Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the physical characteristics and materials of the catheter, and there is no mention of AI, ML, or any software-driven analytical capabilities. The performance studies are bench and design validation, not studies typically associated with evaluating AI/ML performance.

Therapeutic

No
The device is described as an "Intracranial Support Catheter" indicated for the "introduction of interventional devices" into the vasculature, not for providing therapy itself. Its function is to facilitate other interventional devices.

Diagnostic

No
The device is described as an "Intracranial Support Catheter" intended for the "introduction of interventional devices." This indicates a therapeutic or procedural support role, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components like catheters, Nitinol structure, radiopaque marker bands, and hydrophilic coating, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for the introduction of interventional devices into the peripheral and neurovasculature. This is a procedural device used in vivo (within the body) to facilitate other medical interventions.
Device Description: The description details a catheter designed for physical insertion into blood vessels.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.

IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a tool for delivering other devices during a medical procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Product codes

DOY, DQY

Device Description

The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are designed for the introduction of interventional devices into the peripheral and neurovasculature. The Arc™ Mini are a single lumen, flexible, variable stiffness composite catheters with a Nitinol structure. A radiopaque marker band on the distal tip of the devices is used for visualization under fluoroscopy. The distal sections of both catheters are coated with a hydrophilic coating, which is used to reduce the overall frictional force during intravascular use. The Arc™ and Arc™ Mini dimensions are included in the individual device label. The devices are supplied sterile and are intended for single-use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopy

Anatomical Site

Peripheral and neurovasculature.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use (Part 21 CFR 801 Subpart D)

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)

The following bench testing was performed in support of the Arc™ and Arc™ Mini Intracranial Support Catheter and to establish substantial equivalence to the ReFlex™ Guide Catheter:

Lumen Patency: All devices met acceptance criteria.
Dimensional Inspection: All device met acceptance criteria.
Distal Tip Buckling: Distal tip buckling force met acceptance criteria.
Catheter Injection Flow Rate: Injection flow rate met acceptance criteria.
Catheter Suction Flow Rate: Suction flow rate met acceptance criteria.
Vacuum Resistance: Device was resistant to vacuum collapse under static conditions.
Hub Air Aspiration Leak: Hub air aspiration test met acceptance criteria.
Shaft Peak Tensile Force: Shaft joint peak tensile force met acceptance criteria.
Hub Peak Tensile Force: Hub-shaft joint peak tensile force met acceptance criteria.
Coating Integrity – Baseline: Baseline coating integrity characterized with worst-case defect images. Data collected as engineering reference.
Coating Lubricity/Durability: Coating lubricity and durability testing met acceptance criteria.
Particulate Testing: Number of particulates generated met acceptance criteria.
Coating Integrity Simulated Use: Post-simulated use coating integrity characterized with worst-case defect images.
Kink Resistance: Device was resistant to kinking around small radii.
Liquid Leakage: Liquid leakage met acceptance criteria.
Static/Dynamic Burst: Static/dynamic burst testing met acceptance criteria.
Torque to Failure: Torque to failure testing met acceptance criteria.
Physician Usability Testing: The device was navigated through a tortuous benchtop model to assess compatibility with accessories, device stability, ability to aspirate, ability to inject saline or contrast, and the user's ability to navigate to the M1 and M2 segment of the MCA and retrieve a mechanical thrombectomy device. All test results met the acceptance criteria.

A Design Validation study was performed on a bench model to assess the usability of the Arc™ and ArcTM Mini Intracranial Support Catheter compared to the previously cleared ReFlex™ Guide Catheter.
Biocompatibility testing, sterilization, and a 6-month accelerated aging study were also performed.
No clinical studies were performed.
No animal study was performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

ReFlex™ Guide Catheter, 510(k)#: K110055

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem that resembles an abstract representation of an eagle or a similar bird, with stylized feathers or wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 29, 2015

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ms. Phuong Chau Senior Regulatory Affairs Product Specialist 9775 Toledo Way Irvine, California 92618

Re: K150107

Trade/Device Name: Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: June 26, 2015 Received: June 29, 2015

Dear Ms. Phuong Chau:

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. 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 (reporting of medical device

1

related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena நி/Δ

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K150107

Device Name

ArcTM Intracranial Support Catheter and ArcTM Mini Intracranial Support Catheter

Indications for Use (Describe)

The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Type of Use (Select one or both, as applicable)

For Activities Related to CA SB1383 (Organic Waste)
For Other Composting Activities

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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3

510(k) Summary – K150107

| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration No. 2029214 | | | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Contact Person: | Phuong Chau
Senior Regulatory Affairs Product Specialist
Telephone: (949) 297-5487
E-mail: phuong.chau@covidien.com | | | |
| Date Summary
Prepared: | June 25, 2015 | | | |
| Trade Name of
Device: | Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial
Support Catheter | | | |
| Common Name of
Device: | Catheter, Percutaneous | | | |
| Classification of
Device: | 21 CFR 870.1250 – Class II | | | |
| Product Code: | DQY | | | |
| Predicate Device: | ReFlex™ Guide Catheter, 510(k)#: K110055 | | | |
| Performance Data: | The following bench testing was performed in support of the Arc™ and
Arc™ Mini Intracranial Support Catheter and to establish substantial
equivalence to the ReFlex™ Guide Catheter: | | | |
| | • Lumen Patency | | | |
| | • Dimensional Inspection | | | |
| | • Distal Tip Buckling | | | |
| | • Catheter Injection Flow Rate | | | |
| | • Catheter Suction Flow Rate | | | |
| | • Vacuum Resistance | | | |
| | • Hub Air Aspiration Leak | | | |
| | • Shaft Peak Tensile Force | | | |
| | • Hub Peak Tensile Force | | | |
| | • Coating Integrity – Baseline | | | |
| | • Coating Lubricity/Durability | | | |
| | | | | |

4

. Particulate Testing
Coating Integrity Simulated Use .
. Kink Resistance
Liquid Leakage .
Static/Dynamic Burst .
. Torque to Failure

A Design Validation study was performed on a bench model to assess the usability of the Arc™ and ArcTM Mini Intracranial Support Catheter compared to the previously cleared ReFlex™ Guide Catheter. Biocompatibility testing, sterilization, and a 6-month accelerated aging study were also performed. No clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology of the device.

Conclusion: The ArcTM Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are substantially equivalent to the currently cleared ReFlex™ Guide Catheter based on the successful completion of nonclinical bench and design validation testing as well as similar principles of design, operation and indications for use.

Device Description:

The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are designed for the introduction of interventional devices into the peripheral and neurovasculature. The Arc™ Mini are a single lumen, flexible, variable stiffness composite catheters with a Nitinol structure. A radiopaque marker band on the distal tip of the devices is used for visualization under fluoroscopy. The distal sections of both catheters are coated with a hydrophilic coating, which is used to reduce the overall frictional force during intravascular use. The Arc™ and Arc™ Mini dimensions are included in the individual device label. The devices are supplied sterile and are intended for single-use only.

Indications for Use:

The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Device Comparison

The table below provides a comparison of the technological characteristics of the Arc™ Intracranial Support Catheter and Arc M Mini Intracranial Support Catheter and the currently cleared ReFlex (M Guide Catheter.

| | ReFlex™ Guide
Catheter
(K110055) | Arc™ Intracranial
Support Catheter | Arc™ Mini
Intracranial
Support Catheter | Rationale for
Difference (If
Present) |
|-----------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------|
| Indication for
Use | The ReFlex™
Guide Catheter is
indicated for the
introduction of | The Arc Intracranial
Support Catheter is
indicated for the
introduction of | The Arc Mini
Intracranial Support
Catheter is indicated
for the introduction | N/A |

5

| | ReFlex™ Guide
Catheter
(K110055) | Arc™ Intracranial
Support Catheter | Arc™ Mini
Intracranial
Support Catheter | Rationale for
Difference (If
Present) |
|--------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | interventional
devices into the
peripheral and
neurovasculature. | interventional
devices into the
peripheral and
neurovasculature. | of interventional
devices into the
peripheral and
neurovasculature. | |
| Materials | | | | |
| Catheter
Shaft
Materials | PTFE lined
polymeric catheter,
with hydrophilic
coating | PTFE lined
polymeric catheter,
with hydrophilic
coating | PTFE lined
polymeric catheter,
with hydrophilic
coating | The material used
for the Arc and
Arc Mini catheters
were shown to be
biocompatible per
ISO 10993 testing.
Materials of this
type are widely
used in similar
medical devices. |
| Catheter
Shaft
Support | Nitinol | Same | Same | N/A |
| Marker
band | Platinum | Same | Same | N/A |
| Dimensions | | | | |
| Usable Length | 90 – 130 cm | 132 – 135 cm | 160 – 163 cm | Longer lengths
provided for
additional
navigability
options to user. |
| Distal ID | 0.046" – 0.072" | 0.061" | 0.035" | Smaller distal ID
provided for
improved
trackability over
guide wire to
smaller vessels. |
| Distal OD
(Max) | 0.058"–0.084" max | 0.071" max | 0.049" | Smaller distal
ID/OD provided
for improved
distal flexibility. |
| Proximal ID | 0.046" – 0.072" | 0.069" | 0.044" | Smaller proximal
ID provided for
improved
trackability over
guide wire to |

6

| | ReFlex™ Guide
Catheter
(K110055) | Arc™ Intracranial
Support Catheter | Arc™ Mini
Intracranial
Support Catheter | Rationale for
Difference (If
Present) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------|
| | | | | smaller vessels. |
| Proximal OD
(Max) | 0.058"–0.084" max | 0.0825" max | 0.0620" | N/A |
| Tip
Configuration | Single, straight
flexible tip | Same | Same | N/A |
| Guidewire
Compatibility | Can be navigated
over a guidewire
with a maximum
OD of 0.038 in. | Same | Can be navigated
over a guidewire
with a maximum
OD of 0.032 in. | Largest
compatible
guidewire size
dependent on
smallest ID. |
| Sterilization
Method | Ethylene Oxide | Same | Same | N/A |
| Packaging | Catheter in
polyethylene hoop
attached to
packaging card
inside
PET/PE/Tyvek
pouch inside SBS
carton | Same | Same | N/A |

Sterilization and Shelf Life

The packaged Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are sterilized using a validated ethylene oxide (EO) sterilization cycle at the Sterigenics US; LLC facility located at 4900 Gifford Avenue, Los Angeles, CA. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 10-s in accordance with ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

Aging studies for the Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter devices have established the product and packaging remain functional and maintain sterility for up to 6 months. Aging studies for packaging integrity, seal strength, and device functionality were performed and met all acceptance criteria.

Biocompatibility

Biocompatibility testing was performed in compliance with the FDA consensus standard, recognition number 2-156, AAMI/ANSI/ISO 10993-1: 2009, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process and U.S. Food and Drug Administration (FDA) Blue Book Memorandum G95-1 (1995) guidelines. All studies were conducted in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR Part 58.

7

Test	Result	Conclusion
Plastics (USP)	Meets USP Physicochemical
extraction parameters.	Passes physical chemical
characteristics.
L929 MEM Elution Test - ISO	The test article scored "0" at 24, 48
and 72 ± 4 hours and is considered
non-cytotoxic under the conditions
of this test.	Non-cytotoxic
Klingman Maximization Test -
ISO (Guinea Pig Sensitization)	Under the conditions of this
protocol, the test article did not
elicit a sensitization response.	Non-sensitizer
Intracutaneous Injection Test -
ISO	The differences in the mean test
and control scores of the extract
dermal observations were less than
1.0, indicating that the requirements
of the ISO Intracutaneous
Reactivity Test have been met by
the test article.	Non-irritant
Acute Systemic Injection Test -
ISO	None of the test article extract
treated animals were observed with
clinical signs consistent with
toxicity at any of the observation
periods.	Non-cytotoxic
Materials Mediated Rabbit
Pyrogen - ISO	This response did not exceed the
USP limit and meets the
requirements for this test. Therefore
these results indicate that the test
article was determined to be non-
pyrogenic.	Non-pyrogenic
Hemolysis: Direct Contact /
Indirect Extract	There were no significant
differences between the test article
extract and negative control article
results. The test article is
considered non-hemolytic	Non-hemolytic
Complement activation C3a and
SC5b-9	The levels of C3a and SC5b-9 of
the Dyson catheter are comparable
to the ReFlex and less than that of
the positive control.	Levels of the compliments C3a
and SC5b complements were
similar for Arc and control
device
Thrombosis (in vivo) — Canine
(Arc / ReFlex)	The thromboresistance properties
of the Arc and Arc Mini
Intracranial Support Catheters are
acceptable in clinical use.	Acceptable, expected to be
equivalent to ReFlex in clinical
use
in vitro Hemocompatibility
Assay	Neither the Arc nor the ReFlex
Guide Catheter resulted in a
decrease in any blood component	No adverse effect on platelet
and leukocyte counts

8

Test	Result	Conclusion
	as compared to the reference
material. These results indicate that
the cause of thrombi is not related
to the materials exposed to human
blood during use.
Partial Thromboplastin Time	Clotting times for Arc and the
ReFlex (predicate device) test arms
were similar to the negative control
and the reference material (HDPE),
indicating that the device materials
are not an activator of the intrinsic
coagulation pathway.	No adverse effect on
prothrombin coagulation time
of human plasma.
Ames bacterial Mutagenicity 4
salmonella+1e.coli	Based on the criteria and conditions
of the study protocol, the test article
is considered non-mutagenic.	Non-mutagenic
in vitro Mouse Lymphoma Assay
with Extended Treatment	The test article is considered to be
non-mutagenic (non-genotoxic and
non-clastogenic) in this test system.	Non-mutagenic
in vivo Mouse Micronucleus
Assay	Based on the criteria of the assay,
the test article is considered non-
mutagenic in this test system.	Non-mutagenic

Performance Testing – Bench

A summary of the pre-clinical bench testing performed for the Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter is presented in the table below.

Test	Method	Conclusions
Lumen Patency	The total length of the device
must pass a mandrel of the
required size from the proximal
hub to distal tip.	All devices met acceptance
criteria.
Dimensional Inspection	The usable length, proximal and
distal inner and outer diameters
were measured and recorded.	All device met acceptance
criteria.
Distal Tip Buckling	Repeated distal tip buckling force
under compressive load was
evaluated for stiffness.	Distal tip buckling force met
acceptance criteria.
Catheter Injection Flow Rate	Device flow rate was measured
using ISO 10555-1, Annex E test
methods with injection through
proximal hub.	Injection flow rate met
acceptance criteria.
Test	Method	Conclusions
Catheter Suction Flow Rate	Device flow rate was measured
using ISO 10555-1, Annex E test
methods with injection through
distal tip.	Suction flow rate met acceptance
criteria.
Vacuum Resistance	Device was evaluated for
resistance to vacuum collapse
under static conditions with a
60cc syringe.	Device was resistant to vacuum
collapse under static conditions.
Hub Air Aspiration Leak	Device was tested for ISO
10555-1, Annex D hub air
aspiration leak.	Hub air aspiration test met
acceptance criteria.
Shaft Peak Tensile Force	Shaft peak tensile strength was
tested to failure for each joint
using ISO 10555-1, Annex B test
methods.	Shaft joint peak tensile force met
acceptance criteria.
Hub Peak Tensile Force	Hub-shaft joint peak tensile
strength was tested to failure
using ISO 10555-1, Annex B test
methods	Hub-shaft joint peak tensile force
met acceptance criteria.
Coating Integrity - Baseline	Fully assembled devices were
inspected under a minimum 2.5x
magnification for worst-case
coating defects.	Baseline coating integrity
characterized with worst-case
defect images. Data collected as
engineering reference.
Coating Lubricity/Durability	Device coating was evaluated for
average frictional force and
durability.	Coating lubricity and durability
testing met acceptance criteria.
Particulate Testing	Device was evaluated for
particulate generation under
simulated use in a representative
tortuous anatomical model.	Number of particulates generated
met acceptance criteria.
Coating Integrity - Simulated
Use	Fully assembled devices were
pre-conditioned under simulated
use conditions in a representative
tortuous anatomical model.
Coating was inspected under a
minimum 2.5x magnification and
subsequently tested for average
frictional force.	Post-simulated use coating
integrity characterized with
worst-case defect images.
Kink Resistance	Device was wrapped around a
rod of known radius and
inspected in-place for any kinks.	Device was resistant to kinking
around small radii.
Liquid Leakage	Device was tested for ISO	Liquid leakage met acceptance
Test	Method	Conclusions
	10555-1, Annex C liquid leakage
testing.	criteria.
Static/Dynamic Burst	Device was tested under full-
length static conditions to burst
and at pressures experienced
during worst-case dynamic
injections.	Static/dynamic burst testing met
acceptance criteria.
Torque to Failure	Device was tested for full-length
torque strength to determine
number of rotations to failure.	Torque to failure testing met
acceptance criteria.
Physician Usability Testing	The device was navigated
through a tortuous benchtop
model to assess compatibility
with accessories, device stability,
ability to aspirate, ability to inject
saline or contrast, and the user's
ability to navigate to the M1 and
M2 segment of the MCA and
retrieve a mechanical
thrombectomy device.	All test results met the
acceptance criteria.

9

10

Performance Testing - Animal

No animal study was performed as there is no change to the indications for use or the fundamental scientific technology for the new devices. Substantial equivalence of the Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter has been established to the predicate device through the results of bench testing.

Performance Testing - Clinical

No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the new devices. Substantial equivalence of the Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter has been established to the predicate device through the results of bench and design validation testing.