PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH

K043254 · Onset Medical Corporation · EZN · Feb 10, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K043254
• Device Name: PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH
• Applicant: Onset Medical Corporation
• Product Code: EZN · Gastroenterology, Urology
• Decision Date: Feb 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5470
• Device Class: Class 2

Intended Use

The Onset Medical Pathway™ Expandable Ureteral Sheath (the Expandable Sheath) is intended to establish a conduit, aiding the ureter by way of the urethra and bladder, during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.

Device Story

Pathway Expandable Ureteral Sheath functions as a conduit for endoscopic urological procedures. Device is inserted via urethra and bladder into ureter to provide access for endoscopes and instruments. Operates as a mechanical sheath to maintain ureteral access. Used in clinical settings by urologists. Benefits include facilitated instrument passage and maintenance of access during procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ureteral sheath/dilator; mechanical design for ureteral access; dimensions and materials consistent with 21 CFR 876.5470; non-powered; sterile.

Indications for Use

Indicated for use during endoscopic urological procedures to establish a conduit through the urethra, bladder, and ureter to facilitate the passage of endoscopes and other instruments into the urinary tract.

Regulatory Classification

Identification

A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services-USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter of the circle. Inside the circle is a stylized image of a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2005

Onset Medical Corporation c/o Albert Rego, Ph.D. Consultant 27001 La Paz, Suite 312 MISSION VIEJO CA 92691

K043254 Re:

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Trade/Device Name: Pathway Ureteral Access Sheath/Pathway Expandable Ureteral Access Sheath Regulation Number: 21 CFR § 876.5470 Regulation Name: Ureteral dilator Regulatory Class: II Product Code: 78 EZN Dated: January 14, 2005 Received: January 18, 2005

Dear Dr. Rego:

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 the cholors's to e 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 do incl. require to the general controls provisions of the Act. The general controls provisions of the Act de not, subject to an general 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 rippto rary, it 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 I loase or advisod that cover 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 I caraf statues and rogalding, 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) (2) 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 Section 510(k) I mo letter watification. The FDA finding of substantial equivalence of your device to a legally premaince noticate 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 11 you dees office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrb/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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Kc 43254

## Indications for Use

510(k) Number (if known):__Unknown

Device Name:_______Pathway™ Expandable Ureteral Sheath

Indications For Use:

The Onset Medical Pathway™ Expandable Ureteral Sheath (the Expandable Sheath) The Onset Medical Pathway - Exparing endoscopic urological procedures, facilitating is intended to establish a ochault, admig the sureter by way of the ureter by way of the urethra and bladder.

Prescription Use
(Part 21 CFR 801 Subpart D)

ANDIOR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dennis G. Thompson

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ...

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