The Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically, fluoroscopically or during an open surgical procedure by a trained physician.

Device Description

The Tria Soft Ureteral Stent consists of the following:

Tria™ Soft Ureteral Stent with retrieval line
Ureteral Stent Positioner
Pigtail Straightener

AI/ML Overview

Please note: The provided FDA document is a 510(k) clearance letter for a medical device (Tria Soft Ureteral Stent), not a diagnostic AI/ML device. Therefore, the document primarily focuses on demonstrating substantial equivalence to a predicate device through material and performance testing, rather than detailed clinical performance studies typically seen for AI-driven diagnostic tools.

As a result, many of the detailed criteria for AI/ML device performance (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this specific document or type of device clearance.

However, I can extract and interpret the information that is relevant to the acceptance criteria and the study that proves the device meets them, given the context of a ureteral stent:

Description of Acceptance Criteria and Study Proving Device Meets Criteria (for a Ureteral Stent)

This document describes the 510(k) clearance for the Tria Soft Ureteral Stent, which is intended to facilitate drainage from the kidney to the bladder. The clearance is based on demonstrating substantial equivalence to a legally marketed predicate device (Tria Firm Ureteral Stent, K190603). For this type of device, "acceptance criteria" are primarily related to functional performance, safety, and material properties, ensuring the new device performs at least as well as, and poses no new risks compared to, the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a physical medical device (stent) and not an AI/ML diagnostic, the "performance" is about physical and functional attributes rather than diagnostic metrics (e.g., sensitivity, specificity).

Acceptance Criteria (Required Performance)	Reported Device Performance (Study Findings)
Biocompatibility: Materials meet applicable biocompatibility standards (e.g., ISO 10993-1:2009, FDA guidance).	All patient contacting materials meet applicable biocompatibility standards. Testing performed with passing results for: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, Implantation, Chemical Characterization with Toxicological Risk Assessment.
Dimensions: Maintain specified dimensions.	Tested and confirmed to meet initial specifications.
Tensile Strength: Maintain required tensile properties.	Tested and confirmed to meet initial specifications.
Full Functional Tests: Device performs its intended function (facilitating fluid drainage).	Tested and confirmed to meet initial specifications.
Packaging Integrity: Packaging maintains sterility and device integrity.	Tested and confirmed to meet initial specifications.
Sterility: Achieve and maintain sterility (SAL 10⁻⁶).	Continues to be sterilized by ethylene oxide (EO) to an SAL 10⁻⁶ level.
Equivalence in Intended Use/Indications for Use: Same as predicate.	The device has the same intended use (facilitating drainage from kidney to bladder) and same indications for use as the predicate.
Technological Characteristics Equivalence: Principles of operation and scientific technology fundamentally unchanged.	Principles of operation are identical to the predicate. The difference is a minor material change to support a lower durometer (softness), which does not change intended use, scientific technology, or indications for use.
Safety and Effectiveness: No new issues of safety or effectiveness compared to predicate.	Conclusion: Modified device raises no new issues of safety or effectiveness compared to the predicate.

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

Sample Size: The document does not specify exact numerical sample sizes for each specific test (e.g., how many stents were subjected to tensile strength tests). It generally states that "The modifications to the subject Tria Soft Ureteral Stent have been tested in the same manner as the predicate to ensure compliance to the initial specifications."
Data Provenance: Not explicitly stated as retrospective/prospective or country of origin in the context of clinical data. The tests are laboratory-based engineering performance and biocompatibility studies conducted by the manufacturer (Boston Scientific Corporation).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable in the context of this device. Ground truth, for this device, is established by engineering specifications, material science standards (e.g., ISO 10993), and regulatory requirements, not by expert interpretation of images or clinical outcomes in the way an AI diagnostic would require.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication is typically used to resolve discrepancies in human interpretation (e.g., multiple readers for a diagnostic image). For physical and biological performance tests, the results are typically quantitative measurements against predefined specifications.

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

No. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images). This document is for a physical medical implant (stent) and focuses on its material and functional properties, not its interpretive performance.

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

Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

For this device, "ground truth" is defined by:
- Engineering Specifications: Dimensions, tensile strength, functional characteristics.
- Biocompatibility Standards: Compliance with ISO 10993-1:2009 and FDA guidance, demonstrated through various in vitro and in vivo tests.
- Sterilization Standards: Achievement of SAL 10⁻⁶.
- Predicate Device Performance: The predicate device serves as the benchmark for "acceptable" performance and safety.

8. The Sample Size for the Training Set

Not Applicable. This device does not involve machine learning or a "training set."

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

Not Applicable. As above, there is no training set for this type of device.

Summary for this specific device type:

The "study" proving the device meets acceptance criteria for this 510(k) clearance is a series of bench testing (engineering performance tests) and biocompatibility testing. The core of the argument for clearance is substantial equivalence to an existing predicate device, demonstrating that the minor material change to achieve a "softer" stent does not negatively impact its safety or performance, and that it continues to function as intended in the same manner as the predicate. The acceptance criteria are largely met by confirming that the device's measured physical properties and biological interactions align with established standards and are comparable to its predicate.

Summary

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August 16, 2019

Boston Scientific Corporation Justin Kapitan Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

K191609 Re:

Trade/Device Name: Tria Soft Ureteral Stent Regulation Number: 21 CFR 876.4620 Regulation Name: Ureteral stent Regulatory Class: Class II Product Code: FAD Dated: June 14, 2019 Received: June 17, 2019

Dear Justin Kapitan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Glenn B. Bell, Ph.D. Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K191609

Device Name Tria Soft Ureteral Stent

Indications for Use (Describe)

The Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically, fluoroscopically or during an open surgical procedure by a trained physician.

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)

LITERATURE REVIEW

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SECTION 5 510K SUMMARY

510(k) Summary for the Tria Soft Ureteral Stent

A. Sponsor

Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01752

B. Contact

Justin Kapitan Sr. Regulatory Affairs Specialist 508-683-4518 justin.kapitan@bsci.com

Yunus Gulmez Regulatory Affairs Specialist II 508-683-5998 Yunus.Gulmez(@bsci.com

C. Proposed Device

Trade name:	Tria Soft Ureteral Stent
Common/usual name:	Stent, Ureteral
Classification Number:	21 CFR 876.4620
Classification Name:	Ureteral Stent
Classification:	Class II
Product Code:	FAD
Product Code Name:	Stent, Ureteral

D. Predicate Device

Trade name:	Tria Firm Ureteral Stent
Common/usual name:	Stent, Ureteral
Classification Number:	21 CFR 876.4620
Classification Name:	Ureteral Stent
Classification:	Class II
Product Code:	FAD
Product Code Name:	Stent, Ureteral
Identification of Predicate Device:	Tria Firm Ureteral Stent, K190603

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SECTION 5 510K SUMMARY

E. Model Name

Tria™ Soft Ureteral Stent

F. Device(s) Description

The Tria Soft Ureteral Stent consists of the following:

Tria™ Soft Ureteral Stent with retrieval line ●
Ureteral Stent Positioner
Pigtail Straightener ●

F. Intended Use/Indications for Use

The Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically, fluoroscopically or during an open surgical procedure by a trained physician.

G. Technological Characteristics Compared to Predicate

The principles of operation are identical between the predicate and subject devices: The Tria Soft Ureteral Stent provides a lumen that allows fluids to move from the kidney to the bladder.

The difference between the subject device and the predicate is a minor material change to support the lower durometer of the proposed device.

The technological characteristics remain equivalent to the predicate device because the modifications that are the subject of this submission are limited to improvements to the existing design.

The proposed changes do not change the intended use nor fundamentally change the scientific technology of the device, and do not change the indications for use of the device.

H. Substantial Equivalence

The modified Tria Soft Ureteral Stent is substantially equivalent to the predicate Tria Firm Ureteral Stent (K190603). It has the same intended use for facilitating drainage from the kidney to the bladder and the same indications for use. The design and principles of operation remain the same.

I. Biocompatibility

Biocompatibility testing was performed to show that all patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2009 and the FDA guidance: Use of

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SECTION 5 510K SUMMARY

International Standard ISO 10993-1 "Biological evaluation of medical devices. Evaluation and testing within a risk management process."

The following testing was performed with passing results to support the biocompatibility of the device:

. Cytotoxicity
Sensitization ●
Irritation ●
Accute Systemic Toxicity ●
. Materials Mediated Pyrogenicity
. Implantation
Chemical Characterization with Toxicological Risk Assessment (used to address systemic endpoints)

J. Performance Testing

The modifications to the subject Tria Soft Ureteral Stent have been tested in the same manner as the predicate to ensure compliance to the initial specifications. Based on the change assessment including risk analysis, the following design verification tests were repeated. The test methods used were the same as those submitted for the predicate.

Dimensions
. Tensile strength tests
Full Functional tests ●
Packaging tests .
Biocompatibility ●
. Sterility

The device continues to be sterilized by ethylene oxide (EO) to an SAL 106 level.

The conclusion of the assessments demonstrates that the modified device continues to function as intended in a manner equivalent to the predicate device. The modified device raises no new issues of safety or effectiveness compared to the predicate.

K. Conclusion

Based on the test data, the same intended use, and same indications for use, the modified Tria Soft Ureteral Stent is substantially equivalent to its predicate, K190603.

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).