(129 days)
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.
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.
The provided text describes the 510(k) premarket notification for the Mini-ClotTriever Thrombectomy System. This submission focuses on demonstrating substantial equivalence to a predicate device (Inari ClotTriever Thrombectomy System, K210689) through non-clinical testing. It does not present a study proving the device meets acceptance criteria related to AI/algorithm performance.
The document primarily covers:
- Device Description: A mechanical thrombectomy system for non-surgical removal of emboli and thrombi from blood vessels in the peripheral vasculature.
- Comparison to Predicate: Details on the similarities and differences in design, materials, and operational principles between the Mini-ClotTriever and its predicate device.
- Non-Clinical Testing: A list of bench tests performed (e.g., biocompatibility, sterilization, dimensional inspections, simulated use, tensile testing, corrosion testing) to demonstrate that the device conforms to established product specifications and the modifications do not raise new questions of safety or effectiveness.
- Conclusion: The device is substantially equivalent to the predicate device based on non-clinical testing, and neither animal nor clinical testing was required for this determination.
Based on the provided text, none of the specific information requested about AI/algorithm acceptance criteria and performance (e.g., sample size for test sets, expert consensus, MRMC studies, standalone performance, training set details) can be extracted because the device is a medical instrument, not an AI/algorithm-based diagnostic or therapeutic tool for which such criteria would apply.
Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance. The document describes a mechanical device and its testing, not an AI study.
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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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PAGE 1 OF 6
510(K) SUMMARY
| Date prepared | August 3, 2022 |
|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618877.923.4747 |
| Contact person | Ellen NguyenRegulatory 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. |
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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-ClotTrieverThrombectomy System(K220887) | ClotTrieverThrombectomy SystemPredicate (K210689) |
|---|---|---|
| Manufacturer | Inari Medical | Inari Medical |
| Product code | QEW | QEW |
| Intendeduse/Indications foruse | The Mini-ClotTrieverThrombectomy System isindicated for:The non-surgical removalof emboli and thrombifrom blood vessels. Injection, infusion, and/oraspiration of contrastmedia and other fluids intoor from a blood vessel. | The ClotTrieverThrombectomy System isindicated for:The non-surgicalremoval of emboli andthrombi from bloodvessels. Injection, infusion,and/or aspiration ofcontrast media andother fluids into or froma blood vessel. |
| Feature | Mini-ClotTrieverThrombectomy System(K220887) | ClotTrieverThrombectomy SystemPredicate (K210689) |
| The Mini-ClotTrieverThrombectomy System isintended for use in the peripheralvasculature.The Mini-ClotTrieverThrombectomy System is notintended for use in deep veinthrombosis (DVT) treatment. | The ClotTrieverThrombectomy System isintended for use in theperipheral vasculatureincluding deep veinthrombosis (DVT). | |
| Device description | The Mini-ClotTrieverThrombectomy System consistsof the Mini-ClotTriever Sheathand the Mini-ClotTrieverCatheter. The Mini-ClotTrieverSheath is comprised ofreinforced polymeric coaxialsheath shafts equipped with aself-expanding distal meshfunnel, a flush/aspiration port,and a proximal hemostatic valve.The Mini-ClotTriever Catheteris comprised of reinforcedpolymeric coaxial shaftsterminating in an expandablenitinol coring element/collectionbag (basket). Other accessoriesprovided include a pre-dilatorand dilator. | The ClotTrieverThrombectomy Systemconsists of the ClotTrieverSheaths and the ClotTrieverCatheter. The ClotTrieverSheaths are comprised of areinforced polymeric sheathequipped with a self-expanding distal meshfunnel, a flush/aspirationport, and a proximalhemostatic valve. TheClotTriever Catheter iscomprised of reinforcedpolymeric coaxial shaftsterminating in an expandablecoring element and thrombuscollection bag. Otheraccessories provided includea pre-dilator, dilator, thefunnel loading tool, and aLarge Bore 60 cc syringe. |
| Principles ofoperation | The Mini-ClotTriever Catheteris advanced into the vesselbeyond the clot. The self-expanding nitinol coring elementis deployed. The expandedcoring element cores, separates,and entraps thrombus from thevessel as it is being drawn to thefunnel opening of the Mini-ClotTriever Sheath. The coringelement is pulled through theMini-ClotTriever Sheath withthe entrapped clot. A syringe(not provided) can be used forthe aspiration of clot in thesheath and the infusion ofcontrast media and other fluids. | The ClotTriever Catheter isadvanced into the vessel andbeyond the clot. The self-expanding braided nitinolwire net is deployed. Theexpanded net cores,separates, and entrapsthrombus from the vessel asit is being drawn to thefunnel opening of theClotTriever Sheath. The netis collapsed and pulled intoand through the ClotTrieverSheath with the entrappedclot. A 60 cc syringe isprovided for the aspiration ofclot in the sheath and theinfusion of contrast mediaand other fluids. |
| Feature | Mini-ClotTrieverThrombectomy System(K220887) | ClotTrieverThrombectomy SystemPredicate (K210689) |
| Target vessel | Peripheral vessels 4-10 mm | Peripheral vessels 6-16 mm |
| Contraindicatedvessels | < 4 mm | < 6 mm |
| Guidewirecompatibility | 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"IDInner shaft: 0.137" OD/0.110"IDLength: 6 cm | 16 Fr: 0.248" OD/0.215" ID13 Fr: 0.210" OD/0.182" IDLength: 15 cm |
| Shaft material | Pebax 55D, ProPellPTFE LinerStainless steel coilRadiopaque marker band | Pebax 72D and 63D, ProPellPTFE LinerStainless steel coilRadiopaque marker band |
| Outer shaft material | Pebax 40D and 25D, ProPellPTFE Liner | N/A |
| Hemostasis valve | 8 Fr Garrote valveRotating swivel hub with sideport | 13 or 16 Fr Garrote valveRotating swivel hub withside port |
| Handle | Slide actuator enclosed withinhandle housings | N/A |
| Braided funnel | OD: 10 mmLength: 0.70"Nitinol #2 Wire | OD: 14 mmLength: 0.90"Nitinol #2 Wire |
| Side port | Tygon tubing1-way stopcock with femaleLuer connector | Tygon tubingFlushing stopcock and quick-connect |
| Dilator | OD: 0.110"Working length: 17.8 cmTipped LDPE/HDPE extrusionDilator capProximal flush port | OD: 0.206" (16 Fr) or 0.178"(13 Fr)Working length: 26 cmPebax 55D and 72D, ProPellSlide actuator enclosedwithin handle housingsProximal flush portBraid cover/tip |
| Pre-Dilator | OD: 0.13" (10 Fr)Polypropylene, HDPELength: 10.2 cm | OD: 0.53" (16 Fr) or 0.64"(19 Fr)LDPE/HDPE |
| Feature | Mini-ClotTrieverThrombectomy System(K220887) | ClotTrieverThrombectomy SystemPredicate (K210689) |
| Length: 27 cm | ||
| Mini-ClotTriever Catheter | ||
| Delivery catheter(outer) | OD: 0.111"PTFE LinerSS304V BraidRadiopaque marker band | OD: 0.14"PTFE LinerSS304V BraidRadiopaque marker band |
| 63D Pebax Jacket63D Pebax Fluoro-safe markerbandProximal hub with Tuohy Borsthemostasis Y-valve and 1-waystopcock | 63D Pebax Jacket63D Pebax Fluoro-safemarker bandProximal hub withhemostasis valve and sideport with 1-way stopcock | |
| Middle catheter | Braided polyimideRadiopaque marker band | Braided polyimideRadiopaque marker band72D Pebax over-mold |
| Inner catheter | Braided polyimideRadiopaque 55D Pebax tip withProPell | Braided polyimideRadiopaque 72D Pebax,tungsten tip72D Pebax over-mold |
| Length | 65 cm | 80 cm |
| Coring element | Laser-cut nitinolOD: 18 mmLength: 88 mmNo collection bag | Laser-cut nitinolOD: 16 mmLength: 42 mmCollection bag length: 190mm |
| 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
PAGE 3 OF 6
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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.
§ 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).