(133 days)
No
The description focuses on the mechanical function of the catheter for aspiration and removal of thrombi. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is used for the non-surgical removal of emboli and thrombi from blood vessels and for the treatment of pulmonary embolism, which are therapeutic interventions.
No
The device is described as an aspiration catheter used for the removal of thrombi, falling under therapeutic interventions rather than diagnostic assessment.
No
The device description clearly states that the Triever16 Curve is a "single-use, over-the-wire catheter" and describes its physical components and how it is used for aspiration, indicating it is a physical medical device, not software only.
Based on the provided information, the Triever16 Curve is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The Triever16 Curve is a medical device used in vivo (inside the body) for the physical removal of thrombi and emboli from blood vessels. It is a catheter used in a surgical or interventional procedure.
The description clearly outlines its use within the patient's vascular system for therapeutic purposes, not for analyzing biological samples in a lab setting.
N/A
Intended Use / 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 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 Triever 16 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.
Product codes (comma separated list FDA assigned to the subject device)
QEW, KRA
Device Description
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.
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
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:
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
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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
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).
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
2
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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3
PAGE 1 OF 5
510(K) SUMMARY
| Date prepared | March 22, 2023 |
|---|---|
| Name | Inari Medical, Inc. |
| 6001 Oak Canyon, Suite 100 | |
| Irvine, CA 92618 | |
| 877.923.4747 | |
| Contact person | Ellen Nguyen |
| Regulatory 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 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. |
| 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 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. |
4
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 Curve
Proposed (TBD) | Triever20 Curve
Predicate (K213402) | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Manufacturer | Inari Medical | Inari Medical | |
| Product code | QEW | QEW | |
| Intended
use/Indications
for use | The Triever16 Curve is
indicated for: | The Triever20 Curve is used
coaxially within the Triever24
for: | |
| | • The non-surgical removal
of emboli and thrombi
from blood vessels. | • 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. | • 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 Triever20 Curve is
intended for use in the
peripheral vasculature and for
the treatment of pulmonary | |
| Feature | Triever16 Curve | Triever20 Curve | |
| | Proposed (TBD) | Predicate (K213402) | |
| | The Triever16 Curve is not
indicated for use with | embolism. | |
| | FlowTriever Catheters.
The Triever16 Curve is also | The Triever20 Curve is not
indicated for use with
FlowTriever Catheters. | |
| | intended for use in treating clot
in transit in the right atrium but
not in conjunction with
FlowTriever Catheters. | The Triever20 Curve is also
intended for use in treating clot
in transit in the right atrium but
not in conjunction with
FlowTriever Catheters. | |
| Principles of
operation | The Triever16 Curve is inserted
into the vessel standalone or
through a compatible Inari
device over a pre-placed
guidewire and is advanced until
its tip is proximal to the target
thrombus. A 60 cc syringe is
provided for the aspiration of
clot into the catheter and the
infusion of contrast media and
other fluids. | The Triever20 Curve is inserted
into the vessel through the
Triever24 over a pre-placed
guidewire and is advanced until
its tip is proximal to the target
thrombus. A 60 cc syringe is
provided for the aspiration of
clot into the catheter and the
infusion of contrast media and
other fluids. | |
| Target vessel | Peripheral vessels ≥ 6 mm,
pulmonary arteries, right heart,
IVC | Peripheral vessels ≥ 8 mm,
pulmonary arteries, right heart,
IVC | |
| Contraindicated
vessels |