(72 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a ureteral stent and stone removal device, with no mention of AI or ML.
Yes
The device is intended to promote drainage of urine and facilitate the manipulation, capture, and removal of urinary calculi, which are therapeutic actions addressing a medical condition (urinary obstruction or stones).
No
The device is indicated for promoting drainage and for the manipulation, capture, and removal of urinary calculi, which are therapeutic and interventional actions, not diagnostic ones.
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 used within the body ("indwelling ureteral catheter") to promote drainage and manipulate/remove urinary calculi. This is a therapeutic and interventional use, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical device (stent, sheath, pusher) designed for insertion and manipulation within the ureter. This aligns with a medical device used for treatment or intervention, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like urine, blood, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
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
78 FAD, 78 FGO
Device Description
The Fossa Ureteral Stone Sweeper set consists of a flexible, Piqtail 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, 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
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.
Key Metrics
Not Found
Predicate Device(s)
Cook Double Pigtail Polyurethane Stent, Bard Double Pigtail Ureteral Stent, Surgitek Stone Basket, Boston Scientific (Van-Tec) Segura Basket
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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 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: | Cook Double Pigtail Polyurethane Stent |
| Bard Double Pigtail Ureteral Stent | |
| Surgitek Stone Basket | |
| Boston Scientific (Van-Tec) Segura Basket |
Product 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.
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:
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
1
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.
2
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
3
Page _ 1 of __ 1__
A 216002 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)
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-the -Counter Use |
|---|---|---|
| 510001 | ||
| Fossa Industries, Inc. | Ureteral Stone Sweeper |