The pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent is used to facilitate drainage from the kidney to the bladder and stenting of the ureter in patients not less than 2 years old. The Stent may be placed using endoscopic, percutaneous or 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 pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent meets the statutory definition of 21 CFR 876.4620 as a "tube-like", implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. Ureteral stents may have finger-like protrusions or hooked ends to keep the tube in place. They are used in the treatment of ureteral injuries and ureteral obstruction. The purpose of this Special 510(k) is to expand the product line of the pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent [510(k) K163068], to add variations in anchorage profile. The recommended usage of the pAguaMedicina™ PERSISTENTTM Structural Hydrogel Ureteral Stent, to facilitate drainage from the kidney to the bladder and stenting of the ureter in patients not less than 2 years old, remains unchanged. Particular uses and the choice of anchorage profile are left to the physician's discretion and suggestions do not appear in the labeling. The labeling will only identify the type of anchorage profile. All stents are radiopaque. All stents by Q Urological TM Corporation are single use, sterile devices, administrated in healthcare facilities by prescription. As with the cleared / predicate pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent, the modified stent may be placed using endoscopic, percutaneous, or open surgical techniques. The stent should not be implanted for more than 30 days. The product is not intended as a permanent indwelling device. The proposed stents will be made of the same material as the predicate (trademark paguamedicina™), a partiality hydrolyzed polyacrylonitrile, produced in part from a proprietary manufacturing process. The modified device incorporates a wire form which creates a pigtail configuration upon deployment. The wire is composed of metals that have been implanted in the human body in a wide variety of locations (tissue and bone), for numerous applications and are considered to be biocompatible. The manufacturing methods, process parameters, design controls and quality assurance system (QSR - 21 CFR 820) used for all pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stents are the same as those of the cleared / predicate device; [510(k) K163068]. The stents are sterilized by E Beam radiation to a sterility assurance level of 10-6.

AI/ML Overview

This document, a Special 510(k) Summary for the pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent, primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K163068) for an expanded product line with modified anchorage profiles. It explicitly states that "No non-clinical or clinical performance data are included in this Special 510(k)." Therefore, based only on the provided text, it's not possible to provide details on acceptance criteria and a study that proves the device meets them in the traditional sense of a clinical or non-clinical performance study with specific metrics and results.

Instead, the submission relies on the concept of design controls, verification, and validation activities to establish substantial equivalence to the predicate device, implying that the modifications do not introduce new questions of safety or effectiveness.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

As stated above, the document explicitly says "No non-clinical or clinical performance data are included in this Special 510(k)." Therefore, a table of specific acceptance criteria and reported device performance (e.g., success rates, complication rates, specific measurements) is not present in this submission. The "performance" is implicitly tied to the predicate device's established performance and the assertion that the new variations maintain that safety and effectiveness.

The document's argument for substantial equivalence is based on:

Intended Use and Indications for Use: Unchanged from the predicate.
Material: Same raw material (paguamedicina™) as the predicate.
Manufacturing Methods, Process Parameters, Design Controls, and Quality Assurance System (QSR): Same as the predicate.
Sterilization Method: Same (E Beam radiation to a sterility assurance level of 10-6).
Labeling: Consistent with the predicate, with revisions only to reflect the particular anchorage profile.
Validation and Verification Activities: Performed under Design Controls to assess individual risk analysis, concluding that differences in attributes for modified anchorage configurations do not introduce "any different questions of safety and effectiveness" from the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable, as no non-clinical or clinical performance data from a "test set" are presented in this submission. The substantial equivalence argument relies on design controls and equivalence to a previously cleared device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable for the reasons stated above.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This submission does not mention or present any MRMC studies.

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

Not applicable. This device is a physical medical device (ureteral stent), not an algorithm or AI product.

7. The Type of Ground Truth Used:

Not applicable for a performance study in this submission. For the predicate device, the "ground truth" for its clearance would have been established through its own clinical and non-clinical data, which is not detailed here. In this Special 510(k), the "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate device (K163068).

8. The Sample Size for the Training Set:

Not applicable, as this is not an AI/algorithm device submission, nor does it present new performance study data.

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reasons as above.

In summary:

This Special 510(k) relies on demonstrating that modifications (new anchorage profiles) to an already cleared device do not alter its fundamental safety and effectiveness profile. The "study" proving the device meets acceptance criteria is implicitly the design control process, verification, and validation activities performed to ensure that the modified devices are substantially equivalent to the predicate, which itself would have undergone performance testing. The document explicitly states that it does not include new non-clinical or clinical performance data to directly prove acceptance criteria for the modified devices.

Summary

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

October 4, 2017

Q Urological Corporation Scott Epstein Founder / CEO 93 West Street, Suite C1 Medfield, MA 02052

Re: K172289

Trade/Device Name: pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: September 5, 2017 Received: September 6, 2017

Dear Scott 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172289

Device Name

The pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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Special 510(k) Summary 008.

SPECIAL 510(k) NUMBER: K172289

SUBMITTED BY OWNER: Q Urological™ Corporation, (new address: 93 West St; Suite C1, Medfield MA 02052 - 508 728 1031 - OFFICIAL CONTACT: Scott M. Epstein, President

DATE OF PREPARATION: July 21, 2017 (revised September 4, 2017)

TRADE NAME AND MODEL OF DEVICE:

pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent: Models 2 and 3

COMMON AND CLASSIFICATION NAME: Ureteral Stent

REGULATORY DESIGNATION; 21 CFR 876.4620

CLASSIFICATION: Class II

PRODUCT CODE: FAD

CLASSIFICATION PANEL: Gastroenterology / Urology

PREDICATE DEVICE:

pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent [Premarket Notification 510(k): K163068]

This predicate has not been subject to a design-related recall. No historical modifications have been made since the last clearance of the device.

INTENDED USE: To allow for the passage of urine.

Q Urological Corporation / 93 West Street. / Suite C1 / Medfield, MA. 02052 / 508 728 1031

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INDICATIONS FOR USE:

The pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent is used to facilitate drainage from the kidney to the bladder and stenting of the ureter in patients not less than 2 years old. The Stent may be placed using endoscopic, percutaneous, or 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 purpose of this Special 510(k) is to expand the product line of the pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent [510(k) K163068], to add variations in anchorage profile. The recommended usage of the pAguaMedicina™ PERSISTENTTM Structural Hydrogel Ureteral Stent, to facilitate drainage from the kidney to the bladder and stenting of the ureter in patients not less than 2 years old, remains unchanged.

Particular uses and the choice of anchorage profile are left to the physician's discretion and suggestions do not appear in the labeling. The labeling will only identify the type of anchorage profile. All stents are radiopaque. All stents by Q Urological TM Corporation are single use, sterile devices, administrated in healthcare facilities by prescription.

As with the cleared / predicate pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent, the modified stent may be placed using endoscopic, percutaneous, or open surgical techniques. The stent should not be implanted for more than 30 days. The product is not intended as a permanent indwelling device.

The proposed stents will be made of the same material as the predicate (trademark paguamedicina™), a partiality hydrolyzed polyacrylonitrile, produced in part from a proprietary manufacturing process.

The modified device incorporates a wire form which creates a pigtail configuration upon deployment. The wire is composed of metals that have been implanted in the human body in a wide variety of locations (tissue and bone), for numerous applications and are considered to be biocompatible.

The manufacturing methods, process parameters, design controls and quality assurance system (QSR - 21 CFR 820) used for all pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stents are the same as those of the cleared / predicate device; [510(k) K163068].

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The stents are sterilized by E Beam radiation to a sterility assurance level of 10-6.

LEGALLY MARKETED DEVICE: The Subject of this Special 510(k) is being compared for substantially equivalence to the pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent, a legally marketed device, as originally cleared in 510(k) K163068.

SUMMARY STATEMENT:

This Special Premarket Notification proposes to expand the product line of pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stents by adding additional anchorage profiles, providing the physician the ability to select the most appropriate product for the individual patient.

Clearance of the proposed modification, which creates stents with a pigtail loop, will allow for the addition of two new devices, extending the available product offering. In one configuration, the currently cleared bulbous anchorage will be used in the bladder and the proposed pigtail anchorage in the kidney (bulbous / pigtail). In a second device, both ends of the stent will utilized the proposed pigtail anchorage (pigtail / pigtail). Both products will be available in the same sizes and lengths as the unmodified product.

The labeling of the entire product line is consistent with that of the cleared / predicate device as it displays the same insertion, retrieval / removal or exchange procedure; sterility method; stability / expiration dating; and labeled Contraindications, essential Warnings and Precautions, Complications, Single Use Designation, Limitation on Reuse and Resterilization and Prescription Legend. The appropriate labeling components of the modified products will be revised to reflect the particular anchorage profile.

Development of the modification of the pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent was done in accordance with 21 CFR 820.30. Compliance with other aspects of the Quality Systems Regulation (21 CFR 820) was maintained as appropriate. Regardless of anchorage profile, the stents are made from the same raw material (paguamedicina™). The manufacturing methods, process parameters, design controls and quality assurance system are also the same. The stents are sterilized by E Beam radiation to a sterility assurance level of 10-6.

No non-clinical or clinical performance data are included in this Special 510(k). Substantial Equivalence was established under Design Controls by validation and verification activities performed to reflect findings of individual risk analysis.

These verification and validation activities found that any differences in the values of attributes for the modified anchorage configurations do not introduce any different questions of safety and effectiveness from the predicate / cleared product [510(k) K163068].

SUBSTANTIAL EQUIVALENCE: The proposed stents have the same intended use and indication for use as the predicate / cleared, pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stent.

Q Urological Corporation / 93 West Street. / Suite C1 / Medfield, MA. 02052 / 508 728 1031

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The information included in this 510(k) demonstrates that any differences in the technological characteristics of stents with pigtail shaped anchorage do not raise different questions of safety and effectiveness from the predicate / cleared stent. Therefore, the proposed stents are as safe and effective as the predicate / cleared device and can be considered substantially equivalent to the pAguaMedicina™ PERSISTENT™ Structural Hydrogel Ureteral Stents cleared under 510(k) K163068.

Q Urological Corporation / 93 West Street. / Suite CI / Medfield, MA. 02052 / 508 728 1031

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).