Flexor Radial Hydrophilic Introducer Access Set

K152044 · Cook Incorporated · DYB · Aug 14, 2015 · Cardiovascular

Device Facts

• Record ID: K152044
• Device Name: Flexor Radial Hydrophilic Introducer Access Set
• Applicant: Cook Incorporated
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 14, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Flexor® Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.

Device Story

The Flexor Radial Hydrophilic Introducer Access Set is a sterile, single-use medical device used to facilitate radial artery access. The set includes an introducer sheath, dilator, wire guide, and access needle. It is operated by clinicians in a clinical setting to provide a conduit for diagnostic or interventional instruments. The device features a modified Check-Flo valve designed based on physician feedback to manage liquid leakage during procedures. The sheath is available in various French sizes (4.0-7.0 Fr) and lengths (7, 13, 23 cm). By providing a stable access point, the device enables the delivery of therapeutic or diagnostic tools into the arterial system, benefiting patients by allowing minimally invasive vascular interventions.

Clinical Evidence

Bench testing only. Testing included acute performance verification, Check-Flo valve liquid leakage testing, and comprehensive biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance) in conformance with ISO 10993-1:2009. All predetermined acceptance criteria were met.

Technological Characteristics

Introducer set consisting of sheath, dilator, wire guide, and access needle. Sizes: 4.0-7.0 French; lengths: 7, 13, 23 cm. Compatible with 0.018" wire guide. Features a modified Check-Flo valve. Biocompatibility per ISO 10993-1:2009. Sterile, single-use.

Indications for Use

Indicated for patients requiring radial artery access for the introduction of diagnostic and interventional devices.

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

• Flexor® Radial Hydrophilic Introducer Access Set (K132592)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 14, 2015

Cook Incorporated Sarah Reeves Regulatory Engineer 750 Daniels Way, P.O. Box 489 Bloomington, IN, 47402

Re: K152044

Trade/Device Name: Flexor Radial Hydrophilic Introducer Access Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: July 22, 2015 Received: July 23, 2015

Dear Ms. Reeves:

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. 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, 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrand

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### Indications for Use

K152044 510(k) Number (if known):

Device Name: Flexor® Radial Hydrophilic Introducer Access Set

Indications for Use for the Flexor® Radial Hydrophilic Introducer Access Set:

The Flexor® Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-the-Counter Use (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 510(k) SUMMARY

### Submitted By:

Sarah Reeves Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: [phone] x105024 Fax: [phone] Date Prepared: July 22, 2015

# Device:

Trade Name: Common Name: Classification Name: Flexor® Radial Hydrophilic Introducer Access Set Introducer Set Catheter, Introducer DYB (21 CFR §870.1340)

### Indications for Use:

The Flexor® Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.

### Predicate Device:

The device, subject of this submission, is substantially equivalent to the predicate device of identical name, the Flexor® Radial Hydrophilic Introducer Access Set, cleared under 510(k) number K132592.

### Comparison to Predicate Device:

It has been demonstrated that the Flexor® Radial Hydrophilic Introducer Access Set is comparable to the predicate device. The Flexor® Radial Hydrophilic Introducer Access Sets are identical in terms of intended use, principles of operation, basic technological characteristics, and

COOK INCORPORATED

750 DANIELS WAY, P.O. BOX 48

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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in smaller, white block letters. The logo is simple and clean, with a focus on the company name.

materials of construction, with the exception of the check-flo valve, to the predicate device. The check-flo valve has been modified in response to physician feedback. The safety and effectiveness of the modifications are supported by testing.

# Device Description:

The Flexor® Radial Hydrophilic Introducer Access Set is an introducer set, supplied with an introducer sheath, dilator, wire guide and access needle. The introducers are available in whole French sizes from 4.0 through 7.0 French and in lengths of 7, 13 and 23 centimeters. The sets are compatible with the supplied 0.018" wire guide. The sets are supplied sterile and intended for one-time use.

# Test Data:

The following tests were performed to demonstrate that the Flexor® Radial Hydrophilic Introducer Access Set met applicable design and performance requirements and support a determination of substantial equivalence.

- . Acute Performance - Testing performed verified that performance parameters were acceptable for clinical use. The predetermined acceptance criterion was met.
- . Check-Flo valve liquid leakage testing - Testing verified that the Check-Flo valve will not experience excessive leakage when utilized according to the device's intended use. The predetermined acceptance criteria were met.
- . Biocompatibility testing - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, hemocompatibility, complement activation, partial thromboplastin time, and thromboresistance) demonstrated the device as biocompatible. In conformance with the applicable sections of ISO 10993-1:2009, the predetermined acceptance criteria were met.

In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.