URETERAL ACCESS SHEATH SET

K990775 · Applied Medical Resources · FED · Apr 21, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990775
• Device Name: URETERAL ACCESS SHEATH SET
• Applicant: Applied Medical Resources
• Product Code: FED · Gastroenterology, Urology
• Decision Date: Apr 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Ureteral Access Sheath Set is indicated for use in endoscopic urology procedures, by facilitating the passage of endoscopes and other instruments through the urinary tract.

Device Story

The Ureteral Access Sheath Set is a mechanical device used in endoscopic urology procedures. It consists of two components: a dilator with a tapered tip and a tapered sheath. The device is inserted into the urinary tract to create a conduit, facilitating the passage of endoscopes and other surgical instruments. It is operated by a physician in a clinical or surgical setting. By providing a stable access path, the device simplifies instrument navigation, potentially reducing trauma to the urinary tract and improving procedural efficiency.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use.

Technological Characteristics

The device consists of a dilator with a tapered tip and a tapered sheath. It is a mechanical accessory for endoscopes used in urology. No energy source, software, or electronic components are involved.

Indications for Use

Indicated for patients undergoing endoscopic urology procedures requiring the passage of endoscopes or instruments through the urinary tract.

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.

Submission Summary (Full Text)

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4/21/99

## 510(k) SUMMARY

| 510(k) NUMBER: | PENDING K990 775 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Applied Medical Resources Corporation<br>26051 Merit Circle, Unit # 103<br>Laguna Hills, California 92653<br>[phone] |
| CONTACT PERSON: | Anil Bhalani<br>Director of Regulatory Affairs and Clinical Programs |
| DATE OF PREPARATION: | March 5, 1999 |
| NAME OF DEVICE: | Ureteral Access Sheath Set |
| CLASSIFICATION NAME: | Endoscope and Accessories, 21 CFR 876.1500 |
| TRADE NAME: | Not Determined |

## SUMMARY STATEMENT:

The Ureteral Access Sheath Set is indicated for use in endoscopic urology procedures, by facilitating the passage of endoscopes and other instruments through the urinary tract. The Ureteral Access Sheath is comprised of two components: a dilator with a tapered tip and a tapered sheath.

The Applied Medical Ureteral Access Sheath Set is substantially equivalent to predicate devices and introduces no new safety and effectiveness issues when used as instructed.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 1999

Mr. Anil Bhalani Director of Regulatory Affairs and Clinical Programs APPLIED MEDICAL RESOURCES 26051 Merit Circle Building 104 Laguna Hills, CA 92653

Re: K990775

Ureteral Access Sheath Set Dated: March 5, 1999 Received: March 9, 1999 Requiatory Class: Il 21 CFR 876.1500/Procode: 78 FED

Dear Mr. Bhalani:

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 Requlations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes 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 regult in requlatory 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 uitro diagnostic devices), please contact the Office of Compliance at [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 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 [phone] or [phone], 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

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## INDICATIONS FOR USE

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

- 510(k) Number:
Not assigned

KC 990775

Ureteral Access Sheath Set Device Name:

The Ureteral Access Sheath Set is indicated for use in endoscopic urology Indications for Use: procedures, by facilitating the passage of endoscopes and other instruments through the urinary tract.

Signature: Title: *Director RA/Clinical Programs* Date: *3-5-99*

(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 |
|---------------------------------------|----|-----------------------|
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22
(Optional Format -2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices

| 510(k) Number | K990775 |
|---------------|---------|
|---------------|---------|