(201 days)
No
The device description focuses on mechanical components and their function in creating a pathway. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies listed are standard tests for medical devices and do not involve AI/ML evaluation metrics.
No.
The device is used to create a pathway for the delivery of an endoprosthetic and is not a therapeutic device itself.
No
The "Intended Use / Indications for Use" states the device is for "transjugular liver access in diagnostic and interventional procedures," but the "Device Description" clarifies its role in creating a pathway for the delivery of an endoprosthetic and gaining access for puncture tools to connect hepatic and portal veins, which are interventional actions rather than diagnostic ones. The device itself does not perform any diagnostic function.
No
The device description clearly outlines multiple physical components (sheath, dilator, catheter, puncturing tools, bending tool, cannula, needle) and performance testing related to these physical components (tensile strength, torque strength, leakage, burst pressure, corrosion resistance, biocompatibility). This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside of the body (in vitro).
- Device Function: The Traveler™ Portal Vein Access Set is a surgical tool used inside the body (in vivo) to create a pathway through the liver for a medical procedure (specifically, placing a shunt). It is not used to analyze samples or provide diagnostic information based on those samples.
- Intended Use: The intended use clearly states "for transjugular liver access in diagnostic and interventional procedures." While it can be used in diagnostic procedures, its function is to provide access for those procedures, not to perform the diagnostic test itself.
- Device Description: The description details the components used for creating a physical pathway within the body, not for analyzing biological samples.
Therefore, based on the provided information, the Traveler™ Portal Vein Access Set is a surgical access device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Traveler™ Portal Vein Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Product codes
DYB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Liver, Hepatic vein, Portal vein
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance standards have been established under section 514, performance standards, of the Food, Drug and Cosmetic Act for these devices. A series of testing was conducted in accordance with protocols based on requirements outlined in guidances and industry standards and the below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence. The following tests were performed under the specified testing parameters to support the Traveler™ Portal Vein Access Set substantial equivalence. Performance Testing, including:
• Dimensional & Functional Fit
• Surface Inspection
• 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)
The results of all testing demonstrate that the Traveler™ Portal Vein Access Set are substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
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
4
| | 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. |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use: | The Traveler™ Portal Vein Access Set is intended for transjugular liver
access in diagnostic and interventional procedures. |
| Technological
Characteristics: | A comparison of the technological characteristics of the subject
device and the predicate devices shows the Traveler™ Portal Vein
Access Set to be substantially equivalent to the current marketed
predicate devices.
Equivalence is based upon the product performance, design and
intended use. The Traveler™ Portal Vein Access Set and the predicate
devices have similar materials of construction, dimensional
specifications, 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 for
these devices. A series of testing was conducted in accordance with
protocols based on requirements outlined in guidances and industry
standards and the below were shown to meet the acceptance criteria
that were determined to demonstrate substantial equivalence.
The following tests were performed under the specified testing
parameters to support the Traveler™ Portal Vein Access Set
substantial equivalence.
Performance Testing, including:
• Dimensional & Functional Fit
• Surface Inspection |
| Substantial
Equivalence: | Based on the Indication for Use, design, and safety and performance
testing, the Traveler TM Portal Vein Access Set meets the requirements
for its intended use and is substantially equivalent to the predicate
devices. |
5
- 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 | PRIMARY
PREDICATE DEVICE | REFERENCE
PREDICATE DEVICE |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Traveler™ Portal Vein
Access Set | Transjugular Liver
Access 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 using
standard access techniques.
The Introducer sheath and
dilator are inserted over the
guidewire, advanced, and
positioned in the hepatic vein
and the dilator is removed. The
puncturing tool and guide
catheter is inserted into
the introducer sheath and the
puncturing tool is used
to puncture the hepatic vein,
liver parenchyma and access
the portal vein. | SAME | SAME |
| Indication for Use | The Portal Vein Access Set is
intended for transjugular liver
access during diagnostic and
interventional procedures. | Intended for transjugular
liver
access in diagnostic and
interventional procedures. | Intended to be used together
for percutaneous
transjugular liver access
during diagnostic and
interventional procedures in
patients undergoing a
Transjugular
Intrahepatic Portosystemic
Shunt (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 Sheath
Introducer 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. | |
| | 10F
42
Pebax or PTFE Inner Layer
Stainelss Steel Coil
Pebax Outer Layer | 9F or 10F
38.5, 40
PTFE liner
Stainless Steel Coil
Nylon Jacket | 10F
40
PTFE Liner
Stainless Steel Coil
Pebax 6333 Jacket
Pt/IR markerband
Grilamid hub
Hemostatis 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 length
7F Peek Catheter - 51cm in length
OR
0.038" Stainless Steel
Stylet - 69 cm in length
5F Peek Catheter - 66 cm in length
OR
21ga Needle - 72 cm in length
5F Peek Catheter - 67 cm in length | 16ga Stainless Steel Needle
- 50.5 cm in length
9F or 10F Teflon Catheter - 45.5 cm in length
OR
0.038" Stainless Steel
Needle
Stylet - 62.5 cm in length
5.2F Teflon Catheter - 62 cm in length
14ga Stainless Steel
Stiffening Access Cannula - 54.5 cm in length
10F Teflon Catheter - 51.8 cm in length | 16ga Stainless Steel Needle
- 56 cm in length
10F MDPE catheter - 49 cm in length |
| Puncturing Tool, composition | 304 Stainless Steel | SAME | SAME |
| Puncturing Tool Catheter, composition | PEEK | Teflon/nylon | MDPE Extrusion
HDPE 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 - performance
testing including
dimensional, surface and
compatibility of components
• Luer Functional Testing
• Shipping Test
• Resistance to Fracture
testing | • Torque Strength Test
• Liquid leakage
• Air Leakage
• Burst Pressure
• Flexibility & Fracture
• Simulative Use –
performance testing
including dimensional,
surface and compatibility
of components | • 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 Contact
o Complement Activation,
SC5b-9
o In Vivo Thrombogenicity
o Platelet and Leucocyte
Counts
o Partial Thromboplastin
Time (PTT) | • Cytotoxicity (ISO 10993-5)
• Sensitization (ISO 10993-
• Intracutaneous
Reactivity/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 | • Cytotoxicity (ISO 10993-5)
• Sensitization (ISO 10993-10)
• Intracutaneous
Reactivity/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 |
| Packaging
Configuration | PETG Tray in a Tyvek/poly
pouch | Individually pouches
components | Tyvek/Polyethylene-polyester
Film |
| Intended Shelf Life | 3 years | 3 years | 1 year |
6
7
8
Conclusion:
The results of all testing demonstrate that the Traveler™ Portal Vein Access Set are substantially equivalent to the predicate device.