FOSSA URETERAL OPEN STENTS

K072293 · Fossa Medical, Inc. · FAD · Aug 6, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K072293
• Device Name: FOSSA URETERAL OPEN STENTS
• Applicant: Fossa Medical, Inc.
• Product Code: FAD · Gastroenterology, Urology
• Decision Date: Aug 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fossa Ureteral OPEN-8 Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder and to inhibit microbial adherence on the catheter, specifically Proteus Mirabilus and Escherichia Coli.

Device Story

The Fossa Ureteral OPEN-8 Stent is a flexible, pigtail-tipped ureteral catheter designed to facilitate urine drainage from the kidney to the bladder. The device features two open lumens and two external grooves to assist in drainage and inhibit microbial adherence. It is supplied with a radiopaque push catheter for placement. The stent is intended for use by clinicians in a medical setting. By providing a patent pathway for urine, the device helps prevent obstruction and potential complications associated with ureteral blockage. The materials used are consistent with those found in other currently marketed urinary drainage devices.

Clinical Evidence

Bench testing only. Performance testing was conducted in accordance with FDA's Guidance for the Content of Premarket Notifications for Ureteral Stents to demonstrate safety and effectiveness.

Technological Characteristics

Flexible, pigtail-tipped ureteral stent with radiopaque push catheter. Features two open lumens and two external grooves. Constructed from TWE materials used in other marketed urinary drainage devices. Class II device (21 CFR 876.4620).

Indications for Use

Indicated for patients requiring an indwelling ureteral catheter to facilitate urine drainage from the kidney to the bladder; inhibits microbial adherence (Proteus Mirabilus and Escherichia Coli).

Regulatory Classification

Identification

A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.

Predicate Devices

• Fossa Open Lumen Stent (K033368)
• Fossa Double Pigtail Expanding Ureteral Stent (K021140)

Submission Summary (Full Text)

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#### IV. 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-8 Stent (7 Fr and 10 Fr)<br>Or Fossa Open-8 Stent | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 510(k) Sponsor: | Fossa Medical, Inc.<br>P.O. Box 304<br>Milton, MA 02186 | AUG - 6 2008 |
| 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 Open Lumen Stent (K033368)<br>Fossa Double Pigtail Expanding Ureteral Stent (K021140) | |

### Product Description:

The Fossa Ureteral Open-8 Stent set consists of a flexible, piatail-tipped stent with a radiopaque push catheter. The stent is offered in various diameters and working lengths. The stent has two lumens open to the outside of the stent and two external grooves.

#### Indications for Use:

The Fossa Ureteral OPEN-8 Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder and to inhibit microbial adherence on the catheter, specifically Proteus Mirabilus and Escherichia Coli.

#### Safety and Performance:

Product performance testing has been provided in support of this 510(k) in accordance with FDA's Guidance for the Content of Premarket Notifications for Ureteral Stents. TWE® materials used in the construction of the Fossa stent answere in other currently marketed uninary drainage devices.

## Conclusion:

Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the Fossa Ureteral OPEN-8 Stent have been shown to be safe and effective for its intended use.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG - 6 2008

Ms. Gloria Kolb President Fossa Medical, Inc. P.O. Box 304 MILTON MA 02186

Re: K072293

Trade/Device Name: OPEN-8 Stent Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: Class II Product Code: FAD Dated: July 21, 2008 Received: July 22, 2008

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 (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.

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Protecting and Promoting Public Health.

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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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely vours.

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): K072293

Device Name: OPEN-8 Stent

Indications For Use:

The OPEN-8 Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Hutten

Sign-Off) Divis Division of Reproductive, Abdominal. and Radiological Dev 510(k) Number

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Fossa Medical, Inc.