(62 days)
No
The device description and performance studies focus on the mechanical and material properties of a physical introducer sheath and dilator, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an introducer sheath intended to introduce therapeutic or diagnostic devices into the vasculature, rather than being a therapeutic device itself.
No
Explanation: The device is an introducer sheath intended to facilitate the introduction of other therapeutic or diagnostic devices into the vasculature. It does not perform diagnostic functions itself.
No
The device description explicitly details physical components (introducer sheath, valve assembly, dilator) and materials, and the performance studies focus on physical properties and biocompatibility, indicating it is a hardware device.
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 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 introducer sheath and dilator used to access blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The device itself is not performing a diagnostic test on a sample.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo to facilitate procedures within the body.
N/A
Intended Use / Indications for Use
Extra Large Check-Flo introducers and guiding sheaths are intended to introduce therapeutic devices into the vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
Cook Incorporated's Extra Large Check-Flo® Introducer is a single-use, sterile, disposable product that is used to introduce therapeutic or diagnostic devices into the vasculature. The Extra Large Check-Flo® Introducer consists of an introducer sheath, Check-Flo® hemostatic valve assembly, and dilator. The sheath is constructed with a hemostatic valve that accepts a large range of French sizes while preventing blood reflux and air aspiration. The subject device, the Extra Large Check-Flo® Introducer, is manufactured in diameters of 20.0, 22.0 and 24.0 French with sheath lengths of 25, 40, or 65 centimeters. The dilator is manufactured in lengths 16 centimeters longer than the sheath (41, 56, and 81 centimeters, respectively). The diameter of the distal endhole of the dilator measures 0.035 inch. The introducer sheath and dilator are matched as a unit to provide a smooth transition.
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)
The subject device, the Extra Large Check-Flo® Introducer, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests performed are listed below:
- Biocompatibility - Per ANSI AAMI ISO 10993-1, testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility were performed to ensure the biocompatibility of the subject device. Test results indicated that all materials are biocompatible.
- Tensile Testing - Tested in accordance with the requirements of BS EN ISO 11070. Test results met predetermined criteria.
- Compatibility Testing – Tested in accordance with the requirements of BS EN ISO 11070. Test results met predetermined criteria.
- Integrity Testing - Testing verified that, under proper clinical use of the subject device, the sheath tip exhibited no visible damage, including cracks, splits, and rollback. Upon withdrawal of the dilator, the sheath remained patent and unwrinkled. Test results met predetermined criteria.
- Rollback Testing - Tested in accordance with BS EN ISO 11070, Annex A. The predetermined acceptance criterion was met.
- Radiopacity Evaluation - Tested in accordance with ASTM F640-12. Test results met predetermined criteria.
- Dilator Removal Force Testing – The force to remove the dilator from the sheath met the specification and was comparable to the reference device (K171866).
- Dimensional Testing – Effective product dimensions derived from the manufacturing specifications were confirmed.
- Simulated Use Testing - Subject device tested through an anatomical model to test the subject device's reliability in a clinical simulated use scenario.
- Valve Leakage – Tested in accordance with the acceptance criterion established in BS EN ISO 11070.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
Cook Incorporated Reuben Lidster Regulatory Affairs Specialist P.O. Box 489, 750 Daniels Way Bloomington, Indiana 47402
February 16, 2021
Re: K203670
Trade/Device Name: Extra Large Check-Flo Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: December 17, 2020 Received: December 18, 2020
Dear Reuben Lidster:
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,
1
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 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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH and 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 DICE (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe website 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,
Finn Donaldson 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) K203670
Device Name Extra Large Check-Flo® Introducer
Indications for Use (Describe)
Extra Large Check-Flo introducers and guiding sheaths are intended to introduce therapeutic devices into the vasculature.
| 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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3
510(k) Summary
Extra Large Check-Flo® Introducer
Traditional 510(k) Summary
21 CFR §807.92(c)
Date Prepared: December 15, 2020
Submitter Information:
| Applicant: | Cook Incorporated |
|---|---|
| Applicant Address: | 750 Daniels Way |
| Bloomington, IN 47404 | |
| Contact: | Reuben G. Lidster |
| Email: | RegSubmissions@cookmedical.com |
| Contact Phone Number: | 812-335-3575 x 104866 or 812-325-4172 |
| Contact Fax Number: | (812) 332-0281 |
Subject Device Information:
| Trade Name: | Extra Large Check-Flo® Introducer |
|---|---|
| Common Name: | Introducer, Catheter |
| Classification Name: | Catheter Introducer |
| Classification Regulation: | 21 CFR §870.1340, Product Code DYB |
| Device Class/Classification Panel: | Class II, Cardiovascular |
Predicate Device:
The GORE® DrySeal Sheath (K093791) was cleared for commercial distribution on March 22, 2010.
4
Reference Devices:
The GORE® DrySeal Flex Introducer Sheath (K160254) was cleared for commercial distribution on May 12, 2016. The reference device offers additional working lengths (33, 45 and 65 cm), compared to the predicate (28 cm only).
The Medtronic Sentrant Introducer Sheath with Hydrophilic Coating (K171866) was cleared for commercial distribution on December 20, 2017. The reference device offers comparative characterization testing for the dilator removal force.
Subject Device Description:
Cook Incorporated's Extra Large Check-Flo® Introducer is a single-use, sterile, disposable product that is used to introduce therapeutic or diagnostic devices into the vasculature. The Extra Large Check-Flo® Introducer consists of an introducer sheath, Check-Flo® hemostatic valve assembly, and dilator. The sheath is constructed with a hemostatic valve that accepts a large range of French sizes while preventing blood reflux and air aspiration. The subject device, the Extra Large Check-Flo® Introducer, is manufactured in diameters of 20.0, 22.0 and 24.0 French with sheath lengths of 25, 40, or 65 centimeters. The dilator is manufactured in lengths 16 centimeters longer than the sheath (41, 56, and 81 centimeters, respectively). The diameter of the distal endhole of the dilator measures 0.035 inch. The introducer sheath and dilator are matched as a unit to provide a smooth transition.
Intended Use:
Extra Large Check-Flo introducers and guiding sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature.
Comparison to the Predicate Device:
The Extra Large Check-Flo® Introducer, subject of this submission, is substantially equivalent to the predicate device, the GORE® DrySeal Sheath (K093791), in that these devices have the same general intended use, design, fundamental technological characteristics, and method of operation. The following table offers a comparison of different aspects of the subject and predicate device:
5
| PREDICATE DEVICE | SUBJECT DEVICE | |
|---|---|---|
| GORE DrySeal Sheath | Extra Large Check-Flo Introducer | |
| Regulation | ||
| Number | 870.1340 | 870.1340 |
| Product Code | DYB | DYB |
| Classification | Class II | Class II |
| Indications for | ||
| Use | The GORE® DrySeal Sheath is intended to | |
| be inserted in the vasculature to provide a | ||
| conduit for the insertion of endovascular | ||
| devices while minimizing blood loss | ||
| associated with such insertions. | Extra Large Check-Flo introducers and guiding | |
| sheaths are intended to introduce therapeutic or | ||
| diagnostic devices into the vasculature. | ||
| Image | Image: GORE DrySeal Sheath | Image: Extra Large Check-Flo Introducer |
| Introducer Sheath | ||
| Tubing | Polyethylene | Thick Wall Sheathing Radiopaque |
| Tetrafluoroethylene (VRTS) | ||
| Introducer | ||
| Sheath Size (Fr) | 12.0, 14.0, 16.0, 18.0, 20.0, 22.0, 24.0, and | |
| 26.0 | 20.0, 22.0, and 24.0 | |
| Introducer | ||
| Sheath Length | ||
| (Working | ||
| Length) (cm) | 28 | 25, 40, and 65 |
| Tip Shape | Straight | Identical |
| Check-Flo Assembly | ||
| Connecting | ||
| Tube (Material) | Unknown | Non-di(2-ethylhexyl) phthalate (DEHP) Polyvinyl |
| Chloride (PVC) & PVC | ||
| Stopcock | Unknown | Polycarbonate and Polyethylene |
| Check-Flo Body | Unknown | Polycarbonate |
| Check-Flo | ||
| Valve | Silicone | Silicone |
| Check-Flo Cap | Unknown | White Polyacetal |
| Dilator | ||
| Shaft | Unknown | Vinyl Radiopaque Dilator Tubing (VRDT) |
| Hub | Unknown | Polyacetal |
| Introducer | ||
| Dilator Size (Fr) | Unknown | 20.0, 22.0, 24.0 |
| Introducer | ||
| Dilator Length | ||
| (cm) | Unknown | 41, 56, and 81 |
| Dilator Endhole | ||
| Diameter (in) | 0.035 | Identical |
6
Test Data:
The subject device, the Extra Large Check-Flo® Introducer, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests performed are listed below:
- . Biocompatibility - Per ANSI AAMI ISO 10993-1, testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility were performed to ensure the biocompatibility of the subject device. Test results indicated that all materials are biocompatible.
- . Tensile Testing - Tested in accordance with the requirements of BS EN ISO 11070. Test results met predetermined criteria.
- . Compatibility Testing – Tested in accordance with the requirements of BS EN ISO 11070. Test results met predetermined criteria.
- . Integrity Testing - Testing verified that, under proper clinical use of the subject device, the sheath tip exhibited no visible damage, including cracks, splits, and rollback. Upon withdrawal of the dilator, the sheath remained patent and unwrinkled. Test results met predetermined criteria.
- . Rollback Testing - Tested in accordance with BS EN ISO 11070, Annex A. The predetermined acceptance criterion was met.
- . Radiopacity Evaluation - Tested in accordance with ASTM F640-12. Test results met predetermined criteria.
- . Dilator Removal Force Testing – The force to remove the dilator from the sheath met the specification and was comparable to the reference device (K171866).
- . Dimensional Testing – Effective product dimensions derived from the manufacturing specifications were confirmed.
- . Simulated Use Testing - Subject device tested through an anatomical model to test the subject device's reliability in a clinical simulated use scenario.
- . Valve Leakage – Tested in accordance with the acceptance criterion established in BS EN ISO 11070.
7
Conclusion:
The results of the tests support the conclusion that, the Extra Large Check-Flo® Introducer met the design input requirements based on the intended use. Further, these results also support the conclusion that the design and material differences for the subject device, when compared to the predicate device, the GORE® DrySeal Sheath (K093791), support a conclusion that the Extra Large Check-Flo Introducer, subject of this submission, met the design input requirements based on the device's intended use and that it is substantially equivalent to the predicate device.