PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS

K061009 · Onset Medical Corporation · EZN · May 2, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K061009
• Device Name: PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS
• Applicant: Onset Medical Corporation
• Product Code: EZN · Gastroenterology, Urology
• Decision Date: May 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5470
• Device Class: Class 2

Intended Use

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

Device Story

Pathway™ Balloon Expandable Ureteral Access Sheath; used during endoscopic urological procedures. Device establishes conduit for passage of endoscopes/instruments into ureter via urethra and bladder. Balloon expansion mechanism facilitates sheath placement. Used in clinical settings by urologists. Benefits include improved access to ureter for diagnostic or therapeutic instrumentation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Balloon expandable ureteral access sheath. Designed for endoscopic urological access. Mechanical expansion mechanism. Class II device (21 CFR 876.5470).

Indications for Use

Indicated for patients undergoing endoscopic urological procedures requiring a conduit for the passage of endoscopes and instruments into the ureter via the urethra and bladder.

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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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## MAY 2 2006

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

Re: K061009

Trade/Device Name: Pathway™ Balloon Expandable Ureteral Access Sheath Regulation Number: 21 CFR §876.5470 Regulation Name: Ureteral dilator Regulatory Class: II Product Code: EZN Dated: April 6, 2006 Received: April 12, 2006

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 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

oling Public

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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.

This letter will allow you to begin marketing your device as described in your Section 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:

| 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/cdrh/industry/support/index.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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## Indications for Use

510(k) Number (if known): K061009

## Onset Medical Pathway™ Balloon Expandable Ureteral Access Device Name: Sheath

Indications for Use:

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

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device 510(k) Number _

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