DEFLECTING URETERAL ACCESS SHEATH

K030642 · Applied Medical Resources Corp. · FED · May 23, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030642
• Device Name: DEFLECTING URETERAL ACCESS SHEATH
• Applicant: Applied Medical Resources Corp.
• Product Code: FED · Gastroenterology, Urology
• Decision Date: May 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Deflecting Ureteral Access Sheath is indicated for use in endoscopic urology procedures, facilitates the passage of endoscopes and other instruments through the urinary tract. The dilator may also be used to irrigate and aspirate fluids into the urinary tract and kidnev.

Device Story

Deflecting Ureteral Access Sheath facilitates endoscopic urology procedures; provides conduit for endoscopes and instruments through urinary tract. Device comprises tapered dilator and sheath with hydrophilic coating. Sheath features handle/lever mechanism for tip deflection to improve access within kidney; dilator includes female luer fitting for connection to irrigation/suction equipment. Used in clinical settings by physicians; placed over guidewire or independently. Enables targeted instrument maneuvering and fluid management; benefits patient by improving access to surgical sites within urinary tract. Disposable, single-use, sterile device available in 35cm and 60cm lengths.

Clinical Evidence

Bench testing only. Performance and functional testing included surface friction, hydrophilic coating adhesion, kink-free testing, and tip deflection testing to verify design requirements and equivalence to predicate.

Technological Characteristics

Hydrophilic-coated sheath and tapered dilator; handle/lever assembly for mechanical tip deflection. Available in 35cm and 60cm lengths. Single-use, sterile. No electronic components or software.

Indications for Use

Indicated for endoscopic urology procedures to facilitate passage of endoscopes and instruments through the urinary tract; dilator component allows irrigation and aspiration of fluids in the urinary tract and kidney.

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

• Forte Ureteral Access Sheath Set (K993650 and K990775)

Submission Summary (Full Text)

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MAY 2 3 2003

K030 642
pg 1 of 2

## 510(k) SUMMAR Y

| 510(k) NUMBER: | PENDING |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA 92688<br>[phone] |
| CONTACT PERSON: | Anil Bhalani<br>Vice President of Regulatory Affairs and Clinical Programs |
| DATE OF PREPARATION: | February 20, 2003 |
| NAME OF DEVICE: | Deflecting Ureteral Access Sheath |
| CLASSIFICATION NAME: | Sheath, for Endoscope<br>Endoscope and Accessories, 21 CFR 876.1500 |
| TRADE NAME: | Not Determined |
| PREDICATE DEVICES: | Forte Ureteral Access Sheath Set (K993650 and K990775)<br>Applied Medical Resources Corporation<br>Rancho Santa Margarita, CA |

INTENDED USE: The Deflecting Ureteral Access Sheath is indicated for use in endoscopic urology procedures, facilitates the passage of endoscopes and other instruments through the urinary tract. The dilator may also be used to irrigate and aspirate fluids into the urinary tract and kidnev.

DEVICE DESCRIPTION: The Deflecting Ureteral Access Sheath consists of a tapered dilator and a sheath, which are both coated with a hydrophilic coating, which is activated when wet. The tip of the sheath is designed such that it may be deflected in order to position the tip of the sheath to a desired site within the kidney to allow better access to surgical site. The deflecting feature also aids in positioning/maneuvering instruments such as endoscopes positioned inside the sheath.

The Deflecting Ureteral Access Sheath consists of two components, the sheath and the dilator, The sheath consists of an elongated body attached to a lever and handle assembly. Activation of the handle/lever mechanism results in desired deflection of the sheath. The dilator is assembled into the sheath during placement. The tapered tip of the dilator is designed for easy placement. The Deflecting Ureteral Access Sheath can be placed over a guidewire or by itself, The female luer fitting on the dilator is securely attached to the sheath handle during placement. Devices such as syringes and suction and irrigation equipment with luer port connectors may be

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1030642

attached to the dilator when irrigation and/or aspiration of the surgical site is desired. The dilator may also be used by itself in similar procedures.

The Deflecting Ureteral Access Sheaths will be made available as disposable, single use, sterile devices in two sizes (35cm and 60 cm).

PERFORMANCE DATA SUMMARY: The performance and functional testing of the Deflecting Ureteral Access Sheath included tests to verify Surface Friction and Hydrophilic Coating Adhesion, Kink Free Test, Tip Deflection Test. The performance and functional testing demonstrates that the Deflecting Ureteral Access Sheath is substantially equivalent to the predicate devices and it introduces no new safety and effectiveness issues when used as instructed.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

MAY 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Anil Bhalani Vice President of Regulatory Affairs and Clinical Programs Applied Medical Resources 22872 Avenida Empresa RANCHO SANTA MARGARITA CA 92688

Re: K030642

Trade/Device Name: Deflecting Ureteral Access Sheath Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FED Dated: February 20, 2003 Received: February 28, 2003

Dear Mr. Bhalani:

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. Iisting 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 Chrogdon

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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030 642

## INDICATIONS FOR USE

Applied Medical Resources is providing this separate cover page for the Ureteral Access Sheath Set "Indications for Use" as required.

510(k) Number:

K030642 Not assigned

Device Name: Deflecting Ureteral Access Sheath

The Deflecting Ureteral Access Sheath is indicated for use in endoscopic Indications for Use: urology procedures, facilitates the passage of endoscopes and other instruments through the urinary tract. The dilator may also be used to irrigate and aspirate fluids into the urinary tract and kidney.

Signature:

Title: *V.P., RA/Clinical Programs* Date: *2-20-03*

## (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

David A. Symmon

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic

510(k) Number K030642

(Optional Format -2-96)