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 Description

The PTFE Super Sheath Introducer with Sheath/Dilator assembly facilitates vascular 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 mostly HDPE, as the sheath hub, dilator and dilator hub are all HPDE. The sheath tube is composed of PTFE (Teflon). The Super Sheath if gray in color with the exception of the dilator hub which 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 is available in eleven (11) different French sizes ranging from 3F to 9F. The Introducers are available 3F-7F with a Scm length or 3F-9F in the 10cm length option.

AI/ML Overview

The medical device in question is the "PTFE Super Sheath Introducer" manufactured by MARTECH MEDICAL PRODUCTS. This device is intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.

Based on the provided text, the acceptance criteria and the study that proves the device meets these criteria can be summarized as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test Performed	Reported Device Performance
Air Leakage	Performed, results assure reliable design and performance in accordance with ISO standards and/or internal procedures.
Liquid Leakage	Performed, results assure reliable design and performance in accordance with ISO standards and/or internal procedures.
Force at Break	Performed, results assure reliable design and performance in accordance with ISO standards and/or internal procedures.
Simulated Use	Performed, results assure reliable design and performance in accordance with ISO standards and/or internal procedures.
Equipment Interaction	Performed, results assure reliable design and performance in accordance with ISO standards and/or internal procedures.
Surface Examination	Performed, results assure reliable design and performance in accordance with ISO standards and/or internal procedures.
Biocompatibility (ISO 10993)	All biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993.
Substantial Equivalence	The device is substantially equivalent to predicate devices (K000313, K053092, K090394) in terms of intended use, anatomical location, general design, and materials.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided document does not specify the exact sample sizes used for each in-vitro test. It only states that "in-vitro testing was performed." The provenance of the data is not explicitly mentioned (e.g., country of origin), nor whether the tests were retrospective or prospective, though in-vitro tests are inherently experimental and controlled, rather than observing pre-existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable. The device is a medical introducer sheath, and the testing described is primarily mechanical and material performance (in-vitro bench testing) and biocompatibility, not diagnostic or clinical performance that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the testing involves objective measurements against predefined ISO standards and internal procedures, not subjective human assessment needing adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a physical medical instrument (introducer sheath), not an AI-powered diagnostic tool, and therefore MRMC studies with human readers are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical medical instrument; there is no algorithm or AI component involved.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the in-vitro bench testing, the "ground truth" would be the specifications and requirements outlined in the applicable ISO standards and the manufacturer's internal procedures for device design and performance. For biocompatibility, the ground truth is established by ISO 10993 standards. For the substantial equivalence claim, the ground truth is the performance and characteristics of the legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable as the device is not an AI/machine learning system that requires a "training set." The performance is validated through physical and chemical testing.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above; there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image is a logo for a company called MARTECH MEDICAL PRODUCTS. The logo features the word "MARTECH" in large, bold letters at the top. Below the word is a large, stylized letter "M" that is made up of two arrows pointing towards each other. Underneath the "M" is the phrase "MEDICAL PRODUCTS" in smaller letters.

NOV 1 9 2012

510(k) SUMMARY

A. Submitter Information:

Submitter:

Contact: Date Prepared: MARTECH MEDICAL PRODUCTS 1500 Delp Drive Harleysville, PA 19438 (215) 256-8833 Telephone (215) 256-9191 Fax Alexis Erazo March 1, 2012

B. Device Name:

Common Name: Classification Name: C.F.R. Section: Product Code and Class:

Predicate Devices:

Super Sheath Catheter Introducer (74 DYB) 870.1340 DYB; II

PTFE Super Sheath Introducer

K000313: Xentek, Tearaway Introducer Sheath K053092: Medcomp, Vascu-Sheath II K090394: Medcomp, Valved Tearaway Introducer

D. Device Description:

1500 Delp Drive · Harleysville, PA 19438 USA Phone: 215.256.8833 · Fax: 215.256.8837 www.martechmedical.com 22-4

ISO 13485
Certified Quality System

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Image /page/1/Picture/0 description: The image shows a logo for MARTECH. The logo is a stylized letter "M" with arrows pointing in opposite directions. The word "MARTECH" is written in bold, block letters above the "M" symbol. The logo is black and white and has a slightly distressed or textured appearance.

MEDICAL PRODUCTS

E. Intended Use:

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

F. 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.

Comparison to Predicate Devices: G.

The PTFE Super Sheath Introducer is substantially equivalent to the predicate devices in terms of intended use, anatomical location, general design, and materials.

H. 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.

Air Leakage �
Liquid Leakage 0
o Force at Break
Simulated Use o
. Equipment Interaction
Surface Examination 0

Biocompatibility: H.

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.

Image /page/1/Picture/21 description: The image shows the ISO 13485 certification logo. The logo is divided into two parts, with "ISO" on the left and "13485" on the right. Below the numbers, the text "Certified Quality System" is written in a smaller font. The logo is enclosed in a rectangular border.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

NOV 1 9 2012

Martech Medical Products Ms. Alexis Erazo Regulatory Specialist 1500 Delp Drive Harleysville, PA 19438

Re: K120617

Trade/Device Name: PTFE Super Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter, Introducer Regulatory Class: Class II Product Code: DYB Dated: October 22, 2012 Received: October 23, 2012

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.

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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Page 2 - Ms. Alexis Erazo

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours, Matthew G.

Digitally signed by Matthew G. Hillebrenn
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=1300213272,
cn=Matthew G. Hillebrenner
Date: 2012.11.20 11:49:57 -05'00'

Hillebrenner for Bram Zuckerman, M.D.

Director

Division of Cardiac Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Indications for Use

1420617 510(k) Number (if known):

Device Name: PTFE Super Sheath

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 (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sian-C ision of Cardiovascular Devices

120617 510(k) Number

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).