braid<br>Radiopaque marker band | OD: 0.14"<br>PTFE Liner<br>SS304V Braid<br>Radiopaque marker band |
| | 63D Pebax Jacket<br>63D Pebax Fluoro-safe marker<br>band<br>Proximal hub with Tuohy Borst<br>hemostasis Y-valve and 1-way<br>stopcock | 63D Pebax Jacket<br>63D Pebax Fluoro-safe<br>marker band<br>Proximal hub with<br>hemostasis valve and side<br>port with 1-way stopcock |
| Middle catheter | Braided polyimide<br>Radiopaque marker band | Braided polyimide<br>Radiopaque marker band<br>72D Pebax over-mold |
| Inner catheter | Braided polyimide<br>Radiopaque 55D Pebax tip with<br>ProPell | Braided polyimide<br>Radiopaque 72D Pebax,<br>tungsten tip<br>72D Pebax over-mold |
| Length | 65 cm | 80 cm |
| Coring element | Laser-cut nitinol<br>OD: 18 mm<br>Length: 88 mm<br>No collection bag | Laser-cut nitinol<br>OD: 16 mm<br>Length: 42 mm<br>Collection bag length: 190<br>mm |
| Proximal handle | No | Yes |
A tabular comparison of specific technological characteristics between the predicate and subject device is provided below:
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# K220887
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K220887
## Biocompatibility
The following biocompatibility tests were completed for the subject device:
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity .
- . Acute Systemic Toxicity
- Material-Mediated Pyrogenicity .
- Hemocompatibility (Hemolysis, Complement Activation, ● Thromboresistance, Platelet and Leukocyte Count, and Partial Thromboplastin Time)
The passing results demonstrate that the subject device and accessories meet biological safety requirements per ISO 10993-1.
## Sterilization
The subject device, including its accessories, is sterilized using EtO to achieve a sterility assurance level (SAL) of 106. The subject device has been adopted into a
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# PAGE 6 OF 6
validated sterilization process in accordance with the principles of ISO 11135:2014/Amd 1:2018 (Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices – Amendment 1: Revision of Annex E, Single batch release) and AAMI TIR 28:2016 (Product adoption and process equivalence for ethylene oxide sterilization) without deviations.
## 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.
## Conclusion
The Mini-ClotTriever Thrombectomy System has the same intended use and principles of operation as the predicate. Performance data shows that the different technological characteristics between the devices do not raise any new or different questions of safety or effectiveness. Non-clinical bench testing supports the Mini-ClotTriever's substantial equivalence to the predicate device.
