(24 days)
No
The device description and performance studies focus on mechanical components and material properties, with no mention of AI or ML.
No.
This device is for "transjugular liver access in diagnostic and interventional procedures," not primarily for treating a disease or condition. It facilitates access for other procedures.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "transjugular liver access in diagnostic and interventional procedures." The inclusion of "diagnostic" indicates that the device has a diagnostic function.
No
The device description clearly outlines physical components such as catheters, puncturing tools, stylets, needles, cannulas, and sheaths. The performance studies also detail testing related to physical properties and biocompatibility, indicating a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "transjugular liver access in diagnostic and interventional procedures." This describes a surgical or interventional procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device components (catheters, puncturing tools, cannulas, sheaths) are all instruments used to access and navigate within the body. They are not reagents, kits, or instruments designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool for accessing an anatomical site within the body for procedures.
N/A
Intended Use / Indications for Use
The Scorpion Portal Vein Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Product codes
DYB
Device Description
Each Portal Vein Access Set contains a 5F MPA catheter, a puncturing tool that comes in the following variations: 0.040" Stylet with a 5Fr Stylet Catheter (separated with a removable spacer clip) and a 14ga Stiffening Cannula with a 7F Cannula Sheath or 17ga Needle with a 6.2F Catheter (separated with a removable spacer clip) and a 13ga Stiffening Cannula with an 8F Cannula Sheath. The stiffening cannulas and the stylet/needle puncturing tools have curved distal ends, with directional handles that indicate the direction of the curves, which facilitate access into the hepatic vasculature and the creation of a pathway into the portal vein.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
transjugular liver access, hepatic vasculature, 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)
Non-Clinical Testing:
In accordance with the Design Failure Modes and Effects Analysis, verification testing was identified to support the substantial equivalence of the modified Scorpion Portal Vein Access Set. The tests included:
Functional Fit
Hemostasis Leak
Simulative Use (including component compatibility)
The following testing was leveraged from K202141:
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
Biocompatibility
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)
ASTM Hemolysis – Direct and Indirect Contact
Complement Activation, SC5b-9
In Vivo Thrombogenicity
Platelet and Leucocyte counts
Partial Thromboplastin Time (PTT)
Test results demonstrate that all acceptance criteria were met; therefore, the device meets the established product specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
October 14, 2021
Argon Medical Devices, Inc. Scott Bishop Senior Regulatory Affairs Specialist 1445 Flat Creek Road Athens. Texas 75751
Re: K213002
Trade/Device Name: SCORPION Portal Vein Access Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 17, 2021 Received: September 20, 2021
Dear Scott Bishop:
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 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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or
1
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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/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) K213002
Device Name Scorpion® Portal Vein Access Set
Indications for Use (Describe)
The Scorpion Portal Vein Access Set is 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: | September 16, 2021 |
|---|---|
| Company: | Argon Medical Devices, Inc. |
| 1445 Flat Creek Road | |
| Athens, Texas 75751 USA | |
| Facility Registration number: 1625425 | |
| Contact: | Scott Bishop |
| Senior Manager, Regulatory Affairs | |
| Phone: 469-430-0546 | |
| Fax: 469-731-1480 | |
| Email: scott.bishop@argonmedical.com | |
| Device Trade | |
| Name: | Scorpion® Portal Vein Access Set |
| Device | |
| Common | |
| Name: | Catheter Introducer |
| Device | |
| Classification: | Introducer, Catheter |
| Product code, DYB | |
| 21 CFR 870.1340 | |
| Class II | |
| Review Panel: Cardiovascular Devices | |
| Predicate | |
| Device(s): | Primary: K202141 Scorpion™ Portal Vein Access Set |
| Description of | |
| the Device: | Each Portal Vein Access Set contains a 5F MPA catheter, a puncturing tool that comes in |
| the following variations: 0.040" Stylet with a 5Fr Stylet Catheter (separated with a | |
| removable spacer clip) and a 14ga Stiffening Cannula with a 7F Cannula Sheath or 17ga | |
| Needle with a 6.2F Catheter (separated with a removable spacer clip) and a 13ga | |
| Stiffening Cannula with an 8F Cannula Sheath. The stiffening cannulas and the | |
| stylet/needle puncturing tools have curved distal ends, with directional handles that | |
| indicate the direction of the curves, which facilitate access into the hepatic vasculature | |
| and the creation of a pathway into the portal vein. | |
| Indication for Use: | The Scorpion Portal Vein Access Set is intended for transjugular liver access in diagnostic and interventional procedures. |
| Device Modification: | The device modification included in this submission is limited to the removal of the following components from the SCORPION® Stylet Portal Vein Access Set and SCORPION® Needle Portal Vein Access Set: 10F Introducer sheath 10F Dilator |
| Substantial Equivalence: | There is no change of intended use or fundamental scientific technology between the proposed modified and predicate device. The proposed modified device has the same indication for use as the predicate, K202141. |
| Non-Clinical Testing | |
| In accordance with the Design Failure Modes and Effects Analysis, verification testing was identified to support the substantial equivalence of the modified Scorpion Portal Vein Access Set. The tests included: Functional Fit Hemostasis Leak Simulative Use (including component compatibility) The following testing was leveraged from K202141: 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 Biocompatibility Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) |
4
5
| Intracutaneous Irritation (ISO 10993-10)Acute Systemic Toxicity (ISO 10993-11)Material Mediated Pyrogen (ISO 10993-11)Hemocompatibility (ISO10993-4) ASTM Hemolysis – Direct and Indirect ContactComplement Activation, SC5b-9In Vivo ThrombogenicityPlatelet and Leucocyte countsPartial Thromboplastin Time (PTT) | |
|---|---|
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Animal testing was not required for the determination of substantial equivalence.
Clinical testing was not required for the determination of substantial equivalence.
Test results demonstrate that all acceptance criteria were met; therefore, the device meets the established product specifications.
| Conclusion: | The proposed device modifications to the Scorpion Portal Vein Access Set do not change its intended use or principles of operation. Based on the Indication for Use, design, and safety and performance testing, the Scorpion Portal Vein Access Set meets the requirements for its intended use and is substantially equivalent to the predicate device. |
|---|---|
| -------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |