BARD INLAYOPTIMA URETERAL STENT WITH SUTURE

{0}------------------------------------------------ DEC - 7 2004 K043193 Page 1 of 3 ## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. - A. Submitter's Information: | Submitter's Name: | C. R. Bard, Inc., Urological Division | |-------------------------|---------------------------------------------------| | Address: | 8195 Industrial Blvd.<br>Covington, Georgia 30014 | | Contact Person: | Frances E. Harrison, RAC | | Contact Person's Phone: | (770) 784-6257 | | Contact Person's Fax: | (770) 784-6419 | | Date of Preparation: | November 24, 2004 | - B Device Name: | Trade Name: | Bard® InLayOptima™ Ureteral Stent with Suture | |----------------------|-----------------------------------------------| | Common / Usual Name: | Bard Ureteral Stent | | Classification Name: | Ureteral Stent | - C. Predicate Device Name: | Trade Name: | Bard ® InLayOptima™ Ureteral Stent with Suture | |-------------|------------------------------------------------| | | #K022447 | - D. Device Description: The Bard® InLayOptima™ Ureteral Stent and Multi-Length Ureteral Stent is a coated, double pigtail ureteral stent with a monofilament suture loop attached to aid in stent removal. The stent is available in two forms: a single size or a customizable multi-length size. The following items are included with each stent: - 1 Ureteral Stent with Suture - 1 Push Catheter with Radiopaque Tip - ー Pigtail Straightener - Guidewire* (Optional) 1 - *Note: a 4.7 Fr stent is compatible with a .035" guidewire and a 6.7 and 8 Fr stents are compatible with a .038" guidewire. In vitro testing conducted on the Bard® InLayOptima™ Ureteral Stents and Multi-Length Ureteral Stents indicate reduced accumulation of urine calcium salts as assayed by calcium when compared to a control. Correlation of in vitro data to clinical outcome has not been established. Choong, SKS, Wood. S, Whitfield, HN. "A model to quantify encrustation on ureteric stents, urethral catheters, and polymers intended for urological use," BJU International (2000), 86, 414-421. - E. Intended Use: The Bard® InlayOptima™ Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device. {1}------------------------------------------------ K043193 Page 2 of 3 - F. Technological Characteristics Summary: The table below provides a tabulated comparison summary of the technological characteristics of the Bard* InlayOptima™ Ureteral Stent with Suture versus the predicate device | Product<br>Characteristics | Bard® Inlay Optima ™ Ureteral Stent<br>with Suture<br>(this 510(k)) | Bard® Inlay Optima™ Ureteral Stent<br>with Suture<br>(Predicate device - #K022447) | Difference | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | Stent | | | | | Indications or<br>Intended Use | The Bard® Inlay Optima ™ Ureteral Stent<br>is indicated to relieve obstruction in a<br>variety of benign, malignant and post-<br>traumatic conditions in the ureter. These<br>conditions include stones and/or stone<br>fragments or other ureteral obstructions<br>such as those associated with ureteral<br>stricture, malignancy of abdominal<br>organs, retroperitoneal fibrosis or<br>ureteral trauma, or in association with<br>Extracorporeal Shock Wave Lithotripsy<br>(ESWL). The stent may be placed using<br>endoscopic surgical techniques or<br>percutaneously using standard<br>radiographic technique. It is<br>recommended that the indwelling time<br>not exceed 365 days. The stent is not<br>intended as a permanent indwelling<br>device. | The Bard® Inlay Optima ™ Ureteral Stent<br>is indicated to relieve obstruction in a<br>variety of benign, malignant and post-<br>traumatic conditions in the ureter. These<br>conditions include stones and/or stone<br>fragments or other ureteral obstructions<br>such as those associated with ureteral<br>stricture, malignancy of abdominal<br>organs, retroperitoneal fibrosis or<br>ureteral trauma, or in association with<br>Extracorporeal Shock Wave Lithotripsy<br>(ESWL). The stent may be placed using<br>endoscopic surgical techniques or<br>percutaneously using standard<br>radiographic technique. It is<br>recommended that the indwelling time<br>not exceed 365 days. The stent is not<br>intended as a permanent indwelling<br>device. | None | | Disposable | Yes | Yes | None | | Sterile | Yes | Yes | None | | Stent Base Material | Polycarbonate-based Polyurethane* | Polyether-based Polyurethane | Material<br>change | | X-Ray Opaque | Yes | Yes | None | | Coating | | | | | Double Pigtail | Hydrophobic polymer | Hydrophobic polymer | None | | Multilength | Hydrophobic polymer | Hydrophobic polymer | None | | Models and Sizes | | | | | Fr. Sizes Available | 4.7 Fr., 6 Fr., 7 Fr., and 8 Fr. | 4.7 Fr., 6 Fr., 7 Fr., and 8 Fr. | None | | Double Pigtail<br>Lengths | 14. 20-30 cm | 14. 20-30 cm | None | | Multilength Lengths | 23-32cm (one overall adjustable length) | 23-32cm (one overall adjustable length) | None | | Pigtail Geometry | | | | | Double Pigtail | 360° curvature + 45° overlap (both ends) | 360° curvature + 45° overlap (both ends) | None | | Multilength | 2 ½ Turns | 2 ½ Turns | None | | Suture Loop | Yes - USP Medical Grade black nylon<br>monofilament: 3-0 | Yes - USP Medical Grade black<br>monofilament; 3-0 | None | | Guidewire Interface | 4.7 Fr. = 0.035" diameter<br>6. 7. 8 Fr. = 0.038" diameter | 4.7 Fr. = 0.035" diameter<br>6. 7. 8 Fr. = 0.038" diameter | None | | Accessories | | | | | Stent Clamp | No | No | Clamp<br>Removed | | Push Catheter | | | | | Color | Orange | Orange | None | | Material | High Density Polyethylene (HDPE) | High Density Polyethylene (HDPE) | None | | Guidewire Interface | 4.7 Fr. = 0.035" diameter<br>6. 7. 8 Fr. = 0.038" diameter | 4.7 Fr. = 0.035" diameter<br>6. 7. 8 Fr. = 0.038" diameter | None | | Radiopacity | Radiopaque marker band near distal end | Radiopaque marker band near distal end | None | ## Comparison Summary of Technological Characteristics . New feature(s) or change this 510(k) {2}------------------------------------------------ X043193 Page 3 of 3 The Bard" InlayOpima" Ureteral Stent with Suture referenced in this submission is held to the same design, manufacture, and performance specifications as those stents current manufactured by Bard. Performance and functional testing standards are based on the FDA draft "Guidance for the Content of Premarket Notifications for Ureteral Stents" dated February 10, 1993 and the draft ASTM F.04.70.01, "Standard Test Method for Ureteral Stents" dated July 9, 1997. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or forms, often interpreted as representing people or the provision of services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - 7 2004 Frances E. Harrison, RAC Director, Regulatory Affairs C. R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014 Re: K043193 Trade/Device Name: Bard® InlayOptima™ Ureteral Stent with Suture Regulation Number: 21 CFR §876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: 78 FAD Dated: November 10, 2004 Received: November 18, 2004 Dear Ms. Harrison: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your becalled by equivalent (for the indications for use stated in above and nave determined the als at redicate devices marketed in interstate commerce prior to the enclosure) to regary manusical Device Amendments, or to devices that have been May 20, 1770, the clademisine acto 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 do not require approval of a promance approvisions of the Act. The general controls provisions of the Act device, subject to the general connois prove, 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 (Premarket If your device is classified (600 above). Approval), it may be subject to such additional controls. Existing major regulations affecting your Apploval), It they of sabject to antiFederal Regulations, Title 21, Parts 800 to 898. In addition, FDA acvice can be round in the cements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Ficast be advised mar PDT o isoual your device complies with other requirements of the Act or any FDA liade a actemination adaministered by other Federal agencies. You must comply with all the Federal statues and regulations administer to registration and listing (21 CFR Part 807); labeling ACL STEQuirements, metading but noing practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter notification. The FDA finding of substantial equivalence of your device to a legally promation notificate 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 11 you atter of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.gov/cdrh/dsma/dsmamain.html Sincerely yours, Nancy C. brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT 510(k) Number (if known): _K043193 Device Name: Bard® InlayOptima™ Ureteral Stent Indications for Use: The Bard® InlayOptima™ Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE) Prescription Use 1 (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1/2/96) Daniel A. Suggars (Division Sign-Of Division of Reproductive, Abdominal. and Radiological Devic 510(k) Number