PATHWAY ACCESS SHEATH CATHETER

K030662 · Vertelink Corporation · EZN · Sep 3, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030662
• Device Name: PATHWAY ACCESS SHEATH CATHETER
• Applicant: Vertelink Corporation
• Product Code: EZN · Gastroenterology, Urology
• Decision Date: Sep 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The expandable sheath is designed especially for formation of large nephrostomy tracts required for percutaneous removal of renal and ureteral calculi.

Device Story

Pathway™ Access Sheath Catheter is an expandable sheath used during percutaneous nephrolithotomy procedures. Device facilitates creation of large nephrostomy tracts for access to renal and ureteral calculi. Operated by urologists in clinical/surgical settings. Sheath expands to accommodate instruments for stone removal. Benefits include improved access to the renal collecting system, enabling minimally invasive stone extraction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Expandable sheath catheter designed for percutaneous access. Class II device (21 CFR 876.5470, Product Code EZN). Mechanical dilation principle. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous removal of renal and ureteral calculi via the formation of large nephrostomy tracts.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with text around the perimeter and a symbol in the center. The symbol is a stylized version of the Great Seal of the United States, featuring an eagle with its wings spread.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 3 2003

Vertelink Corporation C/O Albert Rego, Ph.D 27001 La Paz Suite 312 Mission Viejo, CA 92691

Re: K030662

Trade/Device Name: Pathway™ Vertelink Access Sheath Catheter Regulation Number: 21 CFR §876.5470 Regulation Name: Ureteral Dilator Regulatory Class: II Product Code: 78 EZN Dated: August 25, 2003 Received: August 26, 2003

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 (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 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 the letter:

| 8xx. Ixxx | [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" (21CFR Part 807.97) you may obtain. 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 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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K 030662

Page of

510(k) Number (if known): K030662

Device Name: Pathway™ Access Sheath Catheter

Indications For Use: The expandable sheath is designed especially for formation of large nephrostomy tracts required for percutaneous removal of renal and ureteral calculi.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

David A. Syverson

(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Numbe

Prescription Use