Who is the manufacturer of TLAB® Transvenous Liver Biopsy System (TF-18C)?

Argon Medical Devices, Inc. filed the 510(k) submission for TLAB® Transvenous Liver Biopsy System (TF-18C) (K241145).

What is the FDA product code for TLAB® Transvenous Liver Biopsy System (TF-18C)?

DYB. It is classified under 21 CFR 870.1340 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for TLAB® Transvenous Liver Biopsy System (TF-18C)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for TLAB® Transvenous Liver Biopsy System (TF-18C)?

TLAB® Transjugular Liver Biopsy System (K022634).

Who can help prepare an FDA 510(k) submission like TLAB® Transvenous Liver Biopsy System (TF-18C)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

K241145 · Argon Medical Devices, Inc. · DYB · Aug 1, 2024 · Cardiovascular

Device Facts

Record ID	K241145
Device Name	TLAB® Transvenous Liver Biopsy System (TF-18C)
Applicant	Argon Medical Devices, Inc.
Product Code	DYB · Cardiovascular
Decision Date	Aug 1, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1340
Device Class	Class 2

Intended 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.

Device Story

The TLAB® Transvenous Liver Biopsy System is a single-use, sterile, disposable kit for percutaneous liver access. It includes an 18G biopsy needle, 7F introducer sheath with curved metal stiffener, 5F straight/curved catheters, tissue removal swabs, and a bending tool. The device is used in clinical settings by physicians to gain venous access (transjugular or transfemoral) to the liver. The bending tool allows for customization of the 7F introducer curve for transfemoral access to tent the caval wall. After guidewire placement and sheath insertion, the biopsy needle is inserted, fired to collect a tissue specimen, and removed. The specimen is then expelled for pathological evaluation. The system facilitates liver biopsy collection in patients where traditional percutaneous access may be contraindicated or difficult, providing a mechanical means for tissue sampling.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including dimensional, visual, radiopacity, corrosion resistance, simulated use, tensile/torque strength, liquid leakage, and ISO-standard functional testing (ISO 80369-7, ISO 10555-1, ISO 9626). Biocompatibility was established per ISO 10993-1:2020 for external communicating devices with limited circulating blood contact (<24 hours).

Technological Characteristics

Materials: PEEK (sheath), 304/302 Stainless Steel (cannula, stylet, bending tool), HDPE (sheath hub/tip), Polycarbonate (needle guide/hub), Nylon, Pebax, Barium Sulfate, Bismuth Subcarbonate, Titanium Dioxide. Sensing/Actuation: Mechanical biopsy needle. Energy: None (manual). Connectivity: None. Sterilization: EtO (SAL 10^-6). Form factor: 18G needle, 7F introducer, 5F catheters.

Indications for Use

Indicated for percutaneous transjugular and transfemoral venous liver access in adult patients (including elderly) of any gender, race, or ethnicity for diagnostic and interventional procedures. Contraindicated in patients with specific characteristics including, but not limited to, occluded IVC, occluded femoral vein, occluded internal jugular vein, or insufficient length of the intrahepatic IVC.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

TLAB® Transjugular Liver Biopsy System (K022634)

Reference Devices

Traveler Portal Vein Access Set (K213638)

Related Devices

K171853 — Liver Access and Biopsy Sets · Cook Incorporated · Aug 24, 2017
K980452 — MANAN LIVER BIOPSY KIT · Medical Device Technologies, Inc. · Feb 18, 1998
K171820 — Transjugular Liver Access Sets · Cook Incorporated · Mar 9, 2018
K160890 — Howell Biliary Introducer Needle · Wilson-Cook Medical, Inc. · Jun 14, 2017
K221440 — Liverty TIPS Access Set · Bard Peripheral Vascular, Inc. · May 31, 2022

Submission Summary (Full Text)

{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…

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

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

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

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!