(264 days)
Not Found
No
The description details a purely mechanical device for vascular access and does not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
No.
The device is an introducer sheath used to facilitate the insertion of catheters or pacing leads, not to provide therapy itself.
No
The device description clearly states its purpose is to "obtain central venous access to facilitate catheter insertion or placing pacing leads," indicating it is an access tool for medical procedures, not a diagnostic one.
No
The device description clearly outlines physical components made of HDPE and PTFE, and the performance studies involve in-vitro testing of these physical properties. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system." This describes a procedure performed directly on a patient's body for therapeutic or diagnostic purposes in vivo.
- Device Description: The description details a physical device used to create an opening in a blood vessel to allow other devices to be inserted. This is a surgical/interventional tool, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Introducer is intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.
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.
Product codes
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
- Force at Break
- Simulated Use
- Equipment Interaction
- Surface Examination
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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:
C.
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:
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.
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
1
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.
2
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
3
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
4
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