(24 days)
The Scorpion Portal Vein Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
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.
The provided text describes a 510(k) premarket notification for a medical device called the "SCORPION Portal Vein Access Set." This report is for a device and not an AI/ML product, so many of the requested fields are not applicable.
Here's the information gleaned from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Fit | Met |
| Hemostasis | Met |
| Leak | Met |
| Simulative Use (including component compatibility) | Met |
| Radiopacity (leveraged from predicate) | Met |
| Echogenicity (leveraged from predicate) | Met |
| Corrosion Resistance (leveraged from predicate) | Met |
| Dimensional & Functional Fit (leveraged from predicate) | Met |
| Tensile Strength (leveraged from predicate) | Met |
| Torque Strength Test (leveraged from predicate) | Met |
| Liquid Leakage (leveraged from predicate) | Met |
| Air Leakage (leveraged from predicate) | Met |
| Burst Pressure (leveraged from predicate) | Met |
| Flow Rate (leveraged from predicate) | Met |
| Simulative Use - performance testing including dimensional, surface and compatibility of components (leveraged from predicate) | Met |
| Luer Functional Testing (leveraged from predicate) | Met |
| Shipping Test (leveraged from predicate) | Met |
| Resistance to Fracture Testing (leveraged from predicate) | Met |
| Biocompatibility (leveraged from predicate): Cytotoxicity (ISO 10993-5) | Met |
| Biocompatibility (leveraged from predicate): Sensitization (ISO 10993-10) | Met |
| Biocompatibility (leveraged from predicate): Intracutaneous Irritation (ISO 10993-10) | Met |
| Biocompatibility (leveraged from predicate): Acute Systemic Toxicity (ISO 10993-11) | Met |
| Biocompatibility (leveraged from predicate): Material Mediated Pyrogen (ISO 10993-11) | Met |
| Biocompatibility (leveraged from predicate): Hemocompatibility (ISO10993-4) - ASTM Hemolysis – Direct and Indirect Contact | Met |
| Biocompatibility (leveraged from predicate): Hemocompatibility (ISO10993-4) - Complement Activation, SC5b-9 | Met |
| Biocompatibility (leveraged from predicate): Hemocompatibility (ISO10993-4) - In Vivo Thrombogenicity | Met |
| Biocompatibility (leveraged from predicate): Hemocompatibility (ISO10993-4) - Platelet and Leucocyte counts | Met |
| Biocompatibility (leveraged from predicate): Hemocompatibility (ISO10993-4) - Partial Thromboplastin Time (PTT) | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a distinct "test set" in the context of an AI/ML model. The evaluation is based on non-clinical performance and biocompatibility testing of the physical medical device and its components. No information is provided regarding data provenance as this is not a data-driven AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a medical device submission, not an AI/ML study relying on expert-established ground truth from images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a medical device submission, not an AI/ML study requiring adjudication of expert interpretations.
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 a medical device submission, not an AI/ML assistance 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. Performance is assessed through non-clinical testing of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is established through engineering and biocompatibility standards and specifications. For example, "Hemostasis" acceptance criteria would be based on validated methods to demonstrate the device prevents blood leakage, not expert consensus on images.
8. The sample size for the training set
Not applicable. This is a medical device submission, not an AI/ML product that undergoes a training phase.
9. How the ground truth for the training set was established
Not applicable. This is a medical device submission, not an AI/ML product.
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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, 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
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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 RoadAthens, Texas 75751 USAFacility Registration number: 1625425 |
| Contact: | Scott BishopSenior Manager, Regulatory AffairsPhone: 469-430-0546Fax: 469-731-1480Email: scott.bishop@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: K202141 Scorpion™ Portal Vein Access Set |
| Description ofthe Device: | Each Portal Vein Access Set contains a 5F MPA catheter, a puncturing tool that comes inthe following variations: 0.040" Stylet with a 5Fr Stylet Catheter (separated with aremovable spacer clip) and a 14ga Stiffening Cannula with a 7F Cannula Sheath or 17gaNeedle with a 6.2F Catheter (separated with a removable spacer clip) and a 13gaStiffening Cannula with an 8F Cannula Sheath. The stiffening cannulas and thestylet/needle puncturing tools have curved distal ends, with directional handles thatindicate the direction of the curves, which facilitate access into the hepatic vasculatureand 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 TestingIn 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) |
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| 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. |
|---|---|
| -------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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).