Triever20 Curve (21-201)
Device Facts
| Record ID | K231848 |
|---|---|
| Device Name | Triever20 Curve (21-201) |
| Applicant | Inari Medical, Inc. |
| Product Code | QEW · Cardiovascular |
| Decision Date | Jul 21, 2023 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Triever20 Curve (21-201) is used coaxially within the Triever24 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 Triever20 Curve (21-201) is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. The Triever20 Curve (21-201) Catheter is not indicated for use with FlowTriever Catheters. Triever20 Curve (21-201) is also intended for use in treating clot in transit in the right atrium, but not in conjunction with FlowTriever Catheters. The Triever20 Curve (21-201) must be used within the Triever24.
Device Story
Triever20 Curve (21-201) is a single-use, over-the-wire embolectomy catheter for minimally invasive treatment of thromboemboli. Device is inserted over a 0.035" guidewire through a Triever24 catheter to the thrombus site. Proximal hemostasis valve allows rotation to target the angled tip. After dilator removal, thrombus is aspirated using a 60 cc large-bore syringe. Used in peripheral vasculature, pulmonary arteries, and right heart. Operated by physicians in clinical settings. Modifications from reference device include length increase, material changes in shaft jacket and hemostasis valve, upgraded dilator, locking cap for garrote valve, and multifilar coil reinforcement. Benefits include effective clot removal via aspiration.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including simulated use (track, torque, tensile), vacuum resistance, clot burden removal validation, and biocompatibility (ISO 10993-1).
Technological Characteristics
Single-use, over-the-wire embolectomy catheter. Materials: Pebax 72D/55D/35D shaft, 304V stainless steel multifilar coil, polyblend/braided polyester hemostasis valve. Dimensions: 20 Fr OD, 111 cm length. 225° tip angle. Sterilization: EtO (ISO 11135). Connectivity: None.
Indications for Use
Indicated for non-surgical removal of emboli and thrombi from peripheral vasculature, pulmonary arteries, and right heart (clot in transit). Also for injection, infusion, or aspiration of fluids/contrast media. Contraindicated for vessels < 8 mm. Must be used coaxially within Triever24; not for use with FlowTriever catheters.
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 FlowTriever Retrieval/ Aspiration System (K213402)
Reference Devices
- Triever20 Curve (K203333)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 21, 2023
Inari Medical Inc. Anthony Lam Sr. Manager Regulatory Affairs 6001 Oak Canyon Suite 100 Irvine, CA 92618
Re: K231848
Trade/Device Name: Triever20 Curve (21-201) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: June 25, 2023 Received: June 26, 2023
## Dear Anthony Lam:
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 medical devices and radiation-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,
Digitally signed by Ariel Ariel G. Ash-G. Ash-shakoor -S Date: 2023.07.21 shakoor -S 14:56:23 -04'00'
For
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) K231848
Device Name Triever20 Curve (21-201)
Indications for Use (Describe) The Triever20 Curve (21-201) is used coaxially within the Triever24 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 Triever20 Curve (21-201) is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The Triever20 Curve (21-201) Catheter is not indicated for use with FlowTriever Catheters.
Triever20 Curve (21-201) is also intended for use in treating clot in transit in the right atrium, but not in conjunction with FlowTriever Catheters.
The Triever20 Curve (21-201) must be used within the Triever24.
Type of Use (Select one or both, as applicable)
| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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# 510(K) SUMMARY
| Date prepared | July 21, 2023 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Inari Medical, Inc.<br>6001 Oak Canyon, Suite 100<br>Irvine, CA 92618<br>949.600.8433 |
| Contact person | Anthony Lam<br>Sr. Manager Regulatory Affairs |
| Name of Device | Triever20 Curve (21-201) |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification<br>number | 21 CFR 870.5150 |
| Product code | QEW |
| Secondary Product<br>Code | KRA |
| Regulatory class | II |
| Predicate device | Inari Medical, Inari FlowTriever Retrieval/ Aspiration System (K213402)<br>This device has not been subject to a design-related recall. |
| Reference device | Inari Medical, Triever20 Curve (K203333) |
| Description | Triever20 Curve, Model 21-201 is a single-use over-the-wire catheter used for the<br>minimally invasive treatment of thromboemboli in the peripheral vasculature and the<br>treatment of pulmonary embolism. A Dilator is provided with the Triever20 Curve<br>Catheter to assist in its advancement over a preplaced 0.035" guidewire to the<br>proximal end of the obstruction (thrombus). The Triever24 Catheter is inserted<br>through an introducer sheath (not provided). After Triever24 Catheter placement, the<br>Dilator is removed. The Triever20 Curve Catheter is then inserted through the<br>Triever24 Catheter and advanced to the thrombus. Thrombus is removed by aspiration<br>with the provided 60 cc Large Bore Syringe. |
| Indications for Use | The Triever20 Curve (21-201) is used coaxially within the Triever24 for:<br>• The non-surgical removal of emboli and thrombi from blood vessels.<br>• Injection, infusion, and/or aspiration of contrast media and other fluids into or<br>from a blood vessel.<br>The Triever20 Curve (21-201) is intended for use in the peripheral vasculature and<br>for the treatment of pulmonary embolism.<br>The Triever20 Curve (21-201) Catheter is not indicated for use with FlowTriever<br>Catheters. |
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| Triever20 Curve (21-201) is also intended for use in treating clot in transit in the<br>right atrium, but not in conjunction with FlowTriever Catheters. | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Triever20 Curve (21-201) must be used within the Triever24. | | | |
| Device<br>Modifications | The device modifications associated with implementing the Triever20 Curve are:<br>A. Removed the Y-connector from the packaging<br>B. Increase in overall catheter length from 43.38" to 43.76"<br>C. Shaft jacket length change<br>D. Hemostasis valve septum and monofilament material change<br>E. Upgraded dilator<br>F. Garrote valve updated to include locking cap for the dilator<br>G. Tapered distal tip change<br>H. Replaced braid and coil with multifilar coil<br>I. Backer card changes | | |
| Comparison of<br>Technological<br>Characteristics with<br>the Predicate Device | The proposed modifications do not change the intended use or principles of operation<br>from the predicate device. The modified and reference device have a similar design<br>and mainly differ in dimensions and materials.<br><br>The modified Triever20 Curve and Triever20 Curve are both tracked over a pre-placed<br>compatible guidewire. The Triever20 Curve Generation 2 performs thrombectomy<br>using aspiration, following the same method as the reference Triever20 Curve.<br><br>Although the predicate and subject devices have different technological<br>characteristics, all leveraged and performed design verification and validation tests<br>confirm that these differences do not raise any new or different questions of safety or<br>effectiveness. | | |
| Summary of<br>substantial<br>equivalence | There is no change of intended use or fundamental scientific technology between the<br>proposed device, reference, and predicate device. Aside from device modifications,<br>the Triever20 Curve has the same indications for use as the predicate device,<br>K213402: both are indicated for the non-surgical removal of emboli and thrombi from<br>blood vessels and the injection, infusion, and/or aspiration of contrast media and other<br>fluids into or from a blood vessel. Both are intended for use in the peripheral<br>vasculature, for the treatment of pulmonary embolism, and for use in treating clot in<br>transit in the right atrium but not in conjunction with FlowTriever Catheters.<br>A tabular comparison of specific technological characteristics between the reference<br>and subject device is provided below: | | |
| | Feature | Triever20 Curve (21-201)<br>Proposed (K231848) | Triever20 Curve<br>Reference (K203333) |
| | Manufacturer | Inari Medical | Inari Medical |
| | Product code | QEW | QEW |
| | Intended<br>use/Indications<br>for use | The Triever20 Curve (21-201)<br>is used coaxially within the<br>Triever24 for:<br>The non-surgical removal<br>of emboli and thrombi from<br>blood vessels. Injection, infusion, and/or<br>aspiration of contrast media | The Triever20 Curve is used<br>coaxially within the Triever24<br>for:<br>The non-surgical removal of<br>emboli and thrombi from<br>blood vessels. Injection, infusion, and/or<br>aspiration of contrast media |
| | | | |
| | and other fluids into or from<br>a blood vessel. | and other fluids into or from<br>a blood vessel. | |
| | The Triever20 Curve (21-201)<br>is intended for use in the<br>peripheral vasculature and for<br>the treatment of pulmonary<br>embolism. | The Triever20 Curve is intended<br>for use in the peripheral<br>vasculature and for the treatment<br>of pulmonary embolism.<br>The Triever20 Curve Catheter is | |
| | The Triever20 Curve (21-201)<br>Catheter is not indicated for use<br>with FlowTriever Catheters. | not indicated for use with<br>FlowTriever Catheters. | |
| | Triever20 Curve (21-201) is<br>also intended for use in treating<br>clot in transit in the right atrium,<br>but not in conjunction with<br>FlowTriever Catheters. | | |
| | The Triever20 Curve (21-201)<br>must be used within the<br>Triever24. | | |
| Principles of<br>operation | The Triever20 Curve (21-201)<br>is inserted over a pre-placed<br>guidewire and through a<br>Triever24 Catheter to a location<br>proximal of the targeted<br>thrombus. The proximal<br>hemostasis valve can be rotated<br>to assist targeting the angled tip.<br>After removing the dilator,<br>thrombus aspiration can be<br>performed using the 60 cc Large<br>Bore Syringe. FlowTriever<br>Catheters can be used for<br>mechanical thrombectomy by<br>removing the Triever20 Curve<br>and either: 1) deploying directly<br>through the Triever24; or 2)<br>replacing the Triever24 with a<br>Triever20 and then deploying<br>the FlowTriever Catheter. | The Triever20 Curve is inserted<br>over a pre-placed guidewire and<br>through a Triever24 Catheter to a<br>location proximal of the targeted<br>thrombus. The proximal<br>hemostasis valve can be rotated<br>to assist targeting the angled tip.<br>After removing the dilator,<br>thrombus aspiration can be<br>performed using the 60 cc Large<br>Bore Syringe. FlowTriever<br>Catheters can be used for<br>mechanical thrombectomy by<br>removing the Triever20 Curve<br>and either: 1) deploying directly<br>through the Triever24; or 2)<br>replacing the Triever24 with a<br>Triever20 and then deploying the<br>FlowTriever Catheter. | |
| Target vessel | Peripheral vessels ≥ 8 mm,<br>pulmonary arteries, right heart,<br>IVC | Peripheral vessels ≥ 8 mm,<br>pulmonary arteries, right heart,<br>IVC | |
| Contraindicated<br>vessels | < 8 mm | < 8 mm | |
| Guidewire<br>compatibility | 0.035" | 0.035" | |
| Shelf-life | 6 months | 2 years | |
| Sterilization | EtO | EtO | |
| Single-use | Yes | Yes | |
| | Catheter | | |
| Dimensions | OD/ID: 20 Fr (6.8 mm)/5.6 mm | OD/ID: 20 Fr (6.8 mm)/5.6 mm | |
| | Length: 111 cm | Length: 110 cm | |
| Shaft material | Proximal: Pebax 72D<br>Middle: Pebax 55D<br>Distal: Pebax 35D<br>Tip: 72D | Proximal: Pebax 72D<br>Middle: Pebax 55D<br>Distal: Pebax 35D<br>Tip: 72D | |
| Shaft support | 304V Stainless Steel Multifilar<br>Coil | 304V Stainless Steel braid and<br>coil | |
| Hemostasis valve | Septum: Polyblend/adhesive<br>Monofilament: Braided<br>polyester | Septum: Braid/silicone<br>Monofilament: Nylon | |
| Tip angle | 225° | 225° | |
| Dilator | | | |
| Length | 112 cm | 111.65 cm | |
| Materials | Pebax 55D with ProPell<br>Pebax 35D with ProPell | LDPE/HDPE | |
| Handle | Overmolded locking hub | Luer connection | |
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# K231848
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