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™ Firm Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically or fluoroscopically or during an open surgical procedure. It is constructed of the same Percuflex polymer as other stents currently marketed by BSC. Tria Firm utilizes a modified extrusion process to provide ureteral stents with an ultra-smooth surface topography.

The Tria™ Firm stent has a double pigtail design and utilizes the same monofilament retrieval lines that are used on other BSC ureteral stents. Tria Firm is packaged with a standard straight stent positioner and a pigtail straightener that are currently provided with other ureteral stents marketed by Boston Scientific.

The purpose of the Tria™ Firm Ureteral Stent is to provide physicians with a product that is aimed at addressing accumulation of urine salt deposits during indwelling. The proprietary surface technology on both the outside and inside of the stent provides maximum coverage from calcium and magnesium salt deposition.

AI/ML Overview

This document is a Premarket Notification (510(k)) for a medical device, the Tria™ Firm Ureteral Stent. It describes the device, its intended use, and why it is considered substantially equivalent to existing devices.

Crucially, this type of FDA submission (510(k)) primarily focuses on demonstrating substantial equivalence to a predicate device rather than proving clinical effectiveness through extensive clinical trials with acceptance criteria for specific outcomes, especially in the context of an AI/algorithm-driven device performance study.

Therefore, most of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for an AI/algorithm is not applicable or present in this document.

The document does mention performance testing for the physical device itself (ureteral stent) and an in vitro study related to a claim about reduced salt accumulation.

Here's an analysis based on the provided document, with explanations for why much of your query cannot be answered:

Analysis of the Provided Document Regarding Device Acceptance and Study

This document describes the regulatory submission for a physical medical device (Tria™ Firm Ureteral Stent), not an AI/algorithm. Thus, the "acceptance criteria" discussed are primarily regulatory in nature (e.g., demonstrating substantial equivalence, biocompatibility, structural integrity, and flow rate of the stent), rather than performance metrics for an AI's diagnostic or predictive capabilities.

The study mentioned is an in vitro test, not a clinical study on human subjects or an AI performance study.

Information Extracted from the Document:

A table of acceptance criteria and the reported device performance:
- The document does not provide a clear, quantifiable table of acceptance criteria for "device performance" in the way you'd expect for an AI/algorithm (e.g., sensitivity, specificity, AUC). Instead, it lists types of performance tests for the physical stent.
- The closest to a quantifiable performance statement is for the in vitro test on salt accumulation.

Acceptance Criteria Category (Derived)	Specific Test/Characteristic	Reported Performance/Finding
Material Properties	Surface Topography	Ultra-smooth surface (modified extrusion process)
Functional Performance	Bladder coil length	Tested (results not quantified in summary)
	Renal coil length/shape	Tested (results not quantified in summary)
	Working length	Tested (results not quantified in summary)
	Flow rate	Tested (results not quantified in summary)
	MRI safety assessment	Tested (results not quantified in summary)
Structural Integrity	Removal force (tensile strength)	Tested (results not quantified in summary)
	Retrieval line to stent shaft tensile	Tested (results not quantified in summary)
	Column strength	Tested (results not quantified in summary)
Biological Safety (Biocompatibility)	Cytotoxicity	Tested (passed, implied by approval)
	Sensitization	Tested (passed, implied by approval)
	Irritation	Tested (passed, implied by approval)
	Acute Systemic Toxicity	Tested (passed, implied by approval)
	Muscle Implantation	Tested (passed, implied by approval)
	Material Mediated Pyrogenicity	Tested (passed, implied by approval)
	Chemical analysis extractables	Tested (passed, implied by approval)
	Risk assessment of potential toxicity	Tested (passed, implied by approval)
Specific Claim Performance (In Vitro)	Minimizing accumulation of urine calcium and magnesium salts (with and without bacteria)	"Statistically significant lower level of urine calcium and magnesium salt accumulation on the stent surface compared to competitive devices."

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the performance tests (e.g., how many stents were tested for flow rate or tensile strength). For the in vitro salt accumulation study, the "sample size" of stents tested is not provided, only that it was a "statistically significant" finding.
- Data Provenance: Not applicable in the context of patient data for an AI/algorithm. All studies appear to be bench (laboratory) tests performed by Boston Scientific or third parties.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is for a physical medical device. Ground truth for most tests (e.g., tensile strength, flow rate) is established by physical measurement standards, not expert consensus interpretation of images or clinical data.
- For the in vitro salt accumulation study, ground truth would be based on lab measurements of salt deposits, not expert readings.
Adjudication method for the test set:
- Not applicable. This is not an AI/imaging interpretation study. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical diagnoses/interpretations, not for physical device testing.
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:
- No, this was not done. MRMC studies are specific to evaluating AI in diagnostic imaging (human-in-the-loop performance). This document is for a physical ureteral stent.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this was not done. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical/mechanical performance tests, the "ground truth" is based on engineering measurements and material science standards.
- For the biocompatibility tests, it's based on established ISO/USP standards for biological reactivity.
- For the in vitro salt accumulation study, the "ground truth" refers to laboratory measurements of calcium and magnesium salt deposition. No human expert or pathology report is involved in establishing this ground truth.
The sample size for the training set:
- Not applicable. This document is not describing an AI/machine learning model, so there is no training set in that context. Device design and manufacturing process optimization would be an analogous "training" phase but without a formal "training set" of data points in the AI sense.
How the ground truth for the training set was established:
- Not applicable for the same reason as #8.

Key takeaway concerning the in vitro claim:

The document explicitly states: "In vitro testing conducted on the Tria™ Firm Ureteral Stent showed a statistically significant lower level of urine calcium and magnesium salt accumulation on the stent surface compared to competitive devices. Correlation of in vitro data to clinical outcomes have not been established." This is a critical disclaimer, indicating that while the lab test showed a positive result, it has not been proven to translate to better patient outcomes in terms of reduced encrustation or longer stent patency in actual human use.

Summary

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

June 22, 2017

Boston Scientific Corporation Christine Shoemaker Sr. Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

Re: K163399

Trade/Device Name: Tria™ Firm Ureteral Stent Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: Mav 19, 2017 Received: May 22, 2017

Dear Christine Shoemaker:

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,

Benjamin R. Fisher -S

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) K163399

Device Name Tria™ Firm 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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5

Boston Scientific

510(k) SUMMARY

510(k) Summary for Tria™ Firm Ureteral Stent

A. Sponsor

Boston Scientific Corporation Urology and Pelvic Health Division 100 Boston Scientific Way Marlborough, MA 01756

B. Contact

Christine Shoemaker Sr. Specialist, Regulatory Affairs 508-683-4214 christine.shoemaker@bsci.com Or Lisa Sullivan Sr. Manager, Regulatory Affairs 508-683-4745 lisa.sullivan@bsci.com

Date Prepared: June 21, 2017

C. Device Name

Trade name: Tria™ Firm Ureteral Stent Common/usual name: stent, ureteral Classification Name: FAD - Stent, Ureteral

D. Predicate and Reference Devices

Contour™ Ureteral Stent (Boston Scientific) Predicate Trade name: Common/usual name: stent, ureteral Classification Name: FAD - Stent, Ureteral Premarket Notification: Contour™ (Modified Ureteral Indwelling Catheter/Stent) Ureteral Stent, K974541, Sep 02, 1998. The Contour Ureteral Stent has not been the subject of a design-related recall.

PercuflexTM Ureteral Stent (Boston Scientific) Reference 1 Trade name: Common/usual name: stent, ureteral Classification Name: FAD - Stent, Ureteral Premarket Notification: K834468, Apr 20, 1984.

Reference 2 Trade name: AdvantixTM Pancreatic Stent (Boston Scientific) Common/usual name: Biliary Catheters and Accessories Classification Name: FGE - Biliary Catheter and accessory Premarket Notification: K133700, May 14, 2014.

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Boston Scientific

510(k) SUMMARY

Reference 3 Trade name: InLay Optima® Ureteral Stent (Bard) Common/usual name: stent, ureteral Classification Name: FAD - Stent, Ureteral Premarket Notification: K022447, Jan 23, 2003.

E. Device Description

In vitro testing conducted on the Tria™ Firm Ureteral Stent showed a statistically significant lower level of urine calcium and magnesium salt accumulation on the stent surface compared to competitive devices. Correlation of in vitro data to clinical outcomes have not been established.

F. Intended 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

The proposed Tria™ Firm Ureteral Stents have the same technological characteristics, fundamental ureteral stent design, and types of materials as the predicate device. A modified extrusion process provides an ultra-smooth surface. The device is packed using a thermoformed, multi-product tray. The lidded tray is then placed in a poly/Tyvek pouch that is heat sealed and labeled. The labeled pouch is placed into a labeled shelf carton along with a DFU.

H. Substantial Equivalence

A direct comparison of key characteristics has been performed and demonstrates that the proposed Tria™ Firm Ureteral Stent is substantially equivalent to the predicate device in terms of intended use, technological characteristics, types of

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SECTION 5

materials and performance characteristics. The proposed Tria Firm Ureteral Stent is as safe, as effective, and performs as well as the predicate device.

I. Performance Testing (Bench Evaluation)

Boston Scientific has conducted performance testing with samples aged at T=0 and 13-months Accelerated Aging in support of the new ureteral stent. Third party testing was performed in support of new claims for 1) minimizing the accumulation of urine calcium and magnesium salts, both with and without the presence of bacteria and 2) the proprietary surface technology on both the outside and inside of the stent providing maximum coverage from calcium and magnesium salt deposition .

The results of the testing listed below support the determination of substantial equivalence.

Performance testing - bladder coil length, renal coil length/shape, working length, flow rate, surface roughness, MRI safety assessment
0 Structural integrity testing - removal force (tensile strength), retrieval line to stent shaft tensile, column strength
Biological safety testing (biocompatibility) ●
Sterile barrier testing ●

J. Biocompatibility Testing

The following testing was performed to support the biocompatibility of the stents:

Cytotoxicity ●
Sensitization ●
Irritation ●
Acute Systemic Toxicity ●
Muscle Implantation ●
Material Mediated Pyrogenicity ●
Chemical analysis extractables ●
Risk assessment of potential toxicity .

K. Conclusions

Based on the information and data provided in this Traditional 510(k), the TriaTM Firm Ureteral Stents are substantially equivalent in intended use, design, principle of operation, technology, materials, and performance to the predicate Contour Ureteral Stents (K974541) and are safe and effective for their intended use. Tria Firm was also demonstrated to be substantially equivalent for specific properties when compared to other reference devices (BSC Percuflex (K834468), BSC Advantix (K133700), and Bard Inlay Optima (K022447)).

1 Proteus mirabilis was used as the microbial challenge due to its known urease production.

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).