PTFE SUPER SHEATH INTRODUCER

K130855 · Martech Medical Products · DYB · Jul 29, 2013 · Cardiovascular

Device Facts

• Record ID: K130855
• Device Name: PTFE SUPER SHEATH INTRODUCER
• Applicant: Martech Medical Products
• Product Code: DYB · Cardiovascular
• Decision Date: Jul 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.

Device Story

The PTFE Super Sheath Introducer 2.0 is a vascular access device used to facilitate the placement of intravascular catheters or pacing leads. The device consists of a sheath and dilator assembly. In clinical use, a physician inserts an introducer needle into a vessel, places a guide wire, and removes the needle. The sheath/dilator assembly is then advanced over the guide wire to dilate the percutaneous opening. Once positioned, the dilator and guide wire are removed, leaving the sheath in place for catheter insertion. The sheath features a peel-away hub design for removal after the catheter is placed. The device is available in various French sizes (3F-9F) and lengths (5cm, 7cm, 10cm) to accommodate different clinical needs. It is intended for use in a clinical setting by trained healthcare professionals.

Clinical Evidence

Bench testing only. In-vitro testing performed to ensure design and performance per ISO standards, including liquid leakage, force at break, simulated use, equipment interaction, and surface examination. Biocompatibility testing confirms materials meet ISO 10993 requirements.

Technological Characteristics

Materials: PTFE (sheath tube), HDPE (sheath hub, dilator hub, 6F-9F dilators), Nylon (3F-5.5F dilators). Sizes: 3F to 9F. Lengths: 5cm, 7cm, 10cm. Principle: Percutaneous vascular access via sheath/dilator assembly. Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring central venous access for catheter insertion or pacing lead placement.

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

• Martech, PTFE Super Sheath Introducer (K120617)
• Medcomp, Micro-Stick Set (K091954)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo for Martech Medical Products. The logo features the word "MARTECH" in bold, uppercase letters above a stylized letter "M" formed by two arrows pointing towards each other. Below the logo, the words "MEDICAL PRODUCTS" are printed in a smaller font.

Image /page/0/Picture/1 description: The image shows the text "510(k) SUMMARY" in bold, uppercase letters. The text is underlined with a thick black line. The text is centered on the image.

KIBO855

#### A.. Submitter Information:

| Submitter: | MARTECH MEDICAL PRODUCTS<br>1500 Delp Drive<br>Harleysville, PA 19438<br>[phone] Telephone<br>[phone] Fax |
|----------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact: | Alexis Erazo |
| Date Prepared: | March 29, 2013 |

JUL 2 9 2013
**B.**

| Device Name: | PTFE Super Sheath Introducer 2.0 |
|-------------------------|----------------------------------|
| Common Name: | Super Sheath 2.0 |
| Classification Name: | Catheter Introducer (74 DYB) |
| C.F.R. Section: | 870.1340 |
| Product Code and Class: | DYB; II |

**C.**

| Predicate Devices: | K120617: Martech, PTFE Super Sheath Introducer<br>K091954: Medcomp, Micro-Stick Set |
|--------------------|-------------------------------------------------------------------------------------|
|--------------------|-------------------------------------------------------------------------------------|

#### D. Device Description:

The PTFE Super Sheath Introducer with Sheath/Dilator assembly facilitates vasular access for placement of intravascular catheters. Inserting an introducer needle into the desired vessel allows for initial access to the vascular system. A guide wire is then placed into the vessel through the needle and the needle is then removed. The sheath/dilator assembly is then inserted over the guide wire and into the percutaneous opening to dilate the opening into the vessel. The dilator and guide wire are then removed leaving the sheath in place. A catheter can then be placed through the sheath. Breaking the sheaths hub and peeling the sheath away from the catheter then allows the sheath to be removed. Its frame is composed of Teflon, HDPE, and Nylon. The sheath hub and dilator hub all HPDE, while the sheath tube is PTFE (Teflon) and the dilator is either Nylon for the 3F through the 5.5F sizes or HDPE for the 6F through 9F sizes. The Super Sheath's sheath is gray in color, with either a Light Blue Nylon dilator (3F-5.5F) or gray HDPE dilator (6F-9F). The dilator hub is composed of a different color to identify each individual French size (3F Purple, 3.5F Pink, 4F Red, 4.5F Yellow. 5F Light Gray, 5.5F Dark Gray, 6F Green, 6.5F Light Green, 7F Orange, 8F Blue, and 9F White), The PTFE Super Sheath 2.0 is available in eleven (11) different French sizes ranging from 3F to 9F. The Introducers are available with 5cm, 7cm or 10cm length options.

1500 Delp Drive · Harleysville, PA 19438 USA 5013485 Phone: [phone] · Fax: [phone] www.martechmedical.com 137 27

page 1 of 3

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for Martech Medical Products. The logo features the word "MARTECH" in bold, uppercase letters above a stylized letter "M". The "M" is formed by two arrows pointing towards each other. Below the logo, the words "MEDICAL PRODUCTS" are written in smaller, uppercase letters.

#### E. Intended Use:

Introducer is intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.

#### p. Indications for Use:

The PTFE Super Sheath Introducers 2.0 are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.

#### G. Comparison to Predicate Devices:

The PTFE Super Sheath Introducer 2.0 is substantially equivalent to the predicate devices in terms of intended use, anatomical location, general design, and materials. The PTFE Super Sheath Introducer 2.0 differs from its Martech PTFE Super Sheath Introducer 510K120617 predicate in regards to minor dimensional changes and material changes for physician preferences. The original Martech PTFE Super Sheath Introducer was composed of a PTFE Sheath with a HDPE Dilator. The PTFE Super Sheath Introducer 2.0 still features a PTFE Sheath, however, sizes 3F-5.5F contain a Nylon Dilator instead of an HDPE Dilator. Dimensionally, the PTFE Super Sheath Introducer 2.0 maintains the identical ID and OD dimensions of the Martech PTFE Super Sheath Introducer with a difference in the dilator lumen length to provide a larger exposed area from end of sheath to tip of dilator. Furthermore, the PTFE Super Sheath Introducer 2.0 is now available in a 7cm length, which is within the range of the original Martech PTFE Super Sheath Introducer. The Nylon Dilator material is equivalent to the Medcomp Micro-Stick Set 510K091954 predicate. The Medcomp Micro-Stick Set Predicate is only used to demonstrate material equivalency to the PTFE Super Sheath Introducer 2.0.

#### ਜ਼. Bench / Performance Data:

The following in-vitro testing was performed on the PTFE Super Sheath Introducer to assure reliable design and performance in accordance with ISO standards and/or internal procedures.

- � Liquid Leakage
- . Force at Break
- Simulated Use *
- Equipment Interaction
- Surface Examination ●

Image /page/1/Picture/15 description: The image shows a logo for ISO 13485. The logo has the letters ISO stacked on top of the numbers 13485. Below the letters and numbers, the words "Certified Quality System" are written in a smaller font. The logo is black and white.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Martech Medical Products. The logo features the word "MARTECH" in bold, uppercase letters above a stylized letter "M" formed by two arrows pointing towards each other. Below the logo, the words "MEDICAL PRODUCTS" are printed in smaller, uppercase letters.

#### H. Biocompatibility:

Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993.

### I. Conclusion:

The proposed devices meet the performance criteria of design verification as specified by ISO standards and test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise new issues of safety and effectiveness. The proposed devices are substantially equivalent to the legally marketed predicate devices.

| 1500 Delp Drive • Harleysville, PA 19438 USA |
|----------------------------------------------|
| Phone: [phone] • Fax: [phone] |
| www.martechmedical.com |

ISO 13485
Certified Quality System

K130855 page 3 of 3

{3}------------------------------------------------

Image /page/3/Picture/0 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 29, 2013

Martech Medical Products c/o Alexis Erazo Regulatory Specialist 1500 Delp Drive Harleysville, PA 19438

Re: K130855

Trade Name: PTFE Super Sheath Introducer 2.0 Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 16, 2013 Received: July 17, 2013

Dear Ms. Erazo:

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.

{4}------------------------------------------------

Page 2 - Ms. Alexis Erazo

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 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" (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.htm.

Sincerely yours,

M.A. Hillemann

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

Enclosure

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known): K130855___

Device Name: PTFE Super Sheath 2.0

Indications for Use:

The PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.

Prescription Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Hillemann