Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit: The Ureteral Stent is intended to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not externally.

Percuflex™ Nephroureteral Stent System: The Percuflex Nephroureteral Stent is intended for use in Percutaneous Drainage to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent.

Amplatz Anchor™ Catheter System: The Amplatz Anchor™ Catheter System is intended for use in applications of percutaneous drainage, particularly percutaneous nephrostomy, abscess or external biliary drainage.

Device Description

The Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit is designed with the classic pigtail shape on each end and is intended to facilitate drainage internally from the renal pelvis to the bladder and stenting of the ureter without external access after placement. The ureteral stent systems contain a suture to adjust the pigtail shape or to remove the stent. These devices are constructed of a proprietary, biocompatible copolymer called Percuflex™ for patient comfort with a radiopaque resin throughout the catheter tube. Designated Percuflex™ Ureteral Stent Systems are also available with a proprietary Glidex™ hydrophilic material for the reduction of surface friction during placement or with a dissolving distal tip (Temp-Tip™). The dissolving tip internal diameter aids in placement, then dissolves soon after placement to allow a larger lumen for drainage.

The Percuflex™ Nephroureteral Stent System is also designed with the classic pigtail shape on each end and facilitates drainage from the internal ureteropelvic junction to the bladder with external access to the stent. The Nephroureteral Stent System also incorporates the Percuflex™ copolymer and a radiopaque resin throughout the catheter tube. Select models are available with a Temp-Tip™ which dissolves soon after placement. A suture is locked in place with a stopcock to retain the pigtail shape. A luer allows for connection to other drainage devices with a conical fitting.

The Amplatz Anchor™ Catheter System is designed with a unique locking Malecot diamond shape to facilitate percutaneous nephrostomy, abscess or external biliary drainage. The Amplatz Anchor™ Catheter Systems also incorporate the Percuflex™ copolymer and a radiopaque resin throughout the catheter tube. A suture is locked in place with a stopcock to retain the 2-winq design. A luer allows for connection to other drainage devices with a conical fitting.

These Percuflex™ Drainage Catheters and Stents are provided sterile, using 100% ethylene oxide (EO) gas sterilization, and are intended for hospital and single use only. Where long-term use is indicated, it is recommended not to exceed 90 days of indwelling time.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Boston Scientific Percuflex Drainage Catheters and Stents, asserting their substantial equivalence to a predicate device (K924608). The document focuses on non-clinical performance testing conducted to support new Magnetic Resonance (MR) compatibility information and cumulative internal changes to the devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format, nor does it specify exact numerical thresholds for "acceptance criteria." Instead, it lists the types of non-clinical tests performed and states that these tests demonstrate "the subject devices are as safe and effective as the predicate devices" and that the changes "do not raise new questions of safety or effectiveness."

However, we can infer the categories of acceptance criteria based on the tests conducted:

Acceptance Criteria Category	Reported Device Performance / Assessment
Magnetic Resonance (MR) Compatibility
Radio Frequency (RF) Heating	Testing performed per ASTM F2182-11a. The submission implies that the results are acceptable, allowing for the addition of MR compatibility information to the Directions for Use without raising new safety/effectiveness questions. Specific numerical values are not provided.
Force Measurement (Displacement)	Testing performed per ASTM F2052-14. The submission implies that the results are acceptable, allowing for the addition of MR compatibility information to the Directions for Use without raising new safety/effectiveness questions. Specific numerical values are not provided.
Image Artifact	Testing performed per ASTM F2119-07. The submission implies that the results are acceptable, allowing for the addition of MR compatibility information to the Directions for Use without raising new safety/effectiveness questions. Specific numerical values are not provided.
Material Changes & Biocompatibility
Material Evaluation (Resin additive)	Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Oxidative Induction Time (OIT), and Dynamic Contact Angle (DCA) analysis performed. Results "demonstrated that both supplied resins present the same thermal transition characteristics, material type (chemistry), and composition."
Design Verification (Resin additive)	Catheter Shaft Tensile, Column Strength, Kink Resistance, and Removal Force testing performed. Renal Coil Resistance-Stent Shaft >5F also performed. The submission indicates these assessed finished device properties were maintained. Specific numerical thresholds or results are not provided.
Biocompatibility (Resin additive)	Testing performed per ISO 10993-1, including Cytotoxicity, Sensitization, Intracutaneous irritation, Material mediated pyrogenicity, Acute systemic toxicity, Genotoxicity (Ames and MLA assays), Muscle implantation (4-week and 13-week studies). A Toxicological Risk Assessment was also performed. The submission implies all tests showed acceptable biocompatibility.
Tensile Performance Specification Update
Dissolving Tip to Shaft Bond	Design verification testing conducted on aged and unaged samples. The submission states this demonstrated "the dissolving tip to shaft bond design output continues to meet the defined design input requirements after sterilization." Specific numerical thresholds or results are not provided.

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

The provided document describes non-clinical performance testing, primarily bench testing and material characterization. It does not mention human subject testing or clinical data. Therefore:

Sample Size for Test Set: Not applicable in terms of patient samples. The sample sizes for the in vitro or material tests (e.g., number of stent units tested for tensile strength, number of material samples for FTIR) are not specified in this summary.
Data Provenance: Not applicable in terms of country of origin for clinical data or retrospective/prospective studies, as no clinical studies are presented. The tests conducted are laboratory-based.

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

Not applicable. Ground truth, in the context of diagnostic performance measured against clinical expert consensus or pathology, is not relevant here as this document describes non-clinical, benchtop, and material science testing of a medical device (stent and catheter systems), not a diagnostic algorithm.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human annotators or readers when establishing ground truth for diagnostic studies. Such a process is not described or relevant for the non-clinical testing presented.

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 document is for a physical medical device (stents and catheters), not an AI/ML-driven diagnostic or assistive device. Therefore, no MRMC study or assessment of AI assistance to human readers was performed.

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

Not applicable. This is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests described is inherent in the material science principles, engineering specifications, and established testing standards (e.g., ASTM, ISO 10993). For instance:

For MR compatibility, the "ground truth" is compliance with the limits defined by ASTM standards for RF heating, displacement force, and image artifact.
For material evaluation, the "ground truth" is that the new material performs identically to the old one in terms of chemical and physical properties as measured by standard analytical techniques.
For biocompatibility, the "ground truth" is that the material elicits no adverse biological reactions based on ISO 10993 guidelines.
For tensile strength, the "ground truth" is meeting predefined engineering specifications for strength and durability.

8. The Sample Size for the Training Set

Not applicable. This document describes non-clinical testing for a physical medical device, not the development or evaluation of an algorithm or AI system that requires a "training set."

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

Not applicable, as there is no training set mentioned or implied for this physical medical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 26, 2021

Boston Scientific Corporation Heidi Shearer Senior Regulatory Affairs Specialist Three Scimed Place Maple Grove, MN 55311

Re: K200260

Trade/Device Name: Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit, Percuflex™ Nephroureteral Stent System, Amplatz Anchor™ Catheter System Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD, FGE Dated: March 25, 2021 Received: March 26, 2021

Dear Heidi Shearer:

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. However, you are responsible to determine that the medical devices you use as components in the Percuflex Ureteral Stent System Kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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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 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 medical devices and radiation-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,

Jessica K. Nguyen, Ph.D. Assistant 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

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Indications for Use

510(k) Number (if known) K200260

Device Name

Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit, Percuflex™ Nephroureteral Stent System Amplatz Anchor™ Catheter System

Indications for Use (Describe)

Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit:

The Ureteral Stent is intended to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not externally.

Percuflex™ Nephroureteral Stent System:

The Percuffex Nephroureteral Stent is intended for use in Percutaneous Drainage to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent.

Amplatz AnchorTM Catheter System:

The Amplatz Anchor™ Catheter System is intended for use in applications of percutaneous drainage, particularly percutaneous nephrostomy, abscess or external biliary drainage.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary - K200260

510(K) Summary Complying with 21 CFR 807.92

I. SUBMITTER INFORMATION

Submitter Name: Boston Scientific Corporation

Submitter Address:

Three Scimed Place Maple Grove, MN 55311-1566 USA

Telephone: 763-255-0056 Fax: 763-494-2222 e-mail: Heidi.Shearer@bsci.com

Contact person name: Heidi Shearer Date Prepared: April 26, 2021

II. DEVICE INFORMATION

Tables 1 to 4 below summarize the relevant subject device information.

Product Trade Name	Model Numbers
Percuflex ™ Ureteral Stent System	M001235490
	M001235500
	M001235510
	M001235520
	M001235530
	M001235570
	M001235580
	M001235590
	M001235600
	M001235610
	M001245490
	M001245500
	M001245510
	M001245520
	M001245530
	M001245570
	M001245580

Table 1: Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit

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510(k) Summary Percuflex Drainage Catheters and Stents

Product Trade Name	Model Numbers
	M001245590
	M001245600
	M001245610
Percuflex™ Ureteral Stent System Kit	M001245620
	M001245630
	M001245640
	M001245650
	M001245660
	M001245720
	M001245730
	M001245740
	M001245750
	M001245760

Table 2: Percuflex™ Nephroureteral Stent System

Product Trade Name	Model Number
Percuflex™ Nephroureteral Stent System	M001221360
	M001221370
	M001221380
	M001221390
	M001221400
	M001221410
	M001221420
	M001221430
	M001231360
	M001231370
	M001231380
	M001231390
	M001231400
	M001231410
	M001231420
	M001231430

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Table 3: Amplatz Anchor™ Catheter System

Product Trade Name	Model Number
Amplatz Anchor™ Catheter System	M001221000
Amplatz Anchor™ Catheter System	M001221010
Amplatz Anchor™ Catheter System	M001221020

Table 4: Additional Device Information

Common orUsual name	ClassificationNumber	ClassificationName	Product Code	Product CodeName	RegulatoryClass
Ureteral StentSystem	21 CFR Part876.4620	Ureteral stent	FAD	stent, ureteral	II
NephroureteralStent System	21 CFR Part876.4620	Ureteral stent	FAD	stent, ureteral	II
Biliary CatheterSystem	21 CFR Part876.5010	Biliary catheterand accessories	FGE	stents, drainsand dilators forthe biliary ducts	II

III. PREDICATE DEVICE IDENTIFICATION

Name of Predicate Device

Medi-Tech Ureteral Stent System, Nephroureteral Stent System, Amplatz Anchor System with Locking Malecot (K924608. Cleared 26-Jan-1994)

Predicate devices referenced above have not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

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Table 5, 6, and 7 below provide information on the differences between the Percuflex™ Drainage Catheters and Stents models, in relation to specific device features such as coating, dissolving tip, and the outside diameter and length dimensions.

Product Trade Name	Product Labeled Features	Model Number	Dimensions(OD/Length)
Percuflex™ UreteralStent System	Percuflex™ TempTip™ Ureteral StentSystem with Dissolving Tip	M001235490	8F/20cm
		M001235500	8F/22cm
		M001235510	8F/24cm
		M001235520	8F/26cm
		M001235530	8F/28cm
		M001235570	10F/20cm
		M001235580	10F/22cm
		M001235590	10F/24cm
		M001235600	10F/26cm
		M001235610	10F/28cm
Percuflex™ UreteralStent System	Percuflex™ Glidex™ HYDROGELCOATING Ureteral Stent System	M001245490	8F/20cm
		M001245500	8F/22cm
		M001245510	8F/24cm
		M001245520	8F/26cm
		M001245530	8F/28cm
		M001245570	10F/20cm
		M001245580	10F/22cm
		M001245590	10F/24cm
		M001245600	10F/26cm
		M001245610	10F/28cm
Percuflex™ UreteralStent System Kit	Percuflex™ Glidex™ HYDROGELCOATING Ureteral Stent System Kit	M001245620	8F/20cm
		M001245630	8F/22cm
		M001245640	8F/24cm
		M001245650	8F/26cm
		M001245660	8F/28cm
Product Trade Name	Product Labeled Features	Model Number	Dimensions(OD/Length)
		M001245720	6F/20cm
		M001245730	6F/22cm
		M001245740	6F/24cm
		M001245750	6F/26cm
		M001245760	6F/28cm

Table 5: Percuflex™ Ureteral Stent System Device Features

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Table 6: Percuflex™ Nephroureteral Stent System Device Features

Product Trade Name	Product Labeled Features	Model Number	Dimensions(OD/Length)
Percuflex™Nephroureteral StentSystem	Percuflex™ Locking PigtailNephroureteral Stent System	M001221360	8F/22cm
		M001221370	8F/24cm
		M001221380	8F/26cm
		M001221390	8F/28cm
	Percuflex™ TempTip™ Locking PigtailNephroureteral Stent System withDissolving Tip	M001221400	10F/22cm
		M001221410	10F/24cm
		M001221420	10F/26cm
		M001221430	10F/28cm
	M001231360	8F/22cm
	M001231370	8F/24cm
	M001231380	8F/26cm
	M001231390	8F/28cm
	M001231400	10F/22cm
	M001231410	10F/24cm
	M001231420	10F/26cm
	M001231430	10F/28cm

Table 7: Amplatz Anchor™ Catheter System Device Features

Product Trade Name	Product Labeled Features	Model Number	Dimensions(OD/Length)
Amplatz Anchor™ Catheter System	Amplatz Anchor™ Locking Malecot,Amplatz Anchor Catheter System	M001221000	8F/30cm
		M001221010	10F/30cm
		M001221020	12F/30cm

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V. INDICATIONS FOR USE

Predicate and subject device Intended use and Indications for Use are the same.

PercuflexTM Drainage Catheters andStents	Indications for Use
PercuflexTM Ureteral Stent System andPercuflexTM Ureteral Stent System Kit	The Ureteral Stent is intended to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally.
PercuflexTM Nephroureteral StentSystem	The Percuflex Nephroureteral Stent is intended for use in Percutaneous Drainage to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent.
Amplatz AnchorTM Catheter System	The Amplatz AnchorTM Catheter System is intended for use in applications of percutaneous drainage, particularly percutaneous nephrostomy, abscess or external biliary drainage.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The Percuflex™ Drainage Catheters and Stents incorporate substantially equivalent design, function, packaging, sterilization process, materials, fundamental technology, indications for use, and operating principles as those featured in the predicate drainage devices (K924608). The difference from the legally marketed predicate device is the addition of Magnetic Resonance (MR) compatibility information to the Directions for Use.

Cumulative changes have been made to the devices internally through Boston Scientific's Design Control System, which meets the quality system requirements of 21 CFR Part 820. These changes include a resin additive material supplier change and tensile performance specification update.

The tensile performance specification update applies to the Percuflex™ TempTip™ Ureteral Stent System with Dissolving Tip and the Percuflex™ TempTip™ Locking Pigtail Nephroureteral Stent System with Dissolving Tip devices. This change updated the dissolving tip to catheter tensile strength performance specification.

VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

In order to support the addition of Magnetic Resonance Compatibility information to the Directions for Use the following non clinical performance testing was performed:

Radio Frequency Heating .
Force Measurement ●
Image Artifact .

FDA guidance Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment (December 11, 2014) and the following standards were used to guide the generation of the non-clinical data:

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Document Name	Document Number	Document Version
Measurement of Radio Frequency Induced HeatingNear Passive Implants During Magnetic ResonanceImaging	ASTM F2182	-11a
Measurement of Magnetically Induced DisplacementForce on Medical Devices in the Magnetic ResonanceEnvironment	ASTM F2052	- 14
Evaluation of MR Image Artifacts from Passive Implants	ASTM F2119	- 07

In order to support the cumulative changes that have been made to the devices internally through Boston Scientific's Design Control System, the following non clinical performance testing was performed:

· Resin additive material supplier change
- o A material evaluation consisted of Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Oxidative Induction Time (OIT), and Dynamic Contact Angle (DCA) analysis was performed. Results demonstrated that both supplied resins present the same thermal transition characteristics, material type (chemistry), and composition.
- o Design Verification testing including Catheter Shaft Tensile, Column Strength, Kink Resistance, Removal Force, and Renal Coil Resistance-Stent Shaft >5F was performed to assess these finished device properties.
- · The following biocompatibility testing was performed per ISO 10993-1:
  - Cytotoxicity
  - Sensitization
  - Intracutaneous irritation testing
  - Material mediated pyrogenicity
  - Acute systemic toxicity testing
  - Genotoxicity testing Ames assay
  - Genotoxicity testing MLA
  - Muscle implantation 4-week study
  - Muscle implantation 13-week study A
  - Toxicological Risk Assessment
· Tensile performance specification update
- o Design verification testing was conducted on aged and unaged samples to demonstrate the dissolving tip to shaft bond design output continues to meet the defined design input requirements after sterilization.

· CONCLUSION

Based on the intended use, technological characteristics, and non-clinical performance data provided, the Percuflex™ Drainage Catheters and Stents are substantially equivalent to the predicate devices (K924608). The Directions for Use update with magnetic resonance compatibility information for the subject devices does not raise new questions of safety or effectiveness, and the subject devices are as safe and effective as the predicate devices.

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).