(28 days)
Protrieve™ Sheath (K220415)
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI/ML algorithms or data-driven analysis.
Yes
The device is used for the non-surgical removal of thrombi and emboli from blood vessels, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is described as a thrombectomy system and an introducer sheath. Its intended use is for the non-surgical removal of thrombi and emboli, and as a conduit for inserting endovascular devices. These functions are therapeutic and interventional, not diagnostic. While it uses fluoroscopic visualization for positioning, the device itself is not designed to diagnose conditions.
No
The device description clearly outlines physical components such as a sheath, dilator, syringe, and radiopaque markers, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for the physical removal of thrombi and emboli from blood vessels, and for the injection/aspiration of fluids. This is a therapeutic and interventional procedure performed in vivo (within the body).
- Device Description: The description details a physical device (sheath, dilator, syringe) used for accessing and manipulating within blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, assays, or analytical instruments used on samples like blood, urine, or tissue.
The device described is a medical device used for a therapeutic intervention within the patient's body, not for diagnostic testing of samples.
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 Thrombectorny 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.
Product codes
QEW, KRA, DYB
Device Description
The Protrieve Sheath is a sterile, single-use over-the-wire introducer sheath with a hydrophilic coating, distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60 cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic visualization
Anatomical Site
Peripheral vasculature. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC).
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 tests were identified and performed only for the attributes impacted by the slide actuator modification to support substantial equivalence. Verification testing was not required for the expanded indications and the testing performed in K220415 remains applicable to support the use of the Protrieve Sheath as a conduit for the insertion of endovascular devices into the peripheral vasculature. The testing demonstrated compliance with relevant product specifications.
The following tests were performed for the slide actuator change on the proposed device to establish substantial equivalence:
- Simulated Use, Flushing - Protrieve Sheath
- Leakage Testing - Protrieve Sheath
- Tensile Testing Protrieve Sheath
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Clinical Testing:
Clinical testing was not required to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Intri24™ Introducer Sheath (K212392)
Reference Device(s)
Protrieve™ Sheath (K220415)
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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 7, 2023
Inari Medical, Inc. Kaitlyn Weinkauf Sr. Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618
Re: K230331
Trade/Device Name: Protrieve Sheath Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA, DYB Dated: February 6, 2023 Received: February 7, 2023
Dear Kaitlyn Weinkauf:
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
1
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 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 Gregory W. Gregory W. O'connell O'connell -S Date: 2023.03.07 13:28:40 -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
Enclosure
2
Indications for Use
510(k) Number (if known) K230331
Device Name Protrieve 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 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.
| 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 6
510(K) SUMMARY
| Date prepared | March 6, 2023 |
|---|---|
| Name | Inari Medical, Inc. |
| 6001 Oak Canyon, Suite 100 | |
| Irvine, CA 92618 | |
| 949-600-8433 | |
| Contact person | Kaitlyn Weinkauf |
| Sr. Regulatory Affairs Specialist | |
| Device Name | Protrieve™ Sheath |
| Trade Name | Protrieve™ Sheath |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Primary product code | QEW |
| Secondary product codes | KRA, DYB |
| Regulatory class | II |
| Predicate device | Intri24™ Introducer Sheath (K212392) |
| Reference device | Protrieve™ Sheath (K220415) |
| Description | The Protrieve Sheath is a sterile, single-use over-the-wire introducer sheath with a |
| hydrophilic coating, distal self-expanding funnel, aspiration port, and proximal hub. A | |
| dilator is provided to aid insertion and positioning of the sheath. Other provided | |
| accessories include a 60 cc large bore syringe that provides a vacuum source and | |
| collects aspirated contents. Radiopaque markers aid sheath positioning under | |
| fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque | |
| marker band near the distal end of the sheath. Target vessels include, but are not limited | |
| to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior | |
| vena cava (SVC). | |
| 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). |
devices into the vasculature while minimizing blood loss associated with such insertions.
4
Device modifications The purpose of this submission is a design modification to the Protrieve Sheath slide actuator specifically and to expand the indications for use statement to include using the Protrieve Sheath as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
There are no proposed changes to the intended use of the Protrieve Sheath.
There are no proposed changes to the intended use and design of the ClotTriever/ClotTriever BOLD Catheter and ClotTriever Sheaths (13 Fr and 16 Fr).
Comparison of Technological Characteristics with the Predicate Device
The predicate Intri24 Introducer Sheath is indicated to "Provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions." The proposed Protrieve Sheath's expanded indications for use are identical. Furthermore, the principles of operation and fundamental scientific technology of the proposed Protrieve Sheath and predicate device are substantially equivalent. Both devices act as a conduit for the insertion and removal of endovascular devices in the vasculature. The design and materials of construction of both devices are also substantially the same. The shafts of both devices contain a hydrophilic coating to reduce the insertion force through skin and tissue. Both sheaths also include an appropriately sized dilator (0.035" guidewire compatible) with a tapered tip to aid in dilation of the target vessel when inserting the sheath. Both sheaths contain a useractuated hemostasis valve that allows for inserting or withdrawing endovascular devices through the sheath while minimizing blood loss.
| Device | Protrieve Sheath
(Proposed) | Intri24 Introducer Sheath
Predicate (K212392) | Protrieve Sheath
Reference (K220415) |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Inari Medical | Inari Medical | Inari Medical |
| Product Code | QEW, KRA, DYB | DYB | QEW, KRA |
| 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 Protrieve Sheath is
indicated for use as a
conduit for the insertion
of endovascular devices
into the vasculature | The Intri24 Introducer Sheath is
indicated to provide a conduit for
the insertion of endovascular
devices into the vasculature while
minimizing blood loss associated
with such insertions. | 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). |
| | | | |
| | while minimizing blood
loss associated with such
insertions. | | |
| Device Description | The Protrieve Sheath is a
single-use, sterile
medical device for use in
the peripheral
vasculature. The
Protrieve Sheath is an
introducer sheath with a
hydrophilic coating,
distal self-expanding
funnel, aspiration port,
and proximal hub. A
dilator is provided to aid
insertion and positioning
of the sheath. Other
provided accessories
include a 60 cc large
bore syringe that
provides a vacuum
source and collects
aspirated contents.
Radiopaque markers aid
sheath positioning under
fluoroscopic
visualization. The dilator
tip is radiopaque, and
there is a radiopaque
marker band near the
distal end of the sheath. | The Intri24 Introducer Sheath is a
single-use, sterile medical device
for use in the peripheral
vasculature. The Intri24 Introducer
Sheath is an introducer sheath
consisting of a short single lumen
catheter with a hydrophilic coating,
proximal hemostasis valve, and
stopcock with flush port. A
radiopaque marker is positioned
near the distal tip of the sheath to
aid with fluoroscopic visualization.
The Intri24 dilator is compatible
with a 0.035" guidewire and has a
tapered leading edge which aids
insertion and positioning of the
Intri24 Sheath. | The Protrieve Sheath is a
single-use, sterile medical
device for use in the
peripheral vasculature. The
Protrieve Sheath is an
introducer sheath with a
hydrophilic coating, distal
self-expanding funnel,
aspiration port, and proximal
hub. A dilator is provided to
aid insertion and positioning
of the sheath. Other provided
accessories include a 60 cc
large bore syringe that
provides a vacuum source
and collects aspirated
contents. Radiopaque markers
aid sheath positioning under
fluoroscopic visualization.
The dilator tip is radiopaque,
and there is a radiopaque
marker band near the distal
end of the sheath. |
| Principles of Operation | The Protrieve Sheath and
dilator are inserted over
a pre-placed 0.035"
guidewire into the
vessel. Under
fluoroscopic guidance,
the funnel is deployed
proximal to the target
site. The Protrieve
Sheath funnel is
deployed by retracting
the sheath's slide
actuator back until it
snaps into place. Once
the funnel is deployed,
the dilator is withdrawn
through the sheath and
from the patient entirely.
The
ClotTriever/ClotTriever | The Intri24 Introducer Sheath and
dilator are inserted over a pre-
placed 0.035" guidewire into the
vessel towards the target treatment
site using fluoroscopic imaging.
After positioning, the dilator is
detached from the hemostasis valve
and withdrawn from the patient. An
endovascular device is then
advanced over the guidewire
through the Intri24 Introducer
Sheath to the targeted treatment
site. Following the diagnostic or
therapeutic procedure, the
endovascular device is retracted
through the Intri24 Introducer
Sheath and removed from the
patient. | The Protrieve Sheath and
dilator are inserted over a pre-
placed 0.035" guidewire into
the vessel. Under
fluoroscopic guidance, the
funnel is deployed proximal
to the target site. The
Protrieve Sheath funnel is
deployed by retracting the
sheath's slide actuator back
until it snaps into place. Once
the funnel is deployed, the
dilator is withdrawn through
the sheath and from the
patient entirely. The
ClotTriever/ClotTriever
BOLD Catheter is then
advanced over the guidewire
through the Protrieve Sheath
to the targeted treatment site.
The ClotTriever/ClotTriever |
| | | | |
| | endovascular device is
then advanced over the
guidewire through the
Protrieve Sheath to the
targeted treatment site.
Following the diagnostic
or therapeutic procedure,
the ClotTriever/
ClotTriever BOLD
Catheter or endovascular
device is retracted
through the Protrieve
Sheath and removed
from the patient. A 60 cc
syringe is provided for
the aspiration of clot in
the sheath and the
infusion of contrast
media and other fluids. | | BOLD Catheter with the
entrapped clot is retracted
through the Protrieve Sheath
and removed from the patient.
A 60 cc syringe is provided
for the aspiration of clot in
the sheath and the infusion of
contrast media and other
fluids. |
| Target Vessel | Peripheral vasculature.
Target vessels include,
but are not limited to, the
iliofemoral, upper and
lower extremity, inferior
vena cava (IVC), and
superior vena
cava
(SVC). | Peripheral vasculature. | Peripheral vasculature.
Target vessels include, but are
not limited to, the iliofemoral,
upper and lower extremity,
inferior vena cava (IVC), and
superior vena cava (SVC). |
| Placement duration |