Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and functional aspects of a biopsy system, with no mention of AI or ML.

Therapeutic

No.
The TLAB® Transvenous Liver Biopsy System is used for 'percutaneous transjugular and transfemoral venous liver access during diagnostic and interventional procedures', which prepares for diagnostic or interventional procedures, but is not therapeutic itself.

Diagnostic

Yes

The Intended Use/Indications for Use explicitly states that the device is intended for use during "diagnostic and interventional procedures." The device description mentions a "Flexcore Biopsy Needle," which is used to obtain tissue samples, a diagnostic procedure.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple physical components (needle, sheath, catheters, swabs, bending tool) and performance studies focus on physical properties and functional testing of these hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the TLAB® Transvenous Liver Biopsy System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for "percutaneous transjugular and transfemoral venous liver access during diagnostic and interventional procedures." This describes a device used within the body to access a site for procedures, not a device used to test samples outside the body.
Device Description: The components listed (needles, sheaths, catheters, etc.) are tools used for accessing and potentially obtaining tissue from the body, not for analyzing biological samples.
Anatomical Site: The anatomical sites listed (Liver, IVC, hepatic vein, femoral vein, jugular vein) are all locations within the body where the device is used.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, tissue, or other bodily fluids) or providing diagnostic information based on such analysis. The device is used to obtain a sample (biopsy needle) or provide access for other procedures.

IVD devices are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The TLAB® system is a tool for accessing and potentially collecting a sample, but it doesn't perform the diagnostic analysis itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The TLAB® Transvenous Liver Biopsy System is intended to be used for percutaneous transjugular and transfemoral venous liver access during diagnostic and interventional procedures.

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

DYB

Device Description

The TLAB® Transvenous Liver Biopsy System is a single use, disposable, sterile device.

The TLAB® Transvenous Liver Biopsy System consists of the following components:
• 18-Gauge (18Ga) Flexcore Biopsy Needle
• 7 French (7Fr) Introducer Sheath with a curved metal stiffener
• 5 French (5Fr) Straight Catheter
• 5 French (5Fr) Curved Catheter
• Tissue Removal Swabs
• Bending Tool (used for transfemoral access).

The system is inserted percutaneously, introducing a guidewire into inferior vena cava (IVC) (from transfemoral venous access), or into the right hepatic vein (from transjugular access), using the 5 Fr curved catheter as wire introducing means. After removing the wire introducer, verification is performed to ensure that the protective sheath on the 7 Fr introducer is securely connected to avoid puncture. For transfemoral procedures, the bending tool in the kit is used to curve the metal stiffening cannula of 7Fr introducer. This curve should cause the caval wall to tent when the cannula is inserted into the intrahepatic region of the IVC. Next the 7 Fr introducer is inserted over the guidewire. Optionally, 5Fr Straight catheter is inserted coaxially into the 7Fr introducer to provide a smooth transition for 7Fr introducer over the guidewire. The guidewire and 5Fr straight catheter (if used) is then removed and the charged needle is inserted through the 7Fr introducer. The biopsy device is then discharged/fired to collect the specimen and is then removed from the patient. The specimen is expelled from the device onto a collection slide and/or placed into fixative for pathological

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Liver

Indicated Patient Age Range

Adult patients to include elderly adults

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

A series of testing was conducted in accordance with protocols based on requirements outlined in guidance and industry standards and the below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence:

Dimensional
Visual
Radiopacity
Corrosion Resistance
Simulated Use
Tensile Strength
Torque Strength
Liquid Leakage
Luer Functional Testing - ISO 80369-7
Catheter Functional Testing - ISO 10555-1
Resistance to Breakage - ISO 9626
Shipping Qualification Testing
Design Validation
Summative Usability

The following Biocompatibility Testing was previously performed under the Predicate device:

ISO10993-5 Cytotoxicity
ISO10993-10 Sensitization
ISO10993-23 Irritation or Intracutaneous Reactivity
ISO10993-11 Material Mediated Pyrogen
ISO10993-11 Acute Systemic Toxicity
ISO 10993-4 Hemocompatibility -
- ASTM Hemolysis Assay, Direct and Extract Methods (ISO)
- In Vivo Thrombogenicity Study (ISO)

The following testing was selected and performed anew based on ISO 10993-1:2018 and FDA Guidance (Flexible SABD 18GA, 7F Introducer, 5F Straight Catheter, and 5F MPA Catheter):

ISO10993-4 Hemocompatibility
- Complement Activation Assay, SC5b-9 Method with Comparison Article (ISO)
- Partial Thromboplastin Time (PTT) Assay with Comparison Article (ISO)
- Heparinized Platelet and Leukocyte Count Assay with Comparison Article (ISO)

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.

K022634

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.

K213638

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

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 1, 2024

Argon Medical Devices, Inc. Jacquelyn Huyghue Sr. Regulatory Affairs Specialist 1445 Flat Creek Road Athens. Texas 75751

Re: K241145

Trade/Device Name: TLAB® Transvenous Liver Biopsy System (TF-18C) Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 2, 2024 Received: July 2, 2024

Dear Jacquelyn Huyghue:

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 (the 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).

1

Your device is also subject to, among other requirements, the Quality System (QS) 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.

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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Colin K. Colin K. Chen -S Date: 2024.08.01 Chen -S 10:45:40 -04'00'

Jessica Carr Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

for

2

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241145

Device Name

TLAB® Transvenous Liver Biopsy System (TF-18C)

Indications for Use (Describe)

The TLAB® Transvenous Liver Biopsy System is intended to be used for percutaneous transjugular and transfemoral venous liver access during diagnostic and interventional procedures.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Image /page/3/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features the word "ARGON" in a bold, sans-serif font, with the letters in a light blue color. Above the word "ARGON" is a stylized blue triangle. Below the word "ARGON" are the words "MEDICAL DEVICES" in a smaller, lighter font.

Date Prepared:	July 31, 2024
Company:	Argon Medical Devices, Inc.
1445 Flat Creek Road
Athens, Texas 75751 USA
Facility Registration number: 1625425
Contact:	Jacquelyn Huyghue
Sr. Regulatory Affairs Specialist
Phone: 412-568-3369
Fax: 903-677-9396
Email: jacquelyn.huyghue@argonmedical.com
Device Trade Name:	TLAB® Transvenous Liver Biopsy System
Device Common Name:	Catheter, Introducer
Device Classification
Name:	Catheter, Introducer
Class II
Product code Product code DYB
21 CFR §870.1340
Review Panel: Cardiovascular Devices
Predicate Device(s):	Primary: K022634, TLAB® Transjugular Liver Access Set
Reference: K213638, Traveler Portal Vein Access Set
Description of
the Device:	The TLAB® Transvenous Liver Biopsy System is a single use, disposable,
sterile device.

The TLAB® Transvenous Liver Biopsy System consists of the following
components:
• 18-Gauge (18Ga) Flexcore Biopsy Needle
• 7 French (7Fr) Introducer Sheath with a curved metal stiffener
• 5 French (5Fr) Straight Catheter
• 5 French (5Fr) Curved Catheter
• Tissue Removal Swabs
• Bending Tool (used for transfemoral access).

The system is inserted percutaneously, introducing a guidewire into inferior
vena cava (IVC) (from transfemoral venous access), or into the right hepatic
vein (from transjugular access), using the 5 Fr curved catheter as wire
introducing means. After removing the wire introducer, verification is
performed to ensure that the protective sheath on the 7 Fr introducer is
securely connected to avoid puncture. For transfemoral procedures, the
bending tool in the kit is used to curve the metal stiffening cannula of 7Fr
introducer. This curve should cause the caval wall to tent when the cannula is
inserted into the intrahepatic region of the IVC. Next the 7 Fr introducer is
inserted over the guidewire. Optionally, 5Fr Straight catheter is inserted
coaxially into the 7Fr introducer to provide a smooth transition for 7Fr
introducer over the guidewire. The guidewire and 5Fr straight catheter (if
used) is then removed and the charged needle is inserted through the 7Fr
introducer. The biopsy device is then discharged/fired to collect the specimen
and is then removed from the patient. The specimen is expelled from the
device onto a collection slide and/or placed into fixative for pathological | | |

4

Image /page/4/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in blue, bold letters. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, gray font.

| Indication for Use: | The TLAB® Transvenous Liver Biopsy System is intended to be used for
percutaneous transjugular and transfemoral venous liver access during
diagnostic and interventional procedures. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | A comparison of the technological characteristics of the subject device and
the predicate devices shows the TLAB® Transvenous Liver Biopsy System to
be substantially equivalent to the current marketed predicate devices.

Equivalence is established on in vitro performance testing, and similarities in
indications for use, materials, packaging, technological characteristics,
principle of operation, design features and sterilization process. |

	Subject Device	Primary Predicate	Reference Predicate
	TLAB®
Transvenous Liver Biopsy
System	TLAB®
Transjugular Liver Biopsy
System K022634	Traveler 0.038 Stylet Portal Vein
Access (TPS001), Traveler 21ga
Needle Portal Vein Access Set
(TPS002), Traveler 16ga Needle
Portal Vein Access Set (TPS003)
K213638 for Bending Tool Only
Manufacturer	Argon Medical Devices, Inc.	Argon Medical Devices, Inc.	Argon Medical Devices, Inc.
FDA Clearance	K241145	K022634	K213638
Class	II	Same	Same
Device Classification
Name	Catheter introducer	Same	Same
Regulation	21 CFR §870.1340	Same	Same
Product Code	DYB	Same	Same
Clinical Comparison
Intended Use	Intended for use in obtaining
liver histology samples via
transjugular and
transfemoral venous
approaches.	Same - intended to collect liver
samples
The TLAB® Transjugular Liver
Biopsy Instrument is designed to
perform consistently in typical
and tortuous
anatomy to collect quality liver
samples.	The Traveler™ Portal Vein Access
Set is intended for transjugular
liver access in diagnostic and
interventional procedures.
	Subject Device	Primary Predicate	Reference Predicate
	TLAB®
Transvenous Liver Biopsy
System	TLAB®
Transjugular Liver Biopsy System
K022634	Traveler 0.038 Stylet Portal Vein
Access (TPS001), Traveler 21ga
Needle Portal Vein Access Set
(TPS002), Traveler 16ga Needle
Portal Vein Access Set (TPS003)
K213638 for Bending Tool Only
Principle of
Operation	The patient is prepared for
transfemoral or transjugular
access per facility clinical
protocols. The components
are removed from the
Transvenous Liver Biopsy
System package using sterile
technique. The components
are then flushed with
heparinized saline or similar
isotonic solution before use.
Prior to obtaining femoral or
jugular access, the needle is
charged by pulling back on
the plunger until a firm click
is felt and heard. The device
is then placed on the table in
the sterile environment.
After prepping the device,
the user will obtain femoral
or jugular access. They will
introduce and seat a
guidewire into the right
femoral vein using a wire
introducing means, such as a
5 Fr curved catheter or by
other methods. After
removing the wire
introducing means, the user
will confirm that the
protective sheath on the 7 Fr
introducer is securely
connected to avoid puncture
and insert the 7 Fr introducer
over the guidewire. The
Bending Tool is used to
increase the bend on the
metal 7F Introducer with
protective sheath per the
anatomy of the patient
The user will make any
appropriate adjustments to
avoid capsular perforation	Same - Subject device includes
additional access point
Establish jugular access and
maintain access with .035"
guidewire, Use the MPA catheter
to guide guidewire into right
hepatic vein. Remove MPA
catheter. Introduce 7F introducer
sheath over the guidewire and
into the right hepatic vein.
Remove guidewire. Lock needle
by pulling back on the plunger
until a click is heard. Introduce
the needle through the safety
guide until the black mark meets
the beginning of the funnel.
Advance the needle. Hold the
introducer system in place &
remove the needle. Pull back on
the plunger until a click is heard,
then push plunger forward to
expose the specimen. Remove
sample by rolling it out of the
notch with a swab. Place sample
in formalin. Re-insert biopsy
needle and repeat.	The Traveler Portal Vein Access
Set is used to deliver an
endoprosthetic shunt
through the liver parenchyma.
This is accomplished by using the
Portal Vein Access
Set to gain access to the hepatic
vein and guide a sharp puncture
tool toward the
parenchyma. The puncture tool is
used to make a pathway from the
hepatic vein to
the portal vein, then the pathway
is dilated to provide access for a
larger sheath. The
shunt (not included) is inserted
through the sheath and deployed
through the
pathway. All of the Portal Vein
Access Set components are then
removed.
	Subject Device	Primary Predicate	Reference Predicate
	TLAB®
Transvenous Liver Biopsy
System	TLAB®
Transjugular Liver Biopsy System
K022634	Traveler 0.038 Stylet Portal Vein
Access (TPS001), Traveler 21ga
Needle Portal Vein Access Set
(TPS002), Traveler 16ga Needle
Portal Vein Access Set (TPS003)
K213638 for Bending Tool Only
	using clinical judgment. Once
the device is inserted, the
user may inject contrast
material through the side
port in the valve assembly of
the 7 Fr Introducer. After
confirming that the desired
location has been achieved,
then the user will remove
the guidewire and insert the
charged needle through the
catheter system. The biopsy
device is then
discharged/fired to collect
the specimen and is then
removed from the patient.
The specimen is expelled
removed from the device
onto a collection slide and/or
placed into fixative for
pathological evaluation. If
additional samples are
needed, the biopsy device is
re-charged, reinserted into
patient, discharged/fired to
collect specimen, and
removed from patient. When
the collection of samples is
finished and if used, the
system is removed from the
patient and disposed. Once
the patient has been
prepped, and hepatic
pressure measurements
have been taken, the
procedure can vary in length
from five to ten minutes.
Mechanism of Action	Mechanical	Same	Same
	Subject Device	Primary Predicate	Reference Predicate
	TLAB®
Transvenous Liver Biopsy
System	TLAB®
Transjugular Liver Biopsy System
K022634	Traveler 0.038 Stylet Portal Vein
Access (TPS001), Traveler 21ga
Needle Portal Vein Access Set
(TPS002), Traveler 16ga Needle
Portal Vein Access Set (TPS003)
K213638 for Bending Tool Only
Indication for Use	The TLAB® Transvenous Liver
Biopsy System is intended to
be used for percutaneous
transjugular and
transfemoral venous liver
access during diagnostic and
interventional procedures.	Similar
This device is intended to be used
for percutaneous transjugular
liver access during diagnostic and
interventional procedures.	The Portal Vein Access Set is
intended for transjugular liver
access during diagnostic and
interventional procedures.
Contraindication	None Known.
Sound professional
judgement should be
used to determine if use
of this product is
inadvisable due to specific
patient characteristics,
including, but not limited
to occluded IVC, occluded
femoral vein, occluded
internal jugular vein and
possibly a short length of
the intrahepatic IVC.	None Known.
Sound professional judgment
should be used to determine if
use of this product is
inadvisable due to specific
patient characteristics,
including, but not limited to:
thrombosis of the internal
jugular vein, untreated
infections or reaction to
contrast medium.	None Known
Target Patient
Population	Adult patients to include
elderly adults, any
gender, race, or ethnicity.	Not Specified	Any patient that requires a
transjugular intrahepatic
portosystemic shunt (TIPS)
endoprosthesis also requires
that a clinician use a TIPS
delivery system to place the
endoprosthesis within the liver
parenchyma. Patients that
require a TIPS
endoprosthesis commonly have
a general liver disease such as
cirrhosis or hepatitis B
or C, and the disease
progression resulted in
narrowed or occluded blood
vessels

| | Subject Device | Primary Predicate | Reference Predicate |
| | TLAB®
Transvenous Liver Biopsy
System | TLAB®
Transjugular Liver Biopsy System
K022634 | Traveler 0.038 Stylet Portal Vein
Access (TPS001), Traveler 21ga
Needle Portal Vein Access Set
(TPS002), Traveler 16ga Needle
Portal Vein Access Set (TPS003)
K213638 for Bending Tool Only |
| | | | reduce the patient's blood
pressure within that system.
Patients can be any gender
or age, but they are more
commonly 40 years old or
older. |
| Single Use | Yes | Same | Same |
| Supplied Sterile | Yes | Same | Same |
| Device Description | The TLAB® Transvenous
Liver Biopsy System is
intended to be used for
percutaneous transjugular
and transfemoral venous
liver access during
diagnostic and
interventional procedures.
The device is a single use,
disposable sterile device.
The TLAB® Transvenous
Liver Biopsy System
consists of the following
components:
● 18-Gauge (18G)
Flexcore Biopsy
Needle, 65 cm
overall length,
17mm notch,
20.83 maximum
throw
● 7 French (7F)
Introducer with
Protective Sheath
and Valve
Assembly with
Safety Guide, 60
cm overall length
and a curved
metal stiffener
● 5 French (5F)
Curved Catheter,
80 cm overall
length | Similar - difference is bending
tool used in Subject device for
femoral access
This device is intended to be used
for percutaneous transjugular
liver access during diagnostic and
interventional procedures. The
device is a single use, disposable
sterile device.
Each TLAB® System contains:
● Flexcore® Biopsy Needle,
18 ga or 19 ga, 65 cm
overall length, 17 mm
notch, 20 mm throw
● 7 Fr Introducer with
Protective Sheath and
Valve Assembly with
Safety Guide, 60 cm
overall length and a
curved metal stiffener
● 5 French (5F) Straight
Catheter
● 5 French (5F) Curved
Catheter
● Tissue Removal Swabs,
10 cm length,
polyurethane foam tip,
nylon handle
● 5 Fr Curved Catheter, 80
cm overall length
● 5 Fr Straight Catheter,
65 cm overall length for
smoother transition
between the 7 fr | Each Portal Vein Access Set
contains a 10F wall-reinforced
Introducer Sheath with
radiopaque tip, a 10F Dilator, a
5F MPA catheter, tool that
comes in the following
variations: 0.038" Stylet with a
5Fr Stylet Catheter (separated
with a removable spacer clip), a
21ga Needle/5Fr Catheter or
16ga Needle/7Fr Catheter
(both are separated with a
removable spacer clip) and a
bending tool. The 14ga
stiffening cannula with cannula
sheath and the 16ga needle
have a curved end, with a
directional handle that
indicates the direction of the
curve. The 10F Introducer
OnlySheath hemostatic valve is
designed to allow entry of a
13F (4.3mm/0.171") access
sleeve but taper down to a 10F
inner diameter. a puncturing
tool |
| | Subject Device | Primary Predicate | Reference Predicate |
| | TLAB®
Transvenous Liver Biopsy
System | TLAB®
Transjugular Liver Biopsy System
K022634 | Traveler 0.038 Stylet Portal Vein
Access (TPS001), Traveler 21ga
Needle Portal Vein Access Set
(TPS002), Traveler 16ga Needle
Portal Vein Access Set (TPS003)
K213638 for Bending Tool Only |
| | 5 French (5F) Straight Catheter, 65 cm overall length for smoother transition between the 7 fr Introducer and guide wire Tissue Removal Swabs 10cm length, polyurethane foam tip, nylon handle Bending Tool (for transfemoral access) | Introducer and guide wire | |
| Technical Design and Biological Comparison | | | |
| Flexcore Biopsy Needle | | | |
| Guage Size | 18ga | 18 ga or 19 ga | N/A |
| Overall Length | 65cm | Same | N/A |
| Notch Size | 17mm | Same | N/A |
| Throw Length | 20mm | Same | N/A |
| Tip Geometry | Bevel | Same | N/A |
| Composition | Flex Sheath: PEEK
Cannula: 304 Stainless Steel
Stylet: 304 Stainless Steel | Same | N/A |
| Introducer Sheath | | | |
| Introducer size | 7F includes metal stiffener
with Protective Sheath and
Valve Assembly with Safety
Guide | Same | N/A |
| Overall Length (cm) | 60 cm | Same | N/A |
| Composition | Sheath hub: HDPE Sheath tip: HDPE | Same | N/A |
| | Subject Device | Primary Predicate | Reference Predicate |
| | TLAB®
Transvenous Liver Biopsy
System | TLAB®
Transjugular Liver Biopsy System
K022634 | Traveler 0.038 Stylet Portal Vein
Access (TPS001), Traveler 21ga
Needle Portal Vein Access Set
(TPS002), Traveler 16ga Needle
Portal Vein Access Set (TPS003)
K213638 for Bending Tool Only |
| | 7F Introducer
Stiffening Cannula:
304 Stainless Steel Torque Handle
Orientation Tab:
Polycarbonate Needle Guide
(Safety Funnel):
Polycarbonate | | |
| Curved Catheter | | | |
| Size | 5F | Same | N/A |
| Overall Length (cm) | 80cm | Same | N/A |
| Composition | Catheter Hub:
Polycarbonate Catheter Shaft
(braided): Nylon,
barium sulfate,
stainless steel Catheter Tip: Pebax,
bismuth
subcarbonate,
titanium dioxide | Same | N/A |
| Straight Catheter | | | |
| Size | 5F | Same | N/A |
| Overall Length (cm) | 65cm | Same | N/A |
| Composition | Catheter Hub:
Polycarbonate Catheter Shaft
Nylon, barium
sulfate Catheter Tip: Pebax,
bismuth
subcarbonate,
titanium dioxide | Same | N/A |
| Tissue Removal Swabs | | | |
| Length (cm) | 10 cm length | Same | N/A |
| Composition | Tip: polyurethane
foam Handle: Nylon | Same | N/A |
| | Subject Device | Primary Predicate | Reference Predicate |
| | TLAB®
Transvenous Liver Biopsy
System | TLAB®
Transjugular Liver Biopsy System
K022634 | Traveler 0.038 Stylet Portal Vein
Access (TPS001), Traveler 21ga
Needle Portal Vein Access Set
(TPS002), Traveler 16ga Needle
Portal Vein Access Set (TPS003)
K213638 for Bending Tool Only |
| Bending Tool | | | |
| Length (inches) | 4 inches | N/A | 4 inches |
| Composition | 302 Stainless Steel | N/A | 302 Stainless Steel |
| Performance Testing | Dimensional
Visual
Radiopacity
Corrosion Resistance
Simulated Use
Tensile Strength
Torque Strength
Liquid Leakage
Luer Functional Testing -
ISO 80369-7
Catheter Functional
Testing – ISO 10555-1
Resistance to Breakage -
ISO 9626
Shipping Qualification | Similar - with testing performed
to current standards on Subject
Device
Dimensional
Visual
Radiopacity
Corrosion Resistance
Simulated Use
Tensile Strength
Torque Strength
Liquid Leakage
Luer Functional Testing 594-1, -2
Catheter Functional Testing - ISO
10555-1
Shipping Qualification | Radiopacity
Echogenicity
Corrosion Resistance
Dimensional & Functional Fit
Tensile Strength
Torque Strength Test
Liquid Leakage
Air Leakage
Burst Pressure
Flow Rate
Simulative Use - performance
testing including dimensional,
surface and compatibility of
components
Luer Functional Testing
Shipping Test |
| Non-Clinical, Animal
Study | No | Yes | No |
| Clinical Study | No | yes | No |
| Biocompatible | Yes, Direct circulating
blood / Limited
(