EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST

K091596 · Evalve, Inc. · DRA · Jul 2, 2009 · Cardiovascular

Device Facts

• Record ID: K091596
• Device Name: EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST
• Applicant: Evalve, Inc.
• Product Code: DRA · Cardiovascular
• Decision Date: Jul 2, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1280
• Device Class: Class 2

Intended Use

The Evalve 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 (SGC01ST) facilitates introduction of cardiovascular catheters into left heart via interatrial septum. System comprises steerable guide catheter and dilator. Guide features proximal/distal shafts, handle with steering knob, hemostasis valve with luer lock flush port, and radiopaque tip ring. Central lumen allows air aspiration, fluid infusion, and conduit for ancillary devices (max diameter 0.204"). Dilator includes radiopaque shaft, echogenic distal tip, and internal lumen for ancillary devices (max diameter 0.035"). Used in clinical settings under fluoroscopic guidance by physicians. Radiopaque components enable visualization. Single-use, EO sterile.

Clinical Evidence

Bench testing only. No clinical data presented. In vitro testing included overall dimensions, bend test, guide-to-dilator transition, echogenicity, and radiopacity.

Technological Characteristics

Catheter and dilator system. Materials include radiopaque tip ring. Features: steerable handle, hemostasis valve, luer lock flush port. Dimensions: guide lumen 0.204", dilator lumen 0.035". Visualization: radiopaque tip and echogenic dilator tip for fluoroscopy/ultrasound. Sterilization: Ethylene Oxide (EO). Single-use.

Indications for Use

Indicated for introducing various cardiovascular catheters into the left side of the heart via the interatrial septum. Prescription use only.

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

• Evalve Steerable Guide Catheter (K083793)

Submission Summary (Full Text)

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510(k) SUMMARY K (41596

Trade Name:

Steerable Guide Catheter

JUL - 2 2009

Common Name: Steerable Catheter

Class II, Catheter Introducer, 21 CFR 870, 1280

Classification Name:

Device Code:

DRA

Evalve, Inc.

Manufacturer's Name:

Manufacturer's Address:

4045 Campbell Avenue Menlo Park, CA 94025

Corresponding Official: Title: Address:

Phone:

Date of Preparation

Predicate

Intended Use:

Device Description:

Cindy Morrow Principal Regulatory Affairs Associate 4045 Campbell Avenue Menlo Park, CA 94025 [phone]

Mav 29, 2009

K083793 Evalve Steerable Guide Catheter

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

The Steerable Guide Catheter consists of a Steerable Guide (Guide) and a Dilator provided EO sterile and The Steerable Guide Catheter for single-use only. consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, a Dilator with a single central lumen and an atraumatic distal The central lumen of the Guide allows for tip. aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of .204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under The Dilator consists of a radiopaque fluoroscopy.

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K041596 pg 2 of 2

shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or The Steerable Guide Catheter and quidewires). Dilator are packaged in two sealed Tyvek pouches, and boxed in a shelf-cardboard carton.

## Comparision to Predicate:

The subject device is substantially equivalent to the predicate device with respect to intended use, indications for use, labeling, patient contacting materials, technological and performance characteristics, ergonomics of patient-user interface, overall dimensions, packaging, and sterilization.

Substantial Equivalence:

Conclusions:

guide-to-dilator transition test, Echogenicity, and Radiopacity, demonstrated that the subject device met performance specifications and is substantially equivalent to the predicate Steerable Guide Catheter and Dilator.

In vitro tests, including overall dimensions, bend test,

The Evalve Steerable Guide Catheter and Dilator has the same indications for use and technological characteristics and performs as well or better than the predicate device.

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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Evalve Incorporated % Ms. Cindy Morrow Principal Regulatory Affairs Associate 4045 Campbell Avenue Menlo Park, California 94025

Re: K091596

> Trade/Device Name: Evalve Steerable Guide Catheter SGC01ST Common Name: Catheter, Steerable Regulation Number: 21 CFR 870.1280 Regulatory Class: II Product Code: DRA Dated: May 29, 2009 Received: June 2, 2009

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.

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

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Page 2 - Ms. Cindy Morrow

(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,

M. A. Stillem

fv

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 Statement

510(k) Number (if known): _K091596

Device Name: Steerable Guide Catheter

Indication for Use:

The Evalve 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)

M. A. Hilleheune

(Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number Ko91596