STEERABLE GUIDE CATHETER

K112239 · Abbott Vascular · DRA · Aug 31, 2011 · Cardiovascular

Device Facts

• Record ID: K112239
• Device Name: STEERABLE GUIDE CATHETER
• Applicant: Abbott Vascular
• Product Code: DRA · Cardiovascular
• Decision Date: Aug 31, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1280
• Device Class: Class 2

Intended Use

The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Device Story

Steerable Guide Catheter system includes guide catheter and dilator; used for percutaneous access to left heart via interatrial septum. Guide features proximal/distal shafts, steering knob handle, hemostasis valve, luer lock flush port, and radiopaque distal tip. Dilator features radiopaque shaft, echogenic distal tip, and hemostasis valve. System allows aspiration of air, infusion of saline, and serves as conduit for ancillary devices (max diameter 0.204"). Dilator accepts ancillary devices (max diameter 0.035"). Operated by physicians in clinical settings; visualization via fluoroscopy. Provides stable access for cardiovascular procedures; benefits patient by facilitating minimally invasive left-heart interventions.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verified through mechanical testing including hemostasis, tensile, and torque evaluations.

Technological Characteristics

Catheter system with steerable guide and dilator. Materials include radiopaque components for fluoroscopic visualization and echogenic features on dilator tip. Single-use, EO sterile. Connectivity: manual luer lock. No software or electronic components.

Indications for Use

Indicated for patients requiring introduction of cardiovascular catheters into the left side of the heart via the interatrial septum.

Regulatory Classification

Identification

A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

Predicate Devices

• Steerable Guide Catheter (K083793)
• Steerable Guide Catheter (K091596)
• Steerable Guide Catheter (K093866)
• Steerable Guide Catheter (K100789)

Submission Summary (Full Text)

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Special 510(k)

## 510(k) SUMMARY

.

| | 510(k) SUMMARY | AUG 3 1 2011 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Trade Name: | Steerable Guide Catheter | |
| Common Name: | Steerable Catheter | |
| Classification Name: | Class II, Catheter Introducer, 21 CFR 870.1280 | |
| Product Code: | DRA | |
| Manufacturer's Name: | Abbott Vascular Structural Heart | |
| Manufacturer's Address: | 4045 Campbell Avenue<br>Menlo Park, CA 94025 | |
| Corresponding Official: | Cindy Morrow | |
| Title: | Principal Regulatory Affairs Associate | |
| Address: | 4045 Campbell Avenue<br>Menlo Park, CA 94025 | |
| Phone: | [phone] | |
| Date of Preparation: | August 3, 2011 | |
| Predicate: | K083793 Steerable Guide Catheter<br>K091596 Steerable Guide Catheter<br>K093866 Steerable Guide Catheter<br>K100789 Steerable Guide Catheter | |
| Intended Use: | The Steerable Guide Catheter is used for introducing various<br>cardiovascular catheters into the left side of the heart through the<br>interatrial septum. | |
| Device Description: | The Steerable Guide Catheter consists of a Steerable Guide<br>Catheter (Guide) and a Dilator provided EO sterile and for single-<br>use only. The Steerable Guide Catheter consists of a distal and<br>proximal catheter shaft, a radiopaque tip ring, a handle with a<br>steering knob, a hemostasis valve with a luer lock flush port, an<br>atraumatic distal tip, and a Dilator with a single central lumen.<br>The central lumen of the Guide allows for aspiration of air and<br>infusion of fluids such as saline, and serves as a conduit during<br>introduction and or exchange of the Dilator and ancillary devices<br>(e.g. catheters) that have a maximum diameter of .204". The<br>atraumatic distal tip of the Steerable Guide Catheter is radiopaque | |

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| | to allow visualization under fluoroscopy. The Dilator consists of a<br>radiopaque shaft, an echogenic feature at the distal tip, a<br>hemostasis valve with a flush port and an internal lumen designed<br>to accept ancillary devices that have a maximum diameter of<br>0.035" (e.g. needles or guidewires). The Steerable Guide Catheter,<br>Dilator and accessories are packaged in a tray enclosed in two<br>sealed Tyvek pouches, and boxed in a cardboard shelf-carton. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>Predicate: | The subject device is substantially equivalent to the predicate<br>devices with respect to intended use, indications for use, labeling,<br>patient contacting materials, technological and performance<br>characteristics, ergonomics of patient-user interface, overall<br>dimensions, packaging, and sterilization. |
| Substantial<br>Equivalence: | Bench testing demonstrated that the subject device met<br>performance specifications and is substantially equivalent to the<br>predicate Steerable Guide Catheter and Dilator and was based in<br>part on the evaluation of the following performance characteristics:<br>1. Guide Hemostasis: Initial Performance<br>2. Guide Hemostasis: Column test with Dilator<br>3. Guide Hemostasis: Short term column test after three insertions<br>and removals<br>4. Guide Hemostasis: Long term column test<br>5. Tensile test: Cap to Housing<br>6. Tensile test shaft: Shaft to Housing<br>7. Torque test for Luer |
| Conclusions: | The Steerable Guide Catheter and Dilator has the same indications<br>for use and technological characteristics and performs as well as<br>the predicate devices. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

Abbott Vascular, Structural Heart

Re: K112239

Cynthia Morrow 4045 Campbell Ave. Menlo Park, CA 94025

> Trade/Device Name: Steerable Guide Catheter Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA Dated: August 3, 2011 Received: August 4, 2011

Dear Ms. Morrow:

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.

AUG 3 1 2011

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## Page 2 -

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.ggv/AboutiFDA/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,

Bram D. Zuckerman M.D.

Director 31 Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

| 510(k) Number (if known): | K112239 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: ___ Steerable Guide Catheter

Indication for Use:

The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

Division Sign-Off) Division of Čardiovascular Devices

510(k) Number