EDWARDS DIRECTIONAL CATHETER

K030630 · Edwards Lifesciences, LLC · DQY · Sep 3, 2003 · Cardiovascular

Device Facts

• Record ID: K030630
• Device Name: EDWARDS DIRECTIONAL CATHETER
• Applicant: Edwards Lifesciences, LLC
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Edwards Directional Catheter is indicated to facilitate the placement of quidewires in bifurcations or any sidebranch vasculature.

Device Story

Edwards Directional Catheter; 99 cm length; 16F outer diameter; two-lumen design. One lumen houses deflectable spring; second lumen tracks 0.035" guidewire. Proximal knob controls spring tip deflection (0° to 180°). Soft tip material for flexibility; higher durometer body for torqueability. Used by clinicians to navigate complex vascular anatomy; facilitates placement of guidewires into bifurcations or sidebranches. Device provides access to vasculature; enables subsequent delivery of interventional or diagnostic devices.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including biocompatibility, chemical acceptability, physical/mechanical specification testing, sterilization testing, and animal studies.

Technological Characteristics

99 cm length, 16F diameter, two-lumen percutaneous catheter. Materials: soft tip for flexibility, higher durometer body for torqueability. Mechanical deflection mechanism via proximal knob. Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for facilitating guidewire placement in bifurcations or sidebranch vasculature.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• BioCardia Universal Deflectable Guide Catheter (K012749)
• Cardima Naviport Deflectable Guide Catheter (K974683)

Submission Summary (Full Text)

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K030630

SEP = 3 2003

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Edwards Lifesciences

CONFIDENTIAL May not be reproduced without written permission from Edwards Lifesciences

## 510(k) Summary

## A. Submitter Information

Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614-5686, USA

Contact: Kevin Drisko, Senior Manager Regulatory Affairs Phone Number: [phone] Fax Number: [phone] Email address: kevin [e-mail]

### B. Device Information

- 1. Trade Name: Edwards Directional Catheter
- 2. Common or Usual Name: Percutaneous Catheter
- 3. Device Classification and Classification Name: Class II (74 DQY, 21 CFR §870.1250)
- 4. Predicate Device Identification: BioCardia Universal Deflectable Guide Catheter (K012749) Cardima Naviport Deflectable Guide Catheter (K974683)

#### 5. Device Description:

The Edwards Directional Catheter is 99 cm in length and 16F outer diameter. The body has two lumens, one for a deflectable spring, and the other to allow it to track on a 0.035" guidewire. The sheath on the subject device provides a smooth transition from the body to the tip of the catheter. The tip of the catheter is made from a soft material that offers flexibility. The body of the catheter is made from a higher durometer material that offers better torqueability. When the sheath of the device is retracted, the spring tip can be deflected using the knob located at the proximal end. The spring tip can be adjusted from approximately 0° to 180° by sliding the knob back and forth. There is also a port that allows a 0.035" guidewire to pass through the catheter and exit through the deflecting tip.

- 6. Intended Use:
The Edwards Directional Catheter is indicated to facilitate the placement of quidewires in bifurcations or any sidebranch vasculature.

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Image /page/1/Picture/1 description: The image shows the Edwards Lifesciences logo. The logo consists of a square graphic on the left and the text "Edwards Lifesciences" on the right. The graphic is a stylized letter "E" inside a square. The text is in a serif font.

CONFIDENTIAL May not be reproduced without written permission from Edwards Lifesciences

- Technological Comparison of Subject Device to Predicate Device: 7. The Edwards Directional Catheter is similar to the predicate devices in that all three provide access to the vasculature and facilitate the placement of guidewires, interventional devices, or therapeutic and diagnostic devices. Similar materials are used in each to enhance maneuverability of the devices and to prevent damage to vessels.
- 8. Summary of Non-Clinical Tests and Conclusions: The following non-clinical testing was performed on the Edwards Directional Catheter:
- Biocompatibility testing/chemical acceptability testing .
- Physical and mechanical specification testing .
- . Sterilization testing
- Animal Studies .

Based on the results of this testing, Edwards Lifesciences has determined that the Edwards Directional Catheter is acceptable in design and construction for its intended use.

- 9. Summary of Clinical Tests and Conclusions: Clinical testing was not deemed necessary to establish the substantial equivalence of the subject device to the predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 3 2003

Edwards Lifesciences LLC c/o Kevin Drisko Senior Manager Regulatory Affairs One Edwards Way Irvine, CA 92614-5686

Re: K030630

> Percutaneous Catheter Regulation Number: 870.1250 Regulation Name: Catheter percutaneous Regulatory Class: Class II Product Code: DQY Dated: June 24, 2003 Received: June 25, 2003

Dear Mr. Drisko:

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 such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Kevin Drisko

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours.

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

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510(k) Number (if known): K030630

Device Name: Edwards Directional Catheter

Indications for Use:

The Edwards Directional Catheter is indicated to facilitate the placement of guidewires in bifurcations or any sidebranch vasculature.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE

NOCeTA

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K030630

Image /page/4/Picture/12 description: The image shows the text "Prescription Use (per 21 CFR 801.109)" with a symbol resembling an X over a line. The text indicates that the product is intended for prescription use, as defined by the Code of Federal Regulations (CFR) section 801.109. The symbol is placed to the right of the text.

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________