← Product Code [FAD](/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD) · K983498 # BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE (K983498) _C.R. Bard, Inc. · FAD · Dec 15, 1998 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD/K983498 ## Device Facts - **Applicant:** C.R. Bard, Inc. - **Product Code:** [FAD](/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD.md) - **Decision Date:** Dec 15, 1998 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 876.4620 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The Bard Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma 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. ## Device Story The Bard InLay Lubricious Double Pigtail Ureteral Stent is a polyurethane device with a hydrophilic coating designed to facilitate insertion and removal while enhancing patient comfort. It features a monofilament suture loop for retrieval. The stent is placed by physicians using endoscopic or percutaneous radiographic techniques to bypass ureteral obstructions. The device acts as a conduit to maintain ureteral patency, allowing urine flow from the kidney to the bladder. It is intended for use in clinical settings by trained medical professionals. The device is supplied sterile and disposable. ## Clinical Evidence No clinical data. Performance and functional testing were conducted in accordance with the FDA draft 'Guidance for the Content of Premarket Notifications for Ureteral Stents' (1993) and draft ASTM F.04.70.01 'Standard Test Method for Ureteral Stents' (1997). ## Technological Characteristics Polyurethane stent with hydrophilic polymer coating; monofilament nylon suture loop; radiopaque; 4.7, 6, 7, and 8 Fr. sizes. Push catheter made of High Density Polyethylene (HDPE). Sterilized, disposable. Mechanical design includes double pigtail configuration with 360° curvature and 45° overlap. ## Regulatory Identification A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction. ## Predicate Devices - Bard Lubricious-Coated Ureteral Stent with Suture ([K903345](/device/K903345.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}------------------------------------------------ K9834498 Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be filled with a solid black color. The font style is blocky and geometric, giving the word a strong and impactful appearance. The letters are evenly spaced and aligned horizontally. ### SECTION VI # 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: Address: Contact Person: Contact Person's Phone: Contact Person's Fax: Date of Preparation: C. R. Bard, Inc., Urological Division 8195 Industrial Blvd. Covington, Georgia 30014 Georgia C. Abernathy (770) 784-6454 (770) 784-6419 September 30, 1998 - B. Device Name: | Trade Name: | Bard® InLay™ Lubricious Double Pigtail Ureteral Stent with
Suture | |----------------------|----------------------------------------------------------------------| | Common / Usual Name: | Bard Lubricious Ureteral Stent | | Classification Name: | Ureteral Stent | - C. Predicate Device Name: Bard Lubricious-Coated Ureteral Stent with Suture Trade Name: - D. Device Description: The Bard Lubricious Ureteral Stent is a polyurethane stent with a hydrophilic (lubricious) coating which is intended to aid in stent insertion/removal and which has the potential to enhance patient comfort while indwelling; the stent also incorporates a monofilament suture loop which aids in stent removal. - E. Intended Use: The Bard Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma 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. {1}------------------------------------------------ - F. Technological Characteristics Summary: - Table VI-1 provides a tabulated comparison summary of the technological characteristics of the Bard Lubricious Ureteral Stent versus the predicate device. | Product Characteristic | Bard Lubricious Ureteral Stent
(this 510(k)) | Bard Lubricious-Coated Ureteral
Stent with Suture
(Predicate device) (#K903345) | Difference | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | | Stent | | | | Indications or Intended
Use | The Bard Lubricious Ureteral Stent is
indicated to relieve obstruction in a
variety of benign, malignant and post-
traumatic conditions in the ureter such as
presence of stones and/or stone
fragments, or other ureteral obstructions
such as those associated with ureteral
stricture, carcinoma 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. | The Bard Lubricious-Coated Ureteral
Stent with Suture is indicated to relieve
obstruction in a variety of benign,
malignant and post-traumatic conditions
in the ureter such as presence of stones
and/or stone fragments, or other ureteral
obstructions such as those associated
with ureteral stricture, carcinoma 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. | None | | Disposable | Yes | Yes | None | | Sterile | Yes | Yes | None | | Stent Base Material | Polyurethane | Polyurethane | None | | X-Ray Opaque | Yes | Yes | None | | Coating
Double Pigtail | Hydrophilic polymer (lubricious)* | Hydrophilic polymer (lubricious) | Different formula,
different supplier | | Multilength | Hydrophilic polymer (lubricious) | None | Not previously
coated | | Fr. Sizes Available | 4.7**, 6, 7 and 8 Fr. | 4.7, 6, 7 and 8 Fr. | 4.7 Fr. stent will
have a taper on the
kidney-end tip | | Double Pigtail Lengths | 14, 20-30cm* | 14-30cm | 16 and 18cm
lengths deleted | | Multilength Lengths | 22-32cm (one overall adjustable length) | 22-32cm (one overall adjustable length) | None | | Pigtail Geometry
Double Pigtail | 360° curvature + 45° overlap (both ends) | "J" curl configuration (no overlap) | Additional curl
length | | Multilength
Suture Loop | Yes-USP Medical Grade black nylon
monofilament; 3-0 | Yes-USP Medical Grade dark blue nylon
monofilament; 3-0 | Color change, both
biocompatible | | Guidewire Interface | 4.7 Fr. = .035" diameter*
6, 7, 8 Fr. = .038" diameter* | 4.7 Fr. = .025" diameter
6, 7, 8 Fr. = .038" diameter* | 4.7 Fr. interfaces
with larger diameter
guidewire | | Stent Clamp? | Yes | Yes | None | | Table VI-1 | |-----------------------------------------------------| | Comparison Summary of Technological Characteristics | {2}------------------------------------------------ | Product Characteristic | Bard Lubricious Ureteral Stent
(this 510(k)) | Bard Lubricious-Coated Ureteral
Stent with Suture
(Predicate device) (#K903345) | Difference | |------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------| | Push Catheter | | | | | Color | Orange* | Green | Color change | | Material | High Density Polyethylene (HDPE) | High Density Polyethylene (HDPE) | None | | Guidewire Interface | 4.7 Fr. = .035" diameter*
6, 7/8 Fr. = .038" diameter* | 4.7 Fr. = .025" diameter
6/7/8 Fr. = .038" diameter | 4.7 Fr. interfaces
with larger diameter
guidewire | | Radiopacity | Radiopaque marker band near distal end* | N/A | Add radiopaque
band | | Length | 4.7, 6, 7, 8 Fr. = 17.75"* | 4.7 Fr. = 22"
6/7/8 Fr. = 16" | Length changed,
OD on new push
catheter same as
stent | New feature(s) or change this 510(k) * - ** 4.7 Fr. stent will have a taper on the kidney-end tip #### G. Performance Data Summary: The Bard Lubricious Ureteral Stent referenced in this submission is held to the same design, manufacture, and performance specifications as those stents currently manufactured. 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is an abstract symbol that resembles an eagle or bird-like figure with stylized wings and body. The symbol is rendered in a thick, black line. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 5 1998 Georgia C. Abernathy Regulatory Affairs Associate C.R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209 Re: K983498 Bard® Inlay™ Lubricious Double Pigtail Ureteral Stent Dated: September 30, 1998 Received: October 5, 1998 Regulatory Class: II 21 CFR 876.4620/Procode: 78 FAD Dear Ms. Georgia: 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 II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 Eederal 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 Compirance 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 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 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 {4}------------------------------------------------ ### SECTION I - D ## INDICATIONS FOR USE STATEMENT 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Bard Lubricious Ureteral Stent Indications for Use: The Bard Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma 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. (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) ، Over The-Counter Use ____________________ OR (Optional Format 1/2/96) David L. Ingram ivision Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD/K983498](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAD/K983498) **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. 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