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 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.

AI/ML Overview

The provided text describes the 510(k) submission for the Fossa Ureteral Open Lumen Stent. However, it does not contain detailed information about specific acceptance criteria or an explicit study proving performance in the context of device accuracy, sensitivity, or specificity, as would be typical for AI/ML-based diagnostic devices.

The document states that the submission is a "Special 510(k): Device Modification" and relies on compliance with design control requirements and risk analysis. The performance testing conducted is primarily related to physical and mechanical properties of the stent, rather than clinical performance metrics.

Therefore, for many of the requested points, the information is not present in the provided text.

Here's a breakdown of the available and missing information:

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

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (Explicitly Stated in Document)
Dimensional inspection (Physical dimensions)	Compliance with design specifications (implied by "certification of compliance to 21 CFR 820.30 Design Control requirements")
Elongation/yield strength testing	Met design requirements (implied)
Tensile strength testing	Met design requirements (implied)
Guidewire passage evaluation	Met design requirements (implied)
Compression strength	Met design requirements (implied)
Flow rate analysis	Met design requirements (implied)
Clinical Performance (e.g., sensitivity, specificity, accuracy)	Not provided or applicable for this type of device modification.

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

Sample size for test set: Not specified. The testing mentioned appears to be bench testing on physical device samples, not a clinical test set with patient data.
Data provenance: Not applicable, as no clinical data or test set with patient data is described.

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. Ground truth as typically defined for diagnostic or AI devices (e.g., true disease presence) is not relevant for this type of stent modification and its associated physical performance testing.

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

Not applicable. There is no mention of clinical data requiring expert 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. An MRMC study is not mentioned as this is a physical medical device (stent), not an AI diagnostic tool involving human readers.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the physical performance testing would be the pre-defined engineering specifications and standards for each test (e.g., a specific tensile strength value that must be met).

8. The sample size for the training set

Not applicable, as this is not an AI/ML device requiring a training set.

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

Not applicable, as this is not an AI/ML device requiring a training set.

Summary of what the document focuses on:

The provided document describes a Special 510(k) for a device modification (Fossa Ureteral Open Lumen Stent). The key aspects of the submission are:

Compliance with Design Control: Fossa Medical certified compliance with 21 CFR 820.30 Design Control requirements.
Risk Analysis: A description of the internal Risk Analysis procedure was provided.
Performance Testing (Benchtop/Physical): Performance testing included:
- Dimensional inspection
- Elongation/yield strength testing
- Tensile strength testing
- Guidewire passage evaluation
- Compression strength
- Flow rate analysis
Comparison to Predicate Devices: The device was deemed substantially equivalent to the Fossa Ureteral Stone Sweeper (K031292) and Fossa Double Pigtail Expanding Ureteral Stent (K021140) based on indications for use, technological characteristics, and the aforementioned performance testing.

The document emphasizes that based on these points, the device was shown to be safe and effective for its intended use as an indwelling ureteral catheter.

Summary

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

Product Description:

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	(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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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)

Over-the -Counter Use

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
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).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.