BARD ER URETERAL STENT WITH SUTURE

K022447 · C.R. Bard, Inc. · FAD · Jan 23, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K022447
• Device Name: BARD ER URETERAL STENT WITH SUTURE
• Applicant: C.R. Bard, Inc.
• Product Code: FAD · Gastroenterology, Urology
• Decision Date: Jan 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4620
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Bard® Inlay Optima™ 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.

Device Story

Coated, double pigtail ureteral stent with attached monofilament suture loop for removal; available in single or multi-length configurations. Input: placed in ureter via endoscopic or percutaneous radiographic techniques. Function: maintains ureteral patency to relieve obstruction. Output: physical stent structure. Used in clinical settings by physicians. Benefits: relieves obstruction; reduces accumulation of urine calcium salts via hydrophobic polymer coating compared to hydrophilic predicate. Healthcare providers use stent to manage ureteral flow; output affects clinical management of obstructive uropathy.

Clinical Evidence

Bench testing only. In vitro testing compared encrustation of subject device to control; results indicated reduced accumulation of urine calcium salts. No clinical data provided.

Technological Characteristics

Stent base: Polycarbonate-based polyurethane. Coating: Hydrophobic polymer. Suture: USP Medical Grade black nylon monofilament (3-0). Push catheter: HDPE. Radiopaque marker band included. Sizes: 4.7, 6, 7, 8 Fr. Sterilization: Sterile. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring relief of ureteral obstruction due to benign, malignant, or post-traumatic conditions, including stones, stone fragments, ureteral stricture, abdominal organ malignancy, retroperitoneal fibrosis, ureteral trauma, or in association with ESWL. Not for permanent indwelling use; maximum indwelling time 365 days.

Regulatory Classification

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® InLay Lubricious Double Pigtail Ureteral Stent with Suture (K983498)

Submission Summary (Full Text)

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Ko22447

JAN 2 3 2003

C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014

## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS INFOR

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 Frances E. Harrison, RAC [phone] [phone] January 17, 2003

- B. Device Name:
Trade Name: Common / Usual Name: Classification Name:

Bard® InLay Optima™ Ureteral Stent with Suture Bard Ureteral Stent Ureteral Stent

- C. Predicate Device Name:
Trade Name:

Bard® InLay Lubricious Double Pigtail Ureteral Stent with Suture #K983498

- D. Device Description: The Bard® (nLay Optima™ Ureteral Stent and Multi-Length Ureteral Stent is a coated, double pigtall 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:
- ా Ureteral Stont with Suture
- Push Catheter with Radiopaque Tip ﻢ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
- Pigtail Straightener 1
- 1 Guidewire* (Optional)
- *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® InLay Optima™ Ureteral Stents and Multi-Length Ureteral Stents indicate reduced accumulation of urine calclum 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. Intencied Use: The Bard® Inlay Optima™ 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 ureferal 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.

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022447

## F. Technological Characteristics Summary:

Table VI-1 provides a tabulated comparison summary of the technological characteristics of the
Bard® Inlay Optima™ Ureteral Stent with Suture versus the predicate device.

Table VI-1 Comparison Summary of Technological Characteriatics

| Product<br>Characteristics | Bard® Inlay Optima™ Ureteral Stent<br>(this 510(k)) | Bard InLay Lubricious Double<br>Pigtail Ureteral Stent with Suture<br>(Predicate device - #K983498) | 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 Lubricious Ureteral Stent<br>is indicated to relieve obstruction in<br>a variety of benign, malignant and<br>post-traumatic conditions in the<br>urater such as presence of stones<br>and/or stone fragments or other<br>ureteral obstructions such as those<br>associated with ureteral stricture,<br>carcinoma of abdominal organs,<br>retroperitoneal fibrosis or ureteral<br>trauma, or in association with -<br>Extracorporeal Shock Wave<br>Lithotriopsy (ESWL). The stent may<br>be placed using endoscopic surgical<br>techniques or percutaneously using<br>standard radiographic technique. | Minimal editorial<br>changes. |
| Disposable | Yes | Yes | None |
| Sterile | Yes | Yes | None |
| Stent Base Material | Polycarbonate-based Polyurethane" | Polyether-based Polyurethane | Different Material |
| X-Ray Opaque | Yes | Yes | None |
| | | Coating | |
| Double Pigtall | Hydrophobic polymer* | Hydrophilic polymer | Different Coating |
| Multilength | Hydrophobic polymer* | Hydrophilic polymer | Different Coating |
| 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<br>length) | None |
| Pigtail Geometry | | | |
| Double Pigtail | 360° curvature + 45° overlap (both ends) | 360° curvature + 45° overlap (both<br>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 | Yes | Clamp Removed |
| Accessories | Yes* | No | Additional<br>Component |
| 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<br>distal end | None |
| Length | 4.7, 6, 7, 8 Fr. = 17.75" | 4.7, 6, 7, 8 Fr. = 17.75" | None |

New feature(s) or change this 510(k)

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## G. Performance Data Summary:

The Bard® Iniay Optima™ Ureteral Stent with Suture referenced in this submission is hald to
the same design, manufacture, and performance specifications as those stents curre 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.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C. R. Bard, Inc. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K022447

Trade/Device Name: InLay Optima™ Ureteral Stent and InLay Optima™ Multi-Length Ureteral Stent (ER Ureteral Stent with Suture)

JAN 2 3 2003

Regulation Number: 21 CFR §876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: 78 FAD Dated: January 8, 2003 Received: January 9, 2003

Dear Mr. Mosenkis:

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 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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

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 one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] 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

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

X022447

Bard® Inlay Optima™ Ureteral Stent Device Name:

Indications for Use:

The Bard® Inlay Optima™ 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 (Per 21 CFR 801.109)

OR Over-The-Counter Use

(Optional Format 1/2/96)

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022447