PROGREAT

{0}------------------------------------------------ ## SECTION II. SUMMARY AND CERTIFICATION ### SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE #### Device Name A. Progreat™ Proprictary Name Classification Name Diagnostic Intravascular Catheter Angiographic Catheter Common Name #### B. Intended Use The Progreat™ is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels, and all coronary vessels. The Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis in procedures including but not limited to Uterine Fibroid Embolization. The Progreat should not be used in cerebral vessels. #### C. Device Description The Progreat catherer is available with or without the following accessories: guide wire, inserter, mandrel (stylet), syringe, wire stopper, and Y-connector. The catheter consists of metal coil reinforced multi-layer polymer tubing. The coil is embedded in the catheter wall the entire length of the catheter. This increases the flexibility, kink resistance, and pressure resistance of the catheter. The inner layer of the catheter is made of PTFE (polytetrafluoroethylene) to ensure smooth movement of devices such as the guide wire. The outer surface of the catheter is coated with a hydrophilic polymer which becomes lubricious when wet with saline solution or blood. The following are accessories to the catheter and will be supplied in different configurations depending on the product code: The guide wire has a super-elastic alloy core and is surface coated with a hydrophilic polymer. This cnhances advancement of the guide wire into a peripheral vessel. {1}------------------------------------------------ The inserter is used to assist the physician in the placement of the guide wire within the catheter. The mandrel (stylct) is used in the shaping of the catheter for procedures that require a catheter with a tip configuration other than straight. The syringe is used in the priming of the catheter. The syringe can be filled with heparinized saline solution and then this solution can be injected into the catheter. The wire stopper can be clipped onto the guide wire to adjust the protruding length of the guide wire. The Y-connector can be used to connect a power injector unit to the end of the catheter for infusion of contrast media. #### Principle of Operation / Technology D. The Progreat catheter and the accessories included in this 510(k) are operated manually or by a manual process. #### E. Design / Materials This device is the identical device cleared under K033583. There are no material or design changes therefore there are no new issues of safety and effectiveness. {2}------------------------------------------------ | Part | Progreat Catheter | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------| | Available Sizes (Fr.) | 2.8/2.7/2.4/2.0 | | Catheter length | 100-150 | | Guide wire size | 0.021" | | Accessories | With guide wire-<br>Syringe, inserter, Y-connector, mandrel (stylet), and wire stopper<br><br>Without guide wire-<br>Mandrel (stylet) | #### Specifications F. Note: This is the same device cleared under K033583 only the intended use has changed for this premarket notification. #### G. Performance The Progreat catheter is available with or without the following accessories: guide wire, inserter, mandrel (stylet), syringe, wire stopper, and Y-connector. All of the accessories are the same as the ones used with the currently cleared device K033583. This device is the identical device that was cleared under K033583 A risk/hazard analysis was conducted according to EN1441 Medical devices- Risk analysis and ISO 14971 Medical Devices -Application of risk management to medical devices. There were no new issues of safety and effectiveness with regards to the new indication. No additional testing was deemed necessary. Therefore the performance of the Progreat Catheter is substantially equivalent to the performance of the Progreat, cleared under K033583. #### H. Additional Safety Information Manufacturing controls include visual, functional, dimensional and sterility tests. The Progreat catheter is classified as an Externally Communicating Device. Circulating Blood, Limited Contact (<24 hrs). The device's blood contacting materials were tested in accordance with the tests recommended in the FDA General {3}------------------------------------------------ Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing". Results of the testing demonstrate that the blood contacting materials are biocompatible. Sterilization conditions have been validated in accordance to AAMI/ANSI/ISO 11135 Medical Devices-Validation and Routine Control of Ethylene Oxide Sterilization. The device is sterilized to a SAL of 106. ETO residuals for the Progreat will not exceed the maximum limits proposed for Part 821 of Title 21 in FR June 23, 1978 (or as finalized or amended). #### I. Substantial Equivalence The Progreat Catheter submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to the Progreat Catheter K.033583. It is also substantially equivalent in intended use and design, technology/principles of operation to the Boston Scientific Corporation Fas-Tracker-3256 Infusion Catheter cleared under K030966. Differences between the devices do not raise any significant issues of safety or effectiveness. #### J. Submitter Information | Prepared By: | Mr. Mark Unterreiner<br>Regulatory Affairs Specialist | |----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Prepared For: | Terumo Medical Corporation<br>125 Blue Ball Road<br>Elkton, MD 21921<br>Phone: (410) 392-7213<br>Fax: (410) 398-6079<br>Email: mark.unterreiner@terumomedical.com | | Date Prepared: | December 16, 2003 | {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mar 1 1 2004 Terumo Medical Corporation c/o Mr. Mark Unterreiner Regulatory Affairs Specialist 125 Blue Ball Road Elkton, MD 21921 Re: K033913 Progreat™ Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, continuous flush Regulatory Class: Class II Product Code: KRA Dated: March 2, 2004 Received: March 4, 2004 Dear Mr. Unterreiner: 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. {5}------------------------------------------------ Page 2 - Mr. Mark Unterreiner 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); good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your Section 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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html Sincerely yours, Diana P. Vicheel A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): ___________ K033913 ______________________________________________________________________________________________________________________________________________________________________ Device Name:___________ Progreat™ Indications For Use: The Progreat™ is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels, and all coronary vessels. The Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis in procedures including but not limited to Uterine Fibroid Embolization. The Progreat should not be used in cerebral vessels. Prescription Use X (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) Donna R. Lachner (Division Sign-Off) Division of Cardiovascular Devices Page 5 510(k) number k033913