CXI Support Catheter

K160884 · Cook Incorporated · KRA · Nov 22, 2016 · Cardiovascular

Device Facts

• Record ID: K160884
• Device Name: CXI Support Catheter
• Applicant: Cook Incorporated
• Product Code: KRA · Cardiovascular
• Decision Date: Nov 22, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CXI™ Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.

Device Story

CXI Support Catheter is a braided, kink-resistant, hydrophilic-coated catheter; facilitates wire guide exchange, wire guide support, and delivery of saline or diagnostic contrast agents. Used in small vessel or superselective anatomy for diagnostic and interventional procedures. Available in 2.6 and 4.0 French sizes and 65, 90, 135, and 150 cm lengths. Designed for one-time use; supplied sterile. May be used coaxially (2.6F catheter within 4.0F catheter). Operated by clinicians during peripheral procedures to navigate vasculature and deliver fluids.

Clinical Evidence

Animal testing performed to evaluate performance parameters including preparation, introduction, pushability, trackability, flexibility, torquability, withdrawal, and post-use inspection. Results demonstrated the device was adequate or better, supporting substantial equivalence.

Technological Characteristics

Braided, kink-resistant catheter with hydrophilic coating. Available in 2.6 and 4.0 French diameters and 65, 90, 135, and 150 cm lengths. Sterile, single-use device. No electronic components or software.

Indications for Use

Indicated for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• CXI Support Catheter (K072724)

Reference Devices

• CXI Support Catheter (K122796)
• CXI TriForce Peripheral Crossing Set (K111263)

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

November 22, 2016

Cook Incorporated Daniel Corbin Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404

Re: K160884

Trade/Device Name: CXI Support Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: March 29, 2016 Received: March 31, 2016

Dear Mr. Corbin:

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,

Brian D. Pullin -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K160884

Device Name CXI™ Support Catheter

Indications for Use (Describe)

The CXI™ Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.

| 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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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font, also on a red background.

#### 510(k) SUMMARY

| Submitted By: | Daniel J. Corbin |
|---------------|---------------------------------|
| | Cook Incorporated |
| | 750 Daniels Way |
| | P.O. Box 489 |
| | Bloomington, IN 47402 |
| | Phone: [phone] x104018 |
| | Fax: [phone] |
| | Date Prepared: October 25, 2016 |

### Device:

Trade Name: Common Name: Classification Name: CXI™ Support Catheter Continuous Flush Catheter Catheter, Continuous Flush KRA (21 CFR §870.1210)

### Indications for Use:

The CXI" Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.

### Predicate Device:

The device, subject of this submission, is substantially equivalent to the predicate device, the CXI" Support Catheter cleared under 510(k) number K072724.

### Comparison to Predicate Device:

The CXI" Support Catheter is substantially equivalent to the predicate device, the CXI"" Support Catheter (K072724), in the following characteristics: identical intended use, identical fundamental technological characteristics, identical method of operation, and identical materials of construction. The CXT" Support Catheter (subject of this submission) is available in two French sizes (2.6 and 4.0 French) and in four lengths (65, 90, 135, and 150 centimeters), whereas as the predicate CXI" Support Catheter (K072724) was cleared with 2.6 French and 90 and 150 centimeter lengths. The CXI" Support Catheter may be used coaxially with other CXI™ Support Catheters, i.e. the 2.6 French CXI™ Support Catheter may fit into and be used coaxially with the 4.0 French CXI" Support Catheter. The substantial equivalence of the

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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, sans-serif font, stacked on top of the word "MEDICAL" in white, sans-serif font. The words are set against a red background. The word "COOK" is larger than the word "MEDICAL" and has a registered trademark symbol after it.

modified device to the predicate device is supported by testing summarized in this submission. Reference devices for this submission of the CXI" Support Catheter (K160884) include the CXI" Support Catheter (K122796) and CXI" TriForce Peripheral Crossing Set (K111263).

## Device Description:

The CXI™ Support Catheter with hydrophilic coating is a braided, kink-resistant catheter designed to facilitate wire guide exchange, wire guide support and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The CXI" Support Catheter will be available in catheter sizes of 2.6 and 4.0 French and with catheter lengths of 65, 90, 135, and 150 centimeters. The catheters will be supplied sterile and are intended for one-time use.

### Test Data:

The following tests were performed to demonstrate that the CXI™ Support Catheter met applicable design and performance requirements and support a determination of substantial equivalence.

- I Animal Testing - The testing showed that the devices were adequate or better in terms of the following performance parameters: preparation, introduction, pushability, trackability, flexibility, torquability, withdrawal, and inspection after use.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.