The Kodiak™ Dual Port Coaxial Introducer Kit is intended to introduce therapeutic or diagnostic devices into the vasculature. The Kit Model 381416000 contains a coaxial 16F and 14F braided reinforced sheaths with a fluoropolymer coating, an embedded radiopaque marker band, and an over molded hub assembly containing two hemostasis valves and side port with stopcock. It also contains a removable Y-connector with two 7F (ID) ports with hemostasis valves, a 14F dilator, a 16ga blunt flushing needle, and a high-pressure Luer adapter. After percutaneous access is established and a working guidewire is placed, the introducer system is inserted over the guidewire and advanced under imaging. Therapeutic or diagnostic devices are inserted through the system. The Kodiak™ Dual Port Coaxial Introducer Kit is a single use device.

AI/ML Overview

The provided text is a 510(k) Summary for the Kodiak™ Dual Port Coaxial Introducer Kit, which is a medical device for introducing therapeutic or diagnostic devices into the vasculature. The document details the device's characteristics and performance testing to demonstrate substantial equivalence to a predicate device.

It is important to note that this document does not contain information about an AI/ML powered device. Therefore, many of the requested criteria regarding AI/ML studies (like multi-reader multi-case studies, standalone algorithm performance, training set details, ground truth establishment methods for AI) are not applicable.

Below is the information that can be extracted relevant to the performance of the Kodiak™ Dual Port Coaxial Introducer Kit as a non-AI medical device:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Performance Testing	System Leak	Not explicitly stated in the provided text, but implied to be compliance with applicable standards/protocols designed to ensure product safety and clinical function.	"shown to meet the acceptance criteria"
	Tensile Strength	Not explicitly stated	"shown to meet the acceptance criteria"
	Tip Strength	Not explicitly stated	"shown to meet the acceptance criteria"
	Radiopacity	Not explicitly stated, but would likely involve the device being sufficiently visible under fluoroscopy.	"shown to meet the acceptance criteria"
	Kink Testing	Not explicitly stated, but would likely involve maintaining lumen patency and structural integrity when bent to a certain degree.	"shown to meet the acceptance criteria"
	Dimensional	Not explicitly stated, but would refer to conformity to specified measurements (e.g., length, diameter) as detailed in the device description.	"shown to meet the acceptance criteria"
	Functional Fit	Not explicitly stated, but would relate to the proper interaction and assembly of components (e.g., sheath with guidewire, dilator, Y-connector).	"shown to meet the acceptance criteria"
	Simulated Use	Not explicitly stated, but would involve simulating real-world clinical scenarios to ensure the device performs as intended without failure.	"shown to meet the acceptance criteria"
	Luer Testing	Not explicitly stated, but refers to the integrity and leak-proof nature of Luer connections according to ISO standards.	"shown to meet the acceptance criteria"
	Power Injection Testing	Not explicitly stated, but would involve testing the device's ability to withstand pressures from power injection without rupture or leakage.	"shown to meet the acceptance criteria"
	Tip Buckling	Not explicitly stated, but would relate to the resistan ce of the introducer tip to buckle or deform during insertion.	"shown to meet the acceptance criteria"
	Particulate	Not explicitly stated, but would involve testing for the absence of unacceptable levels of particulates that could be introduced into the patient.	"shown to meet the acceptance criteria"
	Packaging Integrity	Not explicitly stated, but would involve ensuring the sterile barrier and physical protection of the device until point of use.	"shown to meet the acceptance criteria"
Biocompatibility Testing	Cytotoxicity (ISO 10993-5)	Not explicitly stated, but would be based on ISO 10993-5 guidelines for cytotoxicity testing.	"shown to meet the acceptance criteria"
	Sensitization (ISO10993-10)	Not explicitly stated, but based on ISO 10993-10 guidelines.	"shown to meet the acceptance criteria"
	Irritation/Intracutaneous Reactivity (ISO10993-23)	Not explicitly stated, but based on ISO 10993-23 guidelines (formerly ISO 10993-10).	"shown to meet the acceptance criteria"
	Acute Systemic Toxicity (ISO10993-11)	Not explicitly stated, but based on ISO 10993-11 guidelines.	"shown to meet the acceptance criteria"
	Pyrogenicity (ISO 10993-11)	Not explicitly stated, but based on ISO 10993-11 guidelines.	"shown to meet the acceptance criteria"
	Hemolysis Direct/Indirect (ISO 10993-4)	Not explicitly stated, but based on ISO 10993-4 guidelines.	"shown to meet the acceptance criteria"
	Thromboresistance (ISO 10993-4)	Not explicitly stated, but based on ISO 10993-4 guidelines, ensuring the device does not promote thrombus formation.	"shown to meet the acceptance criteria"
	Partial Thromboplastin Time (ISO 10993-4)	Not explicitly stated, but based on ISO 10993-4 guidelines, assessing interactions with the coagulation system.	"shown to meet the acceptance criteria"
	Complement Activation (ISO 10993-4)	Not explicitly stated, but based on ISO 10993-4 guidelines, assessing interactions with the complement system.	"shown to meet the acceptance criteria"
	Platelet and Leukocyte Count (ISO 10993-4)	Not explicitly stated, but based on ISO 10993-4 guidelines, assessing effects on blood cellular components.	"shown to meet the acceptance criteria"

The document states, "A series of testing was conducted in accordance with protocols based on requirements outlined in guidance and industry standards and the testing below was shown to meet the acceptance criteria that was determined to demonstrate substantial equivalence."

Study Information (for non-AI device)

Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes (number of units tested) for each individual performance or biocompatibility test. It only states that "a series of testing was conducted." The data provenance is internal testing performed by the device manufacturer, Argon Medical Devices, Inc. The data would be prospective for the purpose of this 510(k) submission, as these are tests specifically conducted for this new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a non-AI medical device. The "ground truth" for its performance is established by objective physical and chemical testing against engineering specifications and international standards, not by expert interpretation of data.
Adjudication method for the test set:
Not applicable for this type of device testing. Results are typically quantitative measurements compared against predefined acceptance limits.
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 non-AI medical device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a non-AI medical device.
The type of ground truth used:
For performance testing, the "ground truth" refers to the objective physical and chemical properties and functional capabilities of the device as measured by standardized test methods against established specifications and international standards (e.g., ISO 10993 for biocompatibility, Luer connector standards, internal engineering specifications).
The sample size for the training set:
Not applicable. This is a non-AI medical device, so there is no "training set."
How the ground truth for the training set was established:
Not applicable. This is a non-AI medical device, so there is no "training set" or corresponding ground truth establishment process in the context of AI/ML.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

May 22, 2023

Argon Medical Devices Pratusha Kudumula Senior Regulatory Affairs Specialist 1445 Flat Creek Road Athens, Texas 75751

Re: K230631

Trade/Device Name: Kodiak™ Dual Port Coaxial Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: March 2, 2023 Received: March 7, 2023

Dear Pratusha Kudumula:

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

{1}------------------------------------------------

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 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 (OS) 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,

Misti E. Malone -S

Misti Malone, PhD 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K230631

Device Name Kodiak™ Dual Port Coaxial Introducer Kit

Indications for Use (Describe)

The Kodiak™ Dual Port Coaxial Introducer Kit is indicated to introduce therapeutic or diagnostic devices into the vasculature.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Date prepared	May 5th, 2023
Name	Argon Medical Devices, Inc.1445 Flat Creek RoadAthens, Texas 75751 USAFacility Registration number:1625425
Contact person	Pratusha KudumulaSr. Regulatory Affairs Specialist309-706-9488
Device Name	Kodiak™ Dual Port Coaxial Introducer Kit
Trade Name	Kodiak™ Dual Port Coaxial Introducer Kit
Common name	Catheter Introducer
Regulation name	Catheter Introducer
Classification number	21 CFR 870. 1340
Primary product code	DYB
Regulatory class	II
Predicate device	Performer Introducer (K171999) Cook, Inc.
Description of theDevice:	The Kodiak™ Dual Port Coaxial Introducer Kit is intended to introducetherapeutic or diagnostic devices into the vasculature. The Kit Model381416000 contains a coaxial 16F and 14F braided reinforced sheaths witha fluoropolymer coating, an embedded radiopaque marker band, and anover molded hub assembly containing two hemostasis valves and sideport with stopcock.It also contains a removable Y-connector with two 7F (ID) ports withhemostasis valves, a 14F dilator, a 16ga blunt flushing needle, and a high-pressure Luer adapter. After percutaneous access is established and aworking guidewire is placed, the introducer system is inserted over theguidewire and advanced under imaging. Therapeutic or diagnostic devicesare inserted through the system. The Kodiak™ Dual Port Coaxial IntroducerKit is a single use device.

510(k) Summary

The Kodiak™ Dual Port Coaxial Introducer Kit is intended to introduce Indication for Use: therapeutic or diagnostic devices into the vasculature.

{4}------------------------------------------------

Technological Characteristics:

A comparison of the technological characteristics of the subject device and the predicate devices shows the Kodiak™ Dual Port Coaxial Introducer Kit to be substantially equivalent to the current marketed predicate devices.

Equivalence is based upon the product performance, design and intended use. The Kodiak™ Dual Port Coaxial Introducer Kit and the predicate devices have similar materials of construction, dimensional specifications, design, and sterilization process.

SUBJECT DEVICE	PRIMARY PREDICATEDEVICE
Kodiak™ Dual Port CoaxialIntroducer Kit	Cook Performer Introducer
Principle of Operation
After percutaneous access isestablished and a workingguidewire is placed, the introducersystem is inserted over theguidewire and advanced underimaging. Therapeutic or diagnosticdevices are inserted through thesystem.	After access is established and aworking guidewire is placed, theintroducer system is inserted overthe guidewire and advancedunder imaging. Therapeutic ordiagnostic devices are insertedthrough the system.
Device Description
The system consists of thefollowing components:• 16F x 45cm outer sheath• 14F x 53cm inner sheath• 14F x 61cm dilator• 7F / 7F Y-connector• 16ga blunt flushing needle• High pressure Luer adapter	Performer® Introducers aredesigned to perform as a• Introducer sheath 6F-18F;13cm – 85cm• 6F - 18F dilators of varyinglengths
Guidewire Compatibility
0.038"	0.035" or 0.038" depending onintroducer size

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 guidance and industry standards and the

{5}------------------------------------------------

testing below was shown to meet the acceptance criteria that was determined to demonstrate substantial equivalence.

The following tests were performed under the specified testing parameters to support the Kodiak™ Dual Port Coaxial Introducer Kit substantial equivalence.

Performance Testing, including:

System Leak ●
. Tensile Strength
Tip Strength ●
Radiopacity ●
Kink Testing .
Dimensional ●
. Functional Fit
Simulated Use ●
Luer Testing .
Power Injection Testing ●
Tip Buckling ●
Particulate ●
Packaging Integrity .

Biocompatibility Testing, including:

. Cytotoxicity (ISO 10993-5)
Sensitization (ISO10993-10) ●
Irritation Intracutaneous Reactivity (ISO10993-23) ●
Acute Systemic Toxicity (ISO10993-11) .
. Pyrogenicity (ISO 10993-11)
. Hemolysis Direct/Indirect (ISO 10993-4)
. Thromboresistance (ISO 10993-4)
Partial thromboplastin time (ISO 10993-4) ●
Complement Activation (ISO 10993-4) ●
Platelet and Leukocyte Count (ISO 10993-4) ●

SubstantialEquivalence:	Based on the Indication for Use, design, and safety and performancetesting, the Kodiak™ Dual Port Coaxial Introducer Kit meets therequirements for its intended use and is substantially equivalent to thepredicate device.
Conclusion:	The results of all testing demonstrate that the Kodiak™ Dual Port CoaxialIntroducer Kit is 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).