The RELIEF™ Ureteral Stent is intended for temporary drainage from the ureteropelvic junction to the bladder of the ureter in a variety of benign, malignant and post-traumatic conditions of the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques. The stent is not intended as a permanent indwelling time should not exceed thirty (30) days.

Device Description

The RELIEF™ Ureteral Stents are sterile, single-use devices. The stents are available in 6Fr, with lengths of 24 cm and 26 cm. The ureteral stent is constructed of a radiopaque polymer tube with a central lumen with side holes positioned along its length to provide drainage of urine from the kidney to the bladder and includes hydrophilic coating. Along the stent are printed insertion markers throughout its length. The stent includes a radiopaque soft polymeric proximal tubular coil and body segment attached to a 4 cm tether of suture material that is placed along the ureter intramural segment, allowing natural opening, and closing of the ureteral orifice, thereby preventing vesicoureteral reflux. The tether is attached to a radiopaque distal bladder coil constructed of a monofilament (non-lumened), polymeric segment, allowing it to float in the bladder, thus precluding any tension on the tether or coil. The RELIEF™ Ureteral Stent package contents consist of: RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm - . RELIEF™ Ureteral Stent - Stent pusher tube with radiopaque tip - . Pigtail straightener The RELIEF™ Ureteral Stent is not intended as a permanent indwelling device and is labeled for indwell time not to exceed thirty (30) days.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the RELIEF™ Ureteral Stent:

The document (K232920) describes a 510(k) premarket notification for a ureteral stent, focusing on a new labeling claim of preventing vesicoureteral reflux due to its design.

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

The document does not explicitly state formal "acceptance criteria" for the clinical study in the form of a pre-defined performance metric that the device had to meet (e.g., "sensitivity must be > X%", "proportion of patients with no reflux must be > Y%"). Instead, it presents the results of a study designed to verify a specific design claim.

However, based on the stated purpose of the clinical data and the reported outcomes, we can infer the primary performance goal: Demonstrate that the new suture tether design does not impede the normal functioning of the urinary orifice to prevent vesicoureteral reflux.

Acceptance Criterion (Inferred from study goal)	Reported Device Performance
Normal functioning of the urinary orifice to prevent vesicoureteral reflux is maintained.	All cystograms, pre- and post-stent implant, were graded at 'No Reflux' in all 19 patients. No adverse complications observed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: 19 patients. The study originally enrolled 26 patients, with 7 excluded based on exclusion criteria, resulting in 19 evaluated patients.
Data Provenance:
- Country of Origin: United States (conducted in the University Hospital Cleveland Medical Center).
- Study Type: Prospective, open-label study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not specify the number of experts or their qualifications for establishing the ground truth (the 'No Reflux' grade on cystograms). It only states, "All cystograms, pre- and post-stent implant, were graded at 'No Reflux'."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method for the cystogram grading. It simply states they "were graded," implying a single assessment without mentioning multiple readers or a consensus process.

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

No, an MRMC comparative effectiveness study was not done. This study is about the physical device and its physiological function, not an AI or software device.

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

No, this study is about a physical medical device (a ureteral stent), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the study was established through expert assessment/grading of cystogram images. The document states that "All cystograms, pre- and post-stent implant, were graded at 'No Reflux'." This implies a clinical evaluation based on imaging.

8. The sample size for the training set

This study relates to a physical medical device. There is no mention of a "training set" in the context of an algorithm. The clinical data of 19 patients serve as the evaluation data for the new labeling claim.

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

Not applicable, as there is no training set for an algorithm in this context.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 22, 2024

Ureteral Stent Company Mike Bunker CEO 45 Glenridge Court Chagrin Falls, Ohio 44022

Re: K232920

Trade/Device Name: RELIEF™ Ureteral Stent Kit: Model: RS-001 - 6 Fr x 24cm, RELIEFTM Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm Regulation Number: 21 CFR 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: September 15, 2023 Received: September 19, 2023

Dear Mike Bunker:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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,

Angel A. Soler-garcia -S

for 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

Enclosure

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Indications for Use

510(k) Number (if known) K232920

Device Name

RELIEF™ Ureteral Stent

Indications for Use (Describe)

These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL).

The stent may be placed using endoscopic surgical techniques.

The stent is not intended as a permanent indwelling time should not exceed thirty (30) days.

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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SUBMITTER INFORMATION

TRADITIONAL 510(K) SUMMARY

Applicant	Ureteral Stent Company, Inc.45 Glenridge Court Chagrin Falls,Ohio 44022
Official Correspondent	Mike BunkerCEO Ureteral Stent Company, Inc.Phone: (216) 258-8047Email:
Date Prepared	March 19, 2024
2. DEVICE NAME
Trade Name of the Device	RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cmRELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
Common Name:	Ureteral Stent
Classification Name:	Stent, Ureteral
Classification Regulation:	21 CFR 876.4620
Device Class:	II
Product Code:	FAD
Panel:	Gastroenterology/Urology
3. PREDICATE DEVICEIDENTIFICATION	RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm

4. DEVICE DESCRIPTION:

RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm

. RELIEF™ Ureteral Stent
Stent pusher tube with radiopaque tip
. Pigtail straightener

The RELIEF™ Ureteral Stent is not intended as a permanent indwelling device and is labeled for indwell time not to exceed thirty (30) days.

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5. INDICATIONS FOR USE:

These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL).

The stent may be placed using endoscopic surgical techniques.

The stent is not intended as a permanent indwelling device. The indwelling time should not exceed thirty (30) days.

Comparison Element	Subject Device:RELIEFTM Ureteral Stent Kit	Predicate Device:RELIEFTM Ureteral Stent Kit
510(k) Number	K232920	K213444
Indications for Use	The RELIEFTM Ureteral Stent isintended for temporary drainagefrom the ureteropelvic junction tothe bladder of the ureter in a varietyof benign, malignant and post-traumatic conditions of the ureter.These conditions include stonesand/or stone fragments or otherureteral obstructions such as thoseassociated with ureteral stricture,malignancy of abdominal organs,retroperitoneal fibrosis or ureteraltrauma, or in association withExtracorporealShockWaveLithotripsy (ESWL).The stent may be placed usingendoscopic surgical techniques.The stent is not intended as apermanent indwelling device. Theindwelling time should not exceedthirty (30) days.	The RELIEFTM Ureteral Stent isintended for temporary drainage fromthe ureteropelvic junction to thebladder of the ureter in a variety ofbenign, malignant and post-traumaticconditions of the ureter.These conditions include stonesand/or stone fragments or otherureteral obstructions such as thoseassociated with ureteral stricture,malignancy of abdominal organs,retroperitoneal fibrosis or ureteraltrauma, or in association withExtracorporeal Shock WaveLithotripsy (ESWL).The stent may be placed usingendoscopic surgical techniques orpercutaneously using standardradiographic technique.The stent is not intended as apermanent indwelling device. Theindwelling time should not exceedthirty (30) days.
Indwell Time	Not exceed thirty (30) days.	Not exceed thirty (30) days.
Diameter	6 Fr.	6 Fr.
Length	24 cm and 26 cm	24 cm and 26 cm
Distal Coil	Distal Coil attached to a distaltether.	Distal Coil attached to a distal tether.
Bladder Coil	3-0 Polypropylene Suture Deklene	3-0 Polypropylene Suture Deklene

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES

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Guidewire	6.0 Fr stents accept 0.035" and0.038" guide wire.	6.0 Fr stents accept 0.035" and0.038" guide wire.
Pusher Tube	Pusher Tube w/radiopaque tip	Pusher Tube w/radiopaque tip
Pigtail Straightener?	Yes	Yes
Sterilization	EtO	EtO
Single Use?	Yes	Yes

As evidenced by the above table, both the subject and the predicate devices have same design, intended use and technological characteristics. In this 510(k), the sponsor included a new labeling claim that if the subject device is appropriately placed along the ureter intramural segment, it will allow the natural opening and closing of the ureteral orifice, thereby preventing vesicoureteral reflux. This labeling claim was supported by clinical data which are summarized below.

7. SUMMARY OF CLINICAL TESTING:

Clinical data collected from 19 patients were provided to verify that the design of the suture tether does not impede the normal functioning of the urinary orifice to prevent vesicoureteral reflux. This data were obtained from a prospective, open label study called 'Clinical Evaluation of RELIEF ™ Stent study' which was conducted in the University Hospital Cleveland Medical Center. The study enrolled 26 patients who were assessed for eligibility based on the inclusion criteria. Seven patients were excluded based on the exclusion criteria. Total 19 patients were evaluated in the study, including 10 male and 9 female patients. Eleven of the evaluated subjects underwent previous stent placement. Four and 15 of the evaluated patients had renal and ureteral calculi, respectively. The demographics and anatomical height of the subjects, inclusion criteria used for the study are listed below:

Demographics

The patient demographics for the clinical performance testing is referenced below:

Gender	Number of participants	Ethnicity
Male	10	All Caucasian
Female	9	Asian (1)Afro-American (2)Caucasian (6)

The age range for the subjects was 39-84 years.

Anatomical Height criteria:

The patient's anatomical height in relation to the RELIEF™ Ureteral Stent length utilized as referenced below:

Anatomical Height	Stent Length
5' 3" – 5' 7"	24 cm
5' 8" – 5' 10"	26 cm

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Inclusion criteria:

1. Male and female patients.
1. Over 18 years of age and willing and able to provide informed consent.
Renal or ureteral stone or both calculi between 5-25 mm measured on plain abdomen X-3. ray Kidney Ureter Bladder (KUB or computed tomography (CT).
Upper or middle third ureteral stricture or stone AND/OR stone located in the renal 4. pelvis.
Patient agrees to participate in the study and signs the informed consent form. న్.
1. Able to complete self-rated questionnaires.

Exclusion criteria:

1. Patients with distal ureteral obstruction regardless of etiology, patients with known or demonstrated ureteral reflux intraoperatively.
Patients with urinary reflux (assessed by pre-stent cystogram). 2.
Patients requiring bilateral surgical stone management procedure or patients with 3. active urinary tract infection (UTI) or sepsis.

Study results:

Across the 19 patients evaluated in the study, no patients experienced adverse complications. All cystograms, pre- and post-stent implant, were graded at 'No Reflux'. The comparison of the cystogram images of the RELIEF™ Ureteral Stent verified that the low-profile tether segment of the subject device placed in the intramural segment of the ureter did not impede the urinary orifice's one-way valve function. The normal function of the urinary orifice's one way valve is to close and seal off during micturition, thereby to prevent vesicoureteral reflux.

8. CONCLUSIONS

Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate.

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).