(57 days)
The 10F Sheath and Dilator Set is indicated for introduction of therapeutic devices into the vasculature, excluding coronary and neuro vasculature.
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.
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.
The provided document describes a 510(k) premarket notification for the "10F Sheath and Dilator Set" and establishes its substantial equivalence to a predicate device based on in vitro performance testing and technological characteristics. It does not include information about an AI-powered device or a study proving that an AI device meets acceptance criteria. Thus, I cannot populate the requested table or answer the questions related to AI device performance.
However, I can extract the acceptance criteria and the study performed for the 10F Sheath and Dilator Set (a non-AI medical device).
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Radiopacity | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Visual | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Dimensional | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Simulative Use | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Leakage (Sheath and Dilator) | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Kink Test (System) | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Tensile (Sheath and Dilator) | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Luer testing | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Shipping Qualification | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Biocompatibility | According to ISO 10993-1:2020 for an external communicating, circulating blood device with limited duration <24hrs. | |
| - Cytotoxicity | (Implicit standard per ISO 10993-5) | Performed following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Sensitization | (Implicit standard per ISO 10993-10) | Performed following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Irritation or Intracutaneous Reactivity | (Implicit standard per ISO 10993-23) | Performed following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Material Mediated Pyrogenicity | (Implicit standard per ISO 10993-11) | Performed following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Acute Systemic Toxicity | (Implicit standard per ISO 10993-11) | Performed following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Hemocompatibility (In-vitro Blood Loop Assay) | (Implicit standard per ISO 10993-4) | Performed with comparison article following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Hemocompatibility (Complement Activation Assay, SC5b-9 Method) | (Implicit standard per ISO 10993-4) | Performed with comparison article following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Hemocompatibility (Heparinized Platelet and Leukocyte Count Assay) | (Implicit standard per ISO 10993-4) | Performed with comparison article following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Hemocompatibility (Partial Thromboplastin Time (PTT) Assay) | (Implicit standard per ISO 10993-4) | Performed with comparison article following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Hemocompatibility (ASTM Hemolysis Assay, Direct and Extract Methods) | (Implicit standard per ISO 10993-4) | Performed following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
Study Information for 10F Sheath and Dilator Set:
Since this document pertains to a traditional medical device (sheath and dilator set) and not an AI/software device, the following points regarding AI studies are not applicable.
- Sample size used for the test set and the data provenance: Not applicable to this type of device. The tests mentioned are bench-top (in vitro) and biocompatibility tests on device components. No "test set" in the context of diagnostic performance, images, or patient data is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic purposes is not involved.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the device's performance is established by meeting predefined engineering specifications, industry standards (e.g., ISO 10993), and regulatory requirements for physical and biological properties.
- The sample size for the training set: Not applicable. This device does not have a "training set" in the context of machine learning.
- How the ground truth for the training set was established: Not applicable.
Summary of the study conducted for the 10F Sheath and Dilator Set:
The study involved a series of non-clinical (bench-top) performance tests and biocompatibility tests. The non-clinical tests included:
- Radiopacity
- Visual inspection
- Dimensional analysis
- Simulative Use
- Leakage (Sheath and Dilator)
- Kink Test (System)
- Tensile (Sheath and Dilator)
- Luer testing
- Shipping Qualification
The biocompatibility testing was conducted according to ISO 10993-1:2020 for an external communicating, circulating blood device with limited duration (<24 hours). These tests included Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Material Mediated Pyrogenicity, Acute Systemic Toxicity, and Hemocompatibility assays (In-vitro Blood Loop, Complement Activation, Heparinized Platelet and Leukocyte Count, Partial Thromboplastin Time (PTT), and ASTM Hemolysis). All biocompatibility studies were performed under Good Laboratory Practices (GLP) in compliance with FDA GLP, 21 CFR Part 58.
The results of these tests demonstrated that the Argon Medical Devices, Inc. 10F Sheath and Dilator Set met the acceptance criteria and was substantially equivalent to the predicate device (Flexor® Check-Flo® Introducer Set) in terms of safety and performance for its intended use.
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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"
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(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
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Center for Devices and Radiological Health
Enclosure
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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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| Date Prepared: | October 10, 2023 |
|---|---|
| Company: | Argon Medical Devices, Inc.1445 Flat Creek RoadAthens, Texas 75751 USAFacility Registration number: 1625425 |
| Contact: | Ana Jimenez-HughesSr. Regulatory Affairs SpecialistPhone: 903-676-4276Fax: 903-677-9396Email: ana.hughes@argonmedical.com |
| Device Trade Name: | 10F Sheath and Dilator Set |
| Device Common Name: | Introducer Sheath |
| Device ClassificationName: | Introducer, CatheterClass IIProduct code DYB21 CFR 870.1340Review Panel: Cardiovascular Devices |
| Predicate Device(s): | Primary: K142829 Flexor® Check-Flo® Introducer Set |
| Description of theDevice: | The 10F Sheath and Dilator Set is designed for single use and intendedto introduce therapeutic or diagnostic devices into the vasculature,excluding coronary and neuro vasculature.The 10F Sheath and Dilator Set consists of a 10F reinforced IntroducerSheath and a matching 10F radiopaque Dilator. |
| Indication for Use: | The 10F Sheath and Dilator Set is indicated for introduction of therapeutic ordiagnostic devices into the vasculature, excluding coronary and neurovasculature. |
| TechnologicalCharacteristics: | A comparison of the technological characteristics of the subject device andthe predicate devices shows the 10F Sheath and Dilator Set to besubstantially equivalent to the current marketed predicate device.Equivalence is established on in vitro performance testing, and similarities inindications for use, materials, technological characteristics, principle ofoperation, 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 ClassificationName | 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 gainvascular access using the Seldingertechnique within any vascular appropriatefor a 10F sheath. It is used to introduceother therapeutic or diagnostic devices intothe patient while hemostasis is maintainedby the sheath. | SAME | |
| Indication for Use | The 10F Sheath and Dilator Set is indicatedfor introduction of therapeutic or diagnosticdevices into the vasculature, excludingcoronary and neuro vasculature. | Flexor Introducers and Guiding Sheathsare intended to introduce therapeutic ordiagnostic 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 coilreinforced sheath with a Platinum Iridiumradiopaque marker band. The sheath has ahemostasis valve and a side port withstopcock.The 10F dilator is made of radiopaque, non-reinforced material with an atraumatic tip tominimize blood loss. The device does notinclude any coating. | Flexor Introducers and Guiding Sheathsincorporate a Flexor shaft with ahemostasis valve and are provided withone or more dilators. These devices areavailable in various sizes, lengths andconfigurations. Configurations includedifferences in shaft construction, such asvarying shaft stiffness and distal tipmaterial and shape, dilator material,hydrophilic coating and/or distalradiopaque markers.*Flexor® Check-Flo® Introducer sheath isa coil reinforced sheath, incorporates ahemostasis valve and a side port tubingwith 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 .041Tip OD: Ø.068 | Tip ID: Ø .041Tip 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 DataBiocompatibility | 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 <24hrs.All studies were performed following the approved protocol under Good Laboratory Practices (GLP) in compliance to FDA GLP, 21 CFR Part 58.Biocompatibility Testing included:ISO 10993-5 Cytotoxicity ISO 10993-10 Sensitization ISO 10993-23 Irritation or Intracutaneous Reactivity ISO 10993-11 Material Mediated Pyrogenicity ISO 10993-11 Acute Systemic Toxicity ISO 10993-4 Hemocompatibility In-vitro Blood Loop Assay with Comparison Article Complement Activation Assay, SC5b-9 Method with Comparison Article (ISO) Heparinized Platelet and Leukocyte Count Assay with Comparison Article (ISO) Partial Thromboplastin Time (PTT) Assay with Comparison Article (ISO) ASTM Hemolysis Assay, Direct and Extract Methods (ISO) |
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| SubstantialEquivalence: | Based on the Indication for Use, design, and safety and performance testing,the 10F Sheath and Dilator Set meets the requirements for its intended useand is substantially equivalent to the predicate devices. |
|---|---|
| Conclusion: | Based on performance testing in vitro, and similarities in indications for use,materials, technological characteristics, principle of operation, designfeatures and sterilization process; the 10F Sheath and Dilator Set issubstantially 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).