Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical design and function of a microcatheter for delivering devices and agents. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No.

The device itself is not a therapeutic device, but rather a delivery system intended for the introduction of other non-liquid interventional devices or therapeutic agents into the vasculature.

Diagnostic

No

The device is a microcatheter used to deliver diagnostic agents (like contrast media) or other interventional devices, rather than performing the diagnostic function itself. The diagnostic function is performed by technologies like fluoroscopy which are used in conjunction with this device.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical microcatheter, a hardware component, and its accessories. There is no mention of software as the primary or sole component of the 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, or tissue) to provide information for diagnosis, monitoring, or screening. This testing happens outside the body (in vitro).
VIA™ 21 Microcatheter Function: The VIA™ 21 Microcatheter is an invasive device used inside the body (in vivo) to deliver other devices or agents directly into the vasculature. It's a tool for accessing and treating anatomical sites, not for analyzing biological samples.

The description clearly states its purpose is for:

Introducing non-liquid interventional devices: This refers to things like stents or flow diverters, which are placed within the blood vessels.
Infusion of diagnostic (such as contrast media) or non-liquid therapeutic agents: Contrast media is used to visualize structures during imaging, and therapeutic agents are delivered for treatment. These are delivered into the body.

Therefore, based on its intended use and function, the VIA™ 21 Microcatheter is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The VIA™ 21 Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or non-liquid therapeutic agents into the neuro, peripheral, and coronary vasculature.

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

DQY, KRA

Device Description

The VIA™ 21 Microcatheter is designed to be introduced over a steerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with manipulation while in the vasculature. Throughout the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Diagnostic, therapeutic and interventional devices can be delivered through the lumen of the catheter to the treatment site.

The VIATM 21 Microcatheter is a sterile single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as an intraluminal flow diverter.

The VIA™ 21 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.021 inches.

The VIA™ 21 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic.

Accessories: Each VIA™ 21 Microcatheter is provided with a shaping mandrel to facilitate distal tip shaping.

In intravascular procedures, the device assists the physician in:

Accessing the targeted vasculature to facilitate the delivery of interventional devices, such as intraluminal flow diverters, infusion of diagnostic agents such as contrast and infusion of therapeutic agents.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

neuro, peripheral, and coronary vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician / Clinical setting

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)

Bench Testing
Sterilization Validation
Packaging and Shelf Life Assessment
Biocompatibility Assessment
Simulated Use Testing in Animals

This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate device, for its intended use in the introduction of interventional devices, infusion of diagnostic and non-liquid therapeutic agents into the vasculature.

The nonclinical tests included:

Physical characteristics unique to the VIA™ 21 Microcatheter, such as visual and dimensional tolerances, kink resistance, and catheter tip shape retention.
Safety features such as burst pressure, tensile force and coating adherence.
Functional characteristics such as navigation and track force. Interventional device retraction and catheter flow rate.

Nonclinical testing demonstrated that the VIA™ 21 Microcatheter can perform as intended, and demonstrated substantial equivalence to the predicate devices.

Use in a clinical setting was conducted in animals to show that no new risks were identified and that the safety and effectiveness profile is similar to well-established comparison market-approved devices. Bench Testing was performed in models representing the higher risk neurovascular anatomy, which is the worst case representation of the cardiac and peripheral vascular anatomies. The ViaTM 21 Microcatheter has equivalent performance characteristics to the comparison devices.

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.

VIA™ (VIA 27) and VIA™ PLUS (VIA 33) Microcatheters (K132652), Headway 21 Microcatheter (K093160), Orion Microcatheter (K113289)

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

§ 870.1250 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 logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of a triple-profile silhouette of a human head, with flowing lines suggesting movement or progress. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

August 28, 2015

Sequent Medical, Inc Ms. Bethany Barrett Regulatory/Clinical Project Manager 11A Columbia Aliso Viejo, California 92656

Re: K150894

Trade/Device Name: VIA™ 21 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: July 27, 2015 Received: July 29, 2015

Dear Ms. Barrett:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) 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 - SD/A

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) K150894

Device Name VIA™ 21 Microcatheter

Indications for Use (Describe)

The VIA™ 21 Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or non-liquid therapeutic agents into the neuro, peripheral, and coronary vasculature.

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).

DATE PREPARED	4/1/2015
APPLICANT	Sequent Medical, Inc.
11A Columbia
Aliso Viejo, CA 92656
Tel: (949) 830-9600
Fax: (949) 830-9658
OFFICIAL
CORRESPONDENT	Bethany Barrett
11A Columbia
Aliso Viejo, CA 92656
bethanyb@sequentmedical.com
Tel: (949) 830-9600 x 113
Fax: (949) 830-9568
TRADE NAME	VIA™ 21 Microcatheter
COMMON NAME	Continuous Flush Catheter
DEVICE
CLASSIFICATION	Class II, 21 CFR §870.1250, 21 CFR §870.1210
PRODUCT CODES	DQY: Percutaneous Catheter
KRA: Continuous Flush Catheter
PREDICATE
DEVICES	VIA™ (VIA 27) and VIA™ PLUS (VIA 33)
Microcatheters (K132652)
Headway 21 Microcatheter (K093160)
Orion Microcatheter (K113289)
PRIOR SUBMISSION	This is an original submission. There has been no prior
submission for the subject device.

SUBSTANTIALLY EQUIVALENT TO:

The VIA™ 21 Microcatheter is substantially equivalent to the previously cleared VIATM (VIA 27) and VIA™ PLUS (VIA 33) Microcatheters (K132652), Headway 21 Microcatheter (K093160) and Orion Microcatheter (K113289).

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The VIA™ 21 Microcatheter is designed to be introduced over a steerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with

4

manipulation while in the vasculature. Throughout the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Diagnostic, therapeutic and interventional devices can be delivered through the lumen of the catheter to the treatment site.

The VIATM 21 Microcatheter is a sterile single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as an intraluminal flow diverter.

The VIA™ 21 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.021 inches.

The VIA™ 21 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic.

Accessories: Each VIA™ 21 Microcatheter is provided with a shaping mandrel to facilitate distal tip shaping.

In intravascular procedures, the device assists the physician in:

Accessing the targeted vasculature to facilitate the delivery of interventional ● devices, such as intraluminal flow diverters, infusion of diagnostic agents such as contrast and infusion of therapeutic agents.

INDICATIONS FOR USE:

The VIA™ 21 Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or non-liquid therapeutic agents into the neuro, peripheral and coronary vasculature.

TECHNICAL CHARACTERISTICS:

The VIA™ 21 Microcatheter incorporates variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The inner lumen incorporates a PTFE liner to facilitate movement of devices through the catheter's lumen to the intended destination in the vasculature. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The tip of the catheter can be steam shaped by physician for proper adjustment to the anatomy prior to use.

5

PERFORMANCE DATA:

Device performance testing confirms that the VIA™ 21 Microcatheter can be used according to its intended use. The VIA™ 21 Microcatheter has been verified and validated according to Sequent Medical's procedures for product design and development. Performance testing included:

Bench Testing ●
Sterilization Validation ●
Packaging and Shelf Life Assessment
Biocompatibility Assessment ●
. Simulated Use Testing in Animals

This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate device, for its intended use in the introduction of interventional devices, infusion of diagnostic and non-liquid therapeutic agents into the vasculature.

The information provided by Sequent Medical in this 510(k) application was found to be substantially equivalent to the predicate devices. VIA™ (VIA 27) and VIATM PLUS (VIA 33) Microcatheters (K132652), Headway 21 Microcatheter (K093160) and Orion Microcatheter (K113289).

NONCLINICAL TESTS DISCUSSION:

The nonclinical tests included:

Physical characteristics unique to the VIA™ 21 Microcatheter, such as visual and ● dimensional tolerances, kink resistance, and catheter tip shape retention.
Safety features such as burst pressure, tensile force and coating adherence.
Functional characteristics such as navigation and track force. Interventional device retraction and catheter flow rate.
The full list of non-clinical tests are listed in Table 1 below: .

| Test | Methodology | Applicable
International
Standard and/or
Sequent Test
Method (TM) | Result | Conclusion |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Visual and Dimensional | Tests conformance to
specified microcatheter
dimensions and visual
criteria. | ISO 10555-1:2013
TM036 | Met performance
specifications
per DTM003 | Complete
conformance to
standard |
| Test | Methodology | Applicable
International
Standard and/or
Sequent Test
Method (TM) | Result | Conclusion |
| Kink Resistance | Measures diameter at
which microcatheter
shaft sections and
junctions will kink. | BS EN 13868:2002
TM035 | Met performance
specifications
per DTM003 | Conformance to
standard with the
following
deviations:
Kink diameter |
| | | | | determined based
on mechanical kink
(drop in
compressive force)
instead of 50%
reduction in water |
| | | | | flow. This method
is appropriate as
the Via 21 is
primarily used to
deliver non-liquid
devices. |
| Tip Buckling | Tests force required for
tip to buckle. | TM034 | Met performance
specifications
per DTM003 | Complete
conformance to
Sequent TM |
| Tracking Force | Tests force required to
advance an
interventional device
through the
microcatheter lumen. | TM032 | Met performance
specifications
per DTM003 | Complete
conformance to
Sequent TM |
| Steam Shaping and
Shape Retention | Tests that microcatheter
can be steam shaped to a
clinically relevant angle
and can maintain a
minimum % of the initial
angle after simulated
use. | TM038 | Met performance
specifications
per DTM003 | Complete
conformance to
Sequent TM |
| Shaft Tensile | Measures the ultimate
tensile strength of all
Pebax and Vestamid
junctions along the
length of the catheter
shaft. | ISO 10555-1:2013
TM031 | Met performance
specifications
per DTM003 | Complete
conformance to
standard |
| Hub-Shaft Tensile | Measures the ultimate
tensile strength of the
hub to shaft junction. | ISO 10555-1:2013
TM031 | Met performance
specifications
per DTM003 | Complete
conformance to
standard |
| Burst | Measures peak pressure
before microcatheter
burst/liquid leakage. | ISO 10555-1:2013
TM037 | Met performance
specifications
per DTM003 | Complete
conformance to
standard |
| Test | Methodology | Applicable
International
Standard and/or
Sequent Test
Method (TM) | Result | Conclusion |
| Coating Friction and
Coating Integrity | Measures the average
peak coating
friction/lubricity.
Coating integrity uses
dye to test that coating
remains adhered to
catheter after simulated
use. | Harland Medical
Systems Coating
Friction and Dye
Test Methods
FDA Guidance
Document, Class II
Special Controls for
PTCA Catheters
(section 12) (Issued
2010) | Met performance
specifications
per DTM003 | Complete
conformance to
Harland test
methods
In line with FDA
guidance document
on coating integrity |
| Coating
Adherence/Particulate | Measures particulate
generated from the
hydrophilic coating on
exterior of
microcatheter, as well as
particulate generated
from advancing an
interventional device
through the inner lumen
of the microcatheter. | TM042
FDA Guidance
Document, Non-
Clinical Engineering
Tests for
Intravascular Stents
and Associated
Delivery Systems
(section 12) (Issued
2010)
FDA Guidance
Document, Class II
Special Controls for
PTCA Catheters
(section 13) (Issued
2010) | Met performance
specifications
per DTM003 | Complete
conformance to
Sequent TM
In line with FDA
guidance
documents on
particulate testing |
| Flow Rate | Measures flow rates
through the
microcatheter at defined
injection rates using
saline and contrast. | ISO 10555-1:2013 | Met performance
specifications
per DTM003 | Complete
conformance to
standard |
| Hub Performance | Tests hub liquid and air
leakage, as well as that
the hub can withstand
adequate forces. Tests
that the hub meets
general requirements for
conical fittings. | ISO 594-1:1986
ISO 594-2:1998
TM043 | Test results
adopted from
VIA 27/VIA33
(K132652) | Conformance to
standard with the
following
deviations:
Used an alternative
ISO 594-2:1998
fitting to test hubs
for Separation
Force and
Unscrewing
Torque. The fitting
used was measured
to have a minor
diameter greater
than called for in |
| | | | the standard. This
was deemed as
worst case for these
tests, therefore
acceptable to use.
Only short term
stress cracking was
inspected for on
hubs. ISO 594-
2:1998 calls for
inspection after 48
hours. Intended use
of Via 21
microcatheter only
requires RHV or
syringes to be
connected for short
durations during
delivery of implant,
therefore long term
testing is not
applicable. | |

Table 1. Non-Clinical Tests

6

510(K) SUMMARY

7

510(K) SUMMARY

8

Nonclinical testing demonstrated that the VIA™ 21 Microcatheter can perform as intended, and demonstrated substantial equivalence to the predicate devices: VIA™ (VIA 27) and VIA™ PLUS (VIA 33) Microcatheters (K132652), Headway 21 Microcatheter (K093160) and Orion Microcatheter (K113289).

BIOCOMPATIBILITY AND CHEMICAL TESTING:

Biocompatibility and chemical testing was adopted from the testing performed on the VIA (VIA 27) Microcatheter. The full list of biocompatibility and chemical testing that was adopted can be found in Table 2 below:

Biocompatibility Testing
Test	Applicable International Standard	Result
Materials Mediated Rabbit Pyrogen Test	ISO10993-11:2006	Non-pyrogenic - Pass
ISO Guinea Pig Maximization Sensitization	ASTM F720-81 (2002)	Non-sensitization response - Pass
ISO Acute Systemic Injection Test	ISO10993-11:2006	Non Toxic - Pass
ISO Intracutaneous Reactivity Test	ISO10993-10:2010	Non-irritant - Pass
Four Hour Thromboresistance Evaluation in Dogs	ISO10993-4:2002 (2006)	Thromboresistance characteristics of test group similar to control – Pass

Table 2. Biocompatibility and Chemical Testing

9

| ASTM Hemolysis Assay Direct
Contact and Extract | ISO10993-4:2002 (2006)
ASTM F619-03
ASTM F756-08 | Non-hemolytic under direct and
extract test conditions - Pass | | |
|----------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--|--|
| Complement Activation with
Comparison Article | ISO10993-4:2002 (2006) | Results of test group comparable
to control group - Pass | | |
| Partial Thromboplastin Time with
Comparison Article | ISO10993-4:2002 (2006)
ASTM F2382-04 | Results of test group comparable
to control group -both non-
activators of the intrinsic
coagulation pathway - Pass | | |
| Platelet and Leukocyte Counts
with Comparison Article | ISO10993-4:2002 (2006) | Results of test group comparable
to control group - Pass | | |
| ISO MEM Elution Assay with L-
929 Mouse Fibroblast | ISO10993-5:2009 | Non-toxic - Pass | | |
| Chemical Testing | | | | |
| Test | Applicable International
Standard | Result | | |
| Colorant Analysis Testing | 21 CFR 74.3045 (2012) | Elemental results meet
requirements of 21 CFR 74.3045

Pass | | |

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

A technological comparison, as well as bench and simulated use testing demonstrate the substantial equivalence of the VIA™ 21 Microcatheter to the predicate devices. Table 3 below shows a summary of the VIA™ 21 technological characteristics as compared to the predicate devices.

10

Table 3. Substantial Equivalence Summary - Technological Characteristics

| Element | SUBJECT DEVICE

VIA™ 21
MICROCATHETER
(K150894) | VIA™ (VIA 27)
AND VIA™ PLUS
(VIA 33)
MICROCATHETER
(K132652) | HEADWAY 21
MICROCATHETER
(K093160) | ORION ™
MICROCATHETER
CATHETER (K113289)
AND CE0297) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Differences in Technological Characteristics | | | | |
| The subject and predicate devices are substantially equivalent with respect to design characteristics. The slight variations in
flexibility as well as differences in ID and OD are what differentiate these catheters. Each manufacturer optimizes these design
variations towards a more specific application (e.g. infusion of diagnostic and therapeutic agents) or for the introduction of specific
devices such as embolic agents, coils and stents. Devices are composed of similar materials, all of which have extensive clinical
history of safe use in medical devices | | | | |
| Design Features -
Equivalent ? | | | | |
| Materials | PTFE, Pebax, Vestamid,
Stainless Steel wire,
Polypropylene
Yes | PTFE, Pebax, Vestamid,
Stainless Steel wire,
Polypropylene
Yes | PTFE, Pebax,
Stainless Steel wire,
Nylon Santoprene
Yes | PTFE, Pebax, Stainless
Steel hypotube, Nitinol
braid reinforcement,
polypropylene
Yes |
| Tip Shape | Straight tip configuration
and the physician has the
option to steam shape the
tip using the Shaping
Mandrel prior to use to
ensure proper adjustment
to the anatomy.
Yes | Straight tip configuration
and the physician has the
option to steam shape the tip
using the Shaping Mandrel
prior to use to ensure proper
adjustment to the anatomy.
Yes | Straight tip
configuration and the
physician has the
option to steam shape
the tip prior to use to
ensure proper
adjustment to the
anatomy.
Yes | Straight tip
configuration and the
physician has the
option to steam shape
the tip prior to use to
ensure proper
adjustment to the
anatomy.
Yes |
| Element | SUBJECT DEVICE
VIATM 21
MICROCATHETER
(K150894) | VIATM (VIA 27)
AND VIATM PLUS
(VIA 33)
MICROCATHETER
(K132652) | HEADWAY 21
MICROCATHETER
(K093160) | ORION TM
MICROCATHETER
CATHETER (K113289)
AND CE0297) |
| Effective
Lengths | Via 21: 154 cm
Yes | Via 27: 154 cm
Via 33: 133 cm
Yes | 150 cm
Yes | 150 cm
Yes |
| Proximal/Distal
OD | Via 21: Proximal
2.8F/Distal 2.5F
Yes | Via 27: Proximal
3.2F/Distal 3.0F
Via 33: Proximal 3.8
F/Distal 3.4F
Yes | Proximal OD: 2.5F
Distal OD: 2.0F
Yes | Proximal OD: 2.4F
Distal OD: 2.6F
Yes |
| ID | Via 21: 0.021 inch/ 1.6F
Yes | Via 27: 0.027 inch/ 2.1F
Via 33: 0.033 inch/2.5F
Yes | ID: 0.021 inch
Yes | ID: 0.021 inch
Yes |
| Hydrophilic
Coating Length | Via 21: 100 cm
Yes | Via 27: 100 cm
Via 33: 100 cm
Yes | 100cm (measured)
Yes | 85 cm (measured)
Yes |
| Tip Length | 1 mm
Yes | 1 mm
Yes | 0.66 mm (measured)
Yes | 0.70 mm (measured)
Yes |
| Element | SUBJECT DEVICE
VIATM 21
MICROCATHETER
(K150894) | VIA™ (VIA 27)
AND VIA™ PLUS
(VIA 33)
MICROCATHETER
(K132652) | HEADWAY 21
MICROCATHETER
(K093160) | ORION TM
MICROCATHETER
CATHETER (K113289)
AND CE0297) |
| Distal Tip
Length | Via 21: 5cm
Yes | Via 27:10cm
Via 33: 5 cm
Yes | 15cm (measured)
Yes | 13.5 cm (measured)
Yes |
| Tip Markers | 1 marker, 90%Pt-10%Ir
Yes | 1 marker, 90%Pt-10%Ir
Yes | 2 markers, confirmed
to be radiopaque
Yes | 2 markers, confirmed
to be radiopaque
Yes |
| Coating | Polyvinylpyrrolidone
Yes | Polyvinylpyrrolidone
Yes | Confirmed to be
lubricious
Yes | Confirmed to be
lubricious
Yes |
| Method of
supply | Sterile, single-use, non-
pyrogenic
Yes | Sterile, single-use, non-
pyrogenic
Yes | Sterile, single-use,
non-pyrogenic
Yes | Sterile, single-use, non-
pyrogenic
Yes |
| Packaging | Primary package: Coiled
Hoop within a single
pouch
Secondary Package:
Chipboard unit carton
Yes | Primary package: Coiled
Hoop within a single pouch
Secondary Package:
Chipboard unit carton
Yes | Primary package:
Coiled Hoop within a
single pouch
Secondary Package:
Chipboard unit carton
Yes | Primary package:
Coiled Hoop within a
single pouch
Secondary Package:
Chipboard unit carton
Yes |
| Sterilization | Ethylene Oxide
Sterilization | Ethylene Oxide Sterilization
Yes | Ethylene Oxide
Sterilization | Ethylene Oxide
sterilization |
| Element | SUBJECT DEVICE
VIATM 21
MICROCATHETER
(K150894) | VIATM (VIA 27)
AND VIATM PLUS
(VIA 33)
MICROCATHETER
(K132652) | HEADWAY 21
MICROCATHETER
(K093160) | ORION TM
MICROCATHETER
CATHETER (K113289)
AND CE0297) |
| | Yes | Yes | Yes | Yes |
| Indication for Use
Equivalent ? | | | | |
| The Subject and
the comparison
devices maintain
similar indications | The VIA 21 Microcatheter
is intended for the
introduction of non-liquid
interventional devices
(such as stents/flow
diverters) and infusion of
diagnostic (such as
contrast media) or non-
liquid therapeutic agents
into the neuro, peripheral,
and coronary vasculature.
Yes | The VIA Catheter is
intended for the introduction
of non-liquid interventional
devices (such as stents/flow
diverters) and infusion of
diagnostic (such as contrast
media) or therapeutic agents
into the neuro, peripheral,
and coronary vasculature.
Yes | The Headway 21
Microcatheter
(K093160) is intended
to for general
intravascular use,
including the
peripheral, coronary
and neuro vasculature
for the infusion of
diagnostic agents,
such as contrast
media, and therapeutic
agents, such as
occlusion coils.
Yes | The OrionTM Catheter
(K113289 and
CE0297) is intended
for the controlled
selective infusion of
physician-specified
therapeutics agents or
contrast media into the
vasculature of the
peripheral and neuro
anatomy.
Yes |
| Summary Statement of Substantial Equivalence | | | | |
| Use in a clinical setting was conducted in animals to show that no new risks were identified and that the safety and effectiveness
profile is similar to well-established comparison market-approved devices. Bench Testing was performed in models representing
the higher risk neurovascular anatomy, which is the worst case representation of the cardiac and peripheral vascular anatomies. The
ViaTM 21 Microcatheter has equivalent performance characteristics to the comparison devices. | | | | |

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