(57 days)
Not Found
No
The device description and performance studies focus on physical characteristics and mechanical performance, with no mention of AI/ML or data-driven analysis.
No
The device is described as introducing therapeutic or diagnostic devices, but it is not itself a therapeutic device. It is a sheath and dilator set.
No
Explanation: The device is indicated for the introduction of therapeutic devices and is described as being for introducing therapeutic or diagnostic devices. However, the device itself is a sheath and dilator set, which acts as a conduit for other devices rather than performing diagnostic analysis or measurement on its own. Its primary function is to facilitate access, not to diagnose.
No
The device description explicitly details physical components (sheath, dilator, radiopaque marker band, hemostasis valve, side port, stopcock) and performance studies related to physical properties (radiopacity, dimensional, leakage, kink, tensile, luer testing, shipping qualification), indicating it is a hardware 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 the "introduction of therapeutic devices into the vasculature". This describes a device used in vivo (within the body) for delivering other medical devices.
- Device Description: The description details a physical sheath and dilator designed to facilitate access to blood vessels. It does not mention any components or functions related to analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is purely mechanical and procedural for accessing the vasculature.
N/A
Intended Use / Indications for Use
The 10F Sheath and Dilator Set is indicated for introduction of therapeutic devices into the vasculature, excluding coronary and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The 10F Sheath and Dilator Set is designed for single use and intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
The 10F Sheath and Dilator Set consists of a 10F reinforced Introducer Sheath and a matching 10F radiopaque Dilator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature, excluding coronary and neuro 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)
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 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 10F Sheath and Dilator Set substantial equivalence:
Radiopacity Visual Dimensional Simulative Use Leakage (Sheath and Dilator) Kink Test (System) Tensile (Sheath and Dilator) Luer testing Shipping Qualification
Biocompatibility is established for the 10F Sheath and Dilator Set according to ISO 10993-1:2020 as an external communicating, circulating blood with limited duration
§ 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, 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.
December 8, 2023
Argon Medical Devices, Inc. Ana Jimenez-Hughes Sr. Regulatory Affairs Specialist 1445 Flat Creek Road Athens, Texas 75751
Re: K233432
Trade/Device Name: 10F Sheath and Dilator Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 12, 2023 Received: October 12, 2023
Dear Ana Jimenez-Hughes:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 L. Malone -S
Misti Malone, Ph.D. Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality
2
Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233432
Device Name 10F Sheath and Dilator Set
Indications for Use (Describe)
The 10F Sheath and Dilator Set is indicated for introduction of therapeutic devices into the vasculature, excluding coronary and neuro vasculature.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
| Date Prepared: | October 10, 2023 |
|---|---|
| Company: | Argon Medical Devices, Inc. |
| 1445 Flat Creek Road | |
| Athens, Texas 75751 USA | |
| Facility Registration number: 1625425 | |
| Contact: | Ana Jimenez-Hughes |
| Sr. Regulatory Affairs Specialist | |
| Phone: 903-676-4276 | |
| Fax: 903-677-9396 | |
| Email: ana.hughes@argonmedical.com | |
| Device Trade Name: | 10F Sheath and Dilator Set |
| Device Common Name: | Introducer Sheath |
| Device Classification | |
| Name: | Introducer, Catheter |
| Class II | |
| Product code DYB | |
| 21 CFR 870.1340 | |
| Review Panel: Cardiovascular Devices | |
| Predicate Device(s): | Primary: K142829 Flexor® Check-Flo® Introducer Set |
| Description of the | |
| Device: | The 10F Sheath and Dilator Set is designed for single use and intended |
| to introduce therapeutic or diagnostic devices into the vasculature, | |
| excluding coronary and neuro vasculature. |
The 10F Sheath and Dilator Set consists of a 10F reinforced Introducer
Sheath and a matching 10F radiopaque Dilator. |
| Indication for Use: | The 10F Sheath and Dilator Set is indicated for introduction of therapeutic or
diagnostic devices into the vasculature, excluding coronary and neuro
vasculature. |
| Technological
Characteristics: | A comparison of the technological characteristics of the subject device and
the predicate devices shows the 10F Sheath and Dilator Set to be
substantially equivalent to the current marketed predicate device.
Equivalence is established on in vitro performance testing, and similarities in
indications for use, materials, technological characteristics, principle of
operation, design features and sterilization process. |
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Argon 10F Sheath and Dilator Set | Flexor® Check-Flo® Introducer Set | ||
| Manufacturer | Argon Medical Devices, Inc. | Cook Inc. | |
| FDA Clearance | TBD | K142829 | |
| Class | II | II | |
| Subject Device | Predicate Device | ||
| Argon 10F Sheath and Dilator Set | Flexor® Check-Flo® Introducer Set | ||
| Device Classification | |||
| Name | Introducer, Catheter | Introducer, Catheter | |
| Regulation | 21 CFR 870.1340 | 21 CFR 870.1340 | |
| Product Code | DYB | DYB | |
| Intended Use | Vascular access | Vascular access | |
| Principle of Operation | The 10F Sheath & Dilator Set is used to gain | ||
| vascular access using the Seldinger | |||
| technique within any vascular appropriate | |||
| for a 10F sheath. It is used to introduce | |||
| other therapeutic or diagnostic devices into | |||
| the patient while hemostasis is maintained | |||
| by the sheath. | SAME | ||
| Indication for Use | The 10F Sheath and Dilator Set is indicated | ||
| for introduction of therapeutic or diagnostic | |||
| devices into the vasculature, excluding | |||
| coronary and neuro vasculature. | Flexor Introducers and Guiding Sheaths | ||
| are intended to introduce therapeutic or | |||
| diagnostic devices into the vasculature, | |||
| excluding coronary and neuro vasculature | |||
| Contraindication | None known | None known | |
| Single Use | Yes | SAME | |
| Supplied Sterile | Yes | SAME | |
| Device Description | The 10F Introducer sheath is a coil | ||
| reinforced sheath with a Platinum Iridium | |||
| radiopaque marker band. The sheath has a | |||
| hemostasis valve and a side port with | |||
| stopcock. | |||
| The 10F dilator is made of radiopaque, non- | |||
| reinforced material with an atraumatic tip to | |||
| minimize blood loss. The device does not | |||
| include any coating. | Flexor Introducers and Guiding Sheaths | ||
| incorporate a Flexor shaft with a | |||
| hemostasis valve and are provided with | |||
| one or more dilators. These devices are | |||
| available in various sizes, lengths and | |||
| configurations. Configurations include | |||
| differences in shaft construction, such as | |||
| varying shaft stiffness and distal tip | |||
| material and shape, dilator material, | |||
| hydrophilic coating and/or distal | |||
| radiopaque markers. | |||
| *Flexor® Check-Flo® Introducer sheath is | |||
| a coil reinforced sheath, incorporates a | |||
| hemostasis valve and a side port tubing | |||
| with stopcock. | |||
| Introducer Sheath | |||
| Sheath Inner Diameter (F) | 10.3F | 10F | |
| Sheath Outer Diameter | |||
| (in) | 0.158 | 0.157 | |
| Sheath Length (cm) | 41.5 | 40 | |
| RO Marker | Platinum/Iridium | Platinum/Iridium | |
| Materials | PTFE, Stainless Steel 304V, Nylon | PTFE, Stainless Steel 304V, Nylon | |
| Dilator | |||
| Outer Diameter (F) | 10F | 10F | |
| Length (cm) | 48.8 | 51.9 | |
| Material | Polyethylene, Barium Sulfate | Polyethylene (Radiopaque) | |
| Subject Device | Predicate Device | ||
| Argon 10F Sheath and Dilator Set | Flexor® Check-Flo® Introducer Set | ||
| Dilator Tip Diameter Size | |||
| (in) | Tip ID: Ø .041 | ||
| Tip OD: Ø.068 | Tip ID: Ø .041 | ||
| Tip OD: Ø .062 | |||
| Non-Clinical Data | |||
| (Bench-top Testing): | 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 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 10F Sheath and Dilator Set substantial equivalence: | |||
| Radiopacity Visual Dimensional Simulative Use Leakage (Sheath and Dilator) Kink Test (System) Tensile (Sheath and Dilator) Luer testing Shipping Qualification | |||
| Non-Clinical Data | |||
| Biocompatibility | Biocompatibility is established for the 10F Sheath and Dilator Set according to ISO 10993-1:2020 as an external communicating, circulating blood with limited duration |