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, and/or for the manipulation, capture and removal of urinary calculi.

Device Description

The Fossa Ureteral Stone Sweeper set consists of a flexible, Piqtail tipped, selfexpanding 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, and to permit stone passage into the inner stent's lumen.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Fossa Ureteral Stone Sweeper. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on a clinical study with detailed performance metrics. Typically, devices like the Fossa Ureteral Stone Sweeper (ureteral stents/retrieval baskets) are cleared based on performance testing (bench testing) and material equivalence to existing devices, especially when their mechanism of action is well-understood and similar to previously cleared devices.

Therefore, many of the specific details requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not explicitly stated in this type of 510(k) summary. These types of studies are more common for diagnostic devices or devices with novel mechanisms of action where performance metrics like sensitivity, specificity, or accuracy are critical.

However, based on the provided text, here's what can be inferred or explicitly stated:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of explicit acceptance criteria with specific performance metrics (e.g., success rates, complication rates, or quantitative measurements) for a clinical study. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" mentioned refers to compliance with FDA guidance for ureteral stents and mechanical lithotripters, which generally involves bench testing.

Acceptance Criteria (Inferred from 510(k) process): The device must be demonstrated to be "substantially equivalent" in terms of safety and effectiveness to legally marketed predicate devices. This typically means similar technological characteristics, indications for use, and performance that is at least as safe and effective as the predicates, often validated through non-clinical (bench) testing.
Reported Device Performance (Inferred): "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 and 510(k) Checklist for Mechanical Lithotripters and Stone Dislodgers Used in Gastorenterology and Urology." This indicates the device underwent testing relevant to its function as a ureteral stent and a stone removal device, likely including tests for material properties, structural integrity, flow rates, and stone manipulation/retrieval capabilities. However, specific results (e.g., stent fracture rate, stone fragmentation efficiency) are not quantified in this summary.
Safety and Effectiveness Conclusion: "Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the Fossa Ureteral Stone Sweeper has been shown to be safe and effective for its intended use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable or not provided. This 510(k) summary does not describe a clinical study with a "test set" in the context of human patients for performance evaluation. The "performance testing" referenced is almost certainly non-clinical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as no clinical study or human performance evaluation with expert-established ground truth is presented.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no clinical study or human performance evaluation is presented.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical instrument (ureteral stent/retrieval basket), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For a device like this, "ground truth" often relates to engineering specifications and material science, verified through bench testing against established standards and predicate device characteristics.

8. The sample size for the training set

Not applicable. There is no mention of a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable as no training set for an algorithm is mentioned.

Summary of what is provided:

Device Type: Medical device (ureteral stent/retrieval basket).
Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence.
Basis for Clearance: Comparison to predicate devices (Cook Double Pigtail Polyurethane Stent, Bard Double Pigtail Ureteral Stent, Surgitek Stone Basket, Boston Scientific (Van-Tec) Segura Basket) and non-clinical "product performance testing" in accordance with FDA guidance documents.
Key Argument: The materials used are identical to those in currently marketed urinary drainage and stone removal devices.
Conclusion: The device is "safe and effective for its intended use" based on indications, technological characteristics, performance testing, and predicate comparison.

Summary

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K0 21602

510(k) PREMARKET NOTIFICATION

XII. 510(k) Summary

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 Ureteral Stone Sweeper
510(k) Sponsor:	Fossa Industries, Inc.580 Harrison Avenue, 4th FloorBoston, MA 02118
Device Generic Name:	Ureteral stent / retrieval basket
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II,Performance Standards (78FAD / 78FGO), and isclassified under 21 CFR 876.4620 / 21 CFR 876.4680).
Predicate Devices:	Cook Double Pigtail Polyurethane StentBard Double Pigtail Ureteral StentSurgitek Stone BasketBoston Scientific (Van-Tec) Segura Basket

Product Description:

Indications for Use:

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 and 510(k) Checklist for Mechanical Lithotripters and Stone Dislodgers Used in Gastorenterology and Urology. The materials used in the construction of the Fossa stent are identical to those used in other currently marketed urinary drainage and stone removal devices.

Conclusion:

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

Fossa Industries, Inc.

Ureteral Stone Sweeper

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of three stylized human profiles facing to the right, with three lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 6 2002

Fossa Industries, Inc. c/o Pamela Papineau, RAC Consultant to Fossa Industries, Inc. Delphi Medical Device Consulting 5 Whitcomb Avenue AYER MA 01432

Re: K021602

Trade/Device Name: Fossa Ureteral Stone Sweeper Regulation Number: 21 CFR 876.4620 Regulation Name: Ureteral stent Product Code: 78 FAD Regulation Number: 21 CFR 876.4680 Regulation Name: Ureteral stone dislodger Product Code: 78 FGO Regulatory Class: II Dated: May 9, 2002 Received: May 15, 2002

Dear Ms. Papineau:

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 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:

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 your 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 yours,

Nancy Crogdon

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 _ 1 of __ 1__

A 216002 510(k) Number (if known):

Device Name: Ureteral Stone Sweeper

Indications for Use:

(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)	OR	Over-the -Counter Use

	510001
Fossa Industries, Inc.		Ureteral Stone Sweeper

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).