K Number

Device Name

Versus Catheter (VS110-8B)

Manufacturer

Liquet Medical Inc.

Date Cleared

2024-11-25

(151 days)

Product Code

QEY DQO DYG KRA

Regulation Number

870.5150

Intended Use

The Versus™ Catheter is indicated for: The controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients. The assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring.

Device Description

The Versus™ Pulmonary Artery Catheter is a dual-tip infusion catheter. Two lumens access and deliver physician-specified fluids, including thrombolytics, into the pulmonary arteries of each lung via a single access site. The Secondary Catheter tip telescopes independently to facilitate infusion into the contralateral lung. The device may allow for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Pressure is measured through an interface between the catheter's fluid lumen and an externally located, FDA-cleared, pressure transducer. The device may include an additional lumen that is in communication with a distal flow-directed balloon.

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

K183290, K160084

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical catheter for fluid infusion and pressure monitoring, with no mention of AI or ML capabilities.

Therapeutic

Yes

The device is intended for the infusion of physician-specified fluids, including thrombolytics, and for assessing a patient's hemodynamic condition, which are therapeutic and diagnostic purposes.

Diagnostic

Yes

The device description explicitly states that it "may allow for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring." This function directly contributes to diagnosing a patient's medical state.

SaMD (Software as a Medical Device)

The device description clearly describes a physical catheter with lumens, tips, and a balloon, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Versus™ Catheter is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Versus™ Catheter Function: The Versus™ Catheter is an invasive device inserted into the body (pulmonary artery vasculature) for the direct infusion of fluids and the direct measurement of pressure within the heart and pulmonary arteries. These are in-vivo procedures, not in-vitro tests on samples.

The device's intended use and description clearly indicate it is used within the patient's body for therapeutic (infusion) and diagnostic (pressure monitoring) purposes, not for testing samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Versus™ Catheter is indicated for:
The controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients.
The assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring.

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

OEY, KRA, DOO, DYG

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

pulmonary artery vasculature

Indicated Patient Age Range

adult patients

Intended User / Care Setting

Healthcare facility/hospital

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)

Sterilization and Shelf Life: The device is sterilized using standard methods and the sterilization cycles have been validated following international standards. The shelf life of the devices has been established through stability studies. The sterilization validation complied with ISO 11135:2014. The sterilization cycle was validated to a sterility assurance level of 10-6. The shelf life of the Versus™ Catheter was established through accelerated aging studies and support a shelf life of 3 months.

Biocompatibility: Biocompatibility evaluation has been performed to show the finished, sterilized device is biocompatible and suitable for its intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" were taken into account to evaluate the biocompatibility of the subject device. The testing included an evaluation of:

Acute Systemic Toxicity
Complement Activation Assay
Cytotoxicity
Hemolysis
Heparinized Blood Platelet and Leukocyte Count Assay
Intracutaneous Irritation
Material Mediated Pyrogenicity
Maximization Sensitization Test
Partial Thromboplastin Time (PTT) Assay
Particulate Infrared Spectroscopy

Human Factors Testing: Usability testing was conducted per IEC 62366-1:2015 and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices". The study performed, using the to-be marketed device with intended users, demonstrated that the users were able to perform novel critical tasks of the Versus™ Catheter in an anatomical model in a simulated environment. The results of this testing met the predefined acceptance criteria.

Performance Testing - Bench: Performance testing was performed to characterize the Versus™ Catheter. The testing included an evaluation of:

Kink radius
Trackability
Advancement force
Retraction force
Infusion uniformity
Pressure lumen measurement
Dimensional and visual verification
Luer hub compatibility
Balloon inflation and integrity
Corrosion resistance
Radiopacity
Joint tensile strengths
The performance data demonstrate that the new devices are substantially equivalent to the Primary and Secondary Predicate devices.

Performance Testing – Animal: The Versus™ Catheter was evaluated in a GLP porcine study with comparison to the primary predicate device. All success criteria established for the study were met. Use of the catheter had no adverse effects systemically or pathologically supporting substantially equivalent safety and performance outcomes of the Versus™ Catheter when used in the target vasculature.

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.

K183290, K160084

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 & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 25, 2024

Liquet Medical Inc. Carrie Kuehn Regulatory Affairs Consultant Evergreen Strategic Consulting 108 N Rolling RD Catonsville, Maryland 21228

Re: K241851

Trade/Device Name: Versus™ Catheter (VS110-8B) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: OEY, KRA, DOO, DYG Dated: June 20, 2024 Received: June 27, 2024

Dear Carrie Kuehn:

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 (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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

assistance/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,

Ariel G. Ash- Digitally signed by
shakoor -S Ariel G. Ash-shakoor -S
Date: 2024.11.25
09:26:01 -05'00'

For

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) K241851

Device Name Versus™ Catheter (VS110-8B)

Indications for Use (Describe) The Versus™ Catheter is indicated for:

The controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients.

The assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring.

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 - K241581

VERSUS™ CATHETER (VS110-8B)

l. SUBMITTER'S NAME

Liquet Medical Inc. 5619 Country Hills Ln Glen Allen VA 23059, United States

Contact Name: Carrie M. Kuehn, Head of Regulatory Email: c.kuehn@liquetmedical.com Phone: 301-337-8159 Date prepared: November 21, 2024

II. Device Information

Proprietary Name: Versus™ Catheter (VS110-8B) Common Name: Embolectomy Catheter Classification Name: Mechanical Thrombolysis Catheter Regulation Number: 870.5150 Classification Codes: QEY Associated Product Codes: KRA, DQO, DYG

III. Predicate Devices

Primary Predicate Device: Bashir N-X Endovascular Catheter (K183290) Secondary Predicate Device: Swan Ganz Catheters (K160084)

IV. Device Description

V. Indications for Use

The Versus™ Catheter is indicated for:

The controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients.

The assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring.

VI. Comparison of Technological Characteristics with the Predicate Devices

Table 1. Comparison of Subject Device to Predicate Devices
------------------------------------------------------------	--	--	--

Category	Subject Device –	Predicate Device –	Predicate Device –	Comparison
	Versus™ Catheter (VS110-8B)	Bashir Endovascular Catheter Model	Swan-Ganz Catheters
	K241851	7201, Bashir N-X Endovascular	K160084
		Catheter, Mode 7200
		K183290
Class	II	II	II	Same
Product Code	QEY - Mechanical Thrombolysis	QEY - Mechanical Thrombolysis	DYG - Catheter, Flow Directed	Similar
	Catheter	Catheter	DQE - Catheter, Oximeter, Fiberoptic	A combination of
	KRA - Catheter, Continuous Flush	KRA - Catheter, Continuous Flush	DQO - Catheter, Intravascular,	the predicates'
	DQO - Catheter, Intravascular		Diagnostic	product codes
	Diagnostic		KRA - Catheter, Continuous Flush
	DYG - Catheter, Flow Directed
Device	The Versus™ Pulmonary Artery	The Bashir N-X Endovascular Catheter	The Swan-Ganz thermodilution	Similar
Description	Catheter is a dual-tip infusion catheter	(Ref. No. 7200) is a device intended for	catheters provide diagnostic
	Two lumens access and deliver	the localized infusion of physician-	information to rapidly determine
	physician-specified fluids, including	specified fluids, into the peripheral	hemodynamic pressures and cardiac
	thrombolytics, into the pulmonary	vasculature, including the pulmonary	output when used with a compatible
	arteries of each lung via a single access	arteries. The distal infusion segment of	cardiac output computer.
	site. The Secondary Catheter tip	the device is 12.50 cm (4.94 in) long	In addition to the standard distal
	telescopes independently to facilitate	and consists of a segment with mini-	(pulmonary artery) and injectate
	infusion into the contralateral lung.	infusion catheters, each with multiple	lumens, the Swan-Ganz VIP
	The device may allow for assessment	infusion holes. It is used for the	thermodilution catheter (Models
	of a patient's hemodynamic condition	delivery of the physician-specified	831F75, 831F75P and 831VF75P) has
	through direct intracardiac and	fluids at multiple cross-sectional points	an additional lumen that provides
	pulmonary artery pressure monitoring.	of the target vessel location. The	direct access to the right atrium. The
	Pressure is measured through an	infusion line connector is located on	Swan-Ganz VIP+ tri-lumen infusion
	interface between the catheter's fluid	the handle.	thermodilution catheter (Model
	lumen and an externally located, FDA-	The catheter is advanced over a	834F75) is equipped with a right atrium
	cleared, pressure transducer. The	guidewire using standard endovascular	lumen and an additional lumen. The
	device may include an additional	interventional techniques and is	catheter's right ventricular (RV) lumen
	lumen that is in communication with a	compatible with standard infusion	terminates 19 cm from the catheter tip
	distal flow-directed balloon.	connectors, accessories and	and the right atrial (RA) lumen
		equipment.	terminates at 31 cm. The VIP lumen
			allows for continuous infusion, even
			during cardiac output determinations.
Intended Use	The Versus™ Catheter is intended for	The Bashir N-X Endovascular Catheter	Swan-Ganz thermodilution catheters	Same
	the controlled and selective infusion of	is intended for the controlled and	are indicated for the assessment of a	The subject device
	physician-specified fluids, including	selective infusion of physician-specified	patient's hemodynamic condition	includes one
	thrombolytics, into the pulmonary	fluids into the peripheral and	through direct intracardiac and	intended use from
	artery vasculature in adult patients.	pulmonary artery vasculature.	pulmonary artery pressure monitoring,	the Primary
	The Versus™ Catheter is also intended		cardiac output determination, and for	Predicate and one
	for the assessment of a patient's		infusing solutions.	intended use from
	hemodynamic condition through direct		The distal (pulmonary artery) port also	the Secondary
	intracardiac and pulmonary artery		allows sampling of mixed venous blood	Predicate.
	pressure monitoring.		for the assessment of oxygen transport
			balance and the calculation of derived
			parameters such as oxygen
			consumption, oxygen utilization
			coefficient, and intrapulmonary shunt
			fraction.
Indications for	The Versus™ Catheter is indicated for:	The Bashir N-X Endovascular Catheter	Swan-Ganz thermodilution catheters	Similar
Use		is intended for the controlled and	are indicated for the assessment of a
	The controlled and selective
infusion of physician-
specified fluids, including
thrombolytics, into the
pulmonary artery
vasculature in adult
patients. The assessment of a
patient's hemodynamic
condition through direct
intracardiac and pulmonary
artery pressure monitoring.	selective infusion of physician-specified fluids into the peripheral and
pulmonary artery vasculature.	patient's hemodynamic condition
through direct intracardiac and
pulmonary artery pressure monitoring,
cardiac output determination, and for
infusing solutions.
The distal (pulmonary artery) port also
allows sampling of mixed venous blood
for the assessment of oxygen transport
balance and the calculation of derived
parameters such as oxygen
consumption, oxygen utilization
coefficient, and intrapulmonary shunt
fraction.	The indications for
use contains an
indication from
each predicate
device.
Anatomical site(s)	Insertion through venous access to
pulmonary arteries	Insertion through venous access to
pulmonary arteries or peripheral
vasculature	Insertion through venous access to
pulmonary arteries	Same
Principles of
Operation	The Versus™ Catheter employs dual
lumens to facilitate the delivery of
localized infusion of physician-specified
fluids into the pulmonary arteries. The
distal infusion segment consists of a
segment with multiple infusion holes. It
is used for the delivery of the
physician-specified fluids at multiple
cross-sectional points of the target
vessel location. The infusion line
connector is located on the proximal
hub.
The catheter is advanced over a
guidewire using standard endovascular
interventional techniques and is
compatible with standard infusion
connectors, accessories and
equipment.
Alternatively, the device may include
an inflatable balloon at the tip, which
facilitates its placement into the
pulmonary artery through the flow of
blood.
The Versus™ Catheter has a proximal
luer that can be connected to a
standard pressure transducer in line
with an IBP-compatible patient
monitor for direct intracardiac and
pulmonary artery pressure monitoring.	Localized infusion of physician-
specified fluids, into the peripheral
vasculature, including the pulmonary
arteries. The distal infusion segment
consists multiple infusion holes. It is
used for the delivery of the physician-
specified fluids at multiple cross-
sectional points of the target vessel
location. The infusion line connector is
located on the handle.
The catheter is advanced over a
guidewire using standard endovascular
interventional techniques and is
compatible with standard infusion
connectors, accessories and
equipment.	The Swan-Ganz catheters are well
known pulmonary artery catheters
intended for use on critical care
patients. A Swan-Ganz Catheter
includes an inflatable balloon at the tip,
which facilitates its placement into the
pulmonary artery through the flow of
blood.
The Swan-Ganz catheters can be used
with compatible cardiac output patient
monitors and/or with oximetry
modules (depending on the model
number) to transmit signals for
hemodynamic pressure monitoring,
cardiac output measurements, and/or
oximetry measurements. The Swan-
Ganz catheters are to be used with the
Edwards and/or Edwards' compatible
patient monitors, such as the Vigilance
II.	Same
Guidewire
placement is the
same as Primary
Predicate.
Balloon placement
and pressure
monitoring is the
same as Secondary
Predicate.
Pressure
measurement
location(s)	Image: [heart diagram with balloon]
Balloon
(optional)
RA
LA
PA
LV
RV
PRESSURE
Proximal lumen port has the capability
for direct blood pressure measurement
at ~20cm from distal tip	Image: [heart diagram]
RA
LA
PA
LV
RV
PRESSURE
Distal lumen port has the capability for
direct blood pressure measurement at
the distal tip	Image: [heart diagram]
Balloon
RA
LA
PA
LV
RV
PRESSURE
Proximal lumen port has the capability
for direct blood pressure measurement
at ~30cm from the catheter tip, and
also at the distal tip	Similar
Pressure	mmHg intracardiac or pulmonary	mmHg distal pulmonary artery	mmHg intracardiac proximal lumen	Same as Primary
measurement	artery pressure when connected to an	pressure when connected to an in-line	port, distal pulmonary artery pressure,	Predicate. Similar
outputs	in-line pressure transducer external to	pressure transducer external to the	Cardiac Output (CO), Stroke Volume	to Secondary
	the patient	patient	(SV)	Predicate
				(Subject device
				does not include a
				thermistor to
				output CO, SV
				parameters)
Energy Used	The subject device does not use or	This predicate does not use or deliver	Thermal energy emitted by the thermal	Same as Primary
and/or Delivered	deliver any energy.	any energy.	filament located on the catheter.	Predicate.
Biocompatibility	Both ISO 10993 and FDA Draft	Both ISO 10993 and FDA Draft	Not reported.	Same as Primary
	Guidance "Use of International	Guidance "Use of International		Predicate.
	Standard ISO 10993, Biological	Standard ISO 10993, Biological
	Evaluation of Medical Devices Part 1:	Evaluation of Medical Devices Part 1:
	Evaluation and Testing within a Risk	Evaluation and Testing within a Risk
	Management Process"	Management Process"
Working Length	100 – 107 cm	92.50 cm	75 – 110 cm	Similar
Outer Diameter	8 French	7 French	7 – 7.5 French	Similar
Radiopaque	Radiopaque marker bands at distal and	The distal 12.50 cm (4.94 in) infusion	Not reported.	Similar
Marker	proximal ends of infusion segments,	segment is radiopaque and visible
	and at bifurcation.	under fluoroscopy along its full length.
Guidewire	A 0.035" guidewire for placement of	A 0.035" guidewire, of the required	A 0.025" guidewire for placement	Same as Primary
Compatibility	the Primary Catheter. Guidewire of	length to fit the sheath. Guidewire of		Predicate
	0.014" for placement of the Secondary	0.018" for placement.
	Catheter.
Treatment	Infusion segment length of 12cm for	Infusion segment length of 12.50 cm.	Distal tip infusion, some catalog	Similar to Primary
zone/infusion	both Primary and Secondary		numbers include 3 or 4 infusion	Predicate.
port	Catheters.		lumens.
Infusion flow rate	Set the infusion pump to the desired	Set the infusion pump to the desired	Not relevant	Same as Primary
	infusion rate and activate per standard	infusion rate and activate per standard		Predicate.
	practice.	practice.
Diameter of	13 mm ±2 mm	Not applicable. Device does not have a	13 mm.	Same as Secondary
inflated balloon		balloon.		Predicate.
Sterility	The devices are sterilized using	The devices are sterilized using	Sterile (EtO)	Same as Primary
	standard methods and the sterilization	standard methods and the sterilization		and Secondary
	cycles have been validated following	cycles have been validated following		Predicates.
	international standards. The	international standards. The
	sterilization validation complied with	sterilization validation complied with
	ISO 11135:2014. The sterilization cycle	ISO 11135:2014. The sterilization cycle
	was validated to a sterility assurance	was validated to a sterility assurance
Single Use	level of 10-6
Yes	level of 10-6.
Yes	Yes	Same

Environment for
use	Healthcare facility/hospital	Healthcare facility/hospital	Healthcare facility/hospital	Same as Primary
and Secondary
				Predicates.
Electrical Safety	Contains no electrical components	Contains no electrical components	Warning: Compliance to IEC 60601-1 is	Same as Primary
			only maintained when the catheter or	Predicate.
			probe (CF applied part, defibrillation
			proof) is connected to a patient
			monitor or equipment that has a Type
			CF defibrillation proof rated input
			connector. If attempting to use a third
			party monitor or equipment, check
			with the monitor or equipment
			manufacturer to ensure IEC 60601-1
			compliance and compatibility with the
			catheter or probe. Failure to ensure
			monitor or equipment compliance to
			IEC 60601-1 and
		catheter or probe compatibility may
increase the risk of electrical shock to
the patient/operator.

510(k) Summary – 245181

Versus™ Catheter (VS110-8B)

510(k) Summary – 245181

Versus™ Catheter (VS110-8B)

VII. Summary of Performance Testing (Non-Clinical Testing)

This 510(k) notification provides performance data to establish the substantial equivalence of the Liquet Medical Versus™ Catheter to the Primary and Secondary Predicate devices. The following is a summary of the performance data.

Sterilization and Shelf Life: The device is sterilized using standard methods and the sterilization cycles have been validated following international standards. The shelf life of the devices has been established through stability studies. The sterilization validation complied with ISO 11135:2014. The sterilization cycle was validated to a sterility assurance level of 106. The shelf life of the Versus™ Catheter was established through accelerated aging studies and support a shelf life of 3 months.

Biocompatibility: Biocompatibility evaluation has been performed to show the finished, sterilized device is biocompatible and suitable for its intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" were taken into account to evaluate the biocompatibility of the subject device. The testing included an evaluation of:

Acute Systemic Toxicity
Complement Activation Assay
Cytotoxicity
Hemolysis
Heparinized Blood Platelet and Leukocyte Count Assay
Intracutaneous Irritation
Material Mediated Pyrogenicity
. Maximization Sensitization Test
Partial Thromboplastin Time (PTT) Assay
Particulate Infrared Spectroscopy

Human Factors Testing: Usability testing was conducted per IEC 62366-1:2015 and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices". The study performed, using the to-be marketed device with intended users, demonstrated that the users were able to perform novel critical tasks of the Versus™ Catheter in an anatomical model in a simulated environment. The results of this testing met the predefined acceptance criteria.

Performance Testing- Bench: Performance testing was performed to characterize the Versus™ Catheter. The testing included an evaluation of:

. Kink radius

Versus™ Catheter (VS110-8B)

Trackability
Advancement force
Retraction force
Infusion uniformity
Pressure lumen measurement
Dimensional and visual verification
Luer hub compatibility
Balloon inflation and integrity
Corrosion resistance
Radiopacity
Joint tensile strengths

The performance data demonstrate that the new devices are substantially equivalent to the Primary and Secondary Predicate devices.

Performance Testing – Animal: The Versus™ Catheter was evaluated in a GLP porcine study with comparison to the primary predicate device. All success criteria established for the study were met. Use of the catheter had no adverse effects systemically or pathologically supporting substantially equivalent safety and performance outcomes of the Versus™ Catheter when used in the target vasculature.

Determination of Substantial Equivalence to Predicate Devices VIII.

The information presented in the 510(k) Submission demonstrates that the Liquet Medical Versus™ Catheter (VS110-8B) is substantially equivalent to the Primary and Secondary Predicate devices.