← Product Code [FGE](/productcode/FGE) · K993892 # DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45 (K993892) _C.R. Bard, Inc. · FGE · Jan 6, 2000 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K993892 ## Device Facts - **Applicant:** C.R. Bard, Inc. - **Product Code:** [FGE](/productcode/FGE.md) - **Decision Date:** Jan 6, 2000 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 876.5010 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use For removal of biliary stones from the common bile duct. ## Device Story DURAglide3 Stone Balloon is a sterile, single-patient-use, triple-lumen stone removal balloon catheter. It functions as a line extension to the two-lumen predicate device. Used by clinicians during biliary procedures to retrieve stones from the common bile duct. The device is inserted into the biliary tract; the balloon is inflated to capture and remove stones. The third lumen provides additional functionality compared to the predicate. It is a mechanical device; no software or electronic components are involved. ## Clinical Evidence Bench testing only. Design verification activities were conducted in accordance with 21 CFR 820.30, confirming the device meets all predetermined acceptance criteria. ## Technological Characteristics Triple-lumen stone removal balloon catheter. Sterile, single-patient-use. Materials are biocompatible. Mechanical operation; no energy source or software. ## Regulatory Identification A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap. ## Special Controls *Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. ## Predicate Devices - DURAglide™ Stone Balloon ([K920342](/device/K920342.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K993892 Page 1 of 2 ## Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road, Bldg #3 P.O. Box 7031 Billerica, MA 01821-7031 978-663-8989 JAN - 6 2000 BARD ## 510(k) SUMMARY SAFETY AND EFFECTIVENESS INFORMATION As required by the Safe Medical Devices Act of 1990, codified under Section 513, Part (i)(3)(A) of the Food Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based follows. - A. Submitter Information | Submitter's Name: | Bard Interventional Products Division
C.R. Bard, Inc. | |----------------------------------|----------------------------------------------------------| | Address: | 129 Concord Road, Bldg. #3
Billerica, MA 01821 | | Phone: | 978 – 262 – 4867 | | Fax: | 978 – 262 – 4878 | | Contact Person: | Marion Gordon, R.A.C. | | Date of Preparation: | November 15, 1999 | | B. Device Name | | | Trade Name: | DURAglide3™ Stone Balloon | | Common/Usual Name: | Biliary Catheter | | Classification Name: | Class II, 21 CFR 876.5010, 78FGE | | C. Predicate Device Name: | | | | Stone Removal Balloon Catheter
K920342 | | Trade Name: | DURAglide™ Stone Balloon | ## D. Description: The DURAglide3 ™ Stone Balloon is a sterile, single patient use, triple lumen stone removal balloon catheter. {1}------------------------------------------------ - E. Intended Use: The proposed stone balloon is intended for removal of biliary stones from the common bile duct. - F. Technological Characteristics Summary: The DURAglide3™ is a three-lumen line extension to our two-lumen stone removal balloon. The proposed device has the same intended use and fundamental scientific technology. - G. Performance Standards The FDA under section 514 of the Food, Drug and Cosmetic Act has not established performance standards for the proposed device. All materials used in the Duraglide3™ Stone Balloon are biocompatible. Design control, risk analysis and design verification activities for the proposed device have been conducted in accordance with internal procedures and inclusive of the elements stipulated by 21 CFR 820.30, as applicable to this device. All results obtained during design verification activities met our predetermined acceptance criteria. {2}------------------------------------------------ Public Health Service Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN - 6 2000 Ms. Marion Gordon, R.A.C. Senior Requiatory Affairs Coordinator Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road, Bldg #3 P.O. Box 7031 Billerica, MA 01821-7031 Re: K993892 DURAglide3™ Stone Removal Balloon Catheter (three-lumen) Dated: December 9, 1999 Received: December 10, 1999 Regulatory Class: II 21 CFR 876.5010/Procode: 78 FGE Dear Ms. Gordon: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good 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 inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning 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 our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small 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, CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ | 510(k) Number (if known): | TBD
K993892 | |---------------------------|-------------------------------------------------------------| | Device Name: | DURAglide 3 ™ Stone Balloon | | Indications For Use: | For removal of biliary stones from the common bile
duct. | . . . . . . . . . ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use
(Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use ______
(Optional Format 1-2-96) | |------------------------------------------|---|----|---------------------------------------------------------| |------------------------------------------|---|----|---------------------------------------------------------| (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | 510(k) Number | K993892 / S⁰⁰¹ | |---------------|----------------| |---------------|----------------| 1 --- **Source:** [https://fda.innolitics.com/device/K993892](https://fda.innolitics.com/device/K993892) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com