URETERAL ACCESS SHEATH SET - NEW MODELS

K993650 · Applied Medical Resources · FED · Dec 28, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K993650
• Device Name: URETERAL ACCESS SHEATH SET - NEW MODELS
• Applicant: Applied Medical Resources
• Product Code: FED · Gastroenterology, Urology
• Decision Date: Dec 28, 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 wrinary tract. The Ureteral Access Sheath Set is comprised of two components: a tapered dilator and a sheath; both have a hydrophilic coating.

Device Story

Single-use sterile ureteral access sheath set; facilitates endoscopic urology procedures. Comprised of polyurethane tapered dilator and sheath; both feature hydrophilic coating activated by saline/water for reduced friction during insertion/removal. Dilator includes luer fitting for contrast introduction during retrograde pyelograms; thru-lumen accommodates guidewires up to 0.038 inches. Safety features include luer fitting size preventing over-insertion and latch mechanism locking dilator within sheath. Suture loops on sheath cone allow securing to patient drapes. Used by urologists in clinical settings to maintain access for instruments; benefits include easier navigation and stable positioning during surgery.

Clinical Evidence

Bench testing only. Testing verified surface friction, hydrophilic coating adhesion, fluid flow, handle pull strength, and luer fitting pull strength.

Technological Characteristics

Polyurethane construction; hydrophilic coating; tapered dilator and sheath design. Luer fitting for contrast; latch mechanism for locking; suture loops for fixation. Dimensions: sheath 20-60 cm; dilator 25-70 cm. Guidewire compatibility up to 0.038 inches. Sterile, single-use.

Indications for Use

Indicated for use in endoscopic urology procedures to facilitate passage of endoscopes and 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.

Predicate Devices

• Applied Medical Ureteral Access Sheath Set (K990775)
• Cook Urological's Peel Away Introducer Sets
• Nottingham One-Step Tapered Dilators, Boston Scientific Corporation

Submission Summary (Full Text)

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## 510(k) SUMMARY

| 510(k) NUMBER: | PENDING |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| 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: | October 22, 1999 |
| NAME OF DEVICE: | Ureteral Access Sheath Set |
| CLASSIFICATION NAME: | Endoscope and Accessories, 21 CFR 876.1500 |
| TRADE NAME: | Not Determined |

## PREDICATE DEVICES:

- 1. Applied Medical Ureteral Access Sheath Set (K990775)
- 2. Cook Urological's Peel Away Introducer Sets.
- 3. Nottingham One-Step Tapered Dilators, Boston Scientific Corporation.

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 wrinary tract. The Ureteral Access Sheath Set is comprised of two components: a tapered dilator and a sheath; both have a hydrophilic coating.

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.

DEVICE DESCRIPTION: The Ureteral Access Sheath Set is a single use sterile device, indicated for use in endoscopic urology procedures, to facilitate the passage of endoscopes and other instruments through the urinary tract. It is comprised of two components: a dilator with a tapered tip and a tapered sheath. Both the sheath and the dilator are made from polyurethane. The sheath length varies from 20 cm (shortest) to 60 cm (longest) by model.

A luer fitting made attached to the proximal end of the dilator may be used to introduce contrast during a retrograde pyelogram procedure. The dilators range in length from 25 cm (shortest) to 70 cm (longest). The thru-lumen of the dilator tip is 0.040 - 0.045 inches and it can be used over a guidewire of up to .038 inches diameter.

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70 cm (longest). The thru-lumen of the dilator tip is 0.040 - 0.045 inches and it can be used over a guidewire of up to .038 inches diameter.

The sheath and the dilator are coated with a hydrophilic coating, which is activated by wetting the device in saline or sterile water. The hydrophilic feature allows for easier insertion and removal of the ureteral sheath.

The luer fitting on the dilator cannot be pushed through the lumen of the cone shaped handle because of its larger size and therefore acts as a safety feature by preventing the dilator from being over inserted into the sheath.

A latch mechanism is added to the ureteral access sheath set, which locks the dilator in place inside the sheath during insertion of the dilator and sheath in the urological tract.

Two suture loops are attached at the cone of the sheath, which may be used to secure the sheath to the drapes of the patient to retain the sheath in position during surgery. This feature is a convenience to the surgeon who may otherwise have to hold the sheath in position during surgery.

PERFORMANCE DATA SUMMARY: The performance and functional testing of the Ureteral Access Sheath Set includes tests to verify Surface Friction and Hydrophilic Coating Adhesion. Fluid Flow, Handle Pull Strength and Luer Fitting Pull Strength. The performance and functional testing demonstrates that the Ureteral Access Sheath Set 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/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 8 1999

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

Re: K993650 Ureteral Access Sheath Set Dated: October 29, 1999 Received: October 29, 1999 Requlatory Class: II 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 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 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 regulation may result in regulatory 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 vitro 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 C. Schadt, M.D.

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 Set "Indications for Use" as required.

Not assigned 510(k) Number:

Device Name: Ureteral Access Sheath Set

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.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------_ Title: Director RA/Clinical Programs_ Date: 10-29-99 Signature

(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) | <div></div> |
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OR

| Over-The-Counter Use (Optional Format -2-96) | |
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices

| 510(k) Number | K993650 |
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