(76 days)
Not Found
No
The device description and performance studies focus on the physical and functional characteristics of a medical introducer kit, with no mention of AI or ML capabilities.
No
The device is an introducer kit designed to facilitate the insertion of other therapeutic or diagnostic devices into the vasculature, rather than being a therapeutic device itself.
No
Explanation: The device is an introducer kit designed to facilitate the insertion of other therapeutic or diagnostic devices into the vasculature. It does not perform diagnostic functions itself.
No
The device description clearly outlines physical components like sheaths, hubs, valves, dilators, and needles, and the performance studies focus on physical properties and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "introduce therapeutic or diagnostic devices into the vasculature." This describes a device used in vivo (within the body) to facilitate other procedures, not a device used in vitro (outside the body) to test samples like blood or tissue.
- Device Description: The description details a system of sheaths, dilators, and connectors designed for insertion into blood vessels. This aligns with an in vivo application.
- Anatomical Site: The anatomical site is "vasculature," which is within the body.
- Performance Studies: The performance studies listed (System Leak, Tensile Strength, Tip Strength, etc.) are typical for devices intended for insertion into the body and interacting with the circulatory system. Biocompatibility testing is also crucial for in vivo devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on testing samples in vitro.
Therefore, the Kodiak™ Dual Port Coaxial Introducer Kit is a medical device used in vivo for procedural access, not an IVD.
N/A
Intended Use / Indications for Use
The Kodiak™ Dual Port Coaxial Introducer Kit is indicated to introduce therapeutic or diagnostic devices into the vasculature.
Product codes
DYB
Device Description
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.
The system consists of the following 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
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)
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 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)
Key Results: The results of all testing demonstrate that the Kodiak™ Dual Port Coaxial Introducer Kit is substantially equivalent to the predicate device.
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 & 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)
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)
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3
| Date prepared | May 5th, 2023 |
|---|---|
| Name | Argon Medical Devices, Inc. |
| 1445 Flat Creek Road | |
| Athens, Texas 75751 USA | |
| Facility Registration number:1625425 | |
| Contact person | Pratusha Kudumula |
| Sr. Regulatory Affairs Specialist | |
| 309-706-9488 | |
| 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 the | |
| Device: | 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. |
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 PREDICATE
DEVICE |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Kodiak™ Dual Port Coaxial
Introducer Kit | Cook Performer Introducer |
| Principle of Operation | |
| 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. | After 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. |
| Device Description | |
| The system consists of the
following 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 are
designed to perform as a
• Introducer sheath 6F-18F;
13cm – 85cm
• 6F - 18F dilators of varying
lengths |
| Guidewire Compatibility | |
| 0.038" | 0.035" or 0.038" depending on
introducer 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) ●
| Substantial
Equivalence: | Based on the Indication for Use, design, and safety and performance
testing, the Kodiak™ Dual Port Coaxial Introducer Kit meets the
requirements for its intended use and is substantially equivalent to the
predicate device. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The results of all testing demonstrate that the Kodiak™ Dual Port Coaxial
Introducer Kit is substantially equivalent to the predicate device. |