(29 days)
Not Found
No
The summary describes a mechanical device for stone manipulation and drainage, with no mention of AI/ML terms, image processing, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is described as an indwelling ureteral catheter designed to promote drainage and aid in the manipulation, capture, and removal of urinary calculi, which are therapeutic actions.
No
The device is indicated for promoting drainage of urine and for the manipulation, capture, and removal of urinary calculi. It does not perform any diagnostic function such as identifying, assessing, or predicting a medical condition.
No
The device description clearly outlines physical components like a flexible stent, insertion sheath, and pusher, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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." This describes a surgical or interventional device used directly within the body, not a device used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical stent and associated tools for insertion and removal, consistent with an implantable or interventional medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Fossa Ureteral Stone Sweeper is a medical device used for a therapeutic and interventional purpose, not an in vitro diagnostic device.
N/A
Intended Use / 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, and/or for the manipulation, capture and removal of urinary calculi.
Product codes (comma separated list FDA assigned to the subject device)
78 FAD, FGO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney, bladder, ureteral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing conducted in support of this submission includes dimensional inspection, elongation/yield and tensile strength testing, and lubricity evaluation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
§ 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).
0
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 Floor | |
Boston, MA 02118 | |
Device Generic Name: | Ureteral stent / retrieval basket |
Classification: | According to Section 513 of the Federal Food, Drug, and |
Cosmetic Act, the device classification is Class II, | |
Performance Standards (78FAD / 78FGO), and is | |
classified under 21 CFR 876.4620 / 21 CFR 876.4680). | |
Predicate Devices: | Fossa Ureteral Stone Sweeper (K021602) |
Product 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.
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, and/or for the manipulation, capture and removal of urinary calculi.
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.
1
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.
2
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
3
Page 1
K031292 510(k) Number (if known):
Device Name: Ureteral Stone Sweeper
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, and/or for the manipulation, capture and removal of urinary calculi.
(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