BARD AQUAGUIDE URETERAL CONDUIT

K030438 · C.R. Bard, Inc. · FED · Mar 17, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030438
• Device Name: BARD AQUAGUIDE URETERAL CONDUIT
• Applicant: C.R. Bard, Inc.
• Product Code: FED · Gastroenterology, Urology
• Decision Date: Mar 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The Bard® AquaGuide™ Ureteral Conduit is indicated for use in endoscopic urology procedures where ureteral dilation and continued ureteral access is desired for injection and aspiration of fluids and insertion and removal of endoscopes and related instruments.

Device Story

The Bard® AquaGuide™ Ureteral Conduit is a two-component ureteral dilation system used in endoscopic urology procedures. The system comprises a hydrophilic-coated introducer and a hydrophilic-coated dual-lumen sheath with a multi-function access hub. It is placed over a 0.038" guidewire to facilitate ureteral dilation and provide continued access. The dual-lumen design allows for the simultaneous passage of endoscopes and related instruments, as well as the injection and aspiration of fluids. The device is constructed of materials that soften at body temperature to enhance patient comfort. By providing an additional lumen for fluid management, the device reduces the potential for hypervolemia during procedures. It is intended for use by clinicians in a clinical setting.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Polyurethane. Features: Hydrophilic coating, radiopaque, softening at body temperature. Design: Two-component system (introducer and dual-lumen sheath), 25/35/55cm lengths, 10Fr/12Fr introducer sizes. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for patients undergoing endoscopic urology procedures requiring ureteral dilation and access for fluid management and instrument passage.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Applied Medical Ureteral Access Sheath Set

Submission Summary (Full Text)

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MAR 1 7 2003

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

K0304-38

BARD

## 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: | [phone] |
| Contact Person's Fax: | [phone] |
| Date of Preparation: | November 13, 2002 |

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

Bard® AquaGuide™ Ureteral Conduit Ureteral Conduit Endoscope and Accessories

- C. Predicate Device Name: Applied Medical Ureteral Access Sheath Set
Trade Name: Same as above

- D. Device Description: The Bard® AquaGuide™ Ureteral Conduit is a two-component ureteral dilation system which contains multiple lumens for injection and aspiration of fluids as well as passage of endoscopes and related instruments. The system consists of a hydrophilic-coated introducer with female luer connector and a hydrophilic-coated dual-lumen sheath with multi-function access hub. The system is available in three lengths: 25, 35 and 55cm and with either a 10Fr. Introducer with 12-14 Fr. sheath or a 12 Fr. Introducer with 14-16 Fr. sheath.
- E. Intended Use: The Bard® AquaGuide™ Ureteral Conduit is indicated for use in endoscopic urology procedures where ureteral dilation and continued ureteral access is desired for injection and aspiration of fluids and insertion and removal of endoscopes and related instruments.

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- F. Technological Characteristics Summary: The Bard® AquaGuide™ Ureteral Conduit has a lubricious hydrophilic coating and is constructed of materials that soften at body temperature to enhance patient comfort. The device can be placed over a 0.038" quidewire, allows for passage of endoscopes and related instruments, allows for injection and aspiration of fluids and provides for continuous flow.
- G. Performance Data Summary: The Bard® AquaGuide™ Ureteral Conduit is constructed of biocompatible materials. The additional lumen reduces the potential for hypervolemia (excess fluid build-up). The following table is a summary of the technical features of the Bard® AquaGuide™ Ureteral Conduit compared to the predicate device.

| Product Feature | Bard AquaVue Ureteral<br>(Subject Device) | Applied Medical Ureteral<br>Access Sheath Set<br>(Predicate Device) |
|-------------------------|---------------------------------------------------------|---------------------------------------------------------------------|
| Size Ranges | 10Fr Introducer<br>12014Fr Sheath<br>25,35,55cm Lengths | 10Fr Dilator<br>12-16Fr Sheath<br>35,55cm Lengths |
| | 12Fr Introducer<br>14-16Fr Sheath<br>25,35,55cm Lengths | 12Fr Introducer<br>14-18Fr Sheath<br>20,28,35,55cm Lengths |
| | | 14Fr Introducer<br>14-18Fr Sheath<br>20,28,35cm Lengths |
| Material | Polyurethane | Polyurethane w/Internal<br>SS Coil |
| Softening Material? | Yes | Yes |
| Radiopaque? | Yes | Yes |
| Hydrophilic<br>Coating? | Yes | Yes |
| Irrigation/Aspiration? | Yes, Introducer & Sheath<br>Side Lumen | Yes, Introducer Only |
| Dual-Lumen<br>Sheath? | Yes | No |
| Locking<br>Mechanism? | Yes | Yes |

Buide

. *

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2003

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

Re: K030438

Trade/Device Name: Bard® AquaGuide™ Ureteral Conduit, Models 131125, 131135, and 131155 (with 10 Fr. Introducer, 12-14 Fr. Sheath and lengths of 25, 35 or 55cm); and Models 131225, 131235, and 131255 (with 12 Fr. Introducer, 14-16 Fr. Sheath and lengths of 25, 35 or 55cm)

Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Code: II Product Code: 78 FED Dated: March 4, 2003 Received: March 5, 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 (QS) 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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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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 Crogdon

Nancv 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): | K030438 |
|---------------------------|-----------------------------------------------------------|
| Device Name: | Bard ^® AquaGuide ^™ Ureteral Conduit |

Indications for Use:The Bard® AquaGuide™ Ureteral Conduit is indicated for use in endoscopic urology procedures where ureteral dilation and continued ureteral access is desired for injection and aspiration of fluids and insertion and removal of endoscopes and related instruments.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

## CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR

(Optional Format 1/2/96)

Gabriel A. Aguirre