FOSSA URETERAL OPEN LUMEN STENT

K033368 · Fossa Medical, Inc. · EYB · Nov 26, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K033368
• Device Name: FOSSA URETERAL OPEN LUMEN STENT
• Applicant: Fossa Medical, Inc.
• Product Code: EYB · Gastroenterology, Urology
• Decision Date: Nov 26, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fossa Ureteral Open Lumen Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder.

Device Story

The Fossa Ureteral Open Lumen Stent is a flexible, pigtail-tipped ureteral catheter designed to promote urine drainage from the kidney to the bladder. The device includes a pusher and an optional pre-attached suture to assist with removal. It is available in various diameters and working lengths and features two lumens open to the exterior. The stent is intended for clinical use by healthcare professionals to manage urinary drainage. Performance is verified through mechanical testing, including dimensional inspection, elongation/yield, tensile strength, guidewire passage, compression strength, and flow rate analysis.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included dimensional inspection, elongation/yield, tensile strength, guidewire passage, compression strength, and flow rate analysis.

Technological Characteristics

Flexible, pigtail-tipped ureteral stent with two open lumens. Includes pusher and optional suture. Materials and dimensions vary. Mechanical performance verified via bench testing (tensile, compression, flow).

Indications for Use

Indicated for patients requiring an indwelling ureteral catheter to facilitate urine drainage from the kidney to the bladder.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• Fossa Ureteral Stone Sweeper (K031292)
• Fossa Double Pigtail Expanding Ureteral Stent (K021140)

Submission Summary (Full Text)

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NOV 26 2003

# XIV. 510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Fossa Medical, Inc. is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Fossa chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

| Trade Name: | Fossa Ureteral Open Lumen Stent |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Sponsor: | Fossa Medical, Inc.<br>580 Harrison Avenue, 4th Floor<br>Boston, MA 02118 |
| Device Generic Name: | Ureteral stent |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II,<br>Performance Standards (78FAD), and is classified under<br>21 CFR 876.4620. |
| Predicate Devices: | Fossa Ureteral Stone Sweeper (K031292)<br>Fossa Double Pigtail Expanding Ureteral Stent (K021140) |

#### Product Description:

The Fossa Ureteral Open Lumen Stent set consists of a flexible, pigtail-tipped stent with: "Pusher." and optional pre-attached suture to facilitate stent removal. The stent is offered in various diameters and working lengths. The stent has two lumens open to the outside of the stent.

## Indications for Use:

The Fossa Ureteral Stone Sweeper is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder.

## Safety and Performance:

This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Fossa Medical has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. Performance testing conducted in support of this submission includes dimensional inspection, elongation/vield and tensile strength testing, quidewire passage evaluation, compression strength and flow rate analysis.

#### Conclusion:

Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the Fossa Ureteral Open Lumen Stent has been shown to be safe and effective for its intended use.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above two wavy lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 2003

Ms. Gloria Kolb President Fossa Medical, Inc. 580 Harrison Avenue, 4th Floor BOSTON MA 02118

Re: K033368

Trade/Device Name: Fossa Ureteral Open Lumen Stent Regulation Number: 21 CFR §876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: 78 EYB Dated: October 20, 2003 Received: October 29, 2003

Dear Ms. Kolb:

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 (OS) 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.1xxx | [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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Ureteral Open Lumen Stent Device Name:

Indications for Use:

The Fossa Ureteral Open Lumen Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Office of Device Evaluation (ODE)

David A. Leggott

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 093368 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the -Counter Use