(98 days)
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 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).
Here's a breakdown of the acceptance criteria and study information for the TLAB® Transvenous Liver Biopsy System, based on the provided text:
This document describes a medical device (TLAB® Transvenous Liver Biopsy System) not an AI/ML device, therefore, sections related to AI/ML specific criteria (such as MRMC studies, standalone algorithm performance, training set details) are not applicable.
Acceptance Criteria and Reported Device Performance
Device Trade Name: TLAB® Transvenous Liver Biopsy System (TF-18C)
Regulation Number: 21 CFR 870.1340 - Catheter Introducer
Regulatory Class: Class II
Product Code: DYB
The device demonstrated substantial equivalence to predicate devices (TLAB® Transjugular Liver Access Set K022634 and Traveler Portal Vein Access Set K213638) based on a comparison of technological characteristics, indications for use, materials, packaging, principle of operation, design features, sterilization process, and in-vitro performance testing.
| Acceptance Criteria Category | Specific Criteria / Test Performed | Reported Device Performance / Outcome |
|---|---|---|
| Performance Testing | Dimensional | Met acceptance criteria |
| Visual | Met acceptance criteria | |
| Radiopacity | Met acceptance criteria | |
| Corrosion Resistance | Met acceptance criteria | |
| Simulated Use | Met acceptance criteria | |
| Tensile Strength | Met acceptance criteria | |
| Torque Strength | Met acceptance criteria | |
| Liquid Leakage | Met acceptance criteria | |
| Luer Functional Testing (ISO 80369-7) | Met acceptance criteria | |
| Catheter Functional Testing (ISO 10555-1) | Met acceptance criteria | |
| Resistance to Breakage (ISO 9626) | Met acceptance criteria | |
| Shipping Qualification Testing | Met acceptance criteria | |
| Design Validation | Met acceptance criteria | |
| Summative Usability | Met acceptance criteria | |
| Biocompatibility (ISO 10993-1:2020) | Cytotoxicity (ISO 10993-5) | Previously performed, applicable to new device; met criteria |
| Sensitization (ISO 10993-23) | Previously performed, applicable to new device; met criteria | |
| Irritation or Intracutaneous Reactivity (ISO 10993-10) | Previously performed, applicable to new device; met criteria | |
| Material Mediated Pyrogen (ISO 10993-11) | Previously performed, applicable to new device; met criteria | |
| Acute Systemic Toxicity (ISO 10993-11) | Previously performed, applicable to new device; met criteria | |
| Hemocompatibility (ISO 10993-4): ASTM Hemolysis Assay, Direct and Extract Methods (ISO) | Previously performed, applicable to new device; met criteria | |
| Hemocompatibility (ISO 10993-4): Complement Activation Assay, SC5b-9 Method with Comparison Article (ISO) | Performed anew; met criteria | |
| Hemocompatibility (ISO 10993-4): Partial Thromboplastin Time (PTT) Assay with Comparison Article (ISO) | Performed anew; met criteria | |
| Hemocompatibility (ISO 10993-4): Heparinized Platelet and Leukocyte Count Assay with Comparison Article (ISO) | Performed anew; met criteria | |
| Sterilization | Minimum SAL 10-6, EtO | Met acceptance criteria |
| Shelf-Life | 3 years | Met acceptance criteria (based on predicate) |
Study Details
-
Sample size used for the test set and the data provenance:
- The document primarily describes bench-top testing (in-vitro performance) and biocompatibility testing. Specific sample sizes for each non-clinical test are not explicitly stated in the provided text, but it mentions that "A series of testing was conducted".
- Data Provenance: All studies were performed following approved protocols under Good Laboratory Practices (GLP) in compliance with FDA GLP, 21 CFR Part 58. This indicates the testing was conducted in a controlled laboratory environment. No specific country of origin or retrospective/prospective nature for these non-clinical tests is given beyond GLP compliance.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the described studies are non-clinical, bench-top performance and biocompatibility tests. They do not involve human interpretation or subjective clinical "ground truth" that would require expert consensus. The acceptance criteria themselves serve as the 'ground truth' for these engineering and materials tests.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable as the described studies are non-clinical, bench-top performance and biocompatibility tests. Adjudication methods are typically used in clinical studies or studies involving subjective human interpretation (e.g., image reading) where disagreement among experts needs resolution.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This question is not applicable as this document describes a conventional medical device (a biopsy system), not an AI/ML powered device. Therefore, no MRMC comparative effectiveness study was performed in the context of AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable as this document describes a conventional medical device (a biopsy system), not an AI/ML powered device. There is no algorithm to test in a standalone manner.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Performance Testing: The "ground truth" is defined by the acceptance criteria established in accordance with protocols based on guidance and industry standards. These include established engineering and material science standards (e.g., ISO for luer, catheter, and breakage testing) that define acceptable performance.
- For Biocompatibility Testing: The "ground truth" is defined by the internationally recognized standards for biocompatibility (ISO 10993 series) and FDA Guidance, which specify test methods and acceptable limits for biological responses.
-
The sample size for the training set:
- This question is not applicable as this document describes a conventional medical device (a biopsy system), not an AI/ML powered device. There is no machine learning model that requires a training set.
-
How the ground truth for the training set was established:
- This question is not applicable as this document describes a conventional medical device (a biopsy system), not an AI/ML powered device.
{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)
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 RoadAthens, Texas 75751 USAFacility Registration number: 1625425 | ||
| Contact: | Jacquelyn HuyghueSr. Regulatory Affairs SpecialistPhone: 412-568-3369Fax: 903-677-9396Email: jacquelyn.huyghue@argonmedical.com | ||
| Device Trade Name: | TLAB® Transvenous Liver Biopsy System | ||
| Device Common Name: | Catheter, Introducer | ||
| Device ClassificationName: | Catheter, IntroducerClass IIProduct code Product code DYB21 CFR §870.1340Review Panel: Cardiovascular Devices | ||
| Predicate Device(s): | Primary: K022634, TLAB® Transjugular Liver Access SetReference: K213638, Traveler Portal Vein Access Set | ||
| Description ofthe Device: | The TLAB® Transvenous Liver Biopsy System is a single use, disposable,sterile device.The TLAB® Transvenous Liver Biopsy System consists of the followingcomponents:• 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 inferiorvena cava (IVC) (from transfemoral venous access), or into the right hepaticvein (from transjugular access), using the 5 Fr curved catheter as wireintroducing means. After removing the wire introducer, verification isperformed to ensure that the protective sheath on the 7 Fr introducer issecurely connected to avoid puncture. For transfemoral procedures, thebending tool in the kit is used to curve the metal stiffening cannula of 7Frintroducer. This curve should cause the caval wall to tent when the cannula isinserted into the intrahepatic region of the IVC. Next the 7 Fr introducer isinserted over the guidewire. Optionally, 5Fr Straight catheter is insertedcoaxially into the 7Fr introducer to provide a smooth transition for 7Frintroducer over the guidewire. The guidewire and 5Fr straight catheter (ifused) is then removed and the charged needle is inserted through the 7Frintroducer. The biopsy device is then discharged/fired to collect the specimenand is then removed from the patient. The specimen is expelled from thedevice 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 forpercutaneous transjugular and transfemoral venous liver access duringdiagnostic and interventional procedures. |
|---|---|
| TechnologicalCharacteristics: | A comparison of the technological characteristics of the subject device andthe predicate devices shows the TLAB® Transvenous Liver Biopsy System tobe substantially equivalent to the current marketed predicate devices.Equivalence is established on in vitro performance testing, and similarities inindications for use, materials, packaging, technological characteristics,principle of operation, design features and sterilization process. |
| Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| TLAB®Transvenous Liver BiopsySystem | TLAB®Transjugular Liver BiopsySystem K022634 | Traveler 0.038 Stylet Portal VeinAccess (TPS001), Traveler 21gaNeedle Portal Vein Access Set(TPS002), Traveler 16ga NeedlePortal 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 ClassificationName | Catheter introducer | Same | Same |
| Regulation | 21 CFR §870.1340 | Same | Same |
| Product Code | DYB | Same | Same |
| Clinical Comparison | |||
| Intended Use | Intended for use in obtainingliver histology samples viatransjugular andtransfemoral venousapproaches. | Same - intended to collect liversamplesThe TLAB® Transjugular LiverBiopsy Instrument is designed toperform consistently in typicaland tortuousanatomy to collect quality liversamples. | The Traveler™ Portal Vein AccessSet is intended for transjugularliver access in diagnostic andinterventional procedures. |
| Subject Device | Primary Predicate | Reference Predicate | |
| TLAB®Transvenous Liver BiopsySystem | TLAB®Transjugular Liver Biopsy SystemK022634 | Traveler 0.038 Stylet Portal VeinAccess (TPS001), Traveler 21gaNeedle Portal Vein Access Set(TPS002), Traveler 16ga NeedlePortal Vein Access Set (TPS003)K213638 for Bending Tool Only | |
| Principle ofOperation | The patient is prepared fortransfemoral or transjugularaccess per facility clinicalprotocols. The componentsare removed from theTransvenous Liver BiopsySystem package using steriletechnique. The componentsare then flushed withheparinized saline or similarisotonic solution before use.Prior to obtaining femoral orjugular access, the needle ischarged by pulling back onthe plunger until a firm clickis felt and heard. The deviceis then placed on the table inthe sterile environment.After prepping the device,the user will obtain femoralor jugular access. They willintroduce and seat aguidewire into the rightfemoral vein using a wireintroducing means, such as a5 Fr curved catheter or byother methods. Afterremoving the wireintroducing means, the userwill confirm that theprotective sheath on the 7 Frintroducer is securelyconnected to avoid punctureand insert the 7 Fr introducerover the guidewire. TheBending Tool is used toincrease the bend on themetal 7F Introducer withprotective sheath per theanatomy of the patientThe user will make anyappropriate adjustments toavoid capsular perforation | Same - Subject device includesadditional access pointEstablish jugular access andmaintain access with .035"guidewire, Use the MPA catheterto guide guidewire into righthepatic vein. Remove MPAcatheter. Introduce 7F introducersheath over the guidewire andinto the right hepatic vein.Remove guidewire. Lock needleby pulling back on the plungeruntil a click is heard. Introducethe needle through the safetyguide until the black mark meetsthe beginning of the funnel.Advance the needle. Hold theintroducer system in place &remove the needle. Pull back onthe plunger until a click is heard,then push plunger forward toexpose the specimen. Removesample by rolling it out of thenotch with a swab. Place samplein formalin. Re-insert biopsyneedle and repeat. | The Traveler Portal Vein AccessSet is used to deliver anendoprosthetic shuntthrough the liver parenchyma.This is accomplished by using thePortal Vein AccessSet to gain access to the hepaticvein and guide a sharp puncturetool toward theparenchyma. The puncture tool isused to make a pathway from thehepatic vein tothe portal vein, then the pathwayis dilated to provide access for alarger sheath. Theshunt (not included) is insertedthrough the sheath and deployedthrough thepathway. All of the Portal VeinAccess Set components are thenremoved. |
| Subject Device | Primary Predicate | Reference Predicate | |
| TLAB®Transvenous Liver BiopsySystem | TLAB®Transjugular Liver Biopsy SystemK022634 | Traveler 0.038 Stylet Portal VeinAccess (TPS001), Traveler 21gaNeedle Portal Vein Access Set(TPS002), Traveler 16ga NeedlePortal Vein Access Set (TPS003)K213638 for Bending Tool Only | |
| using clinical judgment. Oncethe device is inserted, theuser may inject contrastmaterial through the sideport in the valve assembly ofthe 7 Fr Introducer. Afterconfirming that the desiredlocation has been achieved,then the user will removethe guidewire and insert thecharged needle through thecatheter system. The biopsydevice is thendischarged/fired to collectthe specimen and is thenremoved from the patient.The specimen is expelledremoved from the deviceonto a collection slide and/orplaced into fixative forpathological evaluation. Ifadditional samples areneeded, the biopsy device isre-charged, reinserted intopatient, discharged/fired tocollect specimen, andremoved from patient. Whenthe collection of samples isfinished and if used, thesystem is removed from thepatient and disposed. Oncethe patient has beenprepped, and hepaticpressure measurementshave been taken, theprocedure can vary in lengthfrom five to ten minutes. | |||
| Mechanism of Action | Mechanical | Same | Same |
| Subject Device | Primary Predicate | Reference Predicate | |
| TLAB®Transvenous Liver BiopsySystem | TLAB®Transjugular Liver Biopsy SystemK022634 | Traveler 0.038 Stylet Portal VeinAccess (TPS001), Traveler 21gaNeedle Portal Vein Access Set(TPS002), Traveler 16ga NeedlePortal Vein Access Set (TPS003)K213638 for Bending Tool Only | |
| Indication for Use | The TLAB® Transvenous LiverBiopsy System is intended tobe used for percutaneoustransjugular andtransfemoral venous liveraccess during diagnostic andinterventional procedures. | SimilarThis device is intended to be usedfor percutaneous transjugularliver access during diagnostic andinterventional procedures. | The Portal Vein Access Set isintended for transjugular liveraccess during diagnostic andinterventional procedures. |
| Contraindication | None Known.Sound professionaljudgement should beused to determine if useof this product isinadvisable due to specificpatient characteristics,including, but not limitedto occluded IVC, occludedfemoral vein, occludedinternal jugular vein andpossibly a short length ofthe intrahepatic IVC. | None Known.Sound professional judgmentshould be used to determine ifuse of this product isinadvisable due to specificpatient characteristics,including, but not limited to:thrombosis of the internaljugular vein, untreatedinfections or reaction tocontrast medium. | None Known |
| Target PatientPopulation | Adult patients to includeelderly adults, anygender, race, or ethnicity. | Not Specified | Any patient that requires atransjugular intrahepaticportosystemic shunt (TIPS)endoprosthesis also requiresthat a clinician use a TIPSdelivery system to place theendoprosthesis within the liverparenchyma. Patients thatrequire a TIPSendoprosthesis commonly havea general liver disease such ascirrhosis or hepatitis Bor C, and the diseaseprogression resulted innarrowed or occluded bloodvessels |
| Subject Device | Primary Predicate | Reference Predicate | |
| TLAB®Transvenous Liver BiopsySystem | TLAB®Transjugular Liver Biopsy SystemK022634 | Traveler 0.038 Stylet Portal VeinAccess (TPS001), Traveler 21gaNeedle Portal Vein Access Set(TPS002), Traveler 16ga NeedlePortal Vein Access Set (TPS003)K213638 for Bending Tool Only | |
| reduce the patient's bloodpressure within that system.Patients can be any genderor age, but they are morecommonly 40 years old orolder. | |||
| Single Use | Yes | Same | Same |
| Supplied Sterile | Yes | Same | Same |
| Device Description | The TLAB® TransvenousLiver Biopsy System isintended to be used forpercutaneous transjugularand transfemoral venousliver access duringdiagnostic andinterventional procedures.The device is a single use,disposable sterile device.The TLAB® TransvenousLiver Biopsy Systemconsists of the followingcomponents:● 18-Gauge (18G)Flexcore BiopsyNeedle, 65 cmoverall length,17mm notch,20.83 maximumthrow● 7 French (7F)Introducer withProtective Sheathand ValveAssembly withSafety Guide, 60cm overall lengthand a curvedmetal stiffener● 5 French (5F)Curved Catheter,80 cm overalllength | Similar - difference is bendingtool used in Subject device forfemoral accessThis device is intended to be usedfor percutaneous transjugularliver access during diagnostic andinterventional procedures. Thedevice is a single use, disposablesterile device.Each TLAB® System contains:● Flexcore® Biopsy Needle,18 ga or 19 ga, 65 cmoverall length, 17 mmnotch, 20 mm throw● 7 Fr Introducer withProtective Sheath andValve Assembly withSafety Guide, 60 cmoverall length and acurved metal stiffener● 5 French (5F) StraightCatheter● 5 French (5F) CurvedCatheter● Tissue Removal Swabs,10 cm length,polyurethane foam tip,nylon handle● 5 Fr Curved Catheter, 80cm overall length● 5 Fr Straight Catheter,65 cm overall length forsmoother transitionbetween the 7 fr | Each Portal Vein Access Setcontains a 10F wall-reinforcedIntroducer Sheath withradiopaque tip, a 10F Dilator, a5F MPA catheter, tool thatcomes in the followingvariations: 0.038" Stylet with a5Fr Stylet Catheter (separatedwith a removable spacer clip), a21ga Needle/5Fr Catheter or16ga Needle/7Fr Catheter(both are separated with aremovable spacer clip) and abending tool. The 14gastiffening cannula with cannulasheath and the 16ga needlehave a curved end, with adirectional handle thatindicates the direction of thecurve. The 10F IntroducerOnlySheath hemostatic valve isdesigned to allow entry of a13F (4.3mm/0.171") accesssleeve but taper down to a 10Finner diameter. a puncturingtool |
| Subject Device | Primary Predicate | Reference Predicate | |
| TLAB®Transvenous Liver BiopsySystem | TLAB®Transjugular Liver Biopsy SystemK022634 | Traveler 0.038 Stylet Portal VeinAccess (TPS001), Traveler 21gaNeedle Portal Vein Access Set(TPS002), Traveler 16ga NeedlePortal 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: PEEKCannula: 304 Stainless SteelStylet: 304 Stainless Steel | Same | N/A |
| Introducer Sheath | |||
| Introducer size | 7F includes metal stiffenerwith Protective Sheath andValve Assembly with SafetyGuide | 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 BiopsySystem | TLAB®Transjugular Liver Biopsy SystemK022634 | Traveler 0.038 Stylet Portal VeinAccess (TPS001), Traveler 21gaNeedle Portal Vein Access Set(TPS002), Traveler 16ga NeedlePortal Vein Access Set (TPS003)K213638 for Bending Tool Only | |
| 7F IntroducerStiffening Cannula:304 Stainless Steel Torque HandleOrientation 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,bismuthsubcarbonate,titanium dioxide | Same | N/A |
| Straight Catheter | |||
| Size | 5F | Same | N/A |
| Overall Length (cm) | 65cm | Same | N/A |
| Composition | Catheter Hub:Polycarbonate Catheter ShaftNylon, bariumsulfate Catheter Tip: Pebax,bismuthsubcarbonate,titanium dioxide | Same | N/A |
| Tissue Removal Swabs | |||
| Length (cm) | 10 cm length | Same | N/A |
| Composition | Tip: polyurethanefoam Handle: Nylon | Same | N/A |
| Subject Device | Primary Predicate | Reference Predicate | |
| TLAB®Transvenous Liver BiopsySystem | TLAB®Transjugular Liver Biopsy SystemK022634 | Traveler 0.038 Stylet Portal VeinAccess (TPS001), Traveler 21gaNeedle Portal Vein Access Set(TPS002), Traveler 16ga NeedlePortal 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 | DimensionalVisualRadiopacityCorrosion ResistanceSimulated UseTensile StrengthTorque StrengthLiquid LeakageLuer Functional Testing -ISO 80369-7Catheter FunctionalTesting – ISO 10555-1Resistance to Breakage -ISO 9626Shipping Qualification | Similar - with testing performedto current standards on SubjectDeviceDimensionalVisualRadiopacityCorrosion ResistanceSimulated UseTensile StrengthTorque StrengthLiquid LeakageLuer Functional Testing 594-1, -2Catheter Functional Testing - ISO10555-1Shipping Qualification | RadiopacityEchogenicityCorrosion ResistanceDimensional & Functional FitTensile StrengthTorque Strength TestLiquid LeakageAir LeakageBurst PressureFlow RateSimulative Use - performancetesting including dimensional,surface and compatibility ofcomponentsLuer Functional TestingShipping Test |
| Non-Clinical, AnimalStudy | No | Yes | No |
| Clinical Study | No | yes | No |
| Biocompatible | Yes, Direct circulatingblood / Limited(<24 hours) | Same | Yes, Direct circulatingblood / Limited(<24 hours) |
| Non-pyrogenic | Yes | Same | Yes |
| Subject Device | Primary Predicate | Reference Predicate | |
| TLAB®Transvenous Liver BiopsySystem | TLAB®Transjugular Liver Biopsy SystemK022634 | Traveler 0.038 Stylet Portal VeinAccess (TPS001), Traveler 21gaNeedle Portal Vein Access Set(TPS002), Traveler 16ga NeedlePortal Vein Access Set (TPS003)K213638 for Bending Tool Only | |
| BiologicalComparison | Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-23) Irritation orIntracutaneousReactivity (ISO 10993-10) Material MediatedPyrogen (ISO 10993-11) Acute Systemic Toxicity(ISO 10993-11 Hemocompatibility(ISO10993-4) In-vitro Blood Assay ComplementActivation, SC5b-9 Heparinized Plateletand LeucocyteCounts PartialThromboplastinTime (PTT) ASTM HemolysisAssay, Direct andExtract Methods(ISO) | Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-23) Irritation orIntracutaneous Reactivity(ISO 10993-10) Material MediatedPyrogen (ISO 10993-11) Acute Systemic Toxicity(ISO 10993-11 Hemocompatibility(ISO10993-4) In-vitro Blood Assay Complement Activation,SC5b-9 Heparinized Platelet andLeucocyte Counts Partial ThromboplastinTime (PTT) ASTM Hemolysis Assay,Direct and Extract Methods(ISO) | Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Intracutaneous Irritation (ISO10993-10) Acute Systemic Toxicity (ISO10993-11) Material Mediated Pyrogen(ISO 10993-11) Hemocompatibility (ISO10993-4) ASTM Hemolysis - Direct andIndirect Contact Complement Activation, SC5b-9 In Vivo ThrombogenicityPlatelet and Leucocyte Counts Partial Thromboplastin Time(PTT) |
| PackagingConfiguration | Sterile Barrier PackagingMaterials:The 6 systemcomponents are sealedindividually inTyvek/poly 1073Bpouches. The individualpouches are insertedinto a masterTyvek/poly 1073B pouchand labeled. 5 mastersystem pouches areplaced in a shipper boxand labeled. 4 shippersare packaged into acorrugated cardboardbox for sterilization. | Similar - same configurationwithout the bending toolThe 5 system components aresealed individually in Tyvek/poly1073B pouches. The individualpouches are inserted into amaster Tyvek/poly 1073B pouchand labeled. 5 master systempouches are placed in a shipperbox and labeled. 4 shippers arepackaged into a corrugatedcardboard box for sterilization. | The components of each kit arepackaged in a PETG Tray andinserted into a labeled poly/Tyvekpouch. The labeled pouch isplaced into a labeled shelf cartonwith one (1) IFU. |
| Subject Device | Primary Predicate | Reference Predicate | |
| TLAB®Transvenous Liver BiopsySystem | TLAB®Transjugular Liver Biopsy SystemK022634 | Traveler 0.038 Stylet Portal VeinAccess (TPS001), Traveler 21gaNeedle Portal Vein Access Set(TPS002), Traveler 16ga NeedlePortal Vein Access Set (TPS003)K213638 for Bending Tool Only | |
| Sterilization | Minimum SAL 10-6, EtO | Same | Minimum SAL 10-6, EtO |
| Shelf-Life | 3 years | Same | 3 years |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in a bold, sans-serif font, also in blue. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, less bold font, also in blue. The overall design is clean and modern, conveying a sense of professionalism and innovation.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in a bold, sans-serif font, also in blue. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, less bold font, also in blue. The overall design is clean and modern, conveying a sense of professionalism and innovation.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo consists of a blue triangle above the word "ARGON" in blue, block letters. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller font size, also in blue.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in a bold, sans-serif font, also in blue. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, lighter blue, sans-serif font. The overall design is clean and modern.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in a bold, blue sans-serif font. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, less bold, blue sans-serif font. The overall design is clean and modern.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a stylized letter "A" in gray above the company name. The word "ARGON" is in a bold, sans-serif font in blue, and below it, "MEDICAL DEVICES" is in a smaller, lighter sans-serif font, also in blue.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle with a gray shadow on the top right corner. Below the triangle, the word "ARGON" is written in a bold, blue sans-serif font. Underneath "ARGON", the words "MEDICAL DEVICES" are written in a smaller, gray sans-serif font.
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in a bold, blue sans-serif font. Below the word "ARGON" are the words "MEDICAL DEVICES" in a smaller, gray sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a stylized letter "A" in blue, with a gray triangle cut out of the center. Below the "A" is the word "ARGON" in large, bold, blue letters. Underneath "ARGON" are the words "MEDICAL DEVICES" in smaller, gray letters.
| Non-Clinical Data(Bench-top Testing): | No performance standards have been established under section 514,performance standards, of the Food, Drug and Cosmetic Act for thesedevices. |
|---|---|
| A series of testing was conducted in accordance with protocols based onrequirements outlined in guidance and industry standards and the belowwere shown to meet the acceptance criteria that were determined todemonstrate substantial equivalence. | |
| The following tests were performed under the specified testing parametersto support the TLAB® Transvenous Liver Biopsy System substantialequivalence: | |
| ● 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 | |
| Non-Clinical DataBiocompatibility | Biocompatibility is established for the TLAB® Transvenous Liver BiopsySystem according to ISO 10993-1:2020 as an external communicating, |
circulating blood with limited duration <24hrs.
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in large, bold, blue letters. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, lighter blue font. The overall design is clean and professional, reflecting the company's focus on medical technology.
All studies were performed following the approved protocol under Good Laboratory Practices (GLP) in compliance to FDA GLP, 21 CFR Part 58.
The following Biocompatibility Testing was previously performed under the Predicate device and is applicable to the TLAB® Transvenous Liver Biopsy System:
- 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) O
- In Vivo Thrombogenicity Study (ISO) O
The following testing was selected and performed anew based on ISO 10993-1:2018 and FDA Guidance are as follows (Flexible SABD 18GA, 7F Introducer, 5F Straight Catheter, and 5F MPA Catheter):
- ISO10993-4 Hemocompatibility .
- Complement Activation Assay, SC5b-9 Method with O Comparison Article (ISO)
- Partial Thromboplastin Time (PTT) Assay with Comparison O Article (ISO)
- Heparinized Platelet and Leukocyte Count Assay with O Comparison Article (ISO)
Conclusion:
The TLAB® Transvenous Liver Biopsy System introduces no additional clinical risk based upon the performance of a literature search, its comparable intended use and mechanism of action.
Based on performance testing in-vitro, similar indications for use, materials, technological characteristics, principle of operation, design features and sterilization process, the TLAB® Transvenous Liver Biopsy System is substantially equivalent to the predicate device..
§ 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).