MODIFICATION TO TRANSSEPTAL INTRODUCER SET

{0}------------------------------------------------ # KO2009 #### 510(k) SUMMARY SECTION VI: [as required by section 807.92(c)] ## FEB 1 1 2002 #### A. Submitter's Information: | Name: | Thomas Medical Products, Inc. | |---------------------------|----------------------------------------------| | Address: | 65 Great Valley Parkway<br>Malvern, PA 19355 | | Telephone Number: | 610.296.3000 | | Facsimile: | 610.296.4591 | | Contact Person: | Tim Stoudt | | Title: | Quality Assurance Engineering Manager | | Date Submission Prepared: | November 13, 2001 | #### 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) Transseptal Introducer Set Common or usual name(s): #### C. Legally marketed device to which equivalence is claimed: Thomas Medical Products, Inc., Transseptal Introducer Set (K932619) #### D. Description of the device: The Thomas Medical Products Inc. modified Transseptal Introducer Sets are designed to provide a conduit to deliver diagnostic and therapeutic catheters into the left side of the heart through the interatrial septum. Each modified Transseptal Introducer Set consists of; 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 Transseptal Introducer Sets as optional accessories. #### E. Intended use of the device: The Transseptal Introducer Set is indicated for the introduction of various types of cardiovascular catheters into the left side of the heart through the interatrial septum. #### F. Summary of the technological characteristics of the device compared to the predicate device: The technological characteristics of the device are the same as those of the predicate device. #### G. Substantial equivalence rationale: The Thomas Medical Products Inc. modified Transseptal Introducer Sets have the same general intended use / indications for use and technological characteristics as other previously cleared devices. Therefore, based on these similarities, the Thomas Medical Products, Inc. modified Transseptal Introducer Sets are substantially equivalent to the legally marketed predicate devices. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 1 2002 Mr. Tim Stoudt Manager, Quality Engineering Thomas Medical Products, Inc. 65 Great Valley Parkway Malvern, PA 19355 K020090 Re: Transseptal Introducer Kit Regulation Number: 870.1340 Regulatory Class: II (two) Product Code: 74 DYB Dated: January 25, 2002 Received: January 28, 2002 Dear Mr. Stoudt: We have reviewed your Section 510(k) notification of intent to market the device referenced we have leviewed your becally be is substantially equivalent (for the indications for use above and we nave dolorininou ano arteted predicate devices marketed in interstate commerce Stated in the encrosare) to logally manows of the Medical Device Amendments or to devices that provision in the provisions with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costlience Act (Act). " Fournaly, therefere responsible to determine that the medical devices you provisions of the 110. "100%er been determined as substantially equivalent under the use as componients in the surve ex.re 510(k) of the act), or were legally on the market prior to premarket notification process (Section of the Medical Device Amendments. Please note: If you May 20, 1970, the channonents in bulk (i.e., unfinished) and further process (e.g., sterilize) purchase your do ree components in luding these components in your kit/tray. The general you must submit a now 9 rott, octore requirements for annual registration, listing of devices, controls provisions of uctice, and labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations (1 remarket Approval) in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good {2}------------------------------------------------ ### Page 2 - Mr. Tim Stoudt Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS Modion Dovroos. General visual assumptions. Failure to comply with the GMP regulation may mspotions, I 27 x was on. Jo addition, the Food and Drug Administration (FDA) may publish festin in regulatory action arming your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the (2) of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from 00 1777 ) . One Economia Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page _ 6 _ of _ 6 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: For the introduction of various types of cardiovascular catheters into the left side of the heart through the interatrial septum. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | <div style="display:inline-block;">✓</div> | OR | Over-The-Counter-Use | |----------------------|--------------------------------------------|----|----------------------| | (Per 21 CFR 801.109) | | | (Optional Format |  | Division of Cardiovascular & Respiratory Devices | | |--------------------------------------------------|---------| | 510(k) Number | K020090 | t 1-2-96)