Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set

K202141 · Argon Medical Devices, Inc. · DYB · Jan 15, 2021 · Cardiovascular

Device Facts

• Record ID: K202141
• Device Name: Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
• Applicant: Argon Medical Devices, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jan 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Scorpion Portal Vein Access Sets facilitate transjugular liver access; used in diagnostic and interventional procedures. System includes 10F introducer sheath, dilator, MPA catheter, stiffening cannula, and puncture tool (either 0.040" Nitinol stylet or 17ga Nitinol needle). Physician inserts introducer sheath into hepatic vein; advances stiffening cannula and puncture tool to create pathway through liver parenchyma to portal vein. Pathway dilated to allow larger sheath insertion for endoprosthetic delivery. Components removed post-procedure. Used in clinical settings; procedure duration up to 4 hours. Benefits include providing controlled access for shunt placement.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included dimensional/functional fit, tensile/torque strength, leakage, burst pressure, flow rate, radiopacity, echogenicity, and resistance to fracture. Biocompatibility testing performed per ISO 10993 standards (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility).

Technological Characteristics

Components include 10F introducer sheath (Pebax/PTFE/Stainless steel coil), 10F dilator (HDPE), 5F MPA catheter (Nylon/Barium Sulfate/Stainless steel), and puncture tools (Nitinol/Stainless steel). PEEK used for catheters. Sterilization via EtO (SAL 10^-6). Manual operation; no software or energy source.

Indications for Use

Indicated for transjugular liver access in diagnostic and interventional procedures for patients requiring such access.

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

• Transjugular Liver Access Sets / Cook Incorporated (K171820)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<br>1445 Flat Creek Road<br>Athens, Texas 75751 USA<br>Facility Registration number: 1625425 |
| Contact: | Amy Clendening-Wheeler<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Trade<br>Name: | Scorpion™ Portal Vein Access Set |
| Device<br>Common<br>Name: | Catheter Introducer |
| Device<br>Classification: | Introducer, Catheter<br>Product code, DYB<br>21 CFR 870.1340<br>Class II<br>Review Panel: Cardiovascular Devices |
| Predicate<br>Device(s): | Primary: K171820 Transjugular Liver Access Sets / Cook Incorporated |
| Description of<br>the<br>Device: | The Scorpion Portal Vein Access Sets have two models. One model has a Stylet as the<br>puncture tool and the other model has a 17ga Needle as the puncture tool.<br>The Scorpion Stylet Portal Vein Access Set contains a 10F Introducer Sheath, a 10F<br>Dilator, a 5F MPA catheter, a 14ga Stiffening Cannula, a 0.040" Nitinol Stylet with a 5Fr<br>PEEK Catheter, and a 7F Cannula Sheath. The 14ga stiffening cannula with cannula<br>sheath has a directional handle that indicates the direction of the curve. The 10F<br>Introducer Sheath hemostatic valve is designed to be compatible with up to 13F<br>(4.3mm/0.171") sleeve. These components are used to create a pathway through the<br>liver parenchyma through which an endoprosthetic can be delivered. The Scorpion<br>Stylet Portal Vein Access Set is used to gain access to the hepatic vein and guide a sharp<br>puncture tool (0.040" Stylet) through the parenchyma. The puncture tool (Stylet) is used |
| Indication for<br>Use: | The Scorpion Portal Vein Access Sets are intended for transjugular liver access in<br>diagnostic and interventional procedures. |
| Technological<br>Characteristics: | A comparison of the technological characteristics of the subject device and the predicate<br>devices shows the Scorpion Portal Vein Access Set to be substantially equivalent to the<br>current marketed predicate devices. |
| | Equivalence is based upon the product performance, design and intended use. The<br>Scorpion Portal Vein Access Set and the predicate devices have similar materials of<br>construction, dimensional specifications, designs and sterilization process. |
| Performance<br>Tests<br>(Non-Clinical): | No performance standards have been established under section 514, performance<br>standards, of the Food, Drug and Cosmetic Act for<br>these devices. A series of testing was conducted in accordance with<br>protocols based on requirements outlined in guidances and industry<br>standards and the below were shown to meet the acceptance criteria that were<br>determined 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.

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.

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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<br>(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 Set<br>is intended for transjugular liver<br>access during diagnostic and<br>interventional procedures. | SAME |
| Principle of Operation | Access to the jugular vein using<br>standard access techniques. The<br>Introducer sheath and dilator are<br>inserted over the guidewire,<br>advanced, and positioned in the<br>hepatic vein and the dilator is<br>removed. The stiffening cannula and<br>cannula sheath, followed by the<br>puncturing tool and guide catheter,<br>are inserted into<br>the introducer sheath and the<br>puncturing tool is used to puncture<br>the hepatic vein, liver parenchyma<br>and access the portal vein. | SAME<br>(In the case of the Ring set, the<br>puncturing tool and guide catheter<br>are inserted without use of a<br>stiffening cannula and cannula<br>sheath) |
| Contraindication | None Known | None Known |
| Single Use | YES | SAME |
| Device Description | Each Portal Vein Access Set contains<br>a 10F wall-reinforced Introducer<br>Sheath with radiopaque tip, a 10F<br>Dilator, a 5F MPA catheter, a<br>puncturing tool that comes in the<br>following variations: 0.040" Stylet<br>with a 5Fr Stylet Catheter (separated<br>with a removable spacer clip) and a<br>14ga Stiffening Cannula with a 7F<br>Cannula Sheath or 17ga Needle/6.2Fr<br>Catheter (separated with a<br>removable spacer clip) and a 13ga<br>Stiffening Cannula with an 8F<br>Cannula Sheath. The stiffening<br>cannulas and the stylet/needle<br>puncturing tools have curved distal | The Transjugular Liver Access Sets<br>are comprised of various<br>components that facilitate<br>transjugular access to the liver for<br>the purpose of performing<br>interventional procedures. The sets<br>are grouped into two basic types:<br>the Ring Transjugular Intrahepatic<br>Access Set and the Rösch- Uchida<br>Transjugular Liver Access Set. Each<br>set includes core components<br>comprised of an introducer sheath<br>and dilator. The Ring Transjugular<br>Intrahepatic Access Set includes a<br>16ga stainless steel needle with 9F<br>or 10F guiding catheter. The Rösch-<br>Uchida Transjugular Liver Access<br>Set includes a 14ga stainless steel<br>stiffening cannula with 10F catheter |
| | but taper down to a 10F inner<br>diameter. | these sets are a Check-Flo<br>Introducer Set, selective<br>catheters, and wire guides. |
| Introducer Set | | |
| Sheath Materials | Pebax or PTFE Inner Layer<br>Stainless Steel Coil<br>Pebax Outer Layer | PTFE liner<br>Stainless Steel Coil<br>Nylon Jacket |
| Sheath Marker Band | Pebax with 80% Tungsten black<br>Pebax | Platinum/Iridium |
| Sheath hub material | Polycarbonate (Makrolon) | Nylon |
| Sheath Inner Diameter<br>(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<br>(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,<br>Titanium dioxide | N/A |
| Hub material | Polycarbonate | Polycarbonate |
| | | |
| Puncturing Tool<br>Assembly | Stylet Set:<br>14ga Stiffening Cannula -Stainless<br>steel<br>7F Cannula Sheath - HDPE<br>0.040" x 73 cm Nitinol Stylet<br>reinforced with stainless steel<br>hypotube with a 5Fr Stylet PEEK<br>Catheter<br>HDPE Spacer clip<br>OR<br>Needle Set:<br>13ga Stiffening Cannula- Stainless<br>steel<br>8F Cannula Sheath - HDPE<br>17ga x 73 cm Stainless Steel /<br>Nitinol composite Needle<br>6.2F x 64 cm PEEK Catheter<br>HDPE Spacer clip | Rosch-Uchida Set (Stylet and<br>catheter assembly)<br>14ga Stiffening Access Cannula-<br>Stainless Steel<br>10F Teflon Catheter<br>0.038" Stainless Steel Needle<br>Stylet x 62.5cm with 5.2F Teflon<br>Catheter<br>OR<br>Ring Set (Colapinto Needle and<br>catheter assembly)<br>16ga Stainless Steel Needle<br>9F or 10F x 45.5 cm Teflon Catheter |
| Puncturing Tool<br>Catheter, composition | PEEK | Teflon/nylon |
| Bench Testing | | |
| Performance Testing | • Radiopacity<br>• Echogenicity<br>• Corrosion Resistance<br>• Dimensional & Functional Fit<br>• Tensile Strength<br>• Torque Strength Test<br>• Liquid Leakage<br>• Air Leakage<br>• Burst Pressure<br>• Flow Rate<br>• Simulative Use - performance testing including dimensional, surface and compatibility of components<br>• Luer Functional Testing<br>• Shipping Test<br>• Resistance to Fracture Testing | • Radiopacity<br>• Corrosion Resistance<br>• Tensile Strength<br>• Torque Strength Test<br>• Liquid leakage<br>• Air Leakage<br>• Burst Pressure<br>• Flexibility & Fracture<br>• Simulative Use – performance testing including dimensional, surface and compatibility of components |
| Biological Comparison | • Cytotoxicity (ISO 10993-5)<br>• Sensitization (ISO 10993-10)<br>• Intracutaneous Irritation (ISO 10993-10)<br>• Acute Systemic Toxicity (ISO 10993-11)<br>• Material Mediated Pyrogen (ISO 10993-11)<br>• Hemocompatibility (ISO10993-4)<br>o ASTM Hemolysis – Direct and Indirect Contact<br>o Complement Activation, SC5b-9<br>o <i>In Vivo</i> Thrombogenicity<br>o Platelet and Leucocyte counts<br>o Partial Thromboplastin Time (PTT) | • Cytotoxicity (ISO 10993-5)<br>• Sensitization (ISO 10993-10)<br>• Intracutaneous<br>Reactivity/Irritation (ISO 10993-10)<br>• Acute Systemic Toxicity (ISO 10993-11)<br>• Material Mediated Pyrogenicity<br>• Hemocompatibility (ISO10993-4)<br>- Hemolysis Direct/Indirect<br>- Complement Activation (ISO Direct Contact)<br>-In Vivo Thrombogenicity |
| Packaging<br>Configuration | PETG Tray in a Tyvek/poly pouch | Individually pouched components |
| Sterilization | Minimum SAL 10-6<br>EtO | 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.