(143 days)
Not Found
No
The description focuses on the physical construction and intended use of a ureteral stent, with no mention of AI or ML capabilities.
Yes
The device is intended for temporary drainage of the ureter in various conditions, including obstructions and trauma, and is placed using surgical techniques, indicating a direct therapeutic intervention.
No
The device description clearly states its purpose as a ureteral stent for temporary drainage, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical ureteral stent made of radiopaque polymer, along with associated hardware components like a stent pusher tube and pigtail straightener. It is a physical medical device, not software.
Based on the provided information, the RELIEF™ Ureteral Stent is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- RELIEF™ Ureteral Stent Function: The RELIEF™ Ureteral Stent is a physical device inserted into the body (specifically the ureter) to facilitate drainage. It does not analyze or test biological samples in vitro.
- Intended Use: The intended use clearly describes a therapeutic function (drainage) for various conditions of the ureter, not a diagnostic test performed on a sample.
- Device Description: The description details the physical construction and materials of the stent, not components for analyzing biological specimens.
Therefore, the RELIEF™ Ureteral Stent is a medical device used for treatment, not an IVD used for diagnosis.
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 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 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 24cm and 26cm. 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. 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 only). The following models are available for the subject device: - RS-001: 6Fr x 24cm ● - . RS-002: 6Fr x 26cm
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
Not Found
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)
Performance Data: Biocompatibility testing according to ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1" (2016). Ethylene oxide residual testing according to ISO 10993-7:2008 - Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals. EO sterilization according to ISO 11135:2014 Sterilization of health-care products -. Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices. Bench testing based on the FDA guidance "Guidance for the Content of Premarket Notification for Ureteral Stents"(1993) was conducted on the subject stents using established methods to determine the substantial equivalence with the predicates: - Flow Rate ● - Radiopacity ● - Tensile Strength ● - Elongation - Dimensional Verification ● - Retention Strenath ● - Tether Junction - Tensile, Bend Radius and Three Point Bend - Tensile Strength Radiopaque Tip ● - Dynamic Friction ● - Guide wire compatibility ● - . Three Point Bend. All predetermined acceptance criteria were met.
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 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 17, 2022
Ureteral Stent Company Mike Bunker CEO 45 Glenridge Court Chagrin Falls, OH 44022
Re: K213444
Trade/Device Name: RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF 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: February 15, 2022 Received: February 18, 2022
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 (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.
1
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 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 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
2
Indications for Use
510(k) Number (if known) K213444
Device Name
RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
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 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 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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3
510 (k) Summary
1. Submitter Information
| 510 (k) submitter | Ureteral Stent Company, Inc. |
|---|---|
| Address | 45 Glenridge Court |
| Chagrin Falls, | |
| Ohio 44022 | |
| Contact Person | Mike Bunker |
| CEO, Ureteral Stent Company | |
| Phone: (216) 258 – 8047 | |
| Email : mbunker@waldencompanies.com | |
| Preparation date | March 17, 2022 |
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 |
| Panel | Gastroenterology/Urology |
| Product Code | FAD |
3. Predicate Devices
| Primary Predicate | Secondary Predicate | |
|---|---|---|
| Owner | Cook Incorporated | Dornier MedTech America Inc. |
| Trade Name of the Device | Universa® Firm Ureteral Stents and Stent Sets | Dornier |
| CASCADE | ||
| Ureteral Stent | ||
| Classification Name | Stent, Ureteral | Stent, Ureteral |
| Regulation Classification | 21 CFR 876.4620 | 21 CFR 876.4620 |
| Device Class | II | II |
| Panel | Gastroenterology/Urology | Gastroenterology/Urology |
| Product Code | FAD | FAD |
| 510(k) Number | K161236 | K190312 |
4
4. Device Description
The RELIEF™ Ureteral Stents are sterile, single-use devices. The stents are available in 6Fr, with lengths of 24cm and 26cm. 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. 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 only). The following models are available for the subject device:
- RS-001: 6Fr x 24cm ●
- . RS-002: 6Fr x 26cm
Indications For Use 5.
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 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.
5
6. Comparison of the Technological Characteristics with primary Predicate and Secondary Predicate Devices
| Device & Predicate
| Device(s): | K213444 | K161236 | K190312 |
|---|---|---|---|
| General Device | |||
| Characteristics | |||
| IFU statement | 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 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. | The Universa® | ||
| Firm | |||
| Ureteral Stents and Stent | |||
| Sets are intended for | |||
| temporary internal | |||
| drainage from the | |||
| ureteropelvic junction to | |||
| the bladder. Ureteral | |||
| stents have been used to | |||
| relieve obstruction in a | |||
| variety of benign, | |||
| malignant, and post- | |||
| traumatic conditions. The | |||
| stents may be placed | |||
| using endoscopic, | |||
| percutaneous, or open | |||
| surgical techniques. | The Dornier CASCADE | ||
| Ureteral Stent is indicated to | |||
| relieve obstruction in a | |||
| variety of benign, malignant | |||
| and post- traumatic | |||
| conditions in the ureter such | |||
| as presence of stones | |||
| and/or stone fragments, or | |||
| other ureteral obstructions | |||
| such as those | |||
| associated with ureteral | |||
| stricture, carcinoma 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. | |||
| Indwell time | Not to exceed thirty (30) days. | For a 12-month indwell | |
| time | Not to exceed 30 days. | ||
| Diameter | 6 Fr. | 4,6,8 Fr. | 4.9, 6, 7 and 8 Fr. |
| Length | 24 cm and 26 cm | 20, 22, 24, 26, 28 cm | |
| lengths | 14,20,22,24,26,28 cm | ||
| Multilength 22-32cm | |||
| Distal coil | Distal Coil attached to a distal tether | Distal Coil part of the | |
| Ureteral Stent body | Not identified | ||
| Bladder coil | 3-0 Polypropylene Suture Deklene Maxx | Braided or monofilament | |
| tether on proximal pigtail | |||
| loop | monofilament nylon tether to | ||
| proximal pigtail loop | |||
| Guidewire | 6.0 Fr stents accept 0.035" and 0.038" | ||
| guide wire | 6.0 Fr stents accept | ||
| 0.038" guide wire | 4.7 Fr.= .035" diameter; 6, | ||
| 7/8 Fr.= .038" diameter | |||
| Pusher tube | Pusher Tube w/ radiopaque tip | Stent Positioner w/ | |
| radiopaque tip | Pusher Tube w/ | ||
| radiopaque tip | |||
| Pigtail straightener? | Yes | Yes | Yes |
| Sterilization | EtO | EtO | EtO |
| Single use? | Yes | Yes | Yes |
As evidenced by the above table, both the subject and the predicate devices have similar intended use, but the subject and predicate devices have different technological characteristics. However, performance testing was conducted on the subject stents, and it was established that the differences in technological characteristics between the subject and the predicate does not raise different questions of safety or effectiveness.
6
7. Performance Data
Below is a list of the tests that have been performed and successfully completed for the subject stents:
- Biocompatibility testing according to ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1" (2016).
- Ethylene oxide residual testing according to ISO 10993-7:2008 - Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals.
- EO sterilization according to ISO 11135:2014 Sterilization of health-care products -. Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices.
The following list of bench testing based on the FDA guidance "Guidance for the Content of Premarket Notification for Ureteral Stents"(1993) was conducted on the subject stents using established methods to determine the substantial equivalence with the predicates:
- Flow Rate ●
- Radiopacity ●
- Tensile Strength ●
- Elongation
- Dimensional Verification ●
- Retention Strenath ●
- Tether Junction
- Tensile, Bend Radius and Three Point Bend
- Tensile Strength Radiopaque Tip ●
- Dynamic Friction ●
- Guide wire compatibility ●
- . Three Point Bend.
All predetermined acceptance criteria were met.
8. Conclusion
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicates.