K Number

Device Name

ClotTriever BOLD Catheter

Manufacturer

Inari Medical, Inc.

Date Cleared

2023-04-18

(54 days)

Product Code

QEW KRA

Regulation Number

870.5150

Intended 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).

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 the ClotTriever Catheter, ClotTriever BOLD Catheter, ClotTriever 13 Fr and 16 Fr Sheaths, and Protrieve Sheath, each packaged separately. The ClotTriever BOLD Catheter is comprised of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Three ports terminating in two stopcocks and a luer lock connection are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the ClotTriever Catheter, ClotTriever BOLD Catheter, ClotTriever Sheaths, and Protrieve Sheath have radiopaque distal tips.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K212632

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.

Therapeutic

Yes

The device is designed to remove thrombi and emboli from blood vessels, which is a direct therapeutic intervention to treat a medical condition.

Diagnostic

No.
The device is used for the "non-surgical removal of thrombi and emboli from blood vessels" and for "injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel," which are therapeutic and interventional uses, not diagnostic.

SaMD (Software as a Medical Device)

The device description explicitly details physical components like catheters, sheaths, and ports, indicating it is a hardware-based medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the ClotTriever® Thrombectomy System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use 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." This describes a therapeutic and interventional procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
Device Description: The device is described as a system designed to "remove thrombi and emboli from the peripheral vasculature." This is a physical intervention within the body.
Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment.

IVD devices are used to perform tests in vitro (outside the body) on samples to provide diagnostic information. The ClotTriever System operates in vivo (within the body) to treat a condition.

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

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:
In accordance with the design failure modes and effects analysis, verification and validation tests were identified to support the substantial equivalence of the ClotTriever BOLD Catheter 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 and shelf-life:
Packaging Usability Visual and dimensional inspections Deairing/Flushing Radial force Deployment force of ClotTriever BOLD from delivery catheter Retraction force of handle Retraction force of ClotTriever BOLD into delivery catheter Leakage testing, ClotTriever BOLD Catheter Corrosion resistance Simulated use, track and tensile ClotTriever BOLD Catheter Torque testing, ClotTriever BOLD handle Particulate matter Performance test Clot removal from collection bag test Narrow occlusion test

The following testing was not impacted by the design modifications and therefore was leveraged from the predicate ClotTriever BOLD Catheter (K212632):
Pouch seal visual inspection Dye penetration Pouch, peel and seal strength Bubble leak test Visual and dimensional inspections post-simulated use – delivery catheter ID and marker band distance from distal tip Guidewire compatibility Conical fitting with 6% luer taper Insertion of delivery catheter through ClotTriever Sheath Retraction force of ClotTriever BOLD device through ClotTriever Sheath ClotTriever BOLD Catheter kink radius Leakage testing – ClotTriever Sheath Air leakage - ClotTriever Sheath Vacuum testing – ClotTriever Sheath Simulated use, track, and rotation, ClotTriever BOLD Catheter Simulated use, track and tensile, ClotTriever BOLD Catheter (non-affected components) ClotTriever BOLD Catheter radiopacity

The following design verification testing to demonstrate compatibility with the Protrieve Sheath was leveraged from the Protrieve Sheath (K220415):
Insertion of delivery catheter through Protrieve Sheath Retraction force of ClotTriever BOLD device through Protrieve Sheath Leakage testing – Protrieve Sheath Air leakage - Protrieve Sheath Vacuum testing - Protrieve Sheath

As there were no new materials introduced with the design modifications, the following biocompatibility tests were leveraged from the predicate ClotTriever BOLD Catheter:
Cytotoxicity Sensitization Intracutaneous Reactivity Acute Systemic Toxicity (Systemic Injection Test and Rabbit Pyrogen Test) Hemocompatibility (Hemolysis, Effect on Clotting, Complement Activation, and Thrombosis)
The proposed ClotTriever BOLD Catheter and predicate device are of the same general construction and the design differences do not pose a greater challenge to the sterilization process. Therefore, the sterilization validation for the predicate device applies to the proposed ClotTriever BOLD Catheter.
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 BOLD® Catheter (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.

Not Found

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

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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

April 18, 2023

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

Re: K230494

Trade/Device Name: ClotTriever BOLD® Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: February 23, 2023 Received: February 23, 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 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 (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,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2023.04.18
17:38:53 -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

Indications for Use

510(k) Number (if known) K230494

Device Name ClotTriever BOLD® Catheter

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® Thrombectomy 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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510(K) SUMMARY

Date prepared	April 18, 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	ClotTriever® Thrombectomy System
Trade name	ClotTriever BOLD® Catheter
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 BOLD® Catheter (K212632)
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 the ClotTriever Catheter, ClotTriever BOLD Catheter, ClotTriever 13 Fr and 16 Fr
Sheaths, and Protrieve Sheath, each packaged separately.

The ClotTriever BOLD Catheter is comprised of reinforced polymeric coaxial shafts terminating
in an expandable coring element and thrombus collection bag. Three ports terminating in two
stopcocks and a luer lock connection are provided for de-airing the catheter shafts. To aid in
fluoroscopic visualization, the ClotTriever Catheter, ClotTriever BOLD Catheter, ClotTriever
Sheaths, and Protrieve Sheath have radiopaque distal tips. |
| Indications for
Use | The proposed modifications of the ClotTriever BOLD Catheter do not change the indications for
use of the ClotTriever Thrombectomy System.
The ClotTriever Thrombectomy System is indicated for: |

	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 proposed modifications to the ClotTriever BOLD Catheter include: addition of a surface
treatment process to the existing titanium oxide layer of the collection bag resulting in a smoother
thin uniform oxide layer; dimensional change to the collection bag; dimensional change to the
handle plunger shaft and addition of a hypotube in the handle; dimensional change to the coring
element weld ring; change to the plunger inner compression spring; and a change to the short inner
compression spring.
There are no proposed changes to the intended use or design of the ClotTriever Catheter,
ClotTriever Sheaths (13 Fr and 16 Fr), and Protrieve Sheath as part of this submission.
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 listed above, the predicate and proposed devices are the same.
The modifications do not change the basic design or the principles of operation from the predicate
device. There are no new or different questions of safety or efficacy.
There is no change of intended use or fundamental scientific technology between the proposed
device and predicate device.
	Device	ClotTriever BOLD Catheter
(Proposed)	ClotTriever Thrombectomy System
ClotTriever BOLD Catheter Predicate
(K212632)
	Manufacturer	Inari Medical	Inari Medical
	Product Code	QEW, KRA	QEW
	Intended Use	The ClotTriever Thrombectomy System is
intended for use in the peripheral
vasculature including deep vein
thrombosis (DVT).	The ClotTriever Thrombectomy System is
intended for use in the peripheral
vasculature including deep vein thrombosis
(DVT).
	Indications for
Use	The ClotTriever Thrombectomy System is
indicated for:	The ClotTriever Thrombectomy System is
indicated for:
		• The non-surgical removal of thrombi and
emboli from blood vessels.	• 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.	• 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 Thrombectomy System is
intended for use in the peripheral
vasculature including deep vein thrombosis
(DVT).
	Device
Description	The ClotTriever Thrombectomy System
consists of the ClotTriever Sheaths, the
Protrieve Sheath, the ClotTriever Catheter,
and the ClotTriever BOLD Catheter. The
ClotTriever/Protrieve Sheaths are
comprised of a reinforced polymeric	The ClotTriever Thrombectomy System
consists of the ClotTriever Sheaths, the
ClotTriever Catheter, and the ClotTriever
BOLD Catheter. The ClotTriever Sheaths
are comprised of a reinforced polymeric
sheath equipped with a self-expanding distal

		sheath equipped with a self-expanding
distal mesh funnel, a flush/aspiration port,
and a proximal hemostasis valve. The
ClotTriever and ClotTriever BOLD
Catheters are comprised of reinforced
polymeric coaxial shafts terminating in an
expandable coring element and thrombus
collection bag. Other accessories provided
include a pre-dilator, the funnel loading
tool, and a large bore 60 cc syringe.	mesh funnel, a flush/aspiration port, and a
proximal hemostasis valve. The ClotTriever
and ClotTriever BOLD Catheters are
comprised of reinforced polymeric coaxial
shafts terminating in an expandable coring
element and thrombus collection bag. Other
accessories provided include a pre-dilator,
the funnel loading tool, and a large bore 60
cc syringe.
	Principles of
Operation	The 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/Protrieve Sheath. The net is
collapsed and pulled into and through the
ClotTriever/Protrieve 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 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.
	Target Vessel	Peripheral vessels 6-16 mm	Peripheral vessels 6-16 mm
	Catheter	OD: 12 Fr	OD: 12 Fr
	OD/ID	ID: 0.124"	ID: 0.124"
	Collection Bag	Collapsed: 16.5 cm	Collapsed: 24 cm
	Length	Expanded: 13.2 cm	Expanded: 19 cm
	Collection Bag
Material	Nitinol	Nitinol
	Collection Bag
Surface	Titanium Oxide, native oxide layer and
new surface treatment process to achieve a
uniform thin titanium oxide layer	Titanium Oxide, native oxide layer
	Coring
Element
Material	Nitinol	Nitinol
	Coring
Element
Surface	Titanium Oxide, native oxide layer	Titanium Oxide, native oxide layer
	Coring
Element OD	16 mm	16 mm
	Catheter	Deployed: 103 cm	Deployed: 111 cm
	Length	Effective: 80 cm	Effective: 80 cm
	Guidewire
compatibility	0.035"	0.035"
	Shelf-Life	6 months	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 and predicate device 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 ClotTriever BOLD Catheter 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 and
shelf-life:
	Packaging Usability Visual and dimensional inspections Deairing/Flushing Radial force Deployment force of ClotTriever BOLD from delivery catheter Retraction force of handle Retraction force of ClotTriever BOLD into delivery catheter Leakage testing, ClotTriever BOLD Catheter Corrosion resistance Simulated use, track and tensile ClotTriever BOLD Catheter Torque testing, ClotTriever BOLD handle Particulate matter Performance test Clot removal from collection bag test Narrow occlusion test
	The following testing was not impacted by the design modifications and therefore was
leveraged from the predicate ClotTriever BOLD Catheter (K212632):
	Pouch seal visual inspection Dye penetration Pouch, peel and seal strength Bubble leak test Visual and dimensional inspections post-simulated use – delivery catheter ID and marker
band distance from distal tip Guidewire compatibility Conical fitting with 6% luer taper Insertion of delivery catheter through ClotTriever Sheath Retraction force of ClotTriever BOLD device through ClotTriever Sheath ClotTriever BOLD Catheter kink radius Leakage testing – ClotTriever Sheath Air leakage - ClotTriever Sheath Vacuum testing – ClotTriever Sheath Simulated use, track, and rotation, ClotTriever BOLD Catheter Simulated use, track and tensile, ClotTriever BOLD Catheter (non-affected components) ClotTriever BOLD Catheter radiopacity

| The following design verification testing to demonstrate compatibility with the Protrieve Sheath
was leveraged from the Protrieve Sheath (K220415):

Insertion of delivery catheter through Protrieve Sheath Retraction force of ClotTriever BOLD device through Protrieve Sheath Leakage testing – Protrieve Sheath Air leakage - Protrieve Sheath Vacuum testing - Protrieve Sheath
As there were no new materials introduced with the design modifications, the following
biocompatibility tests were leveraged from the predicate ClotTriever BOLD Catheter:

Cytotoxicity Sensitization Intracutaneous Reactivity Acute Systemic Toxicity (Systemic Injection Test and Rabbit Pyrogen Test) Hemocompatibility (Hemolysis, Effect on Clotting, Complement Activation, and Thrombosis) |
| The proposed ClotTriever BOLD Catheter and predicate device are of the same general
construction and the design differences do not pose a greater challenge to the sterilization process.
Therefore, the sterilization validation for the predicate device applies to the proposed ClotTriever
BOLD Catheter. |
| 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 BOLD Catheter do not change its intended
use nor do they change the principles of operation. The verification and validation results
demonstrate that the modified ClotTriever BOLD Catheter is substantially equivalent to the
predicate device. |