(185 days)
Not Found
No
The device description and intended use focus on the physical characteristics and function of a ureteral stent. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance study describes a clinical evaluation of the stent's physical design, not an AI/ML algorithm.
Yes
The device is intended for temporary drainage from the ureteropelvic junction to the bladder of the ureter in various benign, malignant, and post-traumatic conditions, falling under the definition of a therapeutic device as it treats or alleviates a medical condition.
No
This device is a ureteral stent intended for temporary drainage, classifying it as a therapeutic device rather than a diagnostic one. Its purpose is to facilitate the flow of urine, not to diagnose a condition.
No
The device description clearly outlines a physical, sterile, single-use ureteral stent made of radiopaque polymer with various physical components (tube, side holes, coating, markers, tether, coils). It is intended for surgical placement. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The RELIEF™ Ureteral Stent is a physical device inserted into the body to facilitate drainage of urine. It does not analyze biological specimens.
- Intended Use: The intended use describes the device's function in managing physical conditions of the ureter, not in analyzing samples for diagnostic purposes.
- Device Description: The description details the physical construction and materials of the stent, not components for analyzing biological samples.
- Performance Studies: The performance study focuses on the physical function of the stent in preventing reflux, not on the accuracy of a diagnostic test.
The device is a therapeutic device used in a surgical setting, not a diagnostic device used for analyzing samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FAD
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
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteropelvic junction to the bladder of the ureter
Indicated Patient Age Range
Over 18 years of age
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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"
1
(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
2
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
3
Indications for Use
510(k) Number (if known) K232920
Device Name
RELIEF™ Ureteral Stent
Indications for Use (Describe)
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.
| 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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4
- SUBMITTER INFORMATION
TRADITIONAL 510(K) SUMMARY
| Applicant | Ureteral Stent Company, Inc.
45 Glenridge Court Chagrin Falls,
Ohio 44022 |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Official Correspondent | Mike Bunker
CEO Ureteral Stent Company, Inc.
Phone: (216) 258-8047
Email: |
| Date Prepared | March 19, 2024 |
| 2. DEVICE NAME | |
| Trade Name of the Device | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm
RELIEF 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 DEVICE
IDENTIFICATION | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm |
4. 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.
5
5. INDICATIONS FOR USE:
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 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 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 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. | The RELIEFTM 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 fibrosis or ureteral
trauma, or in association with
Extracorporeal Shock Wave
Lithotripsy (ESWL).
The stent may be placed using
endoscopic surgical techniques or
percutaneously using standard
radiographic technique.
The stent is not intended as a
permanent indwelling device. The
indwelling time should not exceed
thirty (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 distal
tether. | 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
6
| Guidewire | 6.0 Fr stents accept 0.035" and
0.038" guide wire. | 6.0 Fr stents accept 0.035" and
0.038" 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 |
7
Inclusion criteria:
-
- Male and female patients.
-
- 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.
-
- Able to complete self-rated questionnaires.
Exclusion criteria:
-
- 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.