(28 days)
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.
Triever20 Curve, Model 21-201 is a single-use over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature and the treatment of pulmonary embolism. A Dilator is provided with the Triever20 Curve Catheter to assist in its advancement over a preplaced 0.035" guidewire to the proximal end of the obstruction (thrombus). The Triever24 Catheter is inserted through an introducer sheath (not provided). After Triever24 Catheter placement, the Dilator is removed. The Triever20 Curve Catheter is then inserted through the Triever24 Catheter and advanced to the thrombus. Thrombus is removed by aspiration with the provided 60 cc Large Bore Syringe.
The provided text is a 510(k) summary for the Triever20 Curve (21-201) device, which is an embolectomy catheter. The document focuses on demonstrating substantial equivalence to a predicate device (Inari FlowTriever Retrieval/Aspiration System K213402) and a reference device (Inari Medical, Triever20 Curve K203333), highlighting physical and material modifications.
The vast majority of the "study" described in this document is non-clinical bench testing to verify the device's physical and functional properties. It is not an AI/ML-based device, so the sections on ground truth, MRMC studies, training/test sets, and expert adjudication are not applicable here.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a typical "acceptance criteria vs. performance" table in the context of clinical outcomes or AI model performance. Instead, it lists numerous non-clinical tests and states that "Test results demonstrated that all acceptance criteria were met; the device conforms to established product specifications."
Here are examples of the non-clinical tests mentioned, and what their acceptance criteria would generally imply:
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Pouch Seal Visual Inspection | No visible defects, proper seal integrity. | Met acceptance criteria. |
| Bubble Leak Test | No detectable leaks. | Met acceptance criteria. |
| Dye Penetration | No dye penetration, indicating seal integrity. | Met acceptance criteria. |
| Packaging Integrity, Visual Inspection | Intact packaging, no damage. | Met acceptance criteria. |
| Visual and Dimensional | Within specified tolerance for all dimensions and visual attributes. | Met acceptance criteria. |
| Dilator Compatibility | Proper fit and function with the catheter. | Met acceptance criteria. |
| T20 Curve Dilator Insertion and Removal | Smooth insertion and removal without damage or excessive force. | Met acceptance criteria. |
| T20 Curve Insertion and Retraction from T24/Protrieve | Smooth insertion and retraction without damage or excessive force, proper coaxial use. | Met acceptance criteria. |
| T20 Curve Rotation within T24/Protrieve | Smooth rotation, proper targeting of angled tip. | Met acceptance criteria. |
| T20 Curve Recovery Angle | Returns to specified angle after bending. | Met acceptance criteria. |
| Kink Radius | Withstands kinking to a specified radius without permanent deformation or occlusion. | Met acceptance criteria. |
| Torque Testing | Withstands specified torque without failure or excessive deformation. | Met acceptance criteria. |
| Simulated Use Track & Tensile (catheter tested) | Maintains integrity and function during simulated use, withstands tensile forces. | Met acceptance criteria. |
| Simulated Use Track & Torque (catheter tested) | Maintains integrity and function during simulated use, withstands torque. | Met acceptance criteria. |
| Clot Burden Removal Validation | Demonstrates effective aspiration/removal of clot in a simulated environment. | Met acceptance criteria. |
| Vacuum Testing Resistance to collapse under vacuum | Maintains patency under negative pressure. | Met acceptance criteria. |
| Determination of Flowrate Through Catheter & Dilator | Meets specified flow rate for contrast media/fluid aspiration/injection. | Met acceptance criteria. |
| Particulate Matter Determination | Particulate levels below specified limits. | Met acceptance criteria. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test, but it would be physical samples of the device and its components. For bench testing, sample sizes are typically determined by statistical methods or industry standards.
- Data Provenance: The study described is non-clinical (bench testing). There is no patient data involved, therefore no country of origin or retrospective/prospective distinction.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is a non-clinical device that does not use AI/ML. The "ground truth" for the tests would be based on engineering specifications, physical measurements, and functional benchmarks. No human experts are establishing "ground truth" in the clinical imaging interpretation sense.
4. Adjudication method for the test set:
Not applicable as this is a non-clinical device. Bench test results are typically recorded and verified by engineers according to test protocols.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This is a physical medical device (catheter), not an AI/ML diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" (or more accurately, the reference standard) for this device's performance is based on engineering specifications, physical measurements, and functional performance benchmarks established through design validation testing. For example, a "clot burden removal validation" test would use a standardized clot model and measure the amount of clot removed, with the "ground truth" being the pre-defined effectiveness threshold.
8. The sample size for the training set:
Not applicable. There is no AI/ML component, so no "training set."
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML component.
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
| Date prepared | July 21, 2023 |
|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618949.600.8433 |
| Contact person | Anthony LamSr. Manager Regulatory Affairs |
| Name of Device | Triever20 Curve (21-201) |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classificationnumber | 21 CFR 870.5150 |
| Product code | QEW |
| Secondary ProductCode | KRA |
| Regulatory class | II |
| Predicate device | Inari Medical, Inari FlowTriever Retrieval/ Aspiration System (K213402)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 theminimally invasive treatment of thromboemboli in the peripheral vasculature and thetreatment of pulmonary embolism. A Dilator is provided with the Triever20 CurveCatheter to assist in its advancement over a preplaced 0.035" guidewire to theproximal end of the obstruction (thrombus). The Triever24 Catheter is insertedthrough an introducer sheath (not provided). After Triever24 Catheter placement, theDilator is removed. The Triever20 Curve Catheter is then inserted through theTriever24 Catheter and advanced to the thrombus. Thrombus is removed by aspirationwith the provided 60 cc Large Bore Syringe. |
| 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 orfrom a blood vessel.The Triever20 Curve (21-201) is intended for use in the peripheral vasculature andfor the treatment of pulmonary embolism.The Triever20 Curve (21-201) Catheter is not indicated for use with FlowTrieverCatheters. |
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| Triever20 Curve (21-201) is also intended for use in treating clot in transit in theright atrium, but not in conjunction with FlowTriever Catheters. | |||
|---|---|---|---|
| The Triever20 Curve (21-201) must be used within the Triever24. | |||
| DeviceModifications | The device modifications associated with implementing the Triever20 Curve are:A. Removed the Y-connector from the packagingB. Increase in overall catheter length from 43.38" to 43.76"C. Shaft jacket length changeD. Hemostasis valve septum and monofilament material changeE. Upgraded dilatorF. Garrote valve updated to include locking cap for the dilatorG. Tapered distal tip changeH. Replaced braid and coil with multifilar coilI. Backer card changes | ||
| Comparison ofTechnologicalCharacteristics withthe Predicate Device | The proposed modifications do not change the intended use or principles of operationfrom the predicate device. The modified and reference device have a similar designand mainly differ in dimensions and materials.The modified Triever20 Curve and Triever20 Curve are both tracked over a pre-placedcompatible guidewire. The Triever20 Curve Generation 2 performs thrombectomyusing aspiration, following the same method as the reference Triever20 Curve.Although the predicate and subject devices have different technologicalcharacteristics, all leveraged and performed design verification and validation testsconfirm that these differences do not raise any new or different questions of safety oreffectiveness. | ||
| Summary ofsubstantialequivalence | There is no change of intended use or fundamental scientific technology between theproposed device, reference, and predicate device. Aside from device modifications,the Triever20 Curve has the same indications for use as the predicate device,K213402: both are indicated for the non-surgical removal of emboli and thrombi fromblood vessels and the injection, infusion, and/or aspiration of contrast media and otherfluids into or from a blood vessel. Both are intended for use in the peripheralvasculature, for the treatment of pulmonary embolism, and for use in treating clot intransit in the right atrium but not in conjunction with FlowTriever Catheters.A tabular comparison of specific technological characteristics between the referenceand subject device is provided below: | ||
| Feature | Triever20 Curve (21-201)Proposed (K231848) | Triever20 CurveReference (K203333) | |
| Manufacturer | Inari Medical | Inari Medical | |
| Product code | QEW | QEW | |
| Intendeduse/Indicationsfor use | The Triever20 Curve (21-201)is used coaxially within theTriever24 for:The non-surgical removalof emboli and thrombi fromblood vessels. Injection, infusion, and/oraspiration of contrast media | The Triever20 Curve is usedcoaxially within the Triever24for:The non-surgical removal ofemboli and thrombi fromblood vessels. Injection, infusion, and/oraspiration of contrast media | |
| and other fluids into or froma blood vessel. | and other fluids into or froma blood vessel. | ||
| The Triever20 Curve (21-201)is intended for use in theperipheral vasculature and forthe treatment of pulmonaryembolism. | The Triever20 Curve is intendedfor use in the peripheralvasculature and for the treatmentof pulmonary embolism.The Triever20 Curve Catheter is | ||
| The Triever20 Curve (21-201)Catheter is not indicated for usewith FlowTriever Catheters. | not indicated for use withFlowTriever Catheters. | ||
| Triever20 Curve (21-201) isalso intended for use in treatingclot in transit in the right atrium,but not in conjunction withFlowTriever Catheters. | |||
| The Triever20 Curve (21-201)must be used within theTriever24. | |||
| Principles ofoperation | The Triever20 Curve (21-201)is inserted over a pre-placedguidewire and through aTriever24 Catheter to a locationproximal of the targetedthrombus. The proximalhemostasis valve can be rotatedto assist targeting the angled tip.After removing the dilator,thrombus aspiration can beperformed using the 60 cc LargeBore Syringe. FlowTrieverCatheters can be used formechanical thrombectomy byremoving the Triever20 Curveand either: 1) deploying directlythrough the Triever24; or 2)replacing the Triever24 with aTriever20 and then deployingthe FlowTriever Catheter. | The Triever20 Curve is insertedover a pre-placed guidewire andthrough a Triever24 Catheter to alocation proximal of the targetedthrombus. The proximalhemostasis valve can be rotatedto assist targeting the angled tip.After removing the dilator,thrombus aspiration can beperformed using the 60 cc LargeBore Syringe. FlowTrieverCatheters can be used formechanical thrombectomy byremoving the Triever20 Curveand either: 1) deploying directlythrough the Triever24; or 2)replacing the Triever24 with aTriever20 and then deploying theFlowTriever Catheter. | |
| Target vessel | Peripheral vessels ≥ 8 mm,pulmonary arteries, right heart,IVC | Peripheral vessels ≥ 8 mm,pulmonary arteries, right heart,IVC | |
| Contraindicatedvessels | < 8 mm | < 8 mm | |
| Guidewirecompatibility | 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 72DMiddle: Pebax 55DDistal: Pebax 35DTip: 72D | Proximal: Pebax 72DMiddle: Pebax 55DDistal: Pebax 35DTip: 72D | |
| Shaft support | 304V Stainless Steel MultifilarCoil | 304V Stainless Steel braid andcoil | |
| Hemostasis valve | Septum: Polyblend/adhesiveMonofilament: Braidedpolyester | Septum: Braid/siliconeMonofilament: Nylon | |
| Tip angle | 225° | 225° | |
| Dilator | |||
| Length | 112 cm | 111.65 cm | |
| Materials | Pebax 55D with ProPellPebax 35D with ProPell | LDPE/HDPE | |
| Handle | Overmolded locking hub | Luer connection |
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K231848
Page 3 of 6
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A tabular comparison of the intended use between the predicate and subject device is provided below:
| Feature | Triever20 Curve (21-201)Proposed (K231848) | FlowTrieverRetrieval/Aspiration SystemPredicate (K213402) |
|---|---|---|
| Manufacturer | Inari Medical | Inari Medical |
| Product code | QEW | QEW |
| SecondaryProduct code | KRA | KRA |
| Intendeduse/Indicationsfor 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. | The FlowTriever Retrieval/Aspiration 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 FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.Triever Catheters are also intended for use in treating clot in transit in the right atrium, but |
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| Triever20 Curve (21-201) isalso intended for use in treatingclot in transit in the right atrium,but not in conjunction withFlowTriever Catheters.The Triever20 Curve (21-201) | not in conjunction withFlowTriever Catheters. | |
|---|---|---|
| must be used within theTriever24. |
Biocompatibility
The following biocompatibility tests were completed for the subject device:
- Cytotoxicity
- . Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- . Material-Mediated Pyrogenicity
- Hemocompatibility ●
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 using a validated sterilization process in accordance with the principles of ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016.
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 modified Triever20 Curve. These tests included:
- Pouch Seal Visual Inspection
- Bubble Leak Test
- · Dye Penetration
- · Packaging Integrity, Visual Inspection
- · Visual and Dimensional
- Dilator Compatibility
- · T20 Curve Dilator Insertion and Removal
- · T20 Curve Insertion and Retraction from T24/Protrieve
- T20 Curve Rotation within T24/Protrieve
- · T20 Curve Recovery Angle
- Kink Radius
- · Torque Testing
- · Simulated Use Track & Tensile (catheter tested)
- · Simulated Use Track & Torque (catheter tested)
- Clot Burden Removal Validation
- Vacuum Testing Resistance to collapse under vacuum
- Determination of Flowrate Through Catheter & Dilator
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| • Particulate Matter Determination |
|---|
| The following testing was not impacted by the design modifications and therefore wasleveraged from the reference device, Triever20 Curve (K203333): |
| • Pouch, Peel, Seal Strength |
| • Aseptic Presentation |
| • Label Integrity, Visual Inspection |
| • Guidewire Compatibility |
| • Unlocking/Locking force/torque and Connection of Dilator Cap to Guide CatheterHemostasis Valve Cap |
| • Push-button force testing - Garrote valve |
| • Leakage Testing |
| • Air leakage during aspiration |
| • Capable of being de-aired |
| • Simulated Use Track & Tensile (dilator and sideport leveraged) |
| • Vacuum Testing - Sufficient vacuum generated for thrombus aspiration |
| • Vacuum Testing - Flushing Stopcock |
| • Functional Testing - Large Bore Syringe |
| • Luer Lock Connection |
| • Dilator Burst |
| • Catheter Burst |
| • Radiopacity Testing |
| • Corrosion Resistance |
| Neither animal testing nor clinical testing were required for the determination ofsubstantial equivalence. Test results demonstrated that all acceptance criteria weremet; the device conforms to established product specifications. |
| Conclusion |
| The modified Triever20 Curve has the same intended use/indications for use andprinciples of operation as the predicate. The testing provided supports the modifiedTriever20 Curve 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).