(18 days)
No
The device description focuses on mechanical components and their function, with no mention of AI/ML, image processing for analysis, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is indicated for "non-surgical removal of thrombi and emboli from blood vessels," which directly addresses a medical condition (thromboemboli) to restore health.
No
Explanation: The ClotTriever Thrombectomy System is designed for the removal of thrombi and emboli and for the injection, infusion, and/or aspiration of fluids. It is a therapeutic device, not one that gathers information about a patient's condition to help diagnose a disease or condition. While the device is used in the presence of thrombi (a diagnosed condition), its function is to treat, not to diagnose.
No
The device description clearly outlines a physical, catheter-based system with components like sheaths, a mesh funnel, hubs, valves, and syringes, indicating it is a hardware medical device.
Based on the provided information, the ClotTriever Thrombectomy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done in vitro (outside the body).
- ClotTriever Function: The ClotTriever System is a surgical device used within the body (in vivo) to physically remove blood clots from blood vessels. It is a mechanical device that interacts directly with the patient's anatomy.
- Intended Use: The intended use clearly describes a procedure performed on the patient, not a test performed on a specimen.
- Device Description: The description details a catheter-based system with mechanical components for clot removal, not equipment for analyzing biological samples.
- Input Imaging Modality: The use of fluoroscopic guidance indicates a procedure performed on the patient, not a laboratory test.
Therefore, the ClotTriever Thrombectomy System falls under the category of a surgical or interventional device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ClotTriever Thrombectomy System is indicated for:
• The non-surgical removal of thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
The ClotTriever Sheaths are indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
Product codes
QEW, KRA, DYB
Device Description
The ClotTriever Thrombectomy System ("ClotTriever System") is a single-use over-the-wire catheter-based system used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system consists of ClotTriever Catheters, ClotTriever Sheaths and Protrieve Sheath, each packaged separately. The ClotTriever Sheath consist of a polymeric shaft with a distal self-expanding nitinol mesh funnel, a proximal hub with a hemostasis valve and a sideport tubing. The mesh funnel is deployed by retracting the slide actuator back until it snaps into place. The mesh funnel self-expands to the diameter of the vessel and serves as a backstop as clot is removed through the lumen of the sheath. A hemostasis valve is integrated into the proximal hub of the sheath to prevent blood loss from devices passing through it. The sideport tubing has a large-bore stopcock and a terminal quick-disconnect coupling for connection to the Large Bore 60 cc Syringe for the aspiration of clot. A pre-dilator is provided with the ClotTriever Sheaths, to expand the target vessel prior to sheath insertion. A dilator is provided to aid insertion and positioning of the sheath, while the loading tool facilitates insertion of the mesh funnel into the dilator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature including deep vein thrombosis (DVT)
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 testing provided in K180329 and K192036 remains applicable to support use of the ClotTriever Sheaths as conduits for the insertion of endovascular devices into the peripheral vasculature.
Clinical Testing: Clinical testing was not required to support substantial equivalence.
Key results: The change to the Indications for Use does not raise new or different questions of safety and effectiveness. Results from previously conducted verification testing demonstrate that the subject device is substantially equivalent to the predicate device. The subject device is therefore substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Protrieve Sheath (K230331)
Reference Device(s)
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an abstract design. To the right of the seal, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font. The logo is simple and professional, and it is easily recognizable.
December 18, 2023
Inari Medical, Inc. Tosan Eweka Principal Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine. California 92618
Re: K233815
Trade/Device Name: ClotTriever Sheath Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA, DYB Dated: November 30, 2023 Received: November 30, 2023
Dear Tosan Eweka:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/1/Picture/6 description: This image shows the name Gregory W. O'connell -S. The image also shows that it was digitally signed by Gregory W. O'connell -S on 2023.12.18. The time stamp is 11:55:40 -05'00'.
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
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Indications for Use
510(k) Number (if known) K233815
Device Name ClotTriever Sheath
Indications for Use (Describe)
The ClotTriever Thrombectomy System is indicated for:
- · The non-surgical removal of thrombi and emboli from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectorny System is in the peripheral vasculature including deep vein thrombosis (DVT).
The ClotTriever Sheaths are indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
| 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 | November 30, 2023 |
|---|---|
| Name | Inari Medical, Inc. |
| 6001 Oak Canyon, Suite 100 | |
| Irvine, CA 92618 | |
| 949.600.8433 | |
| Contact person | Tosan Eweka |
| Principal Regulatory Affairs Specialist | |
| Trade Name | ClotTriever Sheath |
| Device Name | ClotTriever Sheath |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification | |
| number | 21 CFR 870.5150 |
| Product code | QEW, KRA, DYB |
| Regulatory class | II |
| Predicate device | Protrieve Sheath (K230331) |
| Description | The ClotTriever Thrombectomy System ("ClotTriever System") is a single-use over- |
| the-wire catheter-based system used for the minimally invasive treatment of | |
| thromboemboli in the peripheral vasculature. The system consists of ClotTriever | |
| Catheters, ClotTriever Sheaths and Protrieve Sheath, each packaged separately. | |
| The ClotTriever Sheath consist of a polymeric shaft with a distal self-expanding | |
| nitinol mesh funnel, a proximal hub with a hemostasis valve and a sideport tubing. | |
| The mesh funnel is deployed by retracting the slide actuator back until it snaps into | |
| place. The mesh funnel self-expands to the diameter of the vessel and serves as a | |
| backstop as clot is removed through the lumen of the sheath. A hemostasis valve is | |
| integrated into the proximal hub of the sheath to prevent blood loss from devices | |
| passing through it. The sideport tubing has a large-bore stopcock and a terminal quick- | |
| disconnect coupling for connection to the Large Bore 60 cc Syringe for the aspiration | |
| of clot. A pre-dilator is provided with the ClotTriever Sheaths, to expand the target | |
| vessel prior to sheath insertion. A dilator is provided to aid insertion and positioning | |
| of the sheath, while the loading tool facilitates insertion of the mesh funnel into the | |
| dilator. | |
| Indications for Use | The ClotTriever Thrombectomy System is indicated for: |
| • The non-surgical removal of thrombi and emboli from blood vessels. | |
| • Injection, infusion, and/or aspiration of contrast media and other fluids into | |
| or from a blood vessel. | |
| The ClotTriever Thrombectomy System is intended for use in the peripheral | |
| vasculature including deep vein thrombosis (DVT). |
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| Device
Modifications | The ClotTriever Sheaths are indicated for use as a conduit for the insertion of
endovascular devices into the vasculature while minimizing blood loss associated
with such insertions. | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Modifications | The purpose of this submission is to modify the indications for use statement to
include use of the ClotTriever Sheaths as conduits for the insertion of endovascular
devices into the vasculature while minimizing blood loss associated with such
insertions. | | |
| Summary of
substantial
equivalence | The subject device and predicate device have the same intended use and indications
for use. Both devices are intended to be used as conduits for the insertion of
endovascular devices into the vasculature while minimizing blood loss associated
with such insertions. The subject device has the same principle of operation and
similar technological characteristics as the predicate device. A tabular comparison
between the predicate and subject device is provided below: | | |
| | ClotTriever Sheaths
(Subject Device) | Protrieve Sheath
(Predicate Device) | |
| Manufacturer | Inari Medical, Inc. | Inari Medical, Inc. | |
| Model
Designators | 50-101 (13 Fr ClotTriever
Sheath)
51-101 (16 Fr ClotTriever
Sheath) | 60-101 (20 Fr Protrieve
Sheath) | |
| Product Code | QEW, KRA, DYB | QEW, KRA, DYB | |
| Indications for
Use | The ClotTriever
Thrombectomy System is
indicated for:
• The non-surgical removal
of thrombi and emboli from
blood vessels.
• Injection, infusion, and/or
aspiration of contrast media
and other fluids into or from
a blood vessel.
The ClotTriever
Thrombectomy System is
intended for use in the
peripheral vasculature
including deep vein
thrombosis (DVT).
The ClotTriever Sheaths are
indicated for use as a conduit | The ClotTriever
Thrombectomy System is
indicated for:
• The non-surgical removal
of thrombi and emboli from
blood vessels.
• Injection, infusion, and/or
aspiration of contrast media
and other fluids into or from
a blood vessel.
The ClotTriever
Thrombectomy System is
intended for use in the
peripheral vasculature
including deep vein
thrombosis (DVT).
The Protrieve Sheath is
indicated for use as a conduit | |
| | | for the insertion of
endovascular devices into
the vasculature while
minimizing blood loss
associated with such
insertions. | for the insertion of
endovascular devices into
the vasculature while
minimizing blood loss
associated with such
insertions. |
| Principles of
Operation | | The ClotTriever Sheath and
dilator are inserted over a
pre-placed 0.035" guidewire
into the vessel. Under
fluoroscopic guidance, the
Sheath's mesh funnel is
deployed proximal to the
thrombus targeted for
extraction. After
deployment of the funnel,
the dilator is withdrawn
through the Sheath and from
the patient entirely. The
catheter or other
endovascular device is then
advanced over the guidewire
through the ClotTriever
Sheath to the targeted
treatment site. Following the
diagnostic or therapeutic
procedure, the endovascular
device is retracted through
the ClotTriever Sheath and
removed from the patient.
The user-actuated
hemostasis valve integrated
into the Sheath hub allows
for Insertion and withdrawal
of endovascular devices. | The Protrieve Sheath and
dilator are inserted over a
pre-placed 0.035" guidewire
into the vessel. Under
fluoroscopic guidance, the
Sheath's mesh funnel is
deployed proximal to the
thrombus targeted for
extraction. After deployment
of the funnel, the dilator is
withdrawn through the
Sheath and from the patient
entirely. The catheter or
other endovascular device is
then advanced over the
guidewire through the
Protrieve Sheath to the
targeted treatment site.
Following the diagnostic or
therapeutic procedure, the
endovascular device is
retracted through the
Protrieve Sheath and
removed from the patient.
The user-actuated hemostasis
valve integrated into the
Sheath hub allows for
Insertion and withdrawal of
endovascular devices. |
| Target Vessel | | Peripheral vessels | Peripheral vessels |
| Guidewire
compatibility | | 0.035" | 0.035" |
| Sheath shaft
ID/OD | | 13 Fr ID - 0.180"
16 Fr ID - 0.215"
13 Fr OD - 0.210"
16 Fr OD - 0.248" | ID - 0.270"
OD - 0.345" |
| Sheath length
(deployed) | | 15 cm | 32 cm |
| Dilator OD | 13 Fr Sheath - 0.178" | 0.264" | |
| | 16 Fr Sheath - 0.206" | | |
| Dilator Length | 10" | 25" | |
| Sterilization | SAL 10-6, EtO | SAL 10-6, EtO | |
| Shelf-Life | 2 years | 2 years | |
| Non-Clinical Testing | | | |
| Verification testing provided in K180329 and K192036 remains applicable to support
use of the ClotTriever Sheaths as conduits for the insertion of endovascular
devices into the peripheral vasculature. | | | |
| Clinical Testing | | | |
| Clinical testing was not required to support substantial equivalence. | | | |
| Conclusion | | | |
| The change to the Indications for Use does not raise new or different questions of
safety and effectiveness. Results from previously conducted verification testing
demonstrate that the subject device is substantially equivalent to the predicate device.
The subject device is therefore substantially equivalent to the predicate device. | | | |
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