(28 days)
No
The summary describes a mechanical thrombectomy catheter and its use, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is used for the non-surgical removal of emboli and thrombi from blood vessels and for treating pulmonary embolism, which are medical treatments aimed at restoring health.
No
The device description and intended use clearly state that the Triever20 Curve is used for the "non-surgical removal of emboli and thrombi" and for "injection, infusion, and/or aspiration of contrast media and other fluids." These are interventional and therapeutic functions, not diagnostic ones.
No
The device description clearly describes a physical catheter and associated hardware (dilator, syringe) used for a minimally invasive procedure. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Triever20 Curve is a medical device used within the body (in vivo) to physically remove blood clots (emboli and thrombi) from blood vessels. It also facilitates the injection or aspiration of fluids directly into or from blood vessels.
- Intended Use: The intended use clearly describes a therapeutic procedure performed directly on the patient's circulatory system, not the analysis of samples outside the body.
- Device Description: The description details a catheter and syringe used for mechanical removal and fluid handling within the vasculature.
The device is a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
QEW, KRA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, pulmonary arteries, right heart, IVC, right atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Verification and validation testing were identified based on a Design Failure Modes and Effects Analysis. 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, Particulate Matter Determination.
Leveraged testing from the reference device (K203333): Pouch, Peel, Seal Strength, Aseptic Presentation, Label Integrity (Visual Inspection), Guidewire Compatibility, Unlocking/Locking force/torque and Connection of Dilator Cap to Guide Catheter Hemostasis 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.
Results: Test results demonstrated that all acceptance criteria were met; the device conforms to established product specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Inari Medical, Inari FlowTriever Retrieval/ Aspiration System (K213402)
Reference Device(s)
Inari Medical, Triever20 Curve (K203333)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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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3
510(K) SUMMARY
| Date prepared | July 21, 2023 |
|---|---|
| Name | Inari Medical, Inc. |
| 6001 Oak Canyon, Suite 100 | |
| Irvine, CA 92618 | |
| 949.600.8433 | |
| Contact person | Anthony Lam |
| Sr. Manager Regulatory Affairs | |
| Name of Device | Triever20 Curve (21-201) |
| 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 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 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. | |
| 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. |
4
| 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 | |||
| Modifications | The device modifications associated with implementing the Triever20 Curve are: | ||
| A. Removed the Y-connector from the packaging | |||
| B. Increase in overall catheter length from 43.38" to 43.76" | |||
| C. Shaft jacket length change | |||
| D. Hemostasis valve septum and monofilament material change | |||
| E. Upgraded dilator | |||
| F. Garrote valve updated to include locking cap for the dilator | |||
| G. Tapered distal tip change | |||
| H. Replaced braid and coil with multifilar coil | |||
| I. Backer card changes | |||
| 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 reference device have a similar design | |||
| and mainly differ in dimensions and materials. |
The modified Triever20 Curve and Triever20 Curve are both tracked over a pre-placed
compatible guidewire. The Triever20 Curve Generation 2 performs thrombectomy
using aspiration, following the same method as the reference 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. | | |
| Summary of
substantial
equivalence | There is no change of intended use or fundamental scientific technology between the
proposed 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 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 reference
and subject device is provided below: | | |
| | Feature | Triever20 Curve (21-201)
Proposed (K231848) | Triever20 Curve
Reference (K203333) |
| | Manufacturer | Inari Medical | Inari Medical |
| | Product code | QEW | QEW |
| | Intended
use/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 | The Triever20 Curve 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. | 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 is intended
for use in the peripheral
vasculature and for the treatment
of pulmonary embolism.
The Triever20 Curve Catheter is | |
| | The Triever20 Curve (21-201)
Catheter is not indicated for use
with FlowTriever Catheters. | 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. | | |
| Principles of
operation | The Triever20 Curve (21-201)
is inserted over a pre-placed
guidewire and through a
Triever24 Catheter to a location
proximal of the targeted
thrombus. The proximal
hemostasis valve can be rotated
to assist targeting the angled tip.
After removing the dilator,
thrombus aspiration can be
performed using the 60 cc Large
Bore Syringe. FlowTriever
Catheters can be used for
mechanical thrombectomy by
removing the Triever20 Curve
and either: 1) deploying directly
through the Triever24; or 2)
replacing the Triever24 with a
Triever20 and then deploying
the FlowTriever Catheter. | The Triever20 Curve is inserted
over a pre-placed guidewire and
through a Triever24 Catheter to a
location proximal of the targeted
thrombus. The proximal
hemostasis valve can be rotated
to assist targeting the angled tip.
After removing the dilator,
thrombus aspiration can be
performed using the 60 cc Large
Bore Syringe. FlowTriever
Catheters can be used for
mechanical thrombectomy by
removing the Triever20 Curve
and either: 1) deploying directly
through the Triever24; or 2)
replacing the Triever24 with a
Triever20 and then deploying the
FlowTriever Catheter. | |
| Target vessel | Peripheral vessels ≥ 8 mm,
pulmonary arteries, right heart,
IVC | Peripheral vessels ≥ 8 mm,
pulmonary arteries, right heart,
IVC | |
| Contraindicated
vessels | Conclusion |
| The modified Triever20 Curve has the same intended use/indications for use and
principles of operation as the predicate. The testing provided supports the modified
Triever20 Curve substantial equivalence to the predicate device. |