OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER

K093232 · Great Batch Medical · DYB · Mar 15, 2010 · Cardiovascular

Device Facts

• Record ID: K093232
• Device Name: OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER
• Applicant: Great Batch Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The OptiSeal™ Valved PTFE Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Device Story

Small diameter tubular introducer with integrated proximal handles; available in non-sideport and sideport configurations. Sideport configuration includes extension tubing and 3-way stopcock. Device provides atraumatic access to venous system for catheter/lead placement while maintaining hemostatic seal. Introducer is peelable, allowing removal after insertion without disturbing the placed catheter or lead. Packaged in sterile convenience kits with needle, syringe, and guidewire. Used by clinicians in clinical settings for cardiovascular procedures.

Clinical Evidence

Bench testing only. No clinical or animal data deemed necessary due to limited scope of modifications and identical intended use. Verification testing confirmed device performance met all specification criteria.

Technological Characteristics

PTFE tubular introducer; integrated proximal handles; sideport configuration includes extension tubing and 3-way stopcock. Peelable design. Sterile, single-use. Biocompatible materials. No software or electronic components.

Indications for Use

Indicated for percutaneous insertion of pacing leads or catheters into the venous system.

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

• ViaSeal Valved Peelable Introducers (K063182)
• Merit Prelude Sheath Introducer (K070159)

Submission Summary (Full Text)

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K093232

Image /page/0/Picture/1 description: The image shows the logo for Greatbatch Medical. The logo consists of a hexagon shape made up of smaller hexagons, with one of the hexagons filled in black. To the right of the hexagon shape is the text "Greatbatch Medical" in a bold, sans-serif font.

### 510(K) Summary

MAR 1 5 2010

### 5.1 Applicant Information

Submitter's Name: Address:

Greatbatch Medical 2300 Berkshire Lane North Minneapolis, MN 55441

2183787 .

Establishment Registration No:

Contact Person:

Shannon Springer Principal Regulatory Affairs Specialist [e-mail] [phone] (phone) [phone] (fax)

Sterilization Facility:

Steris, Inc. 380 90th Avenue Northwest Minneapolis, MN 55433 Tel: [phone] Fax: [phone] Establishment Registration No: 2183744

### 5.2 Device Information

Trade Name: Classification Name: Product Code: Regulation: Panel:

OptiSeal™ Valved PTFE Peelable Introducer Introducer, Catheter DYB Class II, 21 CFR 870.1340 Cardiovascular

### 5.3 Device Description

The Greatbatch Medical OptiSeal Valved PTFE Peelable Introducer, available in non-sideport and sideport configurations, is a small diameter tubular shaped device with integrated proximal handles. Both configurations of the OptiSeal Valved PTFE Peelable Introducer are designed to provide a relatively atraumatic method for insertion of catheters and pacemaker leads into the venous system while providing hemostatic sealing to venous pressures. Both introducer configurations peel away after use allowing the user to remove the introducer without removing the inserted catheter or pacing lead. The sideport configuration of the OptiSeal Valved Peelable Introducer is equipped with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock.

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The OptiSeal Valved PTFE Peelable Introducer is packaged in sterile convenience kits containing a Valved PTFE Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire. The convenience kits are packaged five (5) per box.

### 5.4 Indications for Use

The OptiSeal™ Valved PTFE Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

# 5.5 Predicate Device Comparison / Technological Characteristics

The OptiSeal Valved PTFE Peelable Introducer, available in both non-sideport and sideport configurations, is a modification of the previously cleared non-sideport ViaSeal Valved Peelable Introducers (K063182). The OptiSeal Valved PTFE Peelable Introducer configurations covered by this submission are identical in function, mechanism of action and intended use as the predicate nonsideport ViaSeal Valved Peelable Introducers (K063182). In addition, the OptiSeal Valved PTFE Peelable Introducer with sideport shares a similar intended use, with respect to use in the venous system, and mechanism of action as the sideported Merit Prelude Sheath Introducer (K070159).

# 5.6 Summary of Testing

The OptiSeal Valved PTFE Peelable Introducer passed all verification specification criteria for dimensional, strength, functional, packaging, sterilization, biocompatibility and shelf life tests. Test results confirm the device performs as intended without raising additional questions of safety and efficacy when compared to the predicate. Given the limited scope of the modifications incorporated to create the OptiSeal Valved PTFE Peelable Introducer and identical intended use.no animal or clinical data was deemed necessary.

### 5.7 Statement of Equivalence

The Greatbatch Medical OptiSeal Valved PTFE Peelable Introducer has identical indications for use, technological characteristics and principles of operation as the market cleared ViaSeal Valved Peelable Introducers (K063182). In addition, the OptiSeal Valved PTFE Peelable Introducer with sideport shares a similar intended use, with respect to use in the venous system, and mechanism of action as the Merit Prelude Sheath Introducer (K070159). The differences between this device and its predicate devices do not raise new questions of safety or efficacy. Therefore, the OptiSeal Valved PTFE Peelable Introducer is substantially equivalent to the previously cleared ViaSeal Valved Peelable Introducers (K063182) and Merit Prelude Sheath Introducer (K070159).

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol, which is often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol. The caduceus is depicted as a stylized design with a bird-like figure and flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Greatbatch Medical c/o Ms. Shannon Springer Principal Regulatory Affairs Specialist 2300 Bershire Lane North Minneapolis, MN 55441

MAR 1 5 2010

Re: K093232

Trade Name: OptiSeal™ Valved PTFE Peelable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II (two) Product Code: DYB Dated: March 8, 2010 Received: March 9, 2010

Dear Ms. Springer:

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.

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Page 2 - Ms. Shannon Springer

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 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.htm1.

Sincerely vours.

R. luchner

>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): K093232

Device Name: OptiSeal Valved PTFE Peelable Introducer

Indications for Use:

The OptiSeal™ Valved PTFE Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(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)

purner R. Valual (Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_k693232