COURIER BALLOON DILATATION CATHETER

{0} K963691 p192 Medi-tech Courier™ Balloon Dilatation Catheter September 12, 1996 # ATTACHMENT H ## SUMMARY OF SAFETY AND EFFECTIVENESS Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation choose to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects..." The summary regarding the adverse health effects of the proposed Courier™ Balloon Dilatation Catheter is as follows: **Trade Name:** Courier™ Balloon Dilatation Catheter **Manufacturer:** Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760 **Device Generic Name:** Balloon Dilatation Catheter **Classification:** According to Section 13 of the Federal Food, Drug and Cosmetic Act, the device classification is Class II, Performance Standards. ### Predicate Devices: The following devices are referenced in this premarket notification as predicate devices for the Diamond™ Balloon Dilatation Catheter: - BSC -- PEMT-5 Balloon Dilatation Catheter - BSC -- Courier™ Balloon Catheter All of the devices mentioned above have been determined substantially equivalent by FDA. ### Device Description: The proposed Courier™ Balloon Dilatation catheter is an over-the-wire catheter designed to be placed over guidewires which have outer diameters of .035" or smaller. ### Indications for Use: The Courier™ Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, certain sizes of the Diamond balloon catheter are indicated for stent deployment / optimization of the J&J Palmaz Biliary Stent into the biliary ducts. 000066 {1} K 96 3691 p292 Medi-tech Courier™ Balloon Dilatation Catheter September 12, 1996 ## Safety and Performance: Functional and integrity bench testing and biocompatibility testing (according to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing") were performed, and the data supported the substantial equivalence of the Courier™ Balloon Dilatation Catheter to the PEMT-5 Balloon Dilatation Catheter. ## Conclusion: Based on the Indication for Use, technological characteristics and safety and performance testing, the Courier™ Balloon Dilatation Catheter has been shown to be safe and effective for its intended use. 000067