EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL

K030944 · Edwards Lifesciences, LLC · DYB · Jun 20, 2003 · Cardiovascular

Device Facts

• Record ID: K030944
• Device Name: EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
• Applicant: Edwards Lifesciences, LLC
• Product Code: DYB · Cardiovascular
• Decision Date: Jun 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter).

Device Story

Percutaneous sheath introducer used for venous access and catheter facilitation. Device includes a convenience kit containing a silk suture. Primary modification involves changing the sterilization process for the suture component from gamma to ethylene oxide (EO) sterilization for the entire kit. Used by clinicians in clinical settings to provide a conduit for catheter placement. Benefits include standardized kit components and maintained sterility assurance for the suture component.

Clinical Evidence

No clinical data. Bench testing only; functional and biocompatibility testing demonstrated compliance with USP 25 standards for nonabsorbable surgical sutures.

Technological Characteristics

Percutaneous sheath introducer with Oligon™ material. Includes silk suture component. Sterilization method: Ethylene oxide. Compliance with USP 25 for nonabsorbable surgical sutures.

Indications for Use

Indicated for patients requiring venous system access and catheter insertion, such as pulmonary artery or infusion catheters.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material
• Surgical Specialities' Sharpoint DC-0218 Suture

Submission Summary (Full Text)

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JUN 2 0 2003

## 510(k) Summary

| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, California 92614 USA |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jason Smith, Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date prepared: | March 25, 2003 |
| Trade Name: | Edwards Lifesciences Percutaneous Sheath Introducers<br>with Oligon™ material |
| Common Name: | Catheter Introducer (21 CFR 870.1340) |
| Predicate Devices: | Edwards Lifesciences Percutaneous Sheath Introducers<br>with Oligon™ material<br>Surgical Specialities' Sharpoint DC-0218 Suture |
| Device Description: | The Edwards Lifesciences Percutaneous Sheath Introducers<br>with Oligon™ material are used to access the venous<br>system and to facilitate catheter insertion.<br><br>Edwards Lifesciences wishes to package the Edwards<br>Lifesciences Percutaneous Sheath Introducers with<br>Oligon™ material in a convenience kit. One of the<br>components of the kit is a silk suture. The suture<br>manufacturer provides the suture either gamma sterilized or<br>non-sterile. Edwards wishes to receive the suture non-<br>sterile, with ethylene oxide sterilization as the final<br>sterilization process for the kit, including the suture. The<br>reason for this submission is the change in sterilization<br>process for the suture component of the kit. |
| Indications for Use: | The Edwards Lifesciences Percutaneous Sheath Introducers<br>with Oligon™ material are indicated for use in patients<br>requiring access of the venous system and to facilitate<br>catheter insertion (e.g. pulmonary artery or infusion<br>catheter). |
| Comparative Analysis: | The introducer is identical to the predicate Edwards<br>Lifesciences Percutaneous Sheath Introducer with<br>Oligon™ material. The ethylene oxide-sterilized sutures |

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have been demonstrated to be in compliance with USP 25, Nonabsorbable Surgical Sutures.

- The ethylene-oxide sterilized sutures have successfully Functional/Safety undergone functional and biocompatibility testing. They Testing: have been shown to be in compliance with USP 25, Nonabsorbable Surgical Sutures.
Conclusion: The Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are substantially equivalent to the predicate devices. The ethylene-oxide sterilized sutures used in the The Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2003

Edwards Lifesciences LLC c/o Mr. Jason Smith One Edwards Way Irvine, CA 92614

Re: K030944

Percutaneous Sheath Introducers with Oligon™ Material Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 25, 2003 Received: March 26, 2003

Dear Mr. Smith:

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. Iisting 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.

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Page 2 - Mr. Jason Smith

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 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. 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]. 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 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 vours.

C. Jefferson Maynes

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

Enclosure

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510(k) Number (if known):

Device Name: Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material

Indications For Use:

The Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). =

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | <div style="display:flex; flex-direction:row;"> <div> <span style="text-decoration: overline;">C. Aelen Mayal</span> </div> <div> <span style="text-decoration: overline;">F. Bo Zuckerman</span> </div> </div> |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Division of Cardiovascular Devices | |
| 510(k) Number | |
| Prescription Use | <span style="text-decoration: overline;">✓</span> |
| | OR |
| Over-The-Counter Use | <span style="text-decoration: overline;"></span> |
| (Per 21 CFR 801.109) | |

(Optional Format 1-2-96)