PTFE PEELABLE INTRODUCER

K093023 · Great Batch Medical · DYB · Oct 29, 2009 · Cardiovascular

Device Facts

• Record ID: K093023
• Device Name: PTFE PEELABLE INTRODUCER
• Applicant: Great Batch Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 29, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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

Device Story

The PTFE Peelable Introducer is a single-use, sterile kit used by clinicians for percutaneous venous access. The kit includes a needle, syringe, guidewire, and a peelable introducer set (dilator and sheath). The dilator is delivered over a guidewire to facilitate sheath placement. The sheath features a 'peel-away' design, allowing the clinician to remove the sheath after the pacing lead or catheter is inserted without disturbing the lead/catheter position. The device is radiopaque for fluoroscopic visualization. It assists in the placement of cardiovascular devices, potentially improving procedural efficiency and patient outcomes during lead or catheter implantation.

Clinical Evidence

No clinical evaluations were performed. Substantial equivalence is supported by bench testing, including functional and dimensional verification.

Technological Characteristics

Materials: High-density polyethylene (dilator/hub), PTFE and TPX (sheath/handle). Dimensions: 3.5F to 16.5F. Features: Radiopaque, peel-away sheath, spin-lock luer connection. Sterilization: Provided sterile, single-use. No software or electronic components.

Indications for Use

Indicated for percutaneous insertion of pacing leads or catheters into the venous system in patients requiring such access.

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

• Greatbatch Medical PTFE Peelable Introducer (K081394)

Submission Summary (Full Text)

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K093023

Greatbatch Medical Special Premarket Notification 510(k)

Image /page/0/Picture/3 description: The image shows the logo for Greatbatch Medical. The logo consists of a hexagon shape made up of six smaller hexagons, with one of the hexagons filled in black. To the right of the hexagon shape is the text "Greatbatch" in a bold, sans-serif font, with the word "Medical" below it in a smaller font. The logo is simple and modern, and the use of the hexagon shape suggests a connection to science or technology.

# 510(K) Summary

## 4.1 Applicant Information

OCT 2 9 2009

| Submitter's Name: | Greatbatch Medical |
|-------------------|---------------------------|
| Address: | 2300 Berkshire Lane North |
| | Minneapolis, MN 55441 |

Establishment Registration No: 2183787

Contact Person: Kristi Fox Regulatory Affairs Associate [e-mail] [phone] (phone) [phone] (fax)

## 4.2 Device Information

| Trade Name: | PTFE Peelable Introducer |
|----------------------|---------------------------|
| Classification Name: | Introducer, Catheter |
| Product Code: | DYB |
| Regulation: | Class II, 21 CFR 870.1340 |
| Panel: | Cardiovascular |

#### 4.3 Performance Standards

No performance standards applicable to this product have been developed under Section 514 of the Act.

#### 4.4 Predicate Device

· Greatbatch Medical PTFE Peelable Introducer (K081394)

### 4.5 Device Description

The Greatbatch Medical PTFE Peelable Introducer kit consists of a disposable needle, a disposable syringe, a guidewire, and a peelable introducer set consisting of a dilator and sheath with integrated proximal handles. The Introducer is available in various lengths in 3.5F through 16.5F. The dilator is designed to be delivered over a guidewire.

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The dilator and hub is constructed of high density polyethylene. The outer sheath and handle is constructed of PTFE and TPX. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub of the dilator has a spin lock design that connects to the luer of the sheath when rotated.

The PTFE Peelable Introducer sheath has a "peel-away" feature which allows the user to remove the sheath without removing the inserted catheter or pacing lead. The PTFE Peelable Introducer is provided sterile and is intended for single use. The device is not intended for sterilization by the user.

#### 4.6 Indications for Use

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

#### 4.7 Summary of Non-Clinical Testing

Performance Testing: The performance testing for this device included testing to verify that the device continues to functions in a safe and effective manner. The performance testing included the device specifications, functional and dimensional testing of the PTFE Peelable Introducer and other testing as applicable to the device. Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user.

#### 4.8 Summary of Clinical Testing

No clinical evaluations of this product have been performed.

#### 4.9 Statement of Equivalence

Through the information presented, Greatbatch Medical considers the PTFE Peelable Introducer to remain substantially equivalent to the currently marketed Greatbatch Medical PTFE Peelable Introducers based on a comparison of the indications for use and the technological characteristics. The testing performed confirms that the PTFE Peelable Introducer will perform as intended.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES * USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller font size.

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

# OCT 2 9 2009

Greatbatch Medical % Ms. Kristi Fox 2300 Berkshire Lane North Minneapolis, MN 55441

Re: K093023

Trade/Device Name: PTFE Peelable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: September 25, 2009 Received: September 29, 2009

Dear Ms. Fox:

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.

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

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Page 2-Ms. Kristi Fox

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,

Le From Zuckerman, M.

Bram 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

Kog3023 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: PTFE Peelable Introducer

Indications for Use:

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

Prescription Use____ X

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

Division of Cardiovascular Devices
510(k) Number K0943023

Confidential ·

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