The Scorpion Portal Vein Access Sets have two models. One model has a Stylet as the puncture tool and the other model has a 17ga Needle as the puncture tool. The Scorpion Stylet Portal Vein Access Set contains a 10F Introducer Sheath, a 10F Dilator, a 5F MPA catheter, a 14ga Stiffening Cannula, a 0.040" Nitinol Stylet with a 5Fr PEEK Catheter, and a 7F Cannula Sheath. The 14ga stiffening cannula with cannula sheath has a directional handle that indicates the direction of the curve. The 10F Introducer Sheath hemostatic valve is designed to be compatible with up to 13F (4.3mm/0.171") sleeve. These components are used to create a pathway through the liver parenchyma through which an endoprosthetic can be delivered. The Scorpion Stylet Portal Vein Access Set is used to gain access to the hepatic vein and guide a sharp puncture tool (0.040" Stylet) through the parenchyma. The puncture tool (Stylet) is used to make a pathway from the hepatic vein to the portal vein, and then the pathway is dilated to provide access for a larger sheath. The shunt is inserted through the sheath and deployed through the pathway. Then, all of the Scorpion Stylet Portal Vein Access Set components are removed.

The Scorpion Needle Portal Vein Access Set contains a 10F Introducer Sheath, a 10F Dilator, a 5F MPA Catheter, a 13ga Scorpion Stiffening Cannula, 17ga Nitinol Needle, a 6.2F PEEK Catheter, and 8F Sheath Introducer. The 13ga stiffening cannula with cannula sheath has a directional handle that indicates the direction of the curve. The 17ga Nitinol Needle has a directional handle that indicates the direction of the 10F Introducer Sheath hemostatic valve is designed to be compatible with up to 13F (4.3mm/0.171″) sleeve. These components are used to create a pathway through the liver parenchyma through which an endoprosthetic can be delivered. The Scorpion Needle Portal Vein Access Set is used to gain access to the hepatic vein and guide a sharp puncture tool (17ga Needle) through the parenchyma. The puncture tool (Needle) is used to make a pathway from the hepatic vein to the portal vein, and then the pathway is dilated to provide access for a larger sheath. The shunt is inserted through the sheath and deployed through the pathway. Then, all of the Scorpion Needle Portal Vein Access Set components are removed.

A Portal Vein Access Set is typically in use in procedures up to 4 hours.

AI/ML Overview

The provided document is a 510(k) summary for the Scorpion Portal Vein Access Set. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

For medical devices applying for 510(k) clearance, the primary study conducted is generally non-clinical performance testing and biocompatibility testing, rather than clinical studies involving human patients or complex AI algorithm performance analysis. The goal is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, not necessarily to prove superior or improved efficacy through a comparative effectiveness study involving human readers with and without AI assistance.

Therefore, the requested information pertaining to AI studies (MRMC studies, standalone AI performance, number of experts for ground truth, sample size for training set, etc.) is not applicable to this type of device clearance.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study proving it meets those criteria:

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

The document lists various performance and biocompatibility tests conducted to demonstrate substantial equivalence to the predicate device. For each test, the implicit acceptance criterion is that the device meets the requirements outlined in the protocols based on guidances and industry standards. The reported device performance is stated as "shown to meet the acceptance criteria" or "meets the requirements for its intended use." Specific quantitative results or detailed pass/fail thresholds for each individual test are generally not included in a 510(k) summary, as it focuses on the conclusion of equivalence rather than the raw data.

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance
Performance Testing	Dimensional and Functional Fit	Met acceptance criteria / Requirements for intended use fulfilled
	Surface Inspection	Met acceptance criteria / Requirements for intended use fulfilled
	Component Compatibility	Met acceptance criteria / Requirements for intended use fulfilled
	Tensile Strength	Met acceptance criteria / Requirements for intended use fulfilled
	Torque Strength Test	Met acceptance criteria / Requirements for intended use fulfilled
	Liquid Leakage	Met acceptance criteria / Requirements for intended use fulfilled
	Air Leakage	Met acceptance criteria / Requirements for intended use fulfilled
	Corrosion Resistance	Met acceptance criteria / Requirements for intended use fulfilled
	Simulative Use	Met acceptance criteria / Requirements for intended use fulfilled
	Radiopacity	Met acceptance criteria / Requirements for intended use fulfilled
	Echogenicity	Met acceptance criteria / Requirements for intended use fulfilled
	Luer Connector Functional Testing	Met acceptance criteria / Requirements for intended use fulfilled
	Burst Pressure	Met acceptance criteria / Requirements for intended use fulfilled
	Flow Rate	Met acceptance criteria / Requirements for intended use fulfilled
	Resistance to Fracture Testing	Met acceptance criteria / Requirements for intended use fulfilled
	Shipping Test	Met acceptance criteria / Requirements for intended use fulfilled
Biocompatibility Testing	Cytotoxicity (ISO 10993-5)	Met acceptance criteria / Requirements for intended use fulfilled
	Sensitization (ISO 10993-10)	Met acceptance criteria / Requirements for intended use fulfilled
	Intracutaneous Irritation (ISO 10993-10)	Met acceptance criteria / Requirements for intended use fulfilled
	Acute Systemic Toxicity (ISO 10993-11)	Met acceptance criteria / Requirements for intended use fulfilled
	Material Mediated Pyrogen (ISO 10993-11)	Met acceptance criteria / Requirements for intended use fulfilled
	Hemocompatibility (ISO 10993-4)	Met acceptance criteria / Requirements for intended use fulfilled
	- ASTM Hemolysis Direct/Indirect Contact	Met acceptance criteria / Requirements for intended use fulfilled
	- Complement Activation, SC5b-9	Met acceptance criteria / Requirements for intended use fulfilled
	- Thrombogenicity	Met acceptance criteria / Requirements for intended use fulfilled
	- Platelet and Leucocyte Counts	Met acceptance criteria / Requirements for intended use fulfilled
	- Partial Thromboplastin Time (PTT)	Met acceptance criteria / Requirements for intended use fulfilled

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

The document does not specify the precise sample sizes for each of the non-clinical performance or biocompatibility tests. These tests typically involve a defined number of devices or material samples as per the relevant ISO or ASTM standards.

Regarding data provenance, the testing was conducted non-clinically and is typically performed at the manufacturer's facility or by a contract testing organization. The document refers to "protocols based on requirements outlined in guidances and industry standards," implying controlled laboratory settings. There is no mention of geographical data provenance for test sets (e.g., country of origin), as this is not a clinical study. The studies are prospective in the sense that they were designed and executed to specifically test the device for this submission.

3. 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 this is a 510(k) submission for a physical medical device (catheter introducer) and involves non-clinical performance and biocompatibility testing, not AI/imaging studies that require expert annotation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used in clinical trials or imaging studies where human interpretation or consensus is required to establish ground truth or assess outcomes. These are not relevant for bench testing of physical device properties.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI-powered diagnostic devices or imaging interpretation aids, which is not the case for the Scorpion Portal Vein Access Set. The device is a surgical access tool, not an AI or imaging product.

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

No, a standalone algorithm performance study was not done. This device does not incorporate an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance and biocompatibility tests, the "ground truth" is established by the defined acceptance criteria within established industry standards (e.g., ISO, ASTM) and internal protocols. For example, a tensile strength test would have a specified minimum breaking strength required by the device's design specifications. Biocompatibility tests have specific endpoints and thresholds defined by ISO 10993 series standards. There is no expert consensus, pathology, or outcomes data used to establish ground truth as these are not clinical or diagnostic studies.

8. The sample size for the training set

This question is not applicable. This device is a physical medical device and does not involve AI algorithms that require a "training set."

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

This question is not applicable for the reasons stated above.

Summary

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Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 15, 2021

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

Re: K202141

Trade/Device Name: Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: December 18, 2020 Received: December 21, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

for

Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202141

Device Name

Scorpion Stylet Portal Vein Access Set and Scorpion Needle Portal Vein Access Set

Indications for Use (Describe)

The Scorpion Portal Vein Access Sets are intended for transjugular liver access in diagnostic and interventional procedures.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared:	December 30, 2020
Company:	Argon Medical Devices, Inc.1445 Flat Creek RoadAthens, Texas 75751 USAFacility Registration number: 1625425
Contact:	Amy Clendening-WheelerRegulatory Affairs ManagerPhone: 469-731-1413Fax: 469-731-1480Email: amy.wheeler@argonmedical.com
Device TradeName:	Scorpion™ Portal Vein Access Set
DeviceCommonName:	Catheter Introducer
DeviceClassification:	Introducer, CatheterProduct code, DYB21 CFR 870.1340Class IIReview Panel: Cardiovascular Devices
PredicateDevice(s):	Primary: K171820 Transjugular Liver Access Sets / Cook Incorporated
Description oftheDevice:	The Scorpion Portal Vein Access Sets have two models. One model has a Stylet as thepuncture tool and the other model has a 17ga Needle as the puncture tool.The Scorpion Stylet Portal Vein Access Set contains a 10F Introducer Sheath, a 10FDilator, a 5F MPA catheter, a 14ga Stiffening Cannula, a 0.040" Nitinol Stylet with a 5FrPEEK Catheter, and a 7F Cannula Sheath. The 14ga stiffening cannula with cannulasheath has a directional handle that indicates the direction of the curve. The 10FIntroducer Sheath hemostatic valve is designed to be compatible with up to 13F(4.3mm/0.171") sleeve. These components are used to create a pathway through theliver parenchyma through which an endoprosthetic can be delivered. The ScorpionStylet Portal Vein Access Set is used to gain access to the hepatic vein and guide a sharppuncture tool (0.040" Stylet) through the parenchyma. The puncture tool (Stylet) is used
Indication forUse:	The Scorpion Portal Vein Access Sets are intended for transjugular liver access indiagnostic and interventional procedures.
TechnologicalCharacteristics:	A comparison of the technological characteristics of the subject device and the predicatedevices shows the Scorpion Portal Vein Access Set to be substantially equivalent to thecurrent marketed predicate devices.
	Equivalence is based upon the product performance, design and intended use. TheScorpion Portal Vein Access Set and the predicate devices have similar materials ofconstruction, dimensional specifications, designs and sterilization process.
PerformanceTests(Non-Clinical):	No performance standards have been established under section 514, performancestandards, 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 criteria that weredetermined to demonstrate substantial equivalence.

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to make a pathway from the hepatic vein to the portal vein, and then the pathway is dilated to provide access for a larger sheath. The shunt is inserted through the sheath and deployed through the pathway. Then, all of the Scorpion Stylet Portal Vein Access Set components are removed.

A Portal Vein Access Set is typically in use in procedures up to 4 hours.

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The following tests were performed under the specified testing parameters to support the Scorpion Portal Vein Access Set substantial equivalence.

Performance Testing, including:

Dimensional and Functional Fit ●
Surface Inspection
Component Compatibility ●
Tensile Strength
Torque Strength Test
Liquid Leakage
Air Leakage
Corrosion Resistance
Simulative Use
Radiopacity
Echogenicity
Luer Connector Functional Testing ●
Burst Pressure
Flow Rate
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 (ISO 10993-4) .
- ASTM Hemolysis Direct and Indirect Contact O
- Complement Activation, SC5b-9 O
- Thrombogenicity O
- Platelet and Leucocyte Counts O
- Partial Thromboplastin Time (PTT) O

Substantial Based on the Indication for Use, design, and safety and performance testing, the Equivalence: Scorpion Portal Vein Access Set meets the requirements for its intended use and is substantially equivalent to the predicate devices.

Substantial Equivalence Table

	SUBJECT DEVICE	PREDICATE DEVICE
	SCORPION	Transjugular Liver Access Sets(Rosch-Uchida and Ring) K171820
Manufacturer	Argon Medical Devices, Inc.	Cook Incorporated
510(k)	K202141	K171820

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Class	II	SAME
Classification Name	Catheter Introducer	SAME
Regulation	21 CFR 870.1340	SAME
Product Code	DYB	SAME
Indication for Use	The Scorpion Portal Vein Access Setis intended for transjugular liveraccess during diagnostic andinterventional procedures.	SAME
Principle of Operation	Access to the jugular vein usingstandard access techniques. TheIntroducer sheath and dilator areinserted over the guidewire,advanced, and positioned in thehepatic vein and the dilator isremoved. The stiffening cannula andcannula sheath, followed by thepuncturing tool and guide catheter,are inserted intothe introducer sheath and thepuncturing tool is used to puncturethe hepatic vein, liver parenchymaand access the portal vein.	SAME(In the case of the Ring set, thepuncturing tool and guide catheterare inserted without use of astiffening cannula and cannulasheath)
Contraindication	None Known	None Known
Single Use	YES	SAME
Device Description	Each Portal Vein Access Set containsa 10F wall-reinforced IntroducerSheath with radiopaque tip, a 10FDilator, a 5F MPA catheter, apuncturing tool that comes in thefollowing variations: 0.040" Styletwith a 5Fr Stylet Catheter (separatedwith a removable spacer clip) and a14ga Stiffening Cannula with a 7FCannula Sheath or 17ga Needle/6.2FrCatheter (separated with aremovable spacer clip) and a 13gaStiffening Cannula with an 8FCannula Sheath. The stiffeningcannulas and the stylet/needlepuncturing tools have curved distal	The Transjugular Liver Access Setsare comprised of variouscomponents that facilitatetransjugular access to the liver forthe purpose of performinginterventional procedures. The setsare grouped into two basic types:the Ring Transjugular IntrahepaticAccess Set and the Rösch- UchidaTransjugular Liver Access Set. Eachset includes core componentscomprised of an introducer sheathand dilator. The Ring TransjugularIntrahepatic Access Set includes a16ga stainless steel needle with 9For 10F guiding catheter. The Rösch-Uchida Transjugular Liver AccessSet includes a 14ga stainless steelstiffening cannula with 10F catheter
	but taper down to a 10F innerdiameter.	these sets are a Check-FloIntroducer Set, selectivecatheters, and wire guides.
Introducer Set
Sheath Materials	Pebax or PTFE Inner LayerStainless Steel CoilPebax Outer Layer	PTFE linerStainless Steel CoilNylon Jacket
Sheath Marker Band	Pebax with 80% Tungsten blackPebax	Platinum/Iridium
Sheath hub material	Polycarbonate (Makrolon)	Nylon
Sheath Inner Diameter(Fr)	10	9 or 10, 10
Sheath Length (cm)	42	38.5, 40
Dilator
Outer diameter (F)	10	9 or 10 (Rosch-Uchida), 10 (Ring)
Material	HDPE w/ Barium Sulfate	Polyethylene
Hub material	HDPE	HDPE
Length (cm)	49	40, 51
Dilator Endhole Size(in)	.041	0.035, 0.038
Catheter (MPA/MPB)
Outer diameter (F)	5	5
Length (cm)	80	80
Endhole size (in.)	.041	0.035
Shaft materials	Nylon, Barium Sulfate, stainless steel	Teflon, Nylon
Tip material	Pebax, Bismute subcarbonate,Titanium dioxide	N/A
Hub material	Polycarbonate	Polycarbonate

Puncturing ToolAssembly	Stylet Set:14ga Stiffening Cannula -Stainlesssteel7F Cannula Sheath - HDPE0.040" x 73 cm Nitinol Styletreinforced with stainless steelhypotube with a 5Fr Stylet PEEKCatheterHDPE Spacer clipORNeedle Set:13ga Stiffening Cannula- Stainlesssteel8F Cannula Sheath - HDPE17ga x 73 cm Stainless Steel /Nitinol composite Needle6.2F x 64 cm PEEK CatheterHDPE Spacer clip	Rosch-Uchida Set (Stylet andcatheter assembly)14ga Stiffening Access Cannula-Stainless Steel10F Teflon Catheter0.038" Stainless Steel NeedleStylet x 62.5cm with 5.2F TeflonCatheterORRing Set (Colapinto Needle andcatheter assembly)16ga Stainless Steel Needle9F or 10F x 45.5 cm Teflon Catheter
Puncturing ToolCatheter, composition	PEEK	Teflon/nylon
Bench Testing
Performance Testing	• 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• Resistance to Fracture Testing	• Radiopacity• Corrosion Resistance• Tensile Strength• Torque Strength Test• Liquid leakage• Air Leakage• Burst Pressure• Flexibility & Fracture• Simulative Use – performance testing including dimensional, surface and compatibility of components
Biological Comparison	• 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 Contacto Complement Activation, SC5b-9o In Vivo Thrombogenicityo Platelet and Leucocyte countso Partial Thromboplastin Time (PTT)	• Cytotoxicity (ISO 10993-5)• Sensitization (ISO 10993-10)• IntracutaneousReactivity/Irritation (ISO 10993-10)• Acute Systemic Toxicity (ISO 10993-11)• Material Mediated Pyrogenicity• Hemocompatibility (ISO10993-4)- Hemolysis Direct/Indirect- Complement Activation (ISO Direct Contact)-In Vivo Thrombogenicity
PackagingConfiguration	PETG Tray in a Tyvek/poly pouch	Individually pouched components
Sterilization	Minimum SAL 10-6EtO	SAME
Intended Shelf Life	3 years	SAME

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K202141

Conclusion: The results of all testing demonstrate that the Scorpion 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).