K Number

Device Name

RevCore Thrombectomy Catheter.

Manufacturer

Inari Medical, Inc.

Date Cleared

2023-03-14

(102 days)

Product Code

QEW

Regulation Number

870.5150

Intended Use

The RevCore Thrombectomy Catheter 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 RevCore Thrombectomy Catheter is intended for use in the peripheral vasculature.

Device Description

The RevCore Thrombectomy Catheter is a single-use, sterile medical device designed for use in the peripheral vasculature. The RevCore Thrombectomy Catheter comprises reinforced polymeric and metal coaxial shafts terminating in an expandable coring element. Two ports are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the RevCore Thrombectomy Catheter distal tip and coring element are radiopaque. The RevCore Thrombectomy Catheter consists of a distal laser-cut nitinol coring element, catheter shafts, and a handle, providing wall-to-wall contact, allowing the engagement and retrieval of clot from blood vessels and from implanted venous stents. The catheter shafts introduce the nitinol coring element percutaneously. The handle allows the physician to retract and turn the nitinol coring element to engage clot, as well as control the diameter of the nitinol coring element with a knob.

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

K201541

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical design and function of the catheter for thrombus removal and fluid management, with no mention of AI or ML capabilities.

Therapeutic

Yes
The "Intended Use / Indications for Use" states that the device is for "The non-surgical removal of thrombi and emboli from blood vessels," which indicates a therapeutic purpose. The device actively treats a medical condition (thrombi/emboli).

Diagnostic

No
Explanation: The device is indicated for the non-surgical removal of thrombi and emboli and for injection, infusion, and/or aspiration of fluids. It is a therapeutic device designed for intervention rather than diagnosis.

SaMD (Software as a Medical Device)

The device description clearly details physical components such as shafts, a coring element, ports, a handle, and mentions materials like polymeric and metal. It is a physical medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the RevCore Thrombectomy Catheter is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury.
RevCore Thrombectomy Catheter's Function: The RevCore Thrombectomy Catheter is a surgical device used within the body (in the peripheral vasculature) to physically remove thrombi and emboli. It is an interventional device, not a device that analyzes samples outside the body.
Intended Use: The intended use clearly describes a procedure performed directly on the patient's blood vessels.
Device Description: The description details a physical catheter with mechanical components designed for insertion and manipulation within the body.

Therefore, the RevCore Thrombectomy Catheter falls under the category of a surgical or interventional medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The RevCore Thrombectomy Catheter 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 RevCore Thrombectomy Catheter is intended for use in the peripheral vasculature system

Product codes

QEW

Device Description

The RevCore Catheter is comprised of reinforced polymeric and metallic coaxial shafts terminating in an expandable coring element. Two ports are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the RevCore Catheter distal tip is radiopaque.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral vasculature

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

A GLP Animal Study was successfully performed to evaluate the safety and performance of the RevCore Thrombectomy Catheter. The GLP animal testing met the predetermined acceptance criteria. All non-clinical test results demonstrated that acceptance criteria were met.

Key Metrics

Not Found

Predicate Device(s)

K212632

Reference Device(s)

K201541

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is a blue square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

March 14, 2023

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

Re: K223609

Trade/Device Name: RevCore™ Thrombectomy Catheter. Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: February 23, 2023 Received: February 24, 2023

Dear Suzanne Moreno:

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 (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 -S O'connell -S Date: 2023.03.14
09:29:30 -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) K223609

Device Name RevCoreTM Thrombectomy Catheter

Indications for Use (Describe) The RevCore Thrombectomy Catheter 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 RevCore Thrombectomy Catheter is intended for use in the peripheral vasculature system

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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Image /page/3/Picture/1 description: The image shows the logo for Inari Medical. The logo consists of a purple circle with three orange lines going through it on the left. To the right of the circle is the word "INARI" in large, purple, bold letters, and below that is the word "MEDICAL" in smaller, gray letters.

510(k) Summary K223609 RevCore™ Thrombectomy Catheter

The following "510(k) Summary" of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

1.0 Submitter Information [ 21 CFR 807.92(a) (1)]

Submitter:	Inari Medical, Inc.
Address:	6001 Oak Canyon, Suite 100
Irvine, CA 92618 USA
Establishment
Registration #:	3020347218
Contact:	Suzanne Moreno
Title:	Sr. Regulatory Affairs Specialist
Telephone:	(949) 694-9459
e-mail	Suzanne.Moreno@inarimedical.com

Date Prepared: January 04, 2023

2.0 Device Information [21 CFR 807.92 (a) (2)]

Device/Trade Name:	RevCore™ Thrombectomy Catheter
Device Classification:	Class II
Primary Product Code:	QEW
Regulation:	21 CFR 870.5150
Regulation Name:	Embolectomy catheter
Common Name:	Embolectomy catheter
Classification Panel:	74-Cardiovascular

3.0 Predicate, and Reference Device Information [21 CFR 807.92(a) (3)]

| Predicate Device | 510(k)
No. | Decision
Date | 510(k) Holder |
|--------------------------------------------|---------------|------------------|---------------------|
| ClotTriever BOLD Catheter | K212632 | 10/18/2021 | Inari Medical, Inc. |
| Reference Device | 510(k)
No. | Decision
Date | 510(k) Holder |
| FlowTriever Retrieval/Aspiration
System | K201541 | 12/04/2020 | Inari Medical, Inc. |

Image /page/4/Picture/0 description: The image is a logo for Inari Medical. The logo features a purple circle with three orange lines going through it on the left side. To the right of the circle is the word "INARI" in large, purple letters, and below that is the word "MEDICAL" in smaller, gray letters.

4.0 Device Description [21 CFR 807.92(a) (4)1

5.0 Intended Use/Indications for use of device and Indications for Use [21 CFR 807.92(a) (5)]

Indications for Use

The RevCore Thrombectomy Catheter 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 RevCore Thrombectomy Catheter is intended for use in the peripheral vasculature.

Image /page/5/Picture/0 description: The image is a logo for Inari Medical. The logo features a purple circle with three orange lines going through it on the left side. To the right of the circle is the word "INARI" in large, purple letters, and below that is the word "MEDICAL" in smaller, gray letters.

6.0 Summary of Substantial Equivalence [21 CFR 807.92 (a) (6)]

The RevCore Thrombectomy Catheter is similar/same in indications for use, fundamental design, principles of operation, materials, labeling/packaging, and sterilization compared to the Inari owned devices, the predicate, the ClotTriever BOLD Catheter (K212632), and the reference device, the FlowTriever Retrieval/Aspiration System (K201541).

	Subject	Predicate Device	Reference Device		Subject	Predicate Device	Reference Device
Device	RevCore Thrombectomy Catheter	ClotTriever BOLD Catheter	FlowTriever Retrieval/Aspiration System	Device	RevCore
Thrombectomy Catheter	ClotTriever BOLD
Catheter	FlowTriever
Retrieval/Aspiration
System
510(k) Number	K223609	K212632	K201541	510(k) Number	K223609	K212632	K201541
Manufacturer	Inari Medical	Inari Medical	Inari Medical	Device
Description	The RevCore Catheter
is a single-use, sterile,
minimally invasive
medical device designed
for use in the peripheral
vasculature.	The ClotTriever BOLD
Catheter is a single-use,
sterile, minimally invasive
medical device designed
for use in the peripheral
vasculature.	The FlowTriever System
is a single-use, sterile,
minimally invasive
medical device designed
for use in the peripheral
vasculature.
Product code	QEW	QEW	QEW
KRA		The RevCore Catheter is
comprised of reinforced
polymeric and metallic
coaxial shafts terminating
in an expandable coring
element.	The ClotTriever BOLD
Catheter is comprised of
reinforced polymeric and
metallic coaxial shafts
terminating in an
expandable coring
element and thrombus
collection bag.	The FlowTriever
Catheters are comprised
of reinforced polymeric
and metallic coaxial
shafts terminating in an
expandable coring
element.
Device Class	Class II	Class II	Class II		Two ports are provided
for de-airing the catheter
shafts.	Three ports are provided
for de-airing the catheter
shafts.	One port is provided for
de-airing the catheter
shafts.
Indications for Use Statements	The RevCore Thrombectomy Catheter 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 RevCore Thrombectomy Catheter is intended for use in the peripheral vasculature.	The ClotTriever BOLD Catheter 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 BOLD Catheter is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).	The FlowTriever 2 Catheter 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 FlowTriever 2 Catheter is intended for use in the peripheral vasculature.		To aid in fluoroscopic
visualization, the
RevCore Catheter
distal tip is radiopaque.	To aid in fluoroscopic
visualization, the
ClotTriever BOLD
Catheter distal tip is
radiopaque.	To aid in fluoroscopic
visualization, the
FlowTriever Catheter
distal tip is radiopaque.
Principles of
operation	The coring element is
composed of self-
expanding nitinol and the
diameter is manually
controlled by a knob in
the handle.	The coring element is
composed of self-
expanding nitinol and the
diameter is manually
controlled by a plunger in
the handle.	The disk(s) are
composed of self-
expanding nitinol which
are deployed by manually
retracting the outer
Delivery Catheter.
	The coring element is
retracted through the
vessel to engage and
remove thrombus and
emboli.	The coring element is
retracted through the
vessel to engage and
remove thrombus and
emboli.	The coring element is
retracted through the
vessel to engage and
remove thrombus and
emboli.
	The device and captured
clot can then be removed
from the vessel through
the introducer sheath.	The device and captured
clot can then be removed
from the vessel through
the introducer sheath.	The device and captured
clot can then be removed
from the vessel through
the introducer sheath.

The comparisons are listed in the table below:

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Image /page/7/Picture/0 description: The image is a logo for Inari Medical. The logo features a purple circle with orange waves inside of it. To the right of the circle is the word "INARI" in large, purple letters. Below the word "INARI" is the word "MEDICAL" in smaller, gray letters.

	Subject	Predicate Device	Reference Device
Device	RevCore
Thrombectomy Catheter	ClotTriever BOLD
Catheter	FlowTriever
Retrieval/Aspiration
System
510(k) Number	K223609	K212632	K201541
Power Source	Manually operated	Manually operated	Manually operated
Sterile	SAL 10-6, EO	SAL 10-6, EO	SAL 10-6, EO
Number of
disks / coring
elements	Model 44-101: 1	Model 42-102: 1	Model 11-102: 1
Model 10-104: 3
Recommended
vessel size
treatment range	Model 44-101:
6mm - 20mm	Model 42-102
6mm - 16mm	Model 11-102
6mm - 16mm
Model 10-104
19mm - 25mm
Maximum Disk /
Coring Element
Size	Model 44-101: 24.0mm	Model 42-102: 16.0mm	Model 11-102: 17.0mm
Model 10-104: 27.9mm
Disk / coring
element
material	Nitinol	Nitinol	Nitinol
Delivery
Catheter shaft
materials	Pebax 6333 SA01 MED,
Pebax 5533 SA01 MED,
304V stainless steel,
PTFE Liner	Pebax 6333 SA01 MED,
Pebax 5533 SA01 MED,
304V stainless steel,
PTFE Liner	Pebax 7233 SA01 MED,
Pebax 4033 SA01 MED,
304V stainless steel,
PTFE Liner
Tip Materials	Pebax 7233 SA01 MED,
45% Tungsten	Pebax 7233 SA01 MED,
70% Tungsten	Pebax 7233 SA01 MED,
70% Tungsten
Delivery
Catheter OD	3.9 mm	3.9 mm	3.8 mm
Delivery
Catheter length	80 cm	80 cm	120 cm
Guidewire
compatibility	.035"	.035"	.035"

7.0 Performance Testing [21 CFR 807.92(b)(1)]

In accordance with the Design Failure Modes and Effects Analysis, verification and validation tests were identified to support the substantial equivalence of the RevCore Thrombectomy Catheter to the predicate device, the ClotTriever BOLD Catheter (K212632), and the reference device, the FlowTriever Retrieval/Aspiration System (K201541).

Image /page/8/Picture/0 description: The image is a logo for Inari Medical. The logo features a purple circle with three orange lines going through it on the left side. To the right of the circle is the word "INARI" in large, purple letters, with the word "MEDICAL" in smaller, gray letters underneath.

7.1 Performance Testing

The following tests were performed for the RevCore Thrombectomy Catheter:

Packaging Tests & Inspections

Pouch Seal Inspection ●
Pouch Dye Penetration ●
Pouch Bubble Leak ●
Aseptic Presentation

Dimensions & Key Characteristics

Visual and Dimensional Inspections ●
- o RevCore Catheter
- RevCore Coring Element o
- RevCore Delivery Catheter o
Guidewire Compatibility ●

Performance & Functional Evaluation

Deairing/Flushing Testing ●
Knob Torque Testing ●
Deployment and Retraction Force through the Delivery Catheter ●
Coring Element Retraction into Delivery Catheter Inspection ●
Distal Catheter Kink Radius Testing ●
Coring Element Durability Inspection (Post-Simulated Use) ●
Insertion through Sheath
Retraction Force through Sheath ●
Sheath Inspection (Post-Simulated Use) ●
Leakage Testing, Sheath (Post-Simulated Use) ●
Vacuum Testing, Sheath (Post-Simulated Use) ●
Leakage Testing, RevCore Catheter (Post-Simulated Use) ●
Delivery Catheter Durability Inspection (Post-Simulated Use) ●
Simulated Use Tracking and Tensile Testing (Post-Simulated Use) ●
Simulated Use Tracking and Torque Testing (Post-Simulated Use) ●
Corrosion Testing
Particulate Matter Determination ●
Luer Testing ●
Safety Testing in Stent Model ●

Image /page/9/Picture/0 description: The image contains the logo for Inari Medical. The logo consists of a circular design with orange lines inside, followed by the word "INARI" in large, purple letters. Below "INARI" is the word "MEDICAL" in smaller, gray letters.

Characterization Tests

Radial Force Characterization ●
Efficacy Testing (Clot & Stent Model) ●
SEM of Stents/RevCore Coring Elements Post-Treatment

Leveraged Tests

Pouch Seal Strength ●
Simulated Use Tracking and Rotation Testing ●
Delivery Catheter Radiopacity ●

Pre-Clinical Study

A GLP Animal Study was successfully performed to evaluate the safety and performance of the RevCore Thrombectomy Catheter. The GLP animal testing met the predetermined acceptance criteria.

7.2 Biocompatibility

Biocompatibility testing for the RevCore Thrombectomy Catheter was completed in accordance with ISO 10993-1 including:

Cytotoxicity ●
Sensitization ●
Intracutaneous Reactivity ●
Acute Systemic Toxicity ●
Pyrogenicity (Material Mediated)
Hemocompatibility ●
- o Hemolysis
- Complement Activation O
- Thrombogenicity O
- Platelet and Leukocyte O
- Partial Thromboplastin Time (PTT) о

7.3 Sterilization

The subject device is sterilized using EtO to achieve a sterility assurance level (SAL) of 10°. The subject device has been adopted into a validated sterilization process in accordance with the principles of ISO 11135:2014 (Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices, and AAMI TIR 28:2016 (Product adoption and process equivalence for ethylene oxide sterilization) without deviations.

Image /page/10/Picture/0 description: The image shows the logo for Inari Medical. The logo consists of a circular design with orange lines inside, followed by the word "INARI" in large, purple letters. Below "INARI" is the word "MEDICAL" in smaller, gray letters.

7.4 Clinical Data [21 CFR 807.92(b) (2)]

Based on the similarities in the safety and effectiveness profiles of the subject predicate, and reference devices per their intended uses, no clinical studies were deemed necessary to support this submission.

All non-clinical test results demonstrated that acceptance criteria were met; therefore, the device conforms to established product specifications.

8.0 Conclusions Safety and Effectiveness SW [21 CFR 807.92(b) (3)]

The subject device has successfully passed all acceptance criteria for nonclinical performance testing and biocompatibility, demonstrating that the subject device is substantially equivalent to the legally marketed predicate ClotTriever BOLD Catheter (K212632).