RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26

K093877 · Edwards Lifesciences, LLC · DYB · Jul 1, 2010 · Cardiovascular

Device Facts

• Record ID: K093877
• Device Name: RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26
• Applicant: Edwards Lifesciences, LLC
• Product Code: DYB · Cardiovascular
• Decision Date: Jul 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The RetroFlex 3™ Introducer Sheath Set is intended for entry of interventional devices into the vascular system.

Device Story

Hydrophilic delivery system for percutaneous introduction of intravascular devices; used over 0.035" guidewire. System comprises sheath, introducer (dilator), and loader. Sheath contains three valves (duckbill, cross-slit, disc) for hemostasis; includes three-way stopcock for fluid infusion/aspiration. Loader facilitates entry of larger devices by bypassing sheath valves; loader includes its own disc valve. Used in clinical settings by healthcare professionals to provide vascular access for interventional procedures. Single-use, sterile device.

Clinical Evidence

Bench testing only. Verification included visual examination, dimensional verification, tensile strength, guidewire compatibility, hydrophilic coating testing, packaging integrity, and sterilization validation. Biocompatibility testing included MEM, Agar Overlay, blood compatibility, mouse systemic injection, rabbit pyrogen, rabbit intracutaneous irritation, guinea pig maximization, complement activation, and porcine thrombogenicity. Chemical testing included material verification and USP physico-chemical tests.

Technological Characteristics

Hydrophilic-coated catheter introducer system. Includes sheath, dilator, and loader. Features three-valve hemostasis system (duckbill, cross-slit, disc) and three-way stopcock. Available in 25F and 28F outer diameters. Tested per ISO 10555-1:1997. Sterile, single-use.

Indications for Use

Indicated for the percutaneous introduction of interventional devices into the vascular system. No specific patient population, age, or gender restrictions are stated.

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 Introducer Sheath (K031087)
• ANCURE® Sheath (K003889)

Submission Summary (Full Text)

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K093817

# 510(k) Summary

JUL· - 1 - 2010

Applicant:

Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 USA Phone: [phone] Fax: [phone]

Date:

May 21, 2010

Contact Persons:

Jason K. Lyon Principal Project Manager, Regulatory Affairs

Irene Parker Sr. Director of Regulatory Affairs

Proprietary Device Name:

RetroFlex 3™ Introducer Sheath Set

Common Device Name:

Catheter Introducer (21 CFR 870.1340, Product Code DYB), and;

Classification:

Predicate Devices:

Class II

Edwards Lifesciences, LLC - Edwards Introducer Sheath cleared under K031087

Guidant EndoVascular Surgery Group -ANCURE® Sheath cleared under K003889

Manufacturer:

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

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### Substantially Equivalent To:

The RetroFlex 3 Introducer Sheath Set was evaluated for in-vitro performance and biocompatibility tests, which are outlined below. The physical characteristics and mode of use of the RetroFlex 3 Introducer Sheath is similar to the Edwards Introducer Sheath and the Ancure® Sheath, and are common in mode of operation, intended use, and dimensions. The devices have only slight variations to technological design and materials. These differences, however, do not alter the fundamental use of the products, which is to facilitate entry into the arterial vasculature.

Based on the data presented in this 510(k) Premarket Notification, the RetroFlex 3 Introducer Sheath Set is substantially equivalent to the predicate devices.

## Description of the Device Subject to Premarket Notification:

The RetroFlex 3 Introducer Sheath Set is a hydrophilic delivery system used over a compatible 0.035" guidewire for the percutaneous introduction of intravascular devices. The RetroFlex 3 houses three (3) valves (a duckbill valve, a cross-slit valve, and a disc valve) to achieve hemostasis and is fitted with a three-way stopcock to allow infusion or aspiration of fluid. Each RetroFlex 3 Introducer Sheath Set contains a sheath, an introducer (or dilator), and a loader. The loader enables a device to enter into the sheath by bypassing all of the three valves within the sheath. The loader also contains a disc valve for hemostasis. The loader allows for larger devices to enter into the vascular system.

The RetroFlex 3 Introducer Sheath is for one-time use only, sold and packaged sterile. The table below identifies the model and sheath diameters. (Table 7.2).

| Model No. | Sheath O.D. | Sheath I.D. |
|-----------|-------------|-------------|
| 9120S23 | 25F | 22F |
| 9120S26 | 28F | 24F |

Table 7.2 - RetroFlex 3™ Introducer Sheaths

#### Indications For Use: 7.3

The RetroFlex 3 Introducer Sheath is intended for entry of interventional devices into the vascular system.

#### Performance Data: 7.4

The RetroFlex 3 Introducer Sheath was verified and tested according to performance testing standards ISO 10555-1:1997, Sec 4.5, Sterile Single Use Intravascular Catheters. The following tests have been conducted to demonstrate substantial equivalence to the predicate devices with respect to intended use, design, materials, and performance. The following non-clinical tests and biocompatibility tests were performed:

- . Visual examination
- Dimensional verification

7.2

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- Tensile strength .
- Guidewire compatibility .
- Hydrophilic coating test .
- . Packaging Integrity
- . Sterilization Validation
- Biocompatibility .
- Medium Eluate Method (MEM) o
- Agar Overlay Method (AO) o
- Blood Compatibility Test Method o
- Mouse Systemic Injection O
- Rabbit Pyrogen (Chemical-Mediated) Test o
- Rabbit Intracutaneous Irritation o
- Guinea Pig Maximization Test o
- Complement Activation Test o
- Thrombogenicity (porcine model) o
- Chemical .
- Material Verification o
- USP Physico-Chemical Test o

#### 7.5 Conclusion:

Based upon the non-clinical testing noted above and the data presented in the 510(k) Premarket Notification, the RetroFlex 3™ Introducer Sheath Set has met the requirements threshold to establish substantial equivalence to the predicate devices for market clearance.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a series of interconnected lines, possibly representing human figures or abstract shapes.

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

JUL - 1 2010

Edwards Lifesciences, LLC c/o Mr. Jason K. Lyon Principal Project Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614

Re: K093877

Trade/Device Name: RetroFlex 3TM Introducer Sheath Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: June 25, 2010 Received: June 28, 2010

Dear Mr. Lyon:

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 (117). general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandijng 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 devine 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 K. Lyon

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 (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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

e. h. hmer

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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### Traditional 510(k) - RetroFlex 3™ Introducer Sheath Set Edwards Lifesciences

## Statement of Indications for Use

Indications for Use

510(k) Number (if known): K093877

Device Name: RetroFlex 3™ Introducer Sheath Set

The RetroFlex 3™ Introducer Sheath Set is intended for entry of interventional devices into the vascular system.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Divina R. Valenzuela

.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Ko 93 877