pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent is used to facilitate temporary internal urinary drainage from is kidney to the bladder and stenting of the ureter in a pediatric patient no less than 2 years old and not more than 12 years old. The stent may be placed endoscopically, percutaneously, or using open surgical techniques. The stent should not be implanted for more than 30 days. This product is not intended as a permanent indwelling device.

Device Description

The Q Urological Corporation pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent is substantially equivalent to several predicate devices including: the Sof-Fiex Pediatic Double Pigtail Ureteral Stent (Cook Urological), the Sillouette Pediatric Ureteral Stem (Applied Medical Resource), the PANAMEX Ureteral Stent (Kingston Technologies) and the Aquasilque Ureteral Stent (American Medical Systems). Differences between the predicates and the pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent are the profile of the anchorage and the stent material. The anchorage section of the stent Urological Corporation is radiopaque. The composition of the stent material has been used before in predicate devices. For the pAguaMedicina Structural Hydrogel Pediaric Ureteral Stent this material has been processed by a proprietary method which delivers equivalent technological characteristics.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically the pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth for AI algorithms is not directly applicable or present in this document.

However, I can extract the relevant information pertaining to the device's performance testing as described for its 510(k) submission, even though it's not structured around "acceptance criteria" and "AI performance" in the way your prompt defines them.

Here's an analysis based on the provided text, addressing your points where possible, and noting when data is not available or relevant to this type of regulatory submission:

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

The document doesn't explicitly state "acceptance criteria" for the device's performance in the typical sense of a target metric for an AI algorithm. Instead, it describes performance testing conducted to demonstrate substantial equivalence to predicate devices. The "acceptance" is implied by favorable comparison.

Performance Metric	Reported Device Performance
Anchorage Force	"The anchorage method withstood a significantly greater force before coming dislodged" compared to several predicate devices.
Elongation and Tensile Strength	Testing was conducted, and "the results compared favorably to those of the predicate devices tested."
Flow Rate	Testing was conducted, and "the results compared favorably to those of the predicate devices tested."
Biocompatibility	Tested "in accordance with the suggestions of ISO 10993 for prolonged exposure." The stent material composition has been used before in predicate devices, and the proprietary processing "delivers equivalent technological characteristics."
Radiopacity	The anchorage section of the stent is radiopaque. (No comparative statement is made, but radiopacity is a functional characteristic).
Equivalent Technological Chars.	The proprietary processing of the material "delivers equivalent technological characteristics" compared to the material in predicate devices.
Intended Use	Has the "same intended use as the predicates."
Technological Differences/Safety	"Has no technological differences which raise new questions of safety and effectiveness, and it is at least as safe and effective as the predicates." (This is a conclusion drawn from the comparative testing and analysis, not a direct performance metric).
Clinical Equivalence (Pediatric Use)	"Predicate stents for pediatric patients have been cleared for the same size as the pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent" (implies a similar sizing and suitability for the pediatric population, though not a direct performance metric of the device itself). This device is cleared for pediatric patients no less than 2 years old and not more than 12 years old.
Implantation Duration	Stent should not be implanted for more than 30 days, and is not intended as a permanent indwelling device. (This is an indication for use/limitation, not a performance metric demonstrating equivalence, but important for its safe use).

2. Sample sizes used for the test set and the data provenance

The document refers to "bench performance testing" using "several predicate devices." It does not specify the number of stents (sample size) used for each test (anchorage force, elongation, tensile strength, flow rate) or for the predicates.

Test Set Sample Size: Not specified.
Data Provenance: The document implies in-house or contracted laboratory bench testing. No country of origin for data is mentioned, as it's not human subject data. The testing is retrospective in the sense that it's comparing the new device against existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this 510(k) submission. This is a medical device for internal drainage, not an AI diagnostic tool requiring expert consensus for images or clinical data as ground truth. The "ground truth" for this device's performance would be the direct measurements from the bench tests (e.g., force required to dislodge, flow rate).

4. Adjudication method for the test set

Not applicable. This is not an AI diagnostic study involving human interpretation that requires adjudication.

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-assisted diagnostic tool. No human readers or AI assistance are involved in its primary function or regulatory submission.

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.)

The "ground truth" for the device's performance is derived from direct bench testing measurements (e.g., force, flow rate, material properties) and comparison against established performance characteristics of predicate devices. For biocompatibility, it's compliance with ISO 10993 standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

Summary

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

510(k) Summary

510(K) NUMBER: Pending (Assigned: K082805)

SUBMITTED BY OWNER:

Q Urological Corporation P.O. Box 793 Natick, MA 01760 781-245-2232

JAN 2 0 2010

PG. I OF 2

OFFICIAL CONTACT:

Scott M. Epstein President

DATE OF PREPARATION: September 22, 2008 (Revised November, 2009)

TRADE NAME AND MODEL OF DEVICE: .

pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent, Model Number, NP330-

CLASSIFICATION NAME:

Ureteral Stent - 21 CFR 876.4620; Product Code FAD

CLASSIFICATION PANEL: Gastroenterology / Urology

SUMMARY STATEMENT:

(Indication for Use Revised--November, 2009)

The Q Urological pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent is used to facilitate temporary internal urinary drainage from the kidney to the bladder and stend to
of the ureter in a pediation no less the care the sidney to the bladder and stentin of the ureter in a pediatic patient no less than 2 years old and not more than 12 years old The stent may be placed endoscopically, percutaneously, or using open surgical techniques. The stent should not be implanted for more than 30 days. This product is not
intended as a permanent indivelling daving intended as a permanent indwelling device.

Differences between the predicates and the pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent are the profile of the anchorage and the stent material.

When tested against several predicate devices, the anchorage method withstood a significantly greater force before coming dislodged. The anchorage method withstood a
significantly greater force before coming dislodged. The anchorage section of the stent Urological Corporation is radiopaque.

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

K082805

PG. 2 OF 2

The composition of the stent material has been used before in predicate devices. For the pAguaMedicina Structural Hydrogel Pediaric Ureteral Stent this material has been processed by a proprietary method which delivers equivalent technological characteristics. It was tested for biocompatibility in accordance with the suggestions of ISO 10993 for prolonged exposure.

Bench performance testing was selected based on the FDA Guidance for the Content of Premarket Notifications for Ureteral Steats. Testing to determine the anchorage force, elongation and tensile strength, and flow rate of the Q Urological Corporation pAguaMedicina Structural Hydrogel Pediatric Ureleval Stept were conducted and the results compared favorably to those of the predicate devices tested.

In addition, predicate stents for pediatric patients have been cleared for the same size as the pAguaMedicina Structural Hydrogel Pediatric Ureteral Steat

The Q Corporation pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent has the same intended use as the predicates and has no technological differences which raise new questions of safety and effectiveness and it is at least as safe and effective as the predicates.

Therefore the Q Corporation pAguaMedicina Structural Hydrogel Pediatric Ureteral Stemt is substantially equivalent.

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

Image /page/2/Picture/0 description: The image shows the logo of the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings and body. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Scott M. Epstein. President O Urological Corporation IE Melvin Street, P.O. Box 793 NATICK MA 01760

JAN 20 2010

Re: K082805

Trade/Device Name: pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent Regulation Number: 21 CFR §876.4620 Regulation Name: Ureteral stent Regulatory Class: II Product Code: FAD Dated: November 25, 2009 Received: November 27, 2009

Dear Mr. Epstein:

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); medical device reporting (reporting of medical

{3}------------------------------------------------

Page 2 -

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (11 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K082805

Device Name: pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent

Indications For Use: pAguaMedicina Structural Hydrogel Pediatric Ureteral Stent is used to facilitate temporary internal urinary drainage from is kidney to the bladder and stenting of the ureter in a pediatric patient no less than 2 years old and not more than 12 years old. The stent may be placed endoscopically, percutaneously, or using open surgical techniques. The stent should not be implanted for more than 30 days. This product is not intended as a permanent indwelling device.

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

Heile Keinen

(Division Sigh-Off) Division of Reproductive, Abdominal ar.d Concellation on Datati, Office of Device Evaluation (ODE) 510(k) Number

Page 1 of

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).