The Traveler™ Portal Vein Access Set contains a 10F wall-reinforced Introducer Sheath with radiopaque tip, a 10F Dilator, a 5F MPA catheter, a puncturing 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 Sheath hemostatic valve is designed to allow entry of a 13F (4.3mm/0.171") access sleeve but taper down to a 10F inner diameter. These components are used to create a pathway through the liver parenchyma through which an endoprosthetic can be delivered. The Portal Vein Access Set is used 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, and then the pathway is dilated to provide access for the 10F Introducer Sheath. The shunt is inserted through the sheath and deployed through the pathway. Then, all of the Portal Vein Access Set components are removed. The Portal Vein Access Set is typically in use in procedures up to 4 hours.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Traveler Portal Vein Access Set), not a study report for an AI/CAD/imaging device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or details about MRMC studies, which are typically associated with AI or imaging diagnostics.

This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance testing and biocompatibility testing for a physical medical device (a catheter introducer).

Here's how the provided information relates to your request, and what is missing due to the nature of the device:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: The document states that a series of tests were conducted "to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not provide a table with specific quantitative acceptance criteria (e.g., "burst pressure must be > X psi") or the exact reported performance values from those tests. It broadly lists the types of tests performed.
Reported Device Performance: The document only states that the device "were shown to meet the acceptance criteria." No specific numerical performance values for tests like "Tensile Strength," "Torque Strength Test," "Burst Pressure," etc., are reported in the provided text.

List of Tests Performed (from text, acting as performance areas):

Acceptance Criteria Area	Reported Device Performance
Dimensional & Functional Fit	Met acceptance criteria (no specific values provided)
Surface Inspection	Met acceptance criteria (no specific values provided)
Component Compatibility	Met acceptance criteria (no specific values provided)
Tensile Strength	Met acceptance criteria (no specific values provided)
Torque Strength Test	Met acceptance criteria (no specific values provided)
Liquid Leakage	Met acceptance criteria (no specific values provided)
Air Leakage	Met acceptance criteria (no specific values provided)
Burst Pressure	Met acceptance criteria (no specific values provided)
Flow Rate	Met acceptance criteria (no specific values provided)
Corrosion Resistance	Met acceptance criteria (no specific values provided)
Simulative Use	Met acceptance criteria (no specific values provided)
Radiopacity	Met acceptance criteria (no specific values provided)
Echogenicity	Met acceptance criteria (no specific values provided)
Luer Connector Functional Testing	Met acceptance criteria (no specific values provided)
Resistance to Fracture Testing	Met acceptance criteria (no specific values provided)
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Material Mediated Pyrogen, Hemocompatibility)	Met acceptance criteria (no specific values provided for each test)
Shipping Test	Met acceptance criteria (no specific values provided)

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified. The document refers to "a series of testing" but does not give the number of units/samples tested for each performance criterion.
Data Provenance: The tests are non-clinical, likely performed in an engineering lab. The "data provenance" in terms of patient data (country of origin, retrospective/prospective) is not applicable or provided as this is a physical device, not an AI/imaging diagnostic.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a catheter introducer, not an AI diagnostic that requires expert interpretation for ground truth establishment. The "ground truth" for this device would be its physical conformance to specifications and its performance in defined engineering tests.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies involving interpretation (e.g., radiology reads). For a physical device, performance is typically measured against objective criteria without "adjudication" in this sense.

5. 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:

Not applicable. This is not an AI/CAD system. No MRMC study was done, nor would it be relevant for this type of device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For the physical properties and performance tests, the "ground truth" would be the engineering specifications, industry standards, and established test methodologies (e.g., ISO standards for biocompatibility). There is no "expert consensus" or "pathology" ground truth in this context.

8. The sample size for the training set:

Not applicable. This device is not an AI or machine learning model that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

In summary, the provided document is a regulatory submission for a physical medical device (catheter introducer) aiming for 510(k) clearance based on substantial equivalence. It is not an evaluation report for an AI/CAD/imaging device. Therefore, most of the detailed information you requested regarding AI performance metrics, clinical study design, and ground truth establishment for AI models is not present and not relevant to this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.

December 22, 2020

Argon Medical Devices, Inc. Amy Clendening-Wheeler Regulatory Affairs Manager 1445 Flat Creek Road Athens, Texas 75751

Re: K201489

Trade/Device Name: Traveler Portal Vein Access Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 20, 2020 Received: November 23, 2020

Dear Amy Clendening-Wheeler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.

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

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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,

Finn Donaldson Assistant Director (Acting) DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201489

Device Name Traveler™ Portal Vein Access Set

Indications for Use (Describe)

The Traveler™ Portal Vein Access Set is intended for transjugular liver access in 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)

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December 18, 2020 Date Prepared: Company: Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, Texas 75751 USA Facility Registration number: 1625425 Amy Clendening-Wheeler Contact: Regulatory Affairs Manager Phone: 469-731-1413 469-731-1480 Fax: Email: amy.wheeler@argonmedical.com Device Trade Name: Traveler™ Portal Vein Access Set Catheter Introducer Device Common Name: Device Classification: Introducer, Catheter Product code, DYB 21 CFR 870.1340 Class II Review Panel: Cardiovascular Devices Predicate Device(s): Primary: K171820 Transjugular Liver Access Sets / Cook Incorporated Reference: K152913 GORE TIPS Set / Creganna Medical Description of the The Traveler™ Portal Vein Access Set contains a 10F wall-reinforced Device: Introducer Sheath with radiopaque tip, a 10F Dilator, a 5F MPA catheter, a puncturing 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 Sheath hemostatic valve is designed to allow entry of a 13F (4.3mm/0.171") access sleeve but taper down to a 10F inner diameter.

510(k) Summary

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	These components are used to create a pathway through the liverparenchyma through which an endoprosthetic can be delivered. ThePortal Vein Access Set is used to gain access to the hepatic vein andguide a sharp puncture tool toward the parenchyma. The puncturetool is used to make a pathway from the hepatic vein to the portalvein, and then the pathway is dilated to provide access for the 10FIntroducer Sheath. The shunt is inserted through the sheath anddeployed through the pathway. Then, all of the Portal Vein AccessSet components are removed. The Portal Vein Access Set is typicallyin use in procedures up to 4 hours.
Indication for Use:	The Traveler™ Portal Vein Access Set is intended for transjugular liveraccess in diagnostic and interventional procedures.
TechnologicalCharacteristics:	A comparison of the technological characteristics of the subjectdevice and the predicate devices shows the Traveler™ Portal VeinAccess Set to be substantially equivalent to the current marketedpredicate devices.Equivalence is based upon the product performance, design andintended use. The Traveler™ Portal Vein Access Set and the predicatedevices have similar materials of construction, dimensionalspecifications, designs and sterilization process.
Performance Tests(Non-Clinical):	No performance standards have been established under section 514,performance standards, of the Food, Drug and Cosmetic Act forthese devices. A series of testing was conducted in accordance withprotocols based on requirements outlined in guidances and industrystandards and the below were shown to meet the acceptance criteriathat were determined to demonstrate substantial equivalence.The following tests were performed under the specified testingparameters to support the Traveler™ Portal Vein Access Setsubstantial equivalence.Performance Testing, including:• Dimensional & Functional Fit• Surface Inspection
SubstantialEquivalence:	Based on the Indication for Use, design, and safety and performancetesting, the Traveler TM Portal Vein Access Set meets the requirementsfor its intended use and is substantially equivalent to the predicatedevices.

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Component Compatibility ●
Tensile Strength
Torque Strength Test ●
Liquid Leakage
Air Leakage ●
Burst Pressure
Flow Rate
Corrosion Resistance
Simulative Use ●
Radiopacity ●
Echogenicity ●
Luer Connector Functional Testing ●
Resistance to Fracture Testing ●

Biocompatibility Testing, including:

Cytotoxicity (ISO 10993-5)
· Sensitization (ISO 10993-10)
· Intracutaneous Irritation (ISO 10993-10)
· Acute Systemic Toxicity (ISO 10993-11)
Material Mediated Pyrogen (ISO 10993-11) ●
· Hemocompatibility (ISO10993-4)
- o ASTM Hemolysis Direct and Indirect Contact
- o Complement Activation, SC5b-9
- O In Vivo Thrombogenicity
- Platelet and Leucocyte Counts O
- O Partial Thromboplastin Time (PTT)

Substantial Equivalence Table

	SUBJECT DEVICE	PRIMARYPREDICATE DEVICE	REFERENCEPREDICATE DEVICE
	Traveler™ Portal VeinAccess Set	Transjugular LiverAccess Sets	GORE® TIPS Set
Manufacturer	Argon Medical Devices, Inc.	Cook Incorporated	Creganna Medical
510(k)	TBD	K171820	K152913
Class	II	SAME	SAME
Classification Name	Catheter Introducer	SAME	SAME
Regulation	21 CFR 870.1340	SAME	SAME
Product Code	DYB	SAME	SAME

Clinical Comparison
Principle of Operation	Access to the jugular vein usingstandard access techniques.The Introducer sheath anddilator are inserted over theguidewire, advanced, andpositioned in the hepatic veinand the dilator is removed. Thepuncturing tool and guidecatheter is inserted intothe introducer sheath and thepuncturing tool is usedto puncture the hepatic vein,liver parenchyma and accessthe portal vein.	SAME	SAME
Indication for Use	The Portal Vein Access Set isintended for transjugular liveraccess during diagnostic andinterventional procedures.	Intended for transjugularliveraccess in diagnostic andinterventional procedures.	Intended to be used togetherfor percutaneoustransjugular liver accessduring diagnostic andinterventional procedures inpatients undergoing aTransjugularIntrahepatic PortosystemicShunt (TIPS) procedure.
Contraindication	None Known	Unknown	Unknown
Single Use	YES	SAME	SAME
Supplied Sterile	YES	SAME	SAME
Sterilization	EtO	SAME	SAME
Technical and Biological Comparison
Introducer SheathIntroducer Sheath, working length (cm)Sheath, composition	Sheath hemostatic valve is designed to allow entry of a 13F (4.3mm/0.171") access sleeve but taper down to a 10F inner diameter.	some of these sets are a Check-Flo Introducer Set, selective catheters, and wire guides.
	10F42Pebax or PTFE Inner LayerStainelss Steel CoilPebax Outer Layer	9F or 10F38.5, 40PTFE linerStainless Steel CoilNylon Jacket	10F40PTFE LinerStainless Steel CoilPebax 6333 JacketPt/IR markerbandGrilamid hubHemostatis seal
Dilator Length (cm)	49	40, 51	47
Dilator end hold size (in)	0.040	0.035, 0.038	0.035
Guidewire Compatibility (in)	0.035, 0.038	SAME	≤ 0.035
Dilator, composition	HDPE with barium sulfate	Polyethylene	HDPE Extrusion
Stiffening Cannula	14ga	SAME	Not Available
Puncturing Tool Assembly	16ga Stainless Steel Needle- 57 cm in length7F Peek Catheter- 51cm in lengthOR0.038" Stainless SteelStylet- 69 cm in length5F Peek Catheter- 66 cm in lengthOR21ga Needle- 72 cm in length5F Peek Catheter- 67 cm in length	16ga Stainless Steel Needle- 50.5 cm in length9F or 10F Teflon Catheter- 45.5 cm in lengthOR0.038" Stainless SteelNeedleStylet- 62.5 cm in length5.2F Teflon Catheter- 62 cm in length14ga Stainless SteelStiffening Access Cannula- 54.5 cm in length10F Teflon Catheter- 51.8 cm in length	16ga Stainless Steel Needle- 56 cm in length10F MDPE catheter- 49 cm in length
Puncturing Tool, composition	304 Stainless Steel	SAME	SAME
Puncturing Tool Catheter, composition	PEEK	Teflon/nylon	MDPE ExtrusionHDPE Hub
Bending Tool	New	Not Available	Not Available
Bending Tool, composition	302 Stainless Steel	Not Available	Not Available
Performance Testing	• Radiopacity	• Radiopacity	• Radiopacity
	• Echogenicity	• Corrosion Resistance	• Echogenicity
	• Corrosion Resistance	• Tensile Strength	• Corrosion Resistance
	• Dimensional & Functional Fit• Tensile Strength• Torque Strength Test• Liquid Leakage• Air Leakage• Burst Pressure• Flow Rate• Simulative Use - performancetesting includingdimensional, surface andcompatibility of components• Luer Functional Testing• Shipping Test• Resistance to Fracturetesting	• Torque Strength Test• Liquid leakage• Air Leakage• Burst Pressure• Flexibility & Fracture• Simulative Use –performance testingincluding dimensional,surface and compatibilityof components	• Tensile Strength• Torque Strength Test• Liquid leakage• Air Leakage• Burst Pressure• Flexibility & Fracture• Simulative Use –performance testingincluding dimensional,surface and compatibility ofcomponents
Biological Comparison	• 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)o ASTM Hemolysis – Directand Indirect Contacto Complement Activation,SC5b-9o In Vivo Thrombogenicityo Platelet and LeucocyteCountso Partial ThromboplastinTime (PTT)	• Cytotoxicity (ISO 10993-5)• Sensitization (ISO 10993-10)• IntracutaneousReactivity/Irritation (ISO10993-10)• Acute Systemic Toxicity(ISO 10993-11)• Material MediatedPyrogenicity• Hemocompatibility(ISO10993-4)- HemolysisDirect/Indirect- Complement Activation(ISO Direct Contact)In Vivo Thrombogenicity	• Cytotoxicity (ISO 10993-5)• Sensitization (ISO 10993-10)• IntracutaneousReactivity/Irritation (ISO10993-10)• Acute Systemic Toxicity (ISO10993-11)• Material MediatedPyrogenicity• Hemocompatibility(ISO10993-4)- Hemolysis Direct/Indirect- Complement Activation(ISO Direct Contact)- In Vivo Thrombogenicity
PackagingConfiguration	PETG Tray in a Tyvek/polypouch	Individually pouchescomponents	Tyvek/Polyethylene-polyesterFilm
Intended Shelf Life	3 years	3 years	1 year

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Conclusion:

The results of all testing demonstrate that the Traveler™ Portal Vein Access Set are substantially equivalent to the predicate device.

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).