Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical thrombectomy system and does not mention any AI or ML components or functionalities.

Therapeutic

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.

Diagnostic

No

The device is indicated for the "non-surgical removal of thrombi and emboli from blood vessels" and "injection, infusion, and/or aspiration of contrast media and other fluids." These are therapeutic or interventional actions, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components such as sheaths, catheters, dilators, syringes, and radiopaque markers, indicating it is a hardware-based medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
ClotTriever Function: The ClotTriever Thrombectomy System is a medical device used inside the body (in vivo) to physically remove blood clots from blood vessels. It is a surgical/interventional tool, not a diagnostic test performed on a sample.

The description clearly states its purpose is the "non-surgical removal of thrombi and emboli from blood vessels" and "Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel." These are all procedures performed directly on the patient's circulatory system.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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).

Product codes (comma separated list FDA assigned to the subject device)

QEW, KRA

Device Description

The ClotTriever Thrombectomy System is a single-use, sterile medical device designed to remove thrombi and emboli from the peripheral vasculature. The ClotTriever Thrombectomy System consists of ClotTriever 13 Fr and 16 Fr Sheaths and Protrieve Sheath ("Sheath"), and the ClotTriever/ClotTriever Bold Catheter (“Catheter"), each packaged separately.

The sheath is an introducer sheath with a 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

Not Found

Anatomical Site

peripheral vasculature including deep vein thrombosis (DVT).
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 and validation tests were identified to support the substantial equivalence of the Protrieve Sheath to the predicate device. This testing demonstrated compliance with relevant product specifications.

The following tests were performed on the proposed device to establish substantial equivalence:

Pouch Seal Visual Inspection and Dye Penetration
Usability
Visual and Dimensional Inspection
Radial Force
Guidewire Compatibility
Insertion/Retraction Force
Deployment/Retraction Force
Locking Cap Force and Unlocking Cap Torque
Kink Radius
Simulated Use, Track - Insertion Verification & Retraction Force of ClotTriever Catheter through Sheath
Dye Stain
Lubricity and Durability
Fluid Leakage
Air Leakage
Vacuum Testing
Push-Button Force Testing
Priming Volume
Flow Test
Dilator Retraction through Clot Analog
Clot Burden Removal
Burst Testing – Garrote Valve
Simulated Use, Track, Tensile & Torque - Sheath and Dilator
Simulated Use, Track, Rotation. & Torque – Garrote Valve
Simulated Use, Track, Rotation, & Torque Resistance - Sheath
Placement Resistance
Corrosion Resistance
Particulate Matter
Small Bore Connector Test

Pouch peel and seal strength testing was leveraged from the Inari Medical Triever20 Catheter (K173672).
The following testing was leveraged from K192036:

Visual and Dimensional Inspection (non-affected components)
Burst Testing – Flushing Stopcock
Torque Testing – Flushing Stopcock
Vacuum Testing – Flushing Stopcock
Sterilization Validation

The following biocompatibility tests were performed on the proposed device as suggested by ISO 10993-1:

Cytotoxicity
Sensitization
Intracutaneous Reactivity
Toxicity
Pyrogenicity
Hemocompatibility – Hemolysis
Hemocompatibility – Complement Activation
Hemocompatibility – Thrombogenicity (in vivo)
Hemocompatibility – Thrombogenicity (in vitro) (Platelet and Leukocyte)
Hemocompatibility – Thrombogenicity (in vitro) (Partial Thromboplastin Time Test)

Clinical testing was not required to support substantial equivalence.
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.

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.

ClotTriever Thrombectomy System (K212632)

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.

Triever24 Catheter (K191710), Triever20 Catheter (K211013, K173672)

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

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo 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.

July 12, 2022

Inari Medical, Inc. Kaitlyn Weinkauf Sr. Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618

Re: K220415

Trade/Device Name: Protrieve Sheath Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: June 8, 2022 Received: June 9, 2022

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

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 (OS) 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

2

Indications for Use

510(k) Number (if known) K220415

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).

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	July 11, 2022
Name	Inari Medical, Inc.
6001 Oak Canyon, Suite 100
Irvine, CA 92618
949-600-8433
Contact
person	Kaitlyn Weinkauf
Sr. Regulatory Affairs Specialist
Name of
Device	ClotTriever® Thrombectomy System
Device Trade
Name	Protrieve™ Sheath
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	ClotTriever Thrombectomy System (K212632)
Reference
device	Triever24 Catheter (K191710)
Triever20 Catheter (K211013, K173672)
Description	The ClotTriever Thrombectomy System is a single-use, sterile medical device designed to remove
thrombi and emboli from the peripheral vasculature. The ClotTriever Thrombectomy System
consists of ClotTriever 13 Fr and 16 Fr Sheaths and Protrieve Sheath ("Sheath"), and the
ClotTriever/ClotTriever Bold Catheter (“Catheter"), each packaged separately.

The sheath is an introducer sheath with a 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). |

4

| Indications for Use | The introduction of the Protrieve Sheath variant does not change the indications for use of the
ClotTriever Thrombectomy System. | | |
|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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). | | |
| Device
modifications | The purpose of this submission is to introduce a ClotTriever Sheath variant, the Protrieve Sheath,
that is larger in diameter and comes in two additional lengths. | | |
| | There have been no changes to the ClotTriever 13 Fr and 16 Fr Sheaths, the ClotTriever Catheter
or the ClotTriever Bold Catheter. | | |
| Comparison
of
Technological
Characteristics
with the
Predicate
Device | The proposed device and predicate device have a similar design and materials of construction.
With the exception of the modifications to the sheath ID/OD, dilator OD, sheath/dilator overall
length, sheath/dilator durometer, funnel OD, and the funnel being preloaded in the sheath cover
shaft, the predicate and proposed devices are the same. These modifications do not change the
basic design or the principles of operation from the predicate device. There are no new questions
of safety or efficacy. See table below for the comparison of the technological characteristics of the
Protrieve Sheath with the predicate device.
There is no change of intended use or fundamental scientific technology between the proposed
device and predicate device. The changes made for the Protrieve Sheath do not change the
technological characteristics of the ClotTriever Thrombectomy System.
There have been no changes made to the ClotTriever Catheter or the ClotTriever Bold Catheter. | | |
| | Device | Protrieve Sheath (Proposed) | ClotTriever Thrombectomy System
Predicate (K212632) |
| | Manufacturer | Inari Medical | Inari Medical |
| | Product Code | QEW | QEW |
| | Intended Use | Removal of thrombus and emboli from, and
infusion of fluids into, the peripheral
vasculature. | Removal of thrombus and emboli
from, and infusion of fluids into, the
peripheral vasculature. |
| | 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 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 |
| | | | Page 3 of 6 |
| Comparison
of
Technological
Characteristics
with the
Predicate
Device | Device
Description | The ClotTriever Thrombectomy System is
intended for use in the peripheral vasculature
including deep vein thrombosis (DVT).

The ClotTriever Thrombectomy System is a
single-use, sterile medical device designed to
remove thrombi and emboli from the
peripheral vasculature. The ClotTriever
Thrombectomy System consists of
ClotTriever 13 Fr, 16 Fr, and 20 Fr Sheaths
("Sheath") and the ClotTriever/ClotTriever
Bold Catheter ("Catheter"), each packaged
separately.
The sheath is an introducer sheath with a
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. | peripheral vasculature including deep
vein thrombosis (DVT).

The ClotTriever Thrombectomy
System is a single-use, sterile medical
device designed to remove thrombi
and emboli from the peripheral
vasculature. The ClotTriever
Thrombectomy System consists of
ClotTriever 13 Fr and 16 Fr Sheaths
("Sheath") and the
ClotTriever/ClotTriever Bold Catheter
("Catheter"), each packaged
separately.
The sheath is an introducer sheath
with a 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 ClotTriever/ClotTriever Bold Catheter is
advanced into the vessel and beyond the clot.
The self-expanding braided nitinol wire net is
deployed. The expanded net cores, separates,
and entraps thrombus from the vessel as it is
being drawn to the funnel opening of the
ClotTriever Sheath/ClotTriever 20 Fr Sheath.
The net is collapsed and pulled into and
through the ClotTriever Sheath with the
entrapped clot. A 60 cc syringe is provided
for the aspiration of clot in the sheath and the
infusion of contrast media and other fluids. | The ClotTriever/ClotTriever Bold
Catheter is advanced into the vessel
and beyond the clot. The self-
expanding braided nitinol wire net is
deployed. The expanded net cores,
separates, and entraps thrombus from
the vessel as it is being drawn to the
funnel opening of the ClotTriever
Sheath. The net is collapsed and
pulled into and through the
ClotTriever Sheath with the entrapped
clot. A 60 cc syringe is provided for
the aspiration of clot in the sheath and
the infusion of contrast media and
other fluids. |
| | Sheath Shaft
Materials | Proximal segment:
Pebax 4533 (45D) SA 01 MED, 4% Violet C
Hydrophilic Coating

Distal segment:
Pebax 3533 (35D) SA 01 MED, Propell, 4%
Violet C | Proximal segment:
Pebax 6333 (63D) SA 01 MED;
Propell, 20% Barium Sulfate, 4%
Violet C

5

K220415

6

7

Page 5 of 6
-------------	--	--	--

| | Large Bore 60cc
Syringe accessory | Large Bore 60cc Syringe Gen. 2: Spring-
loaded release tab that self-locks to maintain
the retracted position | Large Bore 60cc Syringe: Manual
rotation of plunger to maintain the
fully retracted position |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | Shelf-Life | 2 years | 2 years |
| | Sterile | SAL 10-6, EO | SAL 10-6, EO |
| | How provided | Sterile, single use | Sterile, single use |
| Summary of
substantial
equivalence | The proposed device, the Protrieve Sheath, and the predicate device, the ClotTriever 16 Fr Sheath,
have the same indications for use, intended use, principles of operation, and fundamental scientific
technology. | | |
| | Non-Clinical Testing | | |
| | In accordance with the design failure modes and effects analysis, verification and validation tests
were identified to support the substantial equivalence of the Protrieve Sheath to the predicate device.
This testing demonstrated compliance with relevant product specifications. | | |
| | The following tests were performed on the proposed device to establish substantial equivalence: | | |
| | ● Pouch Seal Visual Inspection and Dye Penetration
● Usability
● Visual and Dimensional Inspection
● Radial Force
● Guidewire Compatibility
● Insertion/Retraction Force
● Deployment/Retraction Force
● Locking Cap Force and Unlocking Cap Torque
● Kink Radius
● Simulated Use, Track - Insertion Verification & Retraction Force of ClotTriever Catheter
through Sheath
● Dye Stain
● Lubricity and Durability
● Fluid Leakage
● Air Leakage
● Vacuum Testing
● Push-Button Force Testing
● Priming Volume
● Flow Test
● Dilator Retraction through Clot Analog
● Clot Burden Removal
● Burst Testing – Garrote Valve
● Simulated Use, Track, Tensile & Torque - Sheath and Dilator
● Simulated Use, Track, Rotation. & Torque – Garrote Valve
● Simulated Use, Track, Rotation, & Torque Resistance - Sheath
● Placement Resistance
● Corrosion Resistance
● Particulate Matter
● Small Bore Connector Test | | |

8

Pouch peel and seal strength testing was leveraged from the Inari Medical Triever20 Catheter (K173672). The following testing was leveraged from K192036:
Visual and Dimensional Inspection ( non-affected components ) Burst Testing – Flushing Stopcock Torque Testing – Flushing Stopcock Vacuum Testing – Flushing Stopcock Sterilization Validation
The following biocompatibility tests were performed on the proposed device as suggested by ISO 10993-1:
Cytotoxicity Sensitization Intracutaneous Reactivity Toxicity Pyrogenicity Hemocompatibility – Hemolysis Hemocompatibility – Complement Activation Hemocompatibility – Thrombogenicity ( in vivo ) Hemocompatibility – Thrombogenicity ( in vitro ) (Platelet and Leukocyte) Hemocompatibility – Thrombogenicity ( in vitro ) (Partial Thromboplastin Time Test)
Clinical testing was not required to support substantial equivalence.
Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.
Conclusion
The proposed device modifications to the ClotTriever Thrombectomy System do not change its intended use nor do they change the principles of operation. The verification and validation results demonstrate that the proposed Protrieve Sheath is substantially equivalent to the predicate device.