CROSSCATH SUPPORT CATHTER

K093052 · Cook, Inc. · KRA · Dec 8, 2009 · Cardiovascular

Device Facts

• Record ID: K093052
• Device Name: CROSSCATH SUPPORT CATHTER
• Applicant: Cook, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Dec 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2

Intended Use

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

Device Story

CrossCath Support Catheter is a single-lumen intravascular catheter; designed to support wire guides during vascular access, facilitate wire guide exchange, and deliver saline or diagnostic contrast agents. Device features nine configurations with varying distal/proximal diameters and hydrophilic coatings (distal 40cm or 60cm). Includes three radiopaque markers for length estimation. Used by physicians in clinical settings for peripheral vascular procedures. Provides mechanical support for navigation through small or superselective anatomy; enables fluid delivery. Benefits include improved access to challenging vascular sites.

Clinical Evidence

Bench testing only. Testing included tensile, leakage, burst pressure, flow rate, accelerated aging, and biocompatibility testing to ensure design reliability and performance.

Technological Characteristics

Single-lumen intravascular catheter; hydrophilic coating on distal shaft (40cm or 60cm depending on model); three radiopaque markers for length estimation; variable distal/proximal diameter configurations. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring diagnostic or interventional procedures in small vessel or superselective peripheral anatomy.

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)

Submission Summary (Full Text)

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K093052 page lot 2

Special 510(k): Device Modification CXC Support Catheter Cook Incorporated 29 September 2009

DEC - 8 2009

### 510(k) SUMMARY

Submitted By:

Molly Busenbark Cook Incorporated 750 Daniels Way Bloomington, IN 47404

Device:

Trade Name: Proposed Classification: CrossCath Support Catheter Catheter, Continuous Flush KRA (21 CFR §870.1210)

### Indications for Use:

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

### Predicate Device:

The CrossCath Support Catheter is similar in terms of intended use, principles of operation, materials of construction, and technological characteristics to the predicate device reviewed as a device for use in small vessel or superselective anatomy for diagnostic and interventional procedures.

### Device Description:

CrossCath Support Catheters with hydrophilic coating are single lumen intravascular catheters, designed to support a wire guide during access of vasculature, allow for exchange of wire guides, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

CrossCath Support Catheters are available in nine different configurations. All models have three radiopaque markers spaced equally along the distal shaft to aid in estimating lengths within the vascular system. The distal radiopaque maker is positioned approximately 3 mm from the catheter tip. Each model has a smaller distal portion for passing through smaller vasculature and a larger proximal portion for additional support. The models with 0.014" and 0.018" end holes have hydrophilic coating at the distal 40 cm portion. The models with 0.035" end holes have hydrophilic coating at the distal 60 cm portion.

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K093052 page 262

Special 510(k): Device Modification CXC Support Catheter Cook Incorporated 29 September 2009

## Substantial Equivalence:

Cook Incorporated currently markets the predicate CXI Support Catheter, cleared for marketing on November 9, 2007 (D.C. #K072724). The similar indications for use, principals of operation, and technological characteristics of the CrossCath Support Catheter as compared to the predicate device support a determination of substantial equivalency.

### Test Data:

The proposed CrossCath Support Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters.

- Tensile Testing
- 트 Leakage Testing
- Burst Pressure Testing
- 트 Flow Rate Testing
- Accelerated Aged Testing
- 트 Biocompatibility Testing

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.

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

Cook Incorporated c/o Ms. Molly Busenbark Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47402-0489

Re: K093052

Trade/Device Name: CrossCath Support Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II (two) Product Code: KRA Dated: November 3, 2009 Received: November 4, 2009

Dear Ms. Busenbark:

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.

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.

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Page 2 - Ms. Molly Busenbark

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

pmua R.V.V.hmer

A 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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Special 510(k): Device Modification CrossCath Support Catheter Cook Incorporated 29 September 2009

#### Indications for Use

K093052

510(k) Number (if known):

Device Name: CrossCath Support Catheter

Indications for Use for the CrossCath Support Catheter:

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

Prescription Use XX (Part 21 CFR 801 Subpart D) i 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)

Duna R. Vic hnes

(Division Sign-Off) Division of Cardiovascular Devices

510/k) Numbiar K09 3052