PTFE Super Sheath Introducer 2.1

K153246 · Medcomp (Medical Components, Inc.) · DYB · Feb 12, 2016 · Cardiovascular

Device Facts

• Record ID: K153246
• Device Name: PTFE Super Sheath Introducer 2.1
• Applicant: Medcomp (Medical Components, Inc.)
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 12, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Super Sheath Introducer is intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system. The Super Sheath is compatible with a 0.018" or smaller guidewire.

Device Story

PTFE Super Sheath Introducer 2.1 facilitates central venous access for catheter or pacing lead placement. Device consists of sheath and dilator; compatible with 0.018" or smaller guidewires. Used in clinical settings by healthcare professionals. Operates via standard percutaneous insertion techniques. Provides access path for interventional procedures. Benefits patient by enabling minimally invasive delivery of catheters or leads into central venous system. Modification from predicate involves dilator material change from nylon to nylon/Pebax blend.

Clinical Evidence

Bench testing only. Performance data included liquid leakage, air leakage, force at break, simulated use, and equipment interaction testing. Biocompatibility testing confirmed materials meet ISO 10993 requirements.

Technological Characteristics

Catheter introducer (3F-5.5F). Materials: PTFE sheath, nylon/Pebax blend dilator. Compatible with 0.018" guidewires. Sterilization method identical to predicate. No software or electronic components.

Indications for Use

Indicated for patients requiring central venous access for catheter insertion or pacing lead placement. No specific age or gender restrictions noted.

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

• PTFE Super Sheath Introducer 2.0 (K130855)

Submission Summary (Full Text)

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Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.

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

February 12, 2016

Courtney Nix Regulatory Associate MedComp (Medical Components, Inc.) 1499 Delp Dr. Harleysville, PA 19438

Re: K153246

Trade/Device Name: PTFE Super Sheath Introducer 2.1 Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: January 11, 2016 Received: January 15, 2016

Dear Ms. Nix:

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.

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

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Kenneth J. Cavanaugh -S

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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K153246

Device Name PTFE Super Sheath 2.1

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image features the logo for medCOMP. The logo consists of a stylized geometric shape in red, resembling a house or an abstract letter. Below the shape, the word "med" is written in red, followed by "COMP" in gray. The overall design is clean and modern.

1499 Delp Drive

Harleysville, PA 19438

Tel: [phone]

Fax. [phone]

www.medcompnet.com

| Section 9 | | 510(k) SUMMARY | Special 510K |
|-----------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| A. | Submitter Information: | | |
| | Submitter: | Medcomp (Medical Components, Inc.)<br>1499 Delp Drive<br>Harleysville, PA 19438<br>[phone] Telephone<br>[phone] Fax | |
| | Contact: | Courtney Nix<br>[e-mail] | |
| | Date Prepared: | 11/3/2015 | |
| B. | Device Name: | PTFE Super Sheath Introducer 2.1 | |
| | Common Name: | Super Sheath 2.1 | |
| | Classification Name: | Catheter Introducer (74 DYB) | |
| | C.F.R. Section: | 870.1340 | |
| | Product Code | DYB | |
| | Class: | II | |
| | Sizes: | 3F - 5.5F | |
| C. | Predicate Devices: | K130855<br>PTFE Super Sheath Introducer 2.0 | |
| | | Original Applicant: Martech Medical<br>Products<br>Current: Medcomp (Medical Components, Inc)<br>Transferred: February 12, 2015 | |
| D. | Intended Use: | The Super Sheath Introducer is intended to obtain central<br>venous access to facilitate catheter insertion or placing<br>pacing leads into the central venous system. The Super<br>Sheath is compatible with a 0.018" or smaller guidewire. | |
| | This is the <u>identical intended use</u> as previously cleared in PTFE<br>Super Sheath 2.0, K130855. | | |
| E. | Indications for Use: | | |
| | | | 9-1 |

是

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Image /page/4/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized house or building. Below the shape, the word "med" is written in red, while "COMP" is written in gray. The logo has a clean and modern design.

1499 Delp Drive

Harleysville, PA 19438

F.

Tel: [phone]

Fax. [phone]

www.medcompnet.com

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

This is the identical indications for use as previously cleared in PTFE Super Sheath 2.0, K130855.

Comparison to Predicate Devices:

The PTFE Super Sheath Introducer 2.1 is substantially equivalent to the predicate devices in terms of intended use, indications for use. anatomical location, and general design. The sole difference between the predicate device (K130855; Super Sheath 2.0) and the proposed device is the material change to dilatory. The dilator material that was approved in the predicate 510K submission was nylon, the proposed has a dilator composed of a nylon/Pebax blend.

### G. Substantial Equivalence:

The modified Super Sheath 2.1 has the following similarities to the predicate device (Super Sheath 2.0, K130855):

- Identical indicated use .
- . Identical indications for use
- Identical operating procedure ●
- Identical manufacturing processing and sterilization method .
- o Identical packaging
- Identical design and operation o

In summary the Super Sheath 2.1, as described with modifications in this submission is, in our opinion, substantially equivalent to the predicate device.

### H. Summary of Design Control Activities:

A risk analysis was conducted per ISO 14971 Second Edition 2007-03-01, Medical Devices - Application of Risk Management To Medical Devices (General I (QS/RM)). The design verification tests that were performed as a result of this risk analysis are listed in Section 10: Bench/Performance Data of this submission (Tables 1-6).

The test methods used are the same as those submitted in the original submission.

A declaration of conformity with design controls is included in this submission

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Image /page/5/Picture/0 description: The image shows the MedComp logo. The logo consists of a stylized letter "M" in pink, with the word "med" in pink and "COMP" in gray below it. The "M" is made up of geometric shapes, including a triangle at the top and a diamond shape in the middle.

1499 Delp Drive

Harlevsville, PA 19438

Tel: [phone]

Fax. [phone]

www.medcompnet.com

### Labeling:

-

J.

There are no changes in the labeling or IFU from the predicate device.

### Bench / Performance Data:

The following in-vitro testing was performed PTFE Super Sheath Introducer v2.1 to assure reliable design and performance in accordance with ISO standards and/or internal procedures. (See Section 10: Bench/Performance Data)

- Liquid Leakage g
- の Air Leakage
- Force at Break ●
- Simulated Use 0
- Equipment Interaction @

### H. Biocompatibility:

Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993. (See Section 11: Biocompatibility)

#### ا. Software:

This section in not applicable as the Super Sheath 2.0 does not utilize software.

#### J. Sterility Information:

There are no changes to the sterilization method, or parameters for the proposed device. Sterilization is identical to what was approved for the predicate device, Super Sheath 2.0. K130855.

### K. 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.