The Fossa Double Pigtail Expanding Ureteral Stent is indicated for use as an indwelling ureteral catheter for drainage of urine from the kidney to the bladder.

Device Description

The Fossa Expanding Double Pigtail Ureteral Stent set consists of a flexible, Pigtail tipped, self-expanding stent with: Insertion sheath, "Pusher," and optional pre-attached suture to facilitate stent removal. The stent is offered in various diameters and working lengths. Short slits along the working length of the stent allow radial device expansion to permit fluid flow through and around the device.

AI/ML Overview

The provided text does not contain information about acceptance criteria for a study, nor does it describe a study proving a device meets such criteria. Instead, it is a 510(k) summary and FDA clearance letter for a medical device called the "Fossa Expanding Double Pigtail Ureteral Stent".

The document focuses on:

Device Description: A flexible, pigtail-tipped, self-expanding ureteral stent with an insertion sheath, "Pusher," and optional pre-attached suture. It's offered in various diameters and lengths.
Indications for Use: For use as an indwelling ureteral catheter for drainage of urine from the kidney to the bladder.
Safety and Performance: States that "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." It also mentions that the materials are identical to those used in other currently marketed urinary drainage devices.
Predicate Devices: Cook Double Pigtail Polyurethane Stent and Bard Double Pigtail Ureteral Stent.
Conclusion: Based on indications for use, technological characteristics, performance testing, and comparison to predicate devices, the stent is deemed safe and effective.
FDA Clearance: A letter from the FDA confirming substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving those criteria are met, as this type of information is not present in the provided text. The document is a regulatory submission for device clearance, not a detailed study report.

Summary

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510(k) Summary XII.

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Fossa Industries, 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 Expanding Double Pigtail Ureteral Stent
510(k) Sponsor:	Fossa Industries, Inc.580 Harrison Avenue, 4th FloorBoston, MA 02118
Device Generic Name:	Ureteral stent
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II,Performance Standards (78FAD), and is classified under21 CFR 876.4620.
Predicate Devices:	Cook Double Pigtail Polyurethane StentBard Double Pigtail Ureteral Stent

Product Description:

Indications for Use:

The Fossa Double Pigtail Expanding Ureteral Stent is indicated for use for as an indwelling ureteral catheter for drainage of urine from the kidney to the bladder.

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. The materials used in the construction of the Fossa stent are identical to those used in other currently marketed urinary drainage devices.

Conclusion:

Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the Fossa Double Pigtail Expanding Ureteral 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest the wings and body of the bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 8 2002

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

Re: K021140 Trade/Device Name: Fossa Double Pigtail Expanding Ureteral Stent Regulation Number: 21 CFR 876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: 78 FAD Dated: April 5, 2002 Received: April 9, 2002

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 (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 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 snecific advice for your device on our labeling regulation (21 CFR Part 801), nlease contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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Page ______ of _______________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K021/40

Expanding Ureteral Stent Device Name:

Indications for Use:

The Fossa Double Pigtail Expanding Ureteral Stent is indicated for use as an indwelling ureteral catheter for 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)

Prescription Use(Per 21 CFR 801.109)
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Over-the -Counter Use
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Signature

(Division Sign-Off)
Division of Reproductive, Abdominal,and Radiological Devices
510(k) Number	K021140

Fossa Industries, Inc. 5 Expanding Double Pigtail Ureteral Stent

Regulation Number and Section

§ 876.4620 Ureteral stent.

(a)
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.(b)
Classification. Class II (performance standards).