(148 days)
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 a single-use, sterile medical device designed to remove thrombi and emboli from the peripheral vasculature. The ClotTriever Thrombectomy System consists of ClotTriever 13 Fr and 16 Fr Sheaths and Protrieve Sheath ("Sheath"), and the ClotTriever/ClotTriever Bold Catheter (“Catheter"), each packaged separately.
The sheath is an introducer sheath with a distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60 cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC).
The provided text is a 510(k) summary for the Protrieve Sheath, a medical device. It details the device's technical characteristics and the non-clinical testing performed to establish substantial equivalence to a predicate device.
Crucially, this document states: "Clinical testing was not required to support substantial equivalence." This means there was no clinical study involving human subjects for this specific submission to prove the device meets performance criteria, especially as it relates to AI/machine learning performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML device, as the provided document does not pertain to an AI/ML device or a clinical study for performance.
The acceptance criteria mentioned in the document relate to the non-clinical (engineering and material) testing of the physical device to demonstrate mechanical and material properties are consistent with the predicate device, not performance benchmarks for an AI algorithm.
If you would like to know about the non-clinical acceptance criteria and the tests performed for this specific device, I can provide that information based on the text. However, it will not involve AI/ML performance, ground truth, expert consensus, or clinical effectiveness studies in the way your prompt describes.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 12, 2022
Inari Medical, Inc. Kaitlyn Weinkauf Sr. Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618
Re: K220415
Trade/Device Name: Protrieve Sheath Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: June 8, 2022 Received: June 9, 2022
Dear Kaitlyn Weinkauf:
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
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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) 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 (OS) 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) K220415
Device Name Protrieve Sheath
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 Thrombectorny System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
| 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 | July 11, 2022 |
|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618949-600-8433 |
| Contactperson | Kaitlyn WeinkaufSr. Regulatory Affairs Specialist |
| Name ofDevice | ClotTriever® Thrombectomy System |
| Device TradeName | Protrieve™ Sheath |
| Commonname | Embolectomy catheter |
| Regulationname | Embolectomy catheter |
| Classificationnumber | 21 CFR 870.5150 |
| Primaryproduct code | QEW |
| Secondaryproduct code | KRA |
| Regulatoryclass | II |
| Predicatedevice | ClotTriever Thrombectomy System (K212632) |
| Referencedevice | Triever24 Catheter (K191710)Triever20 Catheter (K211013, K173672) |
| Description | The ClotTriever Thrombectomy System is a single-use, sterile medical device designed to removethrombi and emboli from the peripheral vasculature. The ClotTriever Thrombectomy Systemconsists of ClotTriever 13 Fr and 16 Fr Sheaths and Protrieve Sheath ("Sheath"), and theClotTriever/ClotTriever Bold Catheter (“Catheter"), each packaged separately.The sheath is an introducer sheath with a distal self-expanding funnel, aspiration port, andproximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other providedaccessories include a 60 cc large bore syringe that provides a vacuum source and collects aspiratedcontents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilatortip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Targetvessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior venacava (IVC), and superior vena cava (SVC). |
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| Indications for Use | The introduction of the Protrieve Sheath variant does not change the indications for use of theClotTriever Thrombectomy System. | ||
|---|---|---|---|
| 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 bloodvessel. | |||
| The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature includingdeep vein thrombosis (DVT). | |||
| Devicemodifications | The purpose of this submission is to introduce a ClotTriever Sheath variant, the Protrieve Sheath,that is larger in diameter and comes in two additional lengths. | ||
| There have been no changes to the ClotTriever 13 Fr and 16 Fr Sheaths, the ClotTriever Catheteror the ClotTriever Bold Catheter. | |||
| ComparisonofTechnologicalCharacteristicswith thePredicateDevice | The proposed device and predicate device have a similar design and materials of construction.With the exception of the modifications to the sheath ID/OD, dilator OD, sheath/dilator overalllength, sheath/dilator durometer, funnel OD, and the funnel being preloaded in the sheath covershaft, the predicate and proposed devices are the same. These modifications do not change thebasic design or the principles of operation from the predicate device. There are no new questionsof safety or efficacy. See table below for the comparison of the technological characteristics of theProtrieve Sheath with the predicate device.There is no change of intended use or fundamental scientific technology between the proposeddevice and predicate device. The changes made for the Protrieve Sheath do not change thetechnological characteristics of the ClotTriever Thrombectomy System.There have been no changes made to the ClotTriever Catheter or the ClotTriever Bold Catheter. | ||
| Device | Protrieve Sheath (Proposed) | ClotTriever Thrombectomy SystemPredicate (K212632) | |
| Manufacturer | Inari Medical | Inari Medical | |
| Product Code | QEW | QEW | |
| Intended Use | Removal of thrombus and emboli from, andinfusion of fluids into, the peripheralvasculature. | Removal of thrombus and embolifrom, and infusion of fluids into, theperipheral vasculature. | |
| Indications forUse | The ClotTriever Thrombectomy System isindicated for:• The non-surgical removal of thrombi andemboli from blood vessels.• Injection, infusion, and/or aspiration ofcontrast media and other fluids into or from ablood vessel. | The ClotTriever ThrombectomySystem is indicated for:• The non-surgical removal of thrombiand emboli from blood vessels.• Injection, infusion, and/or aspirationof contrast media and other fluids intoor from a blood vessel.The ClotTriever ThrombectomySystem is intended for use in the | |
| Page 3 of 6 | |||
| ComparisonofTechnologicalCharacteristicswith thePredicateDevice | DeviceDescription | The ClotTriever Thrombectomy System isintended for use in the peripheral vasculatureincluding deep vein thrombosis (DVT).The ClotTriever Thrombectomy System is asingle-use, sterile medical device designed toremove thrombi and emboli from theperipheral vasculature. The ClotTrieverThrombectomy System consists ofClotTriever 13 Fr, 16 Fr, and 20 Fr Sheaths("Sheath") and the ClotTriever/ClotTrieverBold Catheter ("Catheter"), each packagedseparately.The sheath is an introducer sheath with adistal self-expanding funnel, aspiration port,and proximal hub. A dilator is provided to aidinsertion and positioning of the sheath. Otherprovided accessories include a 60 cc largebore syringe that provides a vacuum sourceand collects aspirated contents. Radiopaquemarkers aid sheath positioning underfluoroscopic visualization. The dilator tip isradiopaque, and there is a radiopaque markerband near the distal end of the sheath. | peripheral vasculature including deepvein thrombosis (DVT).The ClotTriever ThrombectomySystem is a single-use, sterile medicaldevice designed to remove thrombiand emboli from the peripheralvasculature. The ClotTrieverThrombectomy System consists ofClotTriever 13 Fr and 16 Fr Sheaths("Sheath") and theClotTriever/ClotTriever Bold Catheter("Catheter"), each packagedseparately.The sheath is an introducer sheathwith a distal self-expanding funnel,aspiration port, and proximal hub. Adilator is provided to aid insertion andpositioning of the sheath. Otherprovided accessories include a 60 cclarge bore syringe that provides avacuum source and collects aspiratedcontents. Radiopaque markers aidsheath positioning under fluoroscopicvisualization. The dilator tip isradiopaque, and there is a radiopaquemarker band near the distal end of thesheath. |
| Principles ofOperation | The ClotTriever/ClotTriever Bold Catheter isadvanced into the vessel and beyond the clot.The self-expanding braided nitinol wire net isdeployed. The expanded net cores, separates,and entraps thrombus from the vessel as it isbeing drawn to the funnel opening of theClotTriever Sheath/ClotTriever 20 Fr Sheath.The net is collapsed and pulled into andthrough the ClotTriever Sheath with theentrapped clot. A 60 cc syringe is providedfor the aspiration of clot in the sheath and theinfusion of contrast media and other fluids. | The ClotTriever/ClotTriever BoldCatheter is advanced into the vesseland beyond the clot. The self-expanding braided nitinol wire net isdeployed. The expanded net cores,separates, and entraps thrombus fromthe vessel as it is being drawn to thefunnel opening of the ClotTrieverSheath. The net is collapsed andpulled into and through theClotTriever Sheath with the entrappedclot. A 60 cc syringe is provided forthe aspiration of clot in the sheath andthe infusion of contrast media andother fluids. | |
| Sheath ShaftMaterials | Proximal segment:Pebax 4533 (45D) SA 01 MED, 4% Violet CHydrophilic CoatingDistal segment:Pebax 3533 (35D) SA 01 MED, Propell, 4%Violet C | Proximal segment:Pebax 6333 (63D) SA 01 MED;Propell, 20% Barium Sulfate, 4%Violet CDistal segment:Pebax 7233 (72D) SA 01 MED;Propell, 20% Barium Sulfate,4%Violet C | |
| Sheath Shaft ID/OD | ID: 0.270"OD: 0.345" | ID: 0.215"OD: 0.248" | |
| Sheath Shaft Length | Model 60-100Overall Length: 72 cmEffective Length: 54 cmModel 60-101Overall Length: 50cmEffective Length: 32cm | Overall Length: 32 cmEffective Length: 15 cm | |
| Sheath Hub Materials | Model 60-100Santoprene 251-70W232 +Lexan HP1-112, PolycarbonateModel 60-101Santoprene 251-70W232 +Makrolon RX2530, Polycarbonate | Makrolon RX2530, Polycarbonate | |
| Mesh Funnel | 0.0067" Nitinol wire | 0.0055" Nitinol wire | |
| Mesh Funnel Length | Length: 1.24" | Length: 0.90" | |
| Mesh Funnel OD | OD: 33.5 mm | OD: 14 mm | |
| Dilator Materials | HDPE DMDA 8920+, 2% Titanium dioxideLDPE 640i, 20% Barium sulfate, 2%Titanium dioxideABS, Cool Gray 6C | Pebax 72D, SA01 MED, Polyetherblock amide; 2% Titanium dioxidePebax 55D SA01 MED, Polyetherblock amide; 20% Barium sulfate, 2%Titanium dioxide, PropellPebax 72D SA01 MED, Polyetherblock amide; 20% Barium sulfate, 2%Titanium dioxide, Propell | |
| Dilator OD | OD: 0.264" | OD: 0.206" | |
| Dilator Length | Model 60-100Length: 80 cmModel 60-101Length: 58 cm | Length: 25 cm | |
| Hemostasis Valve | Tube Septum: Polyblend 1100-45A,Thermoplastic Polyurethane Elastomer Alloy,Loctite AdhesiveMonofilament: Braided PolyethyleneTerephthalate (Polyester) | Tube Septum: Silicone, BraidedNitinol #2, Silicone AdhesiveMonofilament: Nylon | |
| Sideport Tubing with Stopcock and Quick Connect | Yes | Yes | |
| Guidewire compatibility | 0.035" | 0.035" |
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| Page 5 of 6 | |||
|---|---|---|---|
| ------------- | -- | -- | -- |
| Large Bore 60ccSyringe accessory | Large Bore 60cc Syringe Gen. 2: Spring-loaded release tab that self-locks to maintainthe retracted position | Large Bore 60cc Syringe: Manualrotation of plunger to maintain thefully retracted position | |
|---|---|---|---|
| Shelf-Life | 2 years | 2 years | |
| Sterile | SAL 10-6, EO | SAL 10-6, EO | |
| How provided | Sterile, single use | Sterile, single use | |
| Summary ofsubstantialequivalence | The proposed device, the Protrieve Sheath, and the predicate device, the ClotTriever 16 Fr Sheath,have the same indications for use, intended use, principles of operation, and fundamental scientifictechnology. | ||
| Non-Clinical Testing | |||
| In accordance with the design failure modes and effects analysis, verification and validation testswere identified to support the substantial equivalence of the Protrieve Sheath to the predicate device.This testing demonstrated compliance with relevant product specifications. | |||
| The following tests were performed on the proposed device to establish substantial equivalence: | |||
| ● Pouch Seal Visual Inspection and Dye Penetration● Usability● Visual and Dimensional Inspection● Radial Force● Guidewire Compatibility● Insertion/Retraction Force● Deployment/Retraction Force● Locking Cap Force and Unlocking Cap Torque● Kink Radius● Simulated Use, Track - Insertion Verification & Retraction Force of ClotTriever Catheterthrough Sheath● Dye Stain● Lubricity and Durability● Fluid Leakage● Air Leakage● Vacuum Testing● Push-Button Force Testing● Priming Volume● Flow Test● Dilator Retraction through Clot Analog● Clot Burden Removal● Burst Testing – Garrote Valve● Simulated Use, Track, Tensile & Torque - Sheath and Dilator● Simulated Use, Track, Rotation. & Torque – Garrote Valve● Simulated Use, Track, Rotation, & Torque Resistance - Sheath● Placement Resistance● Corrosion Resistance● Particulate Matter● Small Bore Connector Test |
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| Pouch peel and seal strength testing was leveraged from the Inari Medical Triever20 Catheter (K173672). The following testing was leveraged from K192036: |
|---|
| Visual and Dimensional Inspection ( non-affected components ) Burst Testing – Flushing Stopcock Torque Testing – Flushing Stopcock Vacuum Testing – Flushing Stopcock Sterilization Validation |
| The following biocompatibility tests were performed on the proposed device as suggested by ISO 10993-1: |
| Cytotoxicity Sensitization Intracutaneous Reactivity Toxicity Pyrogenicity Hemocompatibility – Hemolysis Hemocompatibility – Complement Activation Hemocompatibility – Thrombogenicity ( in vivo ) Hemocompatibility – Thrombogenicity ( in vitro ) (Platelet and Leukocyte) Hemocompatibility – Thrombogenicity ( in vitro ) (Partial Thromboplastin Time Test) |
| Clinical testing was not required to support substantial equivalence. |
| Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications. |
| Conclusion |
| The proposed device modifications to the ClotTriever Thrombectomy System do not change its intended use nor do they change the principles of operation. The verification and validation results demonstrate that the proposed Protrieve Sheath is substantially equivalent 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).