CATHETER INTRODUCER SHEATH

K131627 · Edwards Lifesciences, LLC · DYB · Mar 6, 2014 · Cardiovascular

Device Facts

• Record ID: K131627
• Device Name: CATHETER INTRODUCER SHEATH
• Applicant: Edwards Lifesciences, LLC
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

Intended to be used to access the venous system and to facilitate catheter insertion and allow access for the administration of fluids and blood sampling.

Device Story

11 Fr. sterile, single-use catheter introducer sheath; consists of single lumen shaft, hemostasis valve, side-arm extension tube with female luer and clamp. Used by clinicians to access venous system; facilitates insertion of catheters (e.g., pulmonary artery) and allows fluid administration/blood sampling. Device provides physical conduit for catheter placement; maintains hemostasis during procedure. Used in clinical settings; intended for short-term use (≤ 72 hours).

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (cytotoxicity, sensitization, irritation, systemic/muscular/subacute toxicity, genotoxicity, haemocompatibility, in vivo thrombogenicity), leak testing, tensile testing, insertion/retraction force testing, and fluoroscopic visibility.

Technological Characteristics

11 Fr. introducer sheath; flexible and non-flexible polymeric materials; single lumen shaft; hemostasis valve; side-arm extension with female luer and clamp. Sterile, non-pyrogenic, single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring venous system access or catheter insertion (e.g., pulmonary artery or infusion catheter). Intended for use ≤ 72 hours.

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

• Baxter Hemostasis Valve Introducer (K981909)

Submission Summary (Full Text)

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Edwards Lifesciences LLC Traditional 510(k) Premarket Notification Catheter Introducer Sheath

### 510(k) Summary

.. )

| Submitter: | Edwards Lifesciences LLC |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Luke Meidell, Regulatory Affairs Associate II<br>12050 Lone Peak Pkwy<br>Draper, UT 84020<br>Ph - [phone]<br>Fax - [phone] |
| Date Prepared: | March 06, 2014 |
| Trade Name: | Edwards Catheter Introducer Sheath |
| Classification Name: | Introducer, Catheter, Cardiovascular Devices Panel;<br>21 CFR §870.1340 Product Code DYB, Class II |
| Predicate Device: | K981909, Baxter Hemostasis Valve Introducer |

### Device Description:

Edwards Lifesciences' Catheter Introducer Sheath is an 11 Fr. sterile, non-pyrogenic, single-use introducer made of flexible and non-flexible polymeric materials. It consists of a single lumen shaft and a hemostasis valve with a side-arm extension tube with a female luer and clamp.

# Intended Use:

Intended to be used to access the venous system and to facilitate catheter insertion and allow access for the administration of fluids and blood sampling.

# Indications for Use:

The Catheter Introducer Sheath is indicated for use in patients requiring access of the venous system or to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). It is intended to be used for ≤ 72 hours.

# Comparative Analysis:

The subject device has the same intended use and technological characteristics (i.e., design, material, chemical composition) as the predicate device. It has been demonstrated that the subject Catheter introducer Sheath is comparable to the predicate

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device in fundamental scientific technology, material types, principles of operation, and functional performance evaluations. No new issues of safety or efficacy have been raised as a result of the packaging configuration change or the revision of the Indications for Use statement.

# Functional/Safety Testing:

The functional data indicate that the Catheter Introducer Sheath performs in a substantially equivalent manner when compared to the predicate device. The following tests were performed:

#### Biocompatibility and Sterility

Cytotoxicity, Sensitization, Irritation/Intracutaneous toxicity, Systemic toxicity, Genotoxicity, Haemocompatibility, Muscular toxicity, Subacute/Subchronic toxicity, In Vivo thrombogenicity,

#### Performance / Shelf Life

- Leak Testing .
Valve Leak after 72-hour insertion of 7 Fr device, Assembly leak, Valve leak after 6-hour insertion of 9 Fr device, Valve leak after 6-hour insertion of 7 Fr device, Valve leak with no insertion conditioning, Valve leak after multiple insertions, Forward valve leak.

#### Tensile Testing .

Introducer joint tensile, Sideport luer tensile, Sideport tubing to body.

#### Compatibility and Additional Testing .

9 Fr ballon catheter insertion force, 9 Fr balloon catheter retraction force, Dilator insertion force, Contamination guard connection, Introducer sheath and dilator transition, Valve retention force, Sideport infusion with empty introducer, Sideport infusion post clamping, Sideport infusion with 10 Fr device, Fluoroscopic visibility, Kink testing.

### Packaging Testing

All data met acceptance criteria.

## Conclusion:

The Edwards Catheter Introducer Sheath is substantially equivalent to the cited predicate device.

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

March 6, 2014

Edwards Lifesciences, LLC. % Luke Meidell Regulatory Affairs Associate III 12050 Lone Peak Pkwy Draper, UT 84020 US

Re: K131627

> Trade/Device Name: Catheter Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: February 12, 2014 Received: February 14, 2014

#### Dear Mr. Meidell:

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.

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 - Mr. Luke Meidell

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours.

MA

for

for 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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K131627, page 1 of 1

Edwards Lifesciences LLC Traditional 510(k) Premarket Notification Catheter Introducer Sheath

# Indications for Use Statement

510(k) Number (if known): K131627

Device Name: Catheter Introducer Sheath

Indications for Use:

. . . . . . . . . .

The Catheter Introducer Sheath is indicated for use in patients requiring access of the venous system or to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). It is intended to be used for ≤ 72 hours.

Prescription Use × (Per 21 CFR 801.109)

OR Over-The-Counter Use

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

MZFDA