Extra Large Check-Flo Introducer

K203670 · Cook Incorporated · DYB · Feb 16, 2021 · Cardiovascular

Device Facts

• Record ID: K203670
• Device Name: Extra Large Check-Flo Introducer
• Applicant: Cook Incorporated
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

Extra Large Check-Flo introducers and guiding sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature.

Device Story

Single-use, sterile introducer system consisting of sheath, hemostatic valve, and dilator; used to introduce therapeutic/diagnostic devices into vasculature. Sheath features hemostatic valve to prevent blood reflux/air aspiration. Available in 20.0, 22.0, 24.0 French sizes with lengths 25, 40, 65 cm. Operated by clinicians in clinical settings. Dilator facilitates smooth insertion; matched to sheath. Device provides conduit for endovascular procedures; benefits patient by enabling device delivery while minimizing blood loss.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1), tensile testing, integrity, rollback, radiopacity (ASTM F640-12), dilator removal force, dimensional verification, simulated use in anatomical models, and valve leakage (ISO 11070). All tests met predetermined acceptance criteria.

Technological Characteristics

Materials: Radiopaque Tetrafluoroethylene (VRTS) sheath, non-DEHP PVC, Polycarbonate, Polyacetal, Silicone valve. Dimensions: 20-24 Fr, 25-65 cm lengths. Sensing/Actuation: Mechanical introducer. Energy: None. Connectivity: None. Sterilization: Sterile. Standards: BS EN ISO 11070, ASTM F640-12, ISO 10993-1.

Indications for Use

Indicated for patients requiring the introduction of therapeutic or diagnostic devices into the vasculature.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• GORE® DrySeal Sheath (K093791)

Reference Devices

• GORE® DrySeal Flex Introducer Sheath (K160254)
• Medtronic Sentrant Introducer Sheath with Hydrophilic Coating (K171866)

Submission Summary (Full Text)

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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,

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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 ([e-mail]) or phone [phone] 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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## 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<br>Bloomington, IN 47404 |
| Contact: | Reuben G. Lidster |
| Email: | [e-mail] |
| Contact Phone Number: | 812-335-3575 x 104866 or 812-325-4172 |
| Contact Fax Number: | [phone] |

## 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.

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## 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:

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| PREDICATE DEVICE | | SUBJECT DEVICE |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| | GORE DrySeal Sheath | Extra Large Check-Flo Introducer |
| Regulation<br>Number | 870.1340 | 870.1340 |
| Product Code | DYB | DYB |
| Classification | Class II | Class II |
| Indications for<br>Use | The GORE® DrySeal Sheath is intended to<br>be inserted in the vasculature to provide a<br>conduit for the insertion of endovascular<br>devices while minimizing blood loss<br>associated with such insertions. | Extra Large Check-Flo introducers and guiding<br>sheaths are intended to introduce therapeutic or<br>diagnostic devices into the vasculature. |
| Image | Image: GORE DrySeal Sheath | Image: Extra Large Check-Flo Introducer |
| Introducer Sheath | | |
| Tubing | Polyethylene | Thick Wall Sheathing Radiopaque<br>Tetrafluoroethylene (VRTS) |
| Introducer<br>Sheath Size (Fr) | 12.0, 14.0, 16.0, 18.0, 20.0, 22.0, 24.0, and<br>26.0 | 20.0, 22.0, and 24.0 |
| Introducer<br>Sheath Length<br>(Working<br>Length) (cm) | 28 | 25, 40, and 65 |
| Tip Shape | Straight | Identical |
| Check-Flo Assembly | | |
| Connecting<br>Tube (Material) | Unknown | Non-di(2-ethylhexyl) phthalate (DEHP) Polyvinyl<br>Chloride (PVC) & PVC |
| Stopcock | Unknown | Polycarbonate and Polyethylene |
| Check-Flo Body | Unknown | Polycarbonate |
| Check-Flo<br>Valve | Silicone | Silicone |
| Check-Flo Cap | Unknown | White Polyacetal |
| Dilator | | |
| Shaft | Unknown | Vinyl Radiopaque Dilator Tubing (VRDT) |
| Hub | Unknown | Polyacetal |
| Introducer<br>Dilator Size (Fr) | Unknown | 20.0, 22.0, 24.0 |
| Introducer<br>Dilator Length<br>(cm) | Unknown | 41, 56, and 81 |
| Dilator Endhole<br>Diameter (in) | 0.035 | Identical |

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# 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.

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### 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.