(96 days)
No
The 510(k) summary describes a physical medical device (ureteral stent) and its mechanical and biocompatibility testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes.
The device is used to relieve obstruction in various medical conditions, indicating a therapeutic purpose.
No
Explanation: The device, Roca.IJ Soft Stents, is described as a ureteral stent used for temporary internal drainage to relieve obstruction. Its function is therapeutic (drainage), not to diagnose a condition.
No
The device description clearly outlines physical components made of flexible radiopaque polyurethane and polypropylene-monofilament suture, along with potential accessories like a pusher and guidewire. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the RocaJJ Soft Stents are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- RocaJJ Soft Stents Function: The description clearly states that the RocaJJ Soft Stents are used for "temporary internal drainage from the ureteropelvic junction to the bladder." They are a physical device inserted into the body to facilitate drainage, not to analyze biological samples.
- Lack of Specimen Analysis: There is no mention of the device interacting with or analyzing any biological specimens. Its function is purely mechanical (drainage).
Therefore, the RocaJJ Soft Stents fall under the category of a therapeutic or interventional device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
FAD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteropelvic junction to the bladder
Indicated Patient Age Range
adults only (at least 22 years old)
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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.
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); 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
2
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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3
510 (k) Summary
A. Submitter Information
| Submitter's Name: | PROMEPLA SAM |
|---|---|
| Address | 9 Avenue Albert II |
| 98000 Monaco | |
| MONACO (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 Stent | ||
| With Suture | Bard | K043193 | |
| 2 | Universa Soft Ureteral Stents and | ||
| Stent Sets | Cook | K151051 |
4
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.
5
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 InLayOptima
Ureteral Stent with
Suture | Universa Soft Ureteral
Stents 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. Urological
Division | Cook Incorporated (Cook) |
| 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. | The Bard InLayOptima
Ureteral Stent and Multi-
Length Ureteral Stent is
indicated to relieve
obstruction in a variety of
benign, malignant and
post-traumatic conditions
in 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
ESWL. The stent may be
placed using endoscopic
surgical techniques or
percutaneously using
standard radiographic
technique. It is
recommended that the
indwelling time not exceed
365 days. The stent is not
intended as a permanent
indwelling device. | The Universa Soft
Ureteral Stents and Stent
Sets aer 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,
percutaneous, or open
surgical 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.
6
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.