(217 days)
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 not in conjunction with FlowTriever Catheters.
The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately:
• Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr)
• FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm)
The FlowTriever Catheter is inserted through the Triever Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The FlowTriever Catheter is retracted into the Triever Catheter to capture the targeted thrombus. Additional clot may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter and FlowTriever Catheter are removed from the patient.
The document provided describes a 510(k) premarket notification for the Inari Medical Triever24 and Triever20 devices. The submission focuses on modifications to existing devices and demonstrates substantial equivalence to a predicate device. This is primarily a mechanical/physical device rather than an AI/software-driven diagnostic tool.
Therefore, the information typically requested regarding acceptance criteria and study design for AI/ML medical devices (such as sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, and training set details) is not applicable to this document.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to biocompatibility and non-clinical performance testing to ensure the modified physical device maintains its safety and effectiveness compared to the predicate device.
Here's an interpretation of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the devices conform to established product specifications."
While a direct table of specific acceptance criteria values and reported performance values is not explicitly presented, the document lists the types of non-clinical tests performed to meet these criteria. Each of these tests would have pre-defined acceptance criteria (e.g., maximum force, minimum flow rate, no leakage). The report confirms that the results of these tests passed these unstated criteria.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Biocompatibility | Devices meet biological safety requirements per ISO 10993-1. | "The passing results demonstrate that the subject devices and accessories meet biological safety requirements per ISO 10993-1." |
| • Cytotoxicity | No cytotoxic effects | Passed |
| • Sensitization | No sensitization | Passed |
| • Intracutaneous Reactivity | No significant irritation/reactivity | Passed |
| • Acute Systemic Toxicity | No acute systemic toxic effects | Passed |
| • Material-Mediated Pyrogenicity | No pyrogenic response | Passed |
| • Hemocompatibility | Acceptable blood compatibility (Hemolysis, Complement Activation, Thromboresistance, Platelet and Leukocyte Count, Partial Thromboplastin Time) | Passed |
| Non-Clinical Performance | Devices conform to relevant product specifications for: | "Test results demonstrated that all acceptance criteria were met; therefore, the devices conform to established product specifications." |
| Visual & Dimensional Insp. | Conformance to design specifications | Met |
| Guidewire & Dilator Comp. | Proper fit and function with guidewires/dilators | Verified |
| 3-Point Bend Test | Acceptable flexibility/stiffness | Met |
| Removal & Insertion Force | Within specified limits | Met |
| Retraction Force | Within specified limits | Met |
| Clot Burden Removal Validation | Effective removal of clot | Validated |
| Air Leakage during Aspiration | No significant air leakage | Met |
| Leak Test | No leaks | Met |
| Vacuum Test | Maintains vacuum | Met |
| Kink Radius Test | Resists kinking at specified radii | Met |
| Flow Rate (Triever24 only) | Satisfactory flow through catheter | Met |
| Stopcock Misuse Leakage Test | No leakage under misuse conditions | Met |
| Simulated Use & Tensile Test | Maintains integrity and function during simulated use | Met |
| Torque Test | Resists twisting, maintains integrity | Met |
| Locking/Unlocking Force/Torque | Within specified limits for secure and easy operation | Met |
| Particulate Matter | Within acceptable limits | Met |
| Pouch Seal Visual Inspection | No visible defects | Met |
| Pouch Peel Seal Strength | Within specified strength range | Met |
| Guidewire & Catheter Comp. | Proper fit and function (previously cleared) | Leveraged from previous clearance |
| Small-Bore Connectors | Conformance to standards | Leveraged from previous clearance |
| Catheter Burst | Withstands specified pressure | Leveraged from previous clearance |
| Corrosion Resistance | No significant corrosion | Leveraged from previous clearance |
| Sheath Compatibility | Proper fit and function with sheaths | Leveraged from previous clearance |
| Push-Button Force Testing | Within specified limits | Leveraged from previous clearance |
2. Sample size used for the test set and the data provenance:
- This is a medical device modification submission, not an AI/ML study.
- The "test set" refers to physical samples of the modified Triever24 and Triever20 devices. The document does not specify the exact number of units tested for each non-clinical test, but it implies standard engineering and laboratory testing protocols were followed for device verification and validation.
- Data provenance: Not applicable in the context of clinical data for AI/ML. The data comes from internal laboratory testing of the devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML diagnostic device requiring expert interpretation of medical images/data for ground truth. The "ground truth" here is established by the engineering and manufacturing specifications and established test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of device submission. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy, to resolve discrepancies in expert readings. Device performance is determined by objective physical and chemical tests.
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, an MRMC study was not done. This is a physical medical device, not an AI-assisted diagnostic tool. Clinical testing was explicitly stated as "not 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. There is no algorithm for standalone performance. The device is a physical catheter system used by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or basis for acceptance) for this device is its adherence to established engineering specifications, material properties, biocompatibility standards (e.g., ISO 10993-1), and functional performance requirements as demonstrated through the listed non-clinical tests. This is not derived from medical expert consensus or patient outcomes data in the typical sense of AI/ML validation, but rather from predefined objective test methods.
8. The sample size for the training set:
- Not applicable. There is no AI/ML model that requires a training set. The device is a physical product.
9. How the ground truth for the training set was established:
- Not applicable as there is no training set for an AI/ML model.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.
May 23, 2022
Inari Medical Kit Cariquitan VP, RA/QA 9 Parker. Suite 100 Irvine, California 92618
Re: K213402
Trade/Device Name: Triever24, Triever20 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: April 27, 2022 Received: April 28, 2022
Dear Kit Cariquitan:
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) K213402
Device Name Triever24, Triever20
| Indications for Use (Describe) | 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 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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510(K) SUMMARY
| Date prepared | October 15, 2021 |
|---|---|
| Name | Inari Medical, Inc.6001 Oak Canyon, Suite 100Irvine, CA 92618949.600.8433 |
| Contact person | Ellen NguyenRegulatory Affairs Specialist |
| Name of Device | Triever24, Triever20 |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Primary product code | QEW |
| Secondary product code | KRA |
| Regulatory class | II |
| Predicate device | Inari FlowTriever Retrieval/Aspiration System (K211013)The Triever20 (K182233) was subject to a design-related recall (Z-2299-2020),initiated by Inari on March 23, 2020 and terminated by FDA on August 13, 2021. |
| Description | The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately:• Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr)• FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm)The FlowTriever Catheter is inserted through the Triever Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The FlowTriever Catheter is retracted into the Triever Catheter to capture the targeted thrombus. Additional clot may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter and FlowTriever Catheter are removed from the patient. |
| Indications for Use | 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 rightatrium but not in conjunction with FlowTriever Catheters. | |
| Device Modifications | The proposed modifications to the Triever24 and Triever20 devices include minorchanges to the catheter shafts; material, design, and dimensional changes to thedilators; and material and dimensional changes to the hemostasis valves andsideports. |
| The purpose of this submission is to introduce modifications to the Triever24 andTriever20 catheters which result in improved catheter deliverability and kinkresistance, hemostasis valve durability and vacuum reliability, dilator support,and overall ease of use for the operator. | |
| There have been no changes to the FlowTriever Catheters. | |
| Comparison ofTechnologicalCharacteristics with thePredicate Device | The proposed devices and predicate device have a similar design and materials ofconstruction. The modifications to the cleared Triever24 catheter proposed in thissubmission include a length increase and the addition of a lubricious additive tothe distal shaft, a corresponding length decrease of the proximal shaft, adurometer change to the transition segment, and a stopcock lumen increase. |
| The modifications to the cleared Triever20 catheter proposed in this submissioninclude the addition of a transition segment, a corresponding length decrease anddurometer change to the proximal shaft, and a sideport tube wall thicknessincrease. | |
| The modifications applicable to both Triever24 and Triever20 catheters devicesproposed in this submission include catheter coil changes, hemostasis valveinner mechanism material changes, dilator material and design changes, and theremoval of the Y-Connector Valve from the packaging, | |
| The modifications do not change the basic design, the indications for use, or theprinciples of operation from the predicate device. All Triever Catheters aretracked over the pre-placed 0.035" guidewires. The Triever16, 20, and 24 caneach be used as a standalone device. The Triever16 can also be used coaxiallythrough a Triever20 or Triever24. | |
| FlowTriever Catheters can be used for mechanical thrombectomy by deployingdirectly through the Triever16, Triever20, or Triever24. | |
| The way the modified Triever24 and Triever20 devices are used alone or inconjunction with the Triever16 or with the FlowTriever Catheters remainsunchanged from the predicate. Therefore, there are no technological differencesbetween the devices. | |
| There have been no changes to the FlowTriever Catheters. | |
| Summary of substantialequivalence | There is no change of intended use or fundamental scientific technology betweenthe proposed devices and predicate device. The Triever24 and Triever20 have thesame indication for use as the predicate device, K211013. |
| Biocompatibility | |
| The following biocompatibility tests were conducted for the subject devices: | |
| • 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 devices and accessories meet biological safety requirements per ISO 10993-1. | |
| 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 Triever24 and Triever20 devices. This testing demonstrated compliance with relevant product specifications. These tests, performed for both devices unless otherwise noted, include: | |
| • Visual & Dimensional Inspection – Catheter | |
| • Visual & Dimensional Inspection – Dilator | |
| • Guidewire and Dilator Compatibility Verification | |
| • 3-Point Bend Test | |
| • Removal and Insertion Force of Dilator | |
| • Retraction Force of Self-Expanding Elements into Catheter | |
| • Clot Burden Removal Validation | |
| • Air Leakage during Aspiration | |
| • Leak Test | |
| • Vacuum Test | |
| • Kink Radius Test | |
| • Flow Rate through Catheter (Triever24 only) | |
| • Stopcock Misuse Leakage Test (Triever24 only) | |
| • Simulated Use and Tensile Test - Catheter and Dilator | |
| • Simulated Use and Tensile Test – Stopcock (Triever24 only) | |
| • Simulated Use and Tensile Test – Swivel Hub and Sideport (Triever20 only) | |
| • Torque Test - Stopcock (Triever24 only) and Catheter | |
| • Locking/Unlocking Force and Torque between Dilator and Catheter Hub | |
| • Particulate Matter | |
| The following testing was leveraged from previously cleared Inari devices for both devices unless otherwise noted: | |
| • Pouch Seal Visual Inspection and Dye Penetration | |
| • Pouch. Peel. Seal Strength | |
| • | Guidewire and Catheter Compatibility (Partial, Triever24 only) |
| • | Test Small-Bore Connectors for Intravascular Applications |
| • | Catheter Burst |
| • | Corrosion Resistance |
| • | Particulate Matter (Partial) |
| • | Sheath Compatibility |
| • | Push-Button Force Testing – Garrote Valve |
| Animal testing was not required for the determination of substantial equivalence. | |
| Clinical testing was not required for the determination of substantial equivalence. | |
| Test results demonstrated that all acceptance criteria were met; therefore, the devices conform to established product specifications. | |
| Conclusion | |
| The proposed device modifications to the Triever24 and Triever20 devices do not change its intended use nor the principles of operation. With consideration of the results of testing, it can be concluded that the modified Triever24 and Triever20 devices are substantially equivalent to the predicate device. |
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§ 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).