(75 days)
For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal perforation / puncture.
The Thomas Medical Products Inc. Braided Guiding Introducer System(s) are designed t to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations in the heart. The sheath may be used for percutaneous entry. Each Braided Guiding Introducer System consists of the following: a sheath, a dilator, and a "J" tip guidewire. In addition, a standard 12 cc syringe, a 18 gage XTW introducer needle, and a pre-dilator may also be packaged with the Braided Guiding Introducer System.
The provided text describes a 510(k) premarket notification for a medical device, the "Braided Guiding Introducer System." However, it does not contain any information regarding acceptance criteria, device performance derived from a study, or details of a study's methodology.
The document states that the device is substantially equivalent to a legally marketed predicate device (Thomas Medical Products, Inc., 6 French Braided Guiding Introducer, K013202) because:
- Identical Intended Use/Indications for Use: The new device has the same indications for use as the predicate device, which is "For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal perforation / puncture."
- Identical Technological Characteristics: The technological characteristics of the new device are the same as those of the predicate device.
Since this is a 510(k) submission based on substantial equivalence, the FDA typically does not require new performance studies if the device is sufficiently similar to an already cleared predicate. The focus is on demonstrating that the new device raises no new questions of safety or effectiveness compared to the predicate.
Therefore, I cannot provide the requested information, as the input text does not contain it. The sections regarding acceptance criteria, reported performance, sample size, ground truth, expert involvement, adjudication, MRMC studies, or standalone studies are not present in the provided 510(k) summary and FDA letter.
{0}------------------------------------------------
Ko40713
510(k) SUMMARY SECTION VI: [as required by section 807.92(c)] Submitter's Information: A. JUN - 1 2004 Thomas Medical Products, Inc. Name: 65 Great Valley Parkway Address: Malvern, PA 19355 610.296.3000 Telephone Number: 610.296.4591 Facsimile: Tim Stoudt Contact Person: Quality Assurance Engineering Manager Title: Date Submission Prepared: February 20, 2004 B. Device Information: Not assigned at the time of submission Trade name: Catheter Introducer (21 CFR §870.1340), Vessel Classification Name(s): Dilator (21 CFR §870.1310), Percutaneous Catheter (21 CFR §870.1250) Braided Guiding Introducer System Common or usual name(s): Legally marketed device to which equivalence is claimed: C. Thomas Medical Products, Inc., 6 French Braided Guiding Introducer (K013202) Description of the device: D. The Thomas Medical Products Inc. Braided Guiding Introducer System(s) are designed t to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations in the heart. The sheath may be used for percutaneous entry. Each Braided Guiding Introducer System consists of the following: a sheath, a dilator, and a "J" tip guidewire. In addition, a standard 12 cc syringe, a 18 gage XTW introducer needle, and a pre-dilator may also be packaged with the Braided Guiding Introducer System. Intended use of the device: E. The Braided Guiding Introducer System is indicated for the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal perforation / puncture. Summary of the technological characteristics of the device compared to the F. predicate device: The technological characteristics of the device are the same as those of the predicate device. Substantial equivalence rationale: G. The Thomas Medical Products Inc. Braided Guiding Introducer System has similar r ne ral intended use / indications for use and technological characteristics as other previously cleared devices. Therefore, based on these similarities, the Thomas Medical Products, Inc. Braided Guiding Introducer System is substantially equivalent to the legally marketed predicate devices.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features an abstract image of an eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2004
Thomas Medical Products, Inc. c/o Mr. Tim Stoudt Manager, Quality Engineering 65 Great Valley Parkway Malvern, PA 19355
K040713 Re: Braided Guiding Introducer System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 21, 2004 Received: May 4, 2004
Dear Mr. Stoudt:
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 such 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.
{2}------------------------------------------------
Page 2 - Mr. Tim Stoudt
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a substition with other requirements of the Act
that FDA has made a determination that your device of a complies . You must that FDA nas made a decemination that your and regulation to registration and listing or any Federal statutes and regulations administer of rot limited to: registration and listing (21 l
east and the Act's requirements, including, but not to reastion requireme comply with all the Act STEquilements, merialism practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sectronic CFR Part 807); iabeling (21 CFR Part 801); good manart 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patty 21 CFR 1000-1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Actile d in your Section 5 product radiation control provisions (Sections 95 cm device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to le This letter will allow you to begin makemig your artial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your de premarket notification. The FDA midnig of Sabstantal Popularian Porty of Survice to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac not and and and the regulation entitled, and the increases and Contact the Office of Comphalled at (So received (21CFR Part 807.97). You may obtain " Misoranding by reference to premation is and the Act from the Division of Small other general information on your responsiveness and its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
(301) +45-0577 of ut its intril.com/cdrh/dsma/dsmamain.html
Sincerely yours,
urmh R. Lochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
{3}------------------------------------------------
Indications for Use
510(k) Number (if known):__K040713
Device Name:__Braided Guiding Introducer System
Indications For Use:
For the percutaneous introduction of various types of cardiovascular catheters to all
e and the supportunities in the first in and transcentel porforetion / puncture For the percularieous introduction of vanode types of the procession / puncture.
OR
For the percutaneous introduction of various types of cardiovascular catheters to all
e and the programment of the supportune stars seental puncture Por the percularieous introduction atrium via transseptal puncture.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dana R. Vachner
(Division Sign-Off) (Division Skyn-Oli)
Division oi Cardiovascular Devices
510(k) Number K040713
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
.. .
§ 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).