(26 days)
The Loop Tail Ureteral Stent is intended to facilitate drainage from the kidney to the bladder.
The Loop Tail Ureteral Stent is a dual durometer ureteral stent with a renal pigtail and a bladder loop configuration. A "long" and "short" loop version will be available, in sizes 5, 6, 7, and 8 Fr., and lengths ranging from 10cm to 30cm.
The provided FDA 510(k) summary for the Loop Tail Ureteral Stent does not contain specific acceptance criteria with quantitative metrics nor details of a clinical study proving the device meets such criteria in the way a contemporary AI/ML device submission might.
Instead, this submission is for a medical device (a ureteral stent) and relies on demonstrating substantial equivalence to a previously cleared predicate device (Contour Polaris Ureteral Stent K010002) rather than proving performance against specific, quantitative acceptance criteria through a clinical study. The performance data section focuses on "physical comparison and functional testing" to support substantial equivalence.
Based on the provided document, here's an analysis:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Functional/Comparative Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Facilitate drainage from the kidney to the bladder. | "The intended use ... [is] identical to the predicate device." |
| Material Equivalence: Made from materials substantially similar to the predicate. | "The materials are identical to the predicate device." |
| Biocompatibility: Demonstrated to be biocompatible. | Supported determination of substantial equivalence. |
| Performance Characteristics: Acceptable during functional testing and physical comparison. | "Results of physical comparison and functional testing support a determination of substantial equivalence." |
No specific quantitative acceptance criteria (e.g., success rates, flow rates, durability metrics) are provided in this summary document, as the submission focuses on substantial equivalence based on design and functional testing rather than a clinical outcome study with predefined metrics.
2. Sample size used for the test set and the data provenance
Not applicable in the context of this 510(k) summary. The submission discusses "physical comparison and functional testing," which would typically involve laboratory bench testing of a sample of devices, but it does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no mention of expert review or ground truth establishment in a clinical context for this device. The assessment is based on engineering and material comparisons, and functional testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of adjudication for a clinical test set.
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 is a medical device (ureteral stent), not an AI/ML-driven diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the sense of clinical ground truth for diagnostic accuracy. The "ground truth" for this submission would be defined by established engineering and material science principles, and the performance of the predicate device.
8. The sample size for the training set
Not applicable. This is a medical device primarily based on engineering design and material science, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. No training set as it's not an ML device.
Summary of the Study Proving the Device Meets Acceptance Criteria (as described in the 510(k) summary):
The device (Loop Tail Ureteral Stent) meets its "acceptance criteria" (which in this context are interpreted as the requirements for substantial equivalence) through a comparison with a legally marketed predicate device (Contour Polaris Ureteral Stent K010002) and a series of non-clinical tests.
The study essentially consists of:
- Technological Characteristics Comparison: The sponsor asserts that the intended use and materials of the proposed device are "identical" to the predicate device. The primary design difference is the bladder loop configuration of the proposed device versus the bladder pigtail of the predicate.
- Functional Testing and Physical Comparison: The submission states that "physical comparison and functional testing support a determination of substantial equivalence." This would involve laboratory bench tests to evaluate properties such as:
- Material integrity
- Mechanical properties (e.g., tensile strength, flexibility)
- Flow characteristics (though not explicitly stated, would be critical for a drainage device)
- Biocompatibility (based on the materials being identical to the predicate)
- Durability
The document mentions adherence to "FDA's 'Guidance for the Content of Premarket Notifications for Ureteral Stents'," indicating that the testing performed would align with regulatory expectations for this device type to demonstrate substantial equivalence.
In conclusion, for this specific 510(k) submission from 2003, the "study" proving acceptance criteria adherence is a demonstration of substantial equivalence through material identity, identical intended use, and a battery of non-clinical physical and functional tests, rather than a clinical trial with specific quantitative performance metrics against a predefined ground truth.
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Special 510(k) Premarket Notification Loop Tail Ureteral Stent
MAR 1 7 2003
Boston Scientific Corporation February 14, 2003
510 (k) SUMMARY 1030503 SPONSOR: Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760 Donna M. Gardner CONTACT PERSON: Senior Regulatory Affairs Specialist Or Lorraine M. Hanley Director Regulatory Affairs DEVICE: To Be Determined Trade Name: Ureteral Stent Common Name: Class II, per 21 CFR Part 876.4620 Classification: PREDICATE DEVICE: Contour Polaris Ureteral Stent (K010002) DESCRIPTION: The Loop Tail Ureteral Stent is a dual durometer ureteral stent with a renal pigtail and a bladder loop configuration. A "long" and "short" loop version will be available, in sizes 5, 6, 7, and 8 Fr., and lengths ranging from 10cm to 30cm. The Loop Tail Ureteral Stent is intended to facilitate drainage INTENDED USE: from the kidney to the bladder. TECHNOLOGICAL CHARACTERISTICS: The intended use and the materials are identical to the predicate device. The proposed device is designed with a bladder loop configuration, whereas the predicate device has a bladder pigtail. FDA's "Guidance for the Content of Premarket Notifications for PERFORMANCE DATA: Ureteral Stents", and the results of physical comparison and functional testing support a determination of substantial equivalence for the proposed device when compared to the predicate device. The proposed device is substantially equivalent to currently marketed ureteral stent devices in terms of performance characteristics, biocompatibility, and intended use.
Proprietary and Confidential Information of Boston Scientific Corporation
000031
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Donna M. Gardner Senior Regulatory Affairs Specialist Microvasive Urology Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537
MAR 1 7 2003
Re: K030503
Trade/Device Name: Contour Polaris Ureteral Stent Regulation Number: 21 CFR §876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: 78 FAD Dated: February 14, 2003 Received: February 19, 2003
Dear Ms. Gardner:
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. Iisting 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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 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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Special 510(k) Premarket Notification Loop Tail Ureteral Stent
INDICATIONS FOR USE STATEMENT K030503
| 510(k) Number | To be determined K030503 |
|---|---|
| Device Name | To be determined (Ureteral Stent) |
| Indications For Use | The Loop Tail Ureteral Stent is intended to facilitate drainage from the kidney to the bladder. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use レ (Per 21 CFR 801.109)
OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
David A. Logman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_
000017
§ 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).