(356 days)
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.
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.
The provided text describes a 510(k) summary for the Fossa Ureteral OPEN-8 Stent. It states that "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." However, the document does not include the specific acceptance criteria or the detailed results of the study demonstrating that the device meets those criteria.
Therefore, many of the requested details cannot be extracted directly from this document.
Here's a summary of what can be inferred or directly stated from the provided text, and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated in Document | Not Explicitly Stated in Document The document generically states: "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." It also mentions: "TWE® materials used in the construction of the Fossa stent answere in other currently marketed uninary drainage devices." The "Conclusion" states: "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." Specifically related to a claim in the "Indications for Use": "...to inhibit microbial adherence on the catheter, specifically Proteus Mirabilus and Escherichia Coli." No performance data is provided to support this claim in the excerpt. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe the specific tests, study design, or sample sizes used.
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. This device is a ureteral stent, not an AI/imaging diagnostic device that requires expert ground truth for its performance evaluation in the way the question implies. The performance testing would likely involve benchtop or in-vivo animal/human studies focused on mechanical properties, biocompatibility, and functional aspects (drainage, microbial adherence).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As above, this type of adjudication method is not relevant for the performance testing of a ureteral stent.
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. This is not relevant for a ureteral stent. MRMC studies are typically for AI-assisted diagnostic tools.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not relevant. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated in the provided text. For a ureteral stent, "ground truth" would relate to whether the device successfully drains urine, prevents microbial adhesion, and remains functional without complications. This would likely be assessed through methods such as:
- Mechanical testing: Benchtop tests for flexibility, tensile strength, crushing resistance, flow rates.
- Biocompatibility testing: In vitro and/or in vivo studies to ensure material safety.
- Microbial adherence studies: In vitro tests specifically for Proteus Mirabilus and Escherichia Coli as claimed.
- Clinical outcomes data: (If human studies were conducted, which is not detailed here), observing drainage, patency, encrustation, infection rates.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would have a "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
In summary: The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices and broadly states that performance testing was conducted according to FDA guidance. It does not provide the specific details of the performance tests, acceptance criteria, or the study results themselves. These details would typically be found in the full 510(k) submission, which is more comprehensive than the summary provided here.
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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 304Milton, MA 02186 | AUG - 6 2008 |
| 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 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.
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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.
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Protecting and Promoting Public Health.
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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
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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.
§ 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).