MODIFIED URETERAL INDWELLING CATHETER/STENT by BOSTON SCIENTIFIC CORP.

The Modified Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement transurethrally, percutaneously, or via open surgery by a trained physician.

Device Description

Modified Ureteral Stent

AI/ML Overview

The provided text pertains to a 510(k) premarket notification for a Modified Ureteral Stent by Boston Scientific Corporation. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed experimental studies with acceptance criteria, sample sizes, or ground truth establishment in the way one would for novel AI/diagnostic devices.

Therefore, most of the requested information (acceptance criteria, specific study details with sample sizes, ground truth, expert qualifications, adjudication, MRMC, or standalone performance for an algorithm) is not applicable to this 510(k) submission for a traditional medical device like a ureteral stent.

Here's an analysis based on the provided text, addressing the applicable points:

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

Acceptance Criteria: Not explicitly stated as quantifiable acceptance criteria in the manner of a diagnostic study (e.g., sensitivity/specificity thresholds). The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to existing legally marketed predicate devices.
Reported Device Performance: The document states: "The proposed modified device is Substantially Equivalent to the predicate devices in terms of performance characteristics tested." It does not provide specific performance metrics (e.g., flow rates, durability, biocompatibility test results) that would typically be associated with acceptance criteria for a new device. The performance is assessed against the predicate device's known performance.

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to predicate devices for performance characteristics. (Implicit within 510(k) process)	"The proposed modified device is Substantially Equivalent to the predicate devices in terms of performance characteristics tested."

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

Not applicable. The submission does not describe a clinical study with a "test set" in the context of a diagnostic algorithm. 510(k)s for traditional devices usually rely on bench testing, materials characterization, and potentially limited animal or human use data (sometimes referred to as "clinical data" but rarely a formal "test set" as in AI studies) to support substantial equivalence. The document does not provide details on such testing.

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. There is no "ground truth" to establish in the context of a ureteral stent's performance in the same way there would be for a diagnostic AI device. The ground truth for device function is based on engineering specifications, material properties, and clinical outcomes attributed to the device type.

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

Not applicable. No adjudication method is described, as there's no diagnostic "test set" that requires expert consensus.

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

Not applicable. This device is a modified ureteral stent, not an AI or imaging diagnostic device. Therefore, no MRMC study, human-in-the-loop, or AI assistance is relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable / Implicit Ground Truth: For a ureteral stent, "ground truth" implicitly relates to the device's ability to safely and effectively facilitate urine drainage from the kidney to the bladder, as per its intended use and based on established engineering and medical principles. This is verified through comparisons to predicate devices, material testing, biocompatibility, and potentially preclinical/clinical performance data (though not detailed here).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable. As above, no training set for an algorithm.

Summary of the Study Proving Device Meets Acceptance Criteria (based on 510(k) context):

The "study" proving the device meets its "acceptance criteria" (i.e., substantial equivalence) is the 510(k) Premarket Notification process itself.

Nature of the Study: This is a regulatory submission where Boston Scientific Corporation provided documentation to the FDA to demonstrate that their "Modified Ureteral Stent" is substantially equivalent to legally marketed predicate devices. The performance characteristics of the modified device were compared to those of the predicate devices.
Proof of Equivalence: The FDA's letter (K974541) confirms: "We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to devices marketed in interstate commence prior to May 28, 1976..."
What was "tested": While specific test results are not in the provided text, the 510(k) process would have included:
- Comparison of technological characteristics (e.g., materials, dimensions, design) to predicate devices.
- Performance testing (e.g., mechanical strength, durability, flow characteristics) to ensure the modified stent performs comparably to the predicate device.
- Biocompatibility testing of materials.
- Sterilization validation.
- Clinical data (if necessary, though often not for minor modifications to well-established devices like stents).
Conclusion: The FDA's clearance (signified by the letter) acts as the "proof" that the device met the regulatory acceptance criterion of substantial equivalence.

Summary

{0}------------------------------------------------

510(k) Premarket Notification Modified Ureteral Stent November 26, 1997

Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

K974541 p.ofl

SECTION VIII 510)K) SUMMARY

FEB - 9 1998

510 (k) Summary Of Safety And Effectiveness

Sponsor:	Boston Scientific CorporationOne Scientific PlaceNatick, MA 01760-1537
Contact Person:	Lorraine M. HanleyManager, Regulatory AffairsorTerry MyersRegulatory Affairs Associate
Submission Date:	November 26, 1997
Common/Usual Names:	Modified Ureteral Stent
Trade/Proprietary Name:	To Be Determined
Device Classificationand Name:	According to CFR 21 Part 876, Section 4620 the Ureteral Stentis a Class II device.Product Code: 78FAD
Substantial Equivalence:	The proposed modified device is Substantially Equivalent to devices previously cleared by the FDA via the 510(k) Notification process and indicated for use as a Ureteral Catheter to provide drainage from the kidney to the bladder.
Performance:	The proposed modified device is Substantially Equivalent to the predicate devices in terms of performance characteristics tested.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1998

Ms Terry Myers Regulatory Affairs Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537 Re: K974541 Modified Ureteral Stents Dated: January 22, 1998 Received: January 26, 1998 Regulatory class: II 21 CFR §876.4620/Product code 78 FAD

Dear Ms. Myers:

We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to devices marketed in interstate commence prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 310(k) premarket notification. The FDA finding of substantial couivalence of your device to a legally marketed prodicate 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 and additionally 809.10 for in vitro directic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmamain.html".

Sincerely yours,

hJliau Yu
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

510(k) Premarket Notification Modified Ureteral Stent November 26, 1997

Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

SECTION I INDICATIONS FOR USE

Page . of of l 1

510(k) Number (if known): 长974541

Device Name:

Modified Ureteral Indwelling Catheter/Stent

Indications For Use:

The Modified Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement transurethrally, percutaneously, or via open surgery by a trained physician.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
\documentclass{article}
\usepackage{amsmath}
\begin{document}
[ \checkmark ]
\end{document}
(Per 21 CFR 801.109)
or
Over-The-Counter Use __

\documentclass{article}
\usepackage{amsmath}
\begin{document}
[ Robert \mathcal{D} \text{Stalling} ]
\end{document}
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
(Optional Format 1-2-96)

510(k) Number _

Regulation Number and Section

§ 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).