(133 days)
The Triever16 Curve 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 Triever16 Curve is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The Triever16 Curve is not indicated for use with FlowTriever Catheters.
The Triever16 Curve is also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.
The Triever16 (“T16”) Curve is a single-use, over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature, the treatment of pulmonary embolism, and the treatment of clot in transit in the right atrium.
The T16 Curve is inserted over a pre-placed 0.035" guidewire, either standalone (i.e., through an introducer sheath without another catheter) or through a compatible Inari device such as the Triever20/24, Intri24 Sheath, 16 Fr ClotTriever Sheath, or Protrieve Sheath (packaged separately), and advanced to the thrombus. Thrombus is removed by aspiration with the provided 60 cc Large Bore Vacuum syringe. After the procedure is complete, the T16 Curve is removed from the patient.
The provided text is a 510(k) summary for the Inari Medical Triever16 Curve, an embolectomy catheter. The document states that "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." This means there is no data presented regarding the device's performance in a clinical setting against acceptance criteria established for clinical effectiveness.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to non-clinical bench testing to demonstrate the device's physical and functional properties, and its substantial equivalence to a predicate device.
Therefore, the following information is based on the non-clinical bench testing described in the document.
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not provide specific numerical acceptance criteria or the exact reported performance values for each test. Instead, it lists the types of tests performed.
| Test Category | Acceptance Criteria (General Description) | Reported Device Performance (General Description) |
|---|---|---|
| Biocompatibility | Meets biological safety requirements per ISO 10993-1 | Passing results for Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility |
| Sterilization | Achieves a sterility assurance level (SAL) of 10^-6 per ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016 | Device adopted into a validated sterilization process without deviations |
| Non-Clinical Functional Tests | Conforms to established product specifications, no new or different questions of safety/effectiveness raised by technological differences | All acceptance criteria were met; device conforms to specifications |
| Visual & Dimensional Inspection (Catheter and Dilator) | Meets specified visual and dimensional requirements | All acceptance criteria were met |
| Guidewire Compatibility | Compatible with 0.035" guidewires | All acceptance criteria were met |
| Insertion and Retraction Force through 16 Fr Introducer Sheath | Demonstrates acceptable insertion and retraction forces | All acceptance criteria were met |
| Rotation inside 16 Fr Introducer Sheath | Demonstrates acceptable rotation performance | All acceptance criteria were met |
| Recovery Angle | Meets specified recovery angle performance | All acceptance criteria were met |
| Kink Radius | Meets specified kink resistance | All acceptance criteria were met |
| Vacuum Testing | Achieves specified vacuum performance | All acceptance criteria were met |
| Catheter and Dilator Flow Rate Testing | Achieves specified flow rates | All acceptance criteria were met |
| Clot Burden Removal Validation | Demonstrates effective clot removal | All acceptance criteria were met |
| Simulated Use, Track & Tensile | Demonstrates adequate tracking and tensile strength under simulated use | All acceptance criteria were met |
| Simulated Use, Track & Torque | Demonstrates adequate tracking and torque performance under simulated use | All acceptance criteria were met |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (number of devices) used for each non-clinical bench test.
- Data Provenance: The data is from non-clinical bench testing conducted to support the 510(k) submission. The country of origin is not explicitly stated, but as the submitting entity (Inari Medical, Inc.) is located in Irvine, California, USA, it is highly probable the testing was conducted in the USA or by facilities approved by US regulatory standards. The testing is inherently prospective in nature, as it was performed specifically to evaluate the new device against predetermined specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This question is not applicable in the context of this document. For non-clinical bench testing of a medical device, "ground truth" is typically established by engineering specifications, material standards, and validated test methods, not by expert consensus on clinical data. The tests are designed to objectively measure physical and functional properties, and the "experts" involved would be qualified engineers, technicians, and quality control personnel.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus on clinical image interpretation or outcomes, not for objective bench testing. The results of bench tests are typically measured quantitatively and compared against pre-defined numerical or qualitative acceptance criteria.
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:
Not applicable. This document pertains to the clearance of a mechanical medical device (embolectomy catheter), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed as described. The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. As noted above, this device is a mechanical catheter and does not involve an algorithm or AI.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical bench tests was based on:
- Engineering Specifications: Predefined design parameters, material properties, and performance requirements.
- International Standards: e.g., ISO 10993-1 for biocompatibility, ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016 for sterilization.
- Validated Test Methods: Procedures established to reliably measure the device's characteristics.
- Predicate Device Characteristics: Comparison against the known characteristics and performance of the legally marketed predicate device (Inari FlowTriever Retrieval/Aspiration System K213402) and reference devices (Penumbra Indigo System Aspiration Catheter 12 K192981) to demonstrate substantial equivalence.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML model that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. As this device is not an AI/ML model, there is no training set or associated ground truth establishment process in that context.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 23, 2023
Inari Medical Ellen Nguyen Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618
Re: K223419
Trade/Device Name: Triever16 Curve Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: February 23, 2023 Received: February 24, 2023
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 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).
Sincerelv.
Gregory W. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2023.03.23
09:30:19 -04-00'
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) K223419
Device Name Triever16 Curve
Indications for Use (Describe) The Triever16 Curve 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 Triever 16 Curve is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The Triever16 Curve is not indicated for use with FlowTriever Catheters.
The Triever16 Curve is also intended for use in transit in the right atrium but not in conjunction with FlowTriever Catheters.
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 5
510(K) SUMMARY
| Date prepared | March 22, 2023 |
|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618877.923.4747 |
| Contact person | Ellen NguyenRegulatory Affairs Specialist |
| Name of Device | Triever16 Curve |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Product code | QEW |
| Secondary product code | KRA |
| Regulatory class | II |
| Predicate device | Inari FlowTriever Retrieval/Aspiration System (K213402) |
| References devices | Penumbra Indigo System Aspiration Catheter 12 (K192981) |
| Description | The Triever16 (“T16”) Curve is a single-use, over-the-wire catheter used for theminimally invasive treatment of thromboemboli in the peripheral vasculature, thetreatment of pulmonary embolism, and the treatment of clot in transit in the rightatrium.The T16 Curve is inserted over a pre-placed 0.035" guidewire, either standalone (i.e.,through an introducer sheath without another catheter) or through a compatible Inaridevice such as the Triever20/24, Intri24 Sheath, 16 Fr ClotTriever Sheath, orProtrieve Sheath (packaged separately), and advanced to the thrombus. Thrombus isremoved by aspiration with the provided 60 cc Large Bore Vacuum syringe. Afterthe procedure is complete, the T16 Curve is removed from the patient. |
| Indications for Use | The Triever16 Curve 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 intoor from a blood vessel.The Triever16 Curve is intended for use in the peripheral vasculature and for thetreatment of pulmonary embolism.The Triever16 Curve is not indicated for use with FlowTriever Catheters.The Triever16 Curve is also intended for use in treating clot in transit in the rightatrium but not in conjunction with FlowTriever Catheters. |
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These modifications introduce the Triever16 Curve, a T20 Curve variant used for aspiration thrombectomy in the peripheral vasculature, pulmonary arteries, and right heart.
Comparison of Technological Characteristics with the Predicate Device The proposed modifications do not change the intended use or principles of operation from the predicate device. The modified and predicate device have a similar design and mainly differ in dimensions and materials.
The Triever16 Curve and Triever20 Curve are both tracked over a pre-placed compatible guidewire. The Triever16 Curve performs thrombectomy using aspiration, following the same method as the predicate Triever20 Curve.
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.
There have been no changes to the 16/20/24 Fr Triever Catheters or FlowTriever Catheters.
Summary of There is no change of intended use or fundamental scientific technology between the substantial equivalence proposed device and predicate device. Aside from the Triever20 Curve's requirement to be used through the Triever24, the Triever16 Curve has the same indications for use as the predicate device. K213402: 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 other fluids into or from a blood vessel. Both are intended for use in the peripheral vasculature, for the treatment of pulmonary embolism, and for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.
A tabular comparison of specific technological characteristics between the predicate and subject device is provided below:
| Feature | Triever16 CurveProposed (TBD) | Triever20 CurvePredicate (K213402) | |
|---|---|---|---|
| Manufacturer | Inari Medical | Inari Medical | |
| Product code | QEW | QEW | |
| Intendeduse/Indicationsfor use | The Triever16 Curve isindicated for: | The Triever20 Curve is usedcoaxially within the Triever24for: | |
| • The non-surgical removalof emboli and thrombifrom blood vessels. | • The non-surgical removalof emboli and thrombifrom blood vessels. | ||
| • Injection, infusion, and/oraspiration of contrastmedia and other fluids intoor from a blood vessel. | • Injection, infusion, and/oraspiration of contrastmedia and other fluids intoor from a blood vessel. | ||
| The Triever16 Curve is intendedfor use in the peripheralvasculature and for the treatmentof pulmonary embolism. | The Triever20 Curve isintended for use in theperipheral vasculature and forthe treatment of pulmonary | ||
| Feature | Triever16 Curve | Triever20 Curve | |
| Proposed (TBD) | Predicate (K213402) | ||
| The Triever16 Curve is notindicated for use with | embolism. | ||
| FlowTriever Catheters.The Triever16 Curve is also | The Triever20 Curve is notindicated for use withFlowTriever Catheters. | ||
| intended for use in treating clotin transit in the right atrium butnot in conjunction withFlowTriever Catheters. | The Triever20 Curve is alsointended for use in treating clotin transit in the right atrium butnot in conjunction withFlowTriever Catheters. | ||
| Principles ofoperation | The Triever16 Curve is insertedinto the vessel standalone orthrough a compatible Inaridevice over a pre-placedguidewire and is advanced untilits tip is proximal to the targetthrombus. A 60 cc syringe isprovided for the aspiration ofclot into the catheter and theinfusion of contrast media andother fluids. | The Triever20 Curve is insertedinto the vessel through theTriever24 over a pre-placedguidewire and is advanced untilits tip is proximal to the targetthrombus. A 60 cc syringe isprovided for the aspiration ofclot into the catheter and theinfusion of contrast media andother fluids. | |
| Target vessel | Peripheral vessels ≥ 6 mm,pulmonary arteries, right heart,IVC | Peripheral vessels ≥ 8 mm,pulmonary arteries, right heart,IVC | |
| Contraindicatedvessels | < 6 mm | < 8 mm | |
| Guidewirecompatibility | 0.035" | 0.035" | |
| Shelf-life | 2 years | 2 years | |
| Sterilization | EtO | EtO | |
| Single-use | Yes | Yes | |
| Catheter | |||
| Dimensions | OD/ID: 16 Fr (5.3 mm)/4.5 mmLength: 110 cm | OD/ID: 20 Fr (6.8 mm)/5.6 mmLength: 102 cm | |
| Shaft material | Distal: Pebax 55D with ProPellTransition: Pebax 35D and 55Dwith ProPellProximal: Pebax 63D | Distal: Pebax 35DTransition: Pebax 55DProximal: Pebax 72D | |
| Metal support | Braid: 110.7 cmCoil: 45.7 cm | Braid: 101.6 cmCoil: 40.64 cm | |
| Hemostasis valve | Septum: Polyblend/adhesiveMonofilament: Braidedpolyester | Septum: Braid/siliconeMonofilament: Nylon | |
| Tip angle | 110° | 225° | |
| Feature | Triever16 CurveProposed (TBD) | Triever20 CurvePredicate (K213402) | |
| Dilator | |||
| Length | 118.9 cm | 113.3 cm | |
| Materials | Pebax 55D with ProPell | LDPE/HDPE | |
| Handle | Overmolded locking hub | Luer connection |
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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 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 Triever16 Curve. These tests included:
- Visual & Dimensional Inspection - Catheter
- Visual & Dimensional Inspection Dilator ●
- Guidewire Compatibility ●
- Insertion and Retraction Force through 16 Fr Introducer Sheath ●
- Rotation inside 16 Fr Introducer Sheath
- Recovery Angle ●
- Kink Radius
- Vacuum Testing .
- Catheter and Dilator Flow Rate Testing ●
- Clot Burden Removal Validation ●
- Simulated Use, Track & Tensile
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- . Simulated Use, Track & Torque
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 Triever16 Curve has the same intended use/indications for 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 Triever16 Curve'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).