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, Pigtail 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 does not contain detailed information about specific acceptance criteria or a dedicated study with quantifiable performance metrics for the Fossa Ureteral Stone Sweeper based on a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone algorithm performance study.

This submission is a Special 510(k): Device Modification, meaning it relies heavily on the substantial equivalence to a predicate device (Fossa Ureteral Stone Sweeper K021602) and a demonstration of compliance with design control requirements and risk analysis. The performance testing mentioned is primarily related to material and mechanical properties, not clinical efficacy or diagnostic accuracy.

Therefore, the following information cannot be extracted from the provided document:

A table of acceptance criteria and reported device performance related to clinical outcomes or diagnostic accuracy.
Sample size used for a test set, its data provenance, or the number/qualifications of experts for ground truth.
Adjudication method for a test set.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
Information about a standalone (algorithm only) performance study.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for a training set or how its ground truth was established.

Here's what can be extracted regarding the "acceptance criteria" and "study" as presented in the document, albeit in a different context than a typical AI/diagnostic device study:

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

The document mentions "Performance testing conducted in support of this submission includes dimensional inspection, elongation/yield and tensile strength testing, and lubricity evaluation." However, it does not provide specific acceptance criteria values (e.g., "tensile strength must be > X N") or the corresponding reported device performance values. The conclusion states the device "has been shown to be safe and effective for its intended use" based on these tests and comparison to the predicate, implying these tests met internal acceptance criteria for substantial equivalence.

Acceptance Criteria Category	Reported Device Performance
Dimensional Inspection	Passed (implied)
Elongation/Yield Testing	Passed (implied)
Tensile Strength Testing	Passed (implied)
Lubricity Evaluation	Passed (implied)

Self-correction: The document explicitly states these tests were performed but does not list the specific numerical criteria or results. The "Passed (implied)" is an inference based on the overall conclusion of safety and effectiveness.

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

Not applicable. The performance testing described (dimensional, tensile, lubricity) would involve material samples, not a clinical "test set" of patients or images. Therefore, data provenance in a clinical sense is not relevant here.

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 there is no mention of a "test set" requiring expert ground truth in the context of clinical or diagnostic performance. The testing pertains to the physical and mechanical properties of the device.

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

Not applicable, as there is no "test set" requiring adjudication.

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

No. The device is a ureteral stent/retrieval basket, not an AI or diagnostic system. Therefore, an MRMC study is not relevant to this submission.

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

No. This is a physical medical device, not an algorithm.

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

For the mechanical and material tests, the "ground truth" would be established by standard engineering and material science testing methods and specifications (e.g., ASTM standards for tensile strength). There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense for these types of tests.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of AI or machine learning.

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

Not applicable.

Summary

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XIV. 510(k) Summary

MAY 22 2003

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 Stone Sweeper
510(k) Sponsor:	Fossa Medical, 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:	Fossa Ureteral Stone Sweeper (K021602)

Product Description:

Indications for Use:

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/yield and tensile strength testing, and lubricity evaluation.

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.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular pattern.

MAY 22 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031292

Trade/Device Name: Fossa Ureteral Stone Sweeper Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral stent Regulation Number: 21 CFR& 876.4680 Regulation Name: Ureteral stone dislodger Regulatory Class: II Product Code: 78 FAD and FGO Dated: April 21, 2003 Received: April 23, 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 (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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Page 2

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	(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" (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 (800) 638-2041 or (301) 443-6597 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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Page 1

K031292 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)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K031292
Prescription Use
(Per 21 CFR 801.109)
OR

Over-the -Counter Use

Fossa Medical, 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).