(96 days)
The Roca.IJ Soft Stents are used 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 techniques.
The stents are not intended as a permanent indwelling devices, it is recommended that:
-
The indwelling time not exceed 6 days when the device is used with the removal string;
-
The indwelling time not exceed 365 days when the device is used without the removal string.
The RocaJJ Soft Stents system is a set consisting of a tubular double pigtail stent made up of flexible radiopaque polyurethane, with a polypropylene-monofilament suture loop in order to facilitate the extraction of the ureteral stent.
The devices may include a pusher with a radiopaque tip, and a guidewire. Otherwise, these sets may include only a pusher.
The RocaJJ Soft Stents are from 4.8 to 8.0 Fr in diameter and from 24 to 30 cm in specified length.
This document is a 510(k) Summary for the RocaJJ Soft Stents. It describes the device, its intended use, and demonstrates substantial equivalence to predicate devices based on various bench tests.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength | All bench testing results confirmed that the products described in this submission met the necessary specification. |
| Sterilization Validation | Validated in accordance with recognized industry standards. |
| Transportation Validation | Validated in accordance with recognized industry standards. |
| Tensile Strength | Test performed, results confirmed adequate mechanical strength. |
| Ultimate Elongation | Test performed, results confirmed adequate mechanical strength. |
| Opening Force of Retaining Loops | Test performed, results confirmed adequate mechanical strength. |
| Drainage Capacity | Test performed, results confirmed adequate mechanical strength. |
| Biocompatibility | Confirmed in accordance with ISO 10993. |
| Shelf Life Validation | Validated in accordance with recognized industry standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for each bench test. The data provenance is described as "bench testing conducted by Promepla SAM," indicating in-house testing. There is no information regarding the country of origin of data or whether it was retrospective or prospective, as these are bench tests, not clinical studies involving patients.
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):
This information is not applicable to this submission. The "ground truth" for the acceptance criteria listed is based on engineering specifications and recognized industry standards (e.g., ISO 10993 for biocompatibility), not expert interpretation of medical data. Therefore, there were no medical experts establishing ground truth for these bench tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically relevant for clinical studies where there's a need to resolve discrepancies in expert interpretation of medical images or patient outcomes. For bench testing, individual tests are performed to specified criteria, and the results either pass or fail.
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:
This information is not applicable. The RocaJJ Soft Stents are a medical device (ureteral stent), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is not an AI algorithm; it's a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance of the RocaJJ Soft Stents is based on:
- Engineering specifications and design requirements: These define what the stent is supposed to do (e.g., withstand certain forces, drain effectively).
- Recognized industry standards: Such as ISO 10993 for biocompatibility.
- Comparison to predicate devices: Demonstration of similar performance characteristics to legally marketed devices.
8. The sample size for the training set:
This information is not applicable. This is a physical medical device and does not involve AI or machine learning models that require a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for a physical medical device.
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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 seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
March 12, 2018
Promepla SAM Alexandre Bareille Regulatory Affairs Manager 9 Avenue Albert II Monaco, 98000 Monaco
Re: K173734
Trade/Device Name: RocaJJ Soft Stents Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: February 15, 2018 Received: February 20, 2018
Dear Alexandre Bareille:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173734
Device Name RocaJJ Soft Stents
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
The Roca.IJ Soft Stents are used 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 techniques.
The stents are not intended as a permanent indwelling devices, it is recommended that:
-
The indwelling time not exceed 6 days when the device is used with the removal string;
-
The indwelling time not exceed 365 days when the device is used without the removal string.
Target population: adults only (at least 22 years old)
| 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
A. Submitter Information
| Submitter's Name: | PROMEPLA SAM |
|---|---|
| Address | 9 Avenue Albert II98000 MonacoMONACO (Principality of) |
| Contact Person | Alexandre Bareille |
| Contact Person's email: | alb@promepla.com |
| Contact Person's Number | (377) 979-842-44 |
| Contact Person's Fax | (377) 920-561-50 |
| Submission date | December 01, 2017 |
B. Device Name
| Trade Name of Device: | RocaJJ Soft Stents |
|---|---|
| Common Name: | Stent, Ureteral |
| Regulation Number: | 21 CFR 876.4620 |
| Regulation Name : | Ureteral stent |
| Regulation Class : | II |
| Product Code : | FAD |
| Panel : | Gastroenterology/Urology |
| Official Contact Person: | Alexandre Bareille |
C. Predicates Devices
| Nº | Product name | Manufacturer | 510(k) number |
|---|---|---|---|
| 1 | Bard InLayOptima Ureteral StentWith Suture | Bard | K043193 |
| 2 | Universa Soft Ureteral Stents andStent Sets | Cook | K151051 |
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D. Device Description:
The RocaJJ Soft Stents system is a set consisting of a tubular double pigtail stent made up of flexible radiopaque polyurethane, with a polypropylene-monofilament suture loop in order to facilitate the extraction of the ureteral stent.
The devices may include a pusher with a radiopaque tip, and a guidewire. Otherwise, these sets may include only a pusher.
The RocaJJ Soft Stents are from 4.8 to 8.0 Fr in diameter and from 24 to 30 cm in specified length.
E. Intended Use:
The RocaJJ Soft Stents are used 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 techniques.
- The stents are not intended as a permanent indwelling devices, it is recommended that:
- The indwelling time not exceed 6 days when the device is used with the removal string; -
- The indwelling time not exceed 365 days when the device is used without the removal string.
Target population: adults only (at least 22 years old)
F. Technological Characteristics and Performance Data:
In support of this 510(k) premarket notification. Promepla SAM has conducted bench testing to demonstrate that RocaJJ Soft Stents provide adequate mechanical strength for their intended use. All bench testing results confirmed that the products described in this submission met the necessary specification.
In addition, the biocompatibility of the devices has been confirmed in accordance with ISO 10993, and the company has conducted sterilization, shelf life and transportation validation in accordance with recognized industry standards.
A list of the tests performed to support substantial equivalence is provided below:
- Sterilization Validation; -
- -Transportation Validation;
- -Tensile strength:
- -Ultimate elongation;
- -Opening force of the retaining loops;
- -Drainage capacity;
- Biocompatibility; -
- Shelf life Validation. -
The results of these evaluations demonstrate that the RocaJJ Ureteral Stents are safe and effective when used in accordance with their intended use and labeling.
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G. Substantial Equivalence:
The RocaJJ Soft Stents are substantially equivalent to the Bard InLayOptima Ureteral Stent and to the Cook Universa Soft Stents in regard to intended use, design, materials and function.
| Product Name | RocaJJ Soft Stents | Bard InLayOptimaUreteral Stent withSuture | Universa Soft UreteralStents and Stent Sets |
|---|---|---|---|
| 510(k) Number | -- | K043193 | K151051 |
| Product Code | FAD | FAD | FAD |
| Regulation Name | Ureteral Stent | Ureteral Stent | Ureteral Stent |
| Manufacturer | PROMEPLA SAM | C.R. Bard. Inc. UrologicalDivision | Cook Incorporated (Cook) |
| Intended Use | The RocaJJ Soft Stentsare used for temporaryinternal drainage from theureteropelvic junction tothe bladder. Ureteralstents have been used torelieve obstruction in avariety of benign,malignant, and post-traumatic conditions. Thestents may be placedusing endoscopictechniques.The stents are notintended as a permanentindwelling devices, it isrecommended that:- The indwelling time notexceed 6 days when thedevice is used with theremoval string;- The indwelling time notexceed 365 days whenthe device is usedwithout the removalstring. | The Bard InLayOptimaUreteral Stent and Multi-Length Ureteral Stent isindicated to relieveobstruction in a variety ofbenign, malignant andpost-traumatic conditionsin the ureter. Theseconditions include stonesand/or stone fragments orother ureteral obstructionssuch as those associatedwith ureteral stricture,malignancy of abdominalorgans, retroperitonealfibrosis or ureteral trauma,or in association withESWL. The stent may beplaced using endoscopicsurgical techniques orpercutaneously usingstandard radiographictechnique. It isrecommended that theindwelling time not exceed365 days. The stent is notintended as a permanentindwelling device. | The Universa SoftUreteral Stents and StentSets aer used fortemporary internaldrainage from theureteropelvic junction tothe bladder. Ureteralstents have been used torelieve obstruction in avariety of benign,malignant, and post-traumatic conditions. Thestents may be placedusing endoscopic,percutaneous, or opensurgical techniques. |
The RocaJJ Soft Stents and its predicates have a similar intended use, diameter, length, indwelling period without the withdrawal string, sterility process, radiopaque properties, materialprocessing and design.
The RocaJJ Soft Stents have a shorter indwelling time withdrawal string than the Universa Soft Stent, which is more favorable.
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RocaJJ Soft Stents pusher is made of Polyamide instead of HDPE for Bard InLay Optima, which is a more resistant material. Length of pusher is equivalent for 6/7/8Fr versions while 4.8Fr pusher is longer in RocaJJ Soft Stents, which is more favorable as it allows an easier handling by physician. RocaJJ Soft Stents exist in a span of lengths from 24 to 30cm, which is narrower than predicate devices and address most of patients.
Guidewire interface is 0.035" for RocaJJ Soft Stents, while predicates allow a guidewire diameter up to 0.038". Standard endoscopic procedures use 0.035" guidewires, while 0.038" guidewires are more commonly used in percutaneous procedures which are not included in RocaJJ Soft Stents intended use.
Hence, the RocaJJ Soft Stents are substantially equivalent to the predicates devices since the basic features and intended uses are the same.
The minor differences between RocaJJ Soft Stents and the predicate devices raise no new issues of safety and effectiveness.
§ 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).