(356 days)
Not Found
No
The summary describes a physical medical device (a ureteral stent) and its intended use for drainage and microbial inhibition. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML technologies in medical devices.
Yes
The device is described as an "indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder and to inhibit microbial adherence," which directly indicates a therapeutic function.
No
The device is a ureteral stent, which is a therapeutic device used to promote drainage and inhibit microbial adherence. It does not diagnose conditions.
No
The device description clearly states it is a physical stent and associated hardware (push catheter), not a software-only 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 it's an "indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder and to inhibit microbial adherence". This describes a device used within the body for a therapeutic purpose (drainage) and a preventative purpose (inhibiting microbial adherence).
- Device Description: The description details a physical device (stent, push catheter) designed to be inserted into the ureter.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve tests on samples like blood, urine, or tissue.
Therefore, the Fossa Ureteral OPEN-8 Stent is a medical device used for internal drainage and microbial inhibition, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fossa Ureteral OPEN-8 Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder and to inhibit microbial adherence on the catheter, specifically Proteus Mirabilus and Escherichia Coli.
Product codes (comma separated list FDA assigned to the subject device)
FAD
Device Description
The Fossa Ureteral Open-8 Stent set consists of a flexible, piatail-tipped stent with a radiopaque push catheter. The stent is offered in various diameters and working lengths. The stent has two lumens open to the outside of the stent and two external grooves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney, bladder
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)
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. TWE® materials used in the construction of the Fossa stent answere in other currently marketed uninary drainage devices.
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.
Fossa Open Lumen Stent (K033368), Fossa Double Pigtail Expanding Ureteral Stent (K021140)
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).
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
IV. 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-8 Stent (7 Fr and 10 Fr)
Or Fossa Open-8 Stent | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 510(k) Sponsor: | Fossa Medical, Inc.
P.O. Box 304
Milton, MA 02186 | AUG - 6 2008 |
| Device Generic Name: | Ureteral stent | |
| Classification: | According to Section 513 of the Federal Food, Drug, and
Cosmetic Act, the device classification is Class II,
Performance Standards (78FAD), and is classified under
21 CFR 876.4620. | |
| Predicate Devices: | Fossa Open Lumen Stent (K033368)
Fossa Double Pigtail Expanding Ureteral Stent (K021140) | |
Product Description:
The Fossa Ureteral Open-8 Stent set consists of a flexible, piatail-tipped stent with a radiopaque push catheter. The stent is offered in various diameters and working lengths. The stent has two lumens open to the outside of the stent and two external grooves.
Indications for Use:
The Fossa Ureteral OPEN-8 Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder and to inhibit microbial adherence on the catheter, specifically Proteus Mirabilus and Escherichia Coli.
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. TWE® materials used in the construction of the Fossa stent answere in other currently marketed uninary drainage devices.
Conclusion:
Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the Fossa Ureteral OPEN-8 Stent have been shown to be safe and effective for its intended use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the image. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG - 6 2008
Ms. Gloria Kolb President Fossa Medical, Inc. P.O. Box 304 MILTON MA 02186
Re: K072293
Trade/Device Name: OPEN-8 Stent Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: Class II Product Code: FAD Dated: July 21, 2008 Received: July 22, 2008
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 (Premarket Approval), it may be subject to such 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.
Image /page/1/Picture/10 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906-2006" are printed. Below the letters, the word "Centennial" is printed in a cursive font. The logo is surrounded by a circular border with text and stars. The text is difficult to read due to the image quality.
Protecting and Promoting Public Health.
2
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
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
Indications for Use
510(k) Number (if known): K072293
Device Name: OPEN-8 Stent
Indications For Use:
The OPEN-8 Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Hutten
Sign-Off) Divis Division of Reproductive, Abdominal. and Radiological Dev 510(k) Number
Page 1 of 1
Fossa Medical, Inc.