(139 days)
No
The device description and performance studies focus on the physical properties and function of a ureteral stent, with no mention of AI or ML technology.
Yes
The device is used for temporary internal drainage of the ureteropelvic junction, which is a treatment for ureteral injuries and obstructions. This directly addresses and alleviates a medical condition.
No
This device is a ureteral stent used for temporary internal drainage of the ureteropelvic junction, which is a treatment rather than a diagnostic function.
No
The device description clearly details physical components such as a tube-like device, polyurethane stent, surgical thread, pusher, and potentially a guidewire, indicating it is a hardware medical 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 JFil® Ureteral Stents are a physical device inserted into the body to facilitate drainage. They do not analyze biological samples in vitro.
- Intended Use: The intended use is for "temporary internal drainage of the ureteropelvic junction," which is a therapeutic and supportive function within the body, not an in vitro diagnostic test.
The description clearly indicates a medical device used for a procedural intervention within the patient's body.
N/A
Intended Use / Indications for Use
The JFil® Ureteral Stents are used for temporary internal drainage of the ureteropelvic junction.
The stents may be placed using endoscopic techniques.
The stents are not intended as permanent indwelling devices, it is recommended that the indwelling time does not exceed 14 days.
Target population: adults only (greater than 21 years of age).
Product codes
FAD
Device Description
The JFil® Ureteral Stents consist of a tube-like device that is inserted into the ureter to allow the passage of the urine in the treatment of ureteral injuries and ureteral obstructions. This polyurethane stent has a single loop on the proximal tip and a polypropylene-monofilament surgical thread on the distal tip. JFil stents are 6.0 or 7.0 French (Fr) in diameter and 8 or 16 cm in specified length. The stent is provided with a 63 cm length pusher and may include a Nitinol Guidewire in the kit. The pusher consists of a radio-opaque ring connected to a tubing, and is intended to allow pushing, placing, and releasing the stent inside the patient. This stents can only be used by trained professionals in a clinic or hospitals environment. The JFil Ureteral Stents are sterile and for single use only. The stents are also available in ECO-kits which do not include a guidewire. The stents can be removed cystoscopically by gently pulling on the surgical thread.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteropelvic junction (ureter)
Indicated Patient Age Range
adults only (greater than 21 years of age).
Intended User / Care Setting
trained professionals in a clinic or hospitals environment.
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 - Bench
In support of this premarket notification, Rocamed conducted the following bench performance testing -
- Drainage capacity, Per ASTM F623-99, "Standard Performance Specification for Foley ● Catheter"
- Curl strength ●
- Tensile and elongation/yield strength
- . Shelf life validation
All bench testing results confirmed that the products described in this submission met the necessary specification.
Biocompatibility Testing
Biocompatibility of the subject stents was confirmed per ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The device met the requirements.
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 contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 10, 2022
Rocamed SAM Tahiana Rasolofoniaina Regulatory Affairs Specialist 9 Avenue Albert II Monaco, Monaco 98000 Monaco
Re: K212868
Trade/Device Name: JFil Ureteral Stents, JFil Ureteral Stents ECO KIT Regulation Number: 21 CFR 876.4620 Regulation Name: Ureteral stent Regulatory Class: Class II Product Code: FAD
Dear Tahiana Rasolofoniaina:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 26, 2022. Specifically, FDA is updating this SE Letter with corrected model numbers of your device as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jessica K. Nguyen, Ph.D., OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, Jessica. Nguyen@fda.hhs.gov.
Sincerely,
Jessica K. Nguyen -S
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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services-USA. The FDA logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION." To the left of the FDA logo is the Department of Health & Human Services logo, which features a stylized emblem. The logos are positioned horizontally, with the Department of Health & Human Services logo on the left and the FDA logo on the right.
January 26, 2022
Rocamed SAM Tahiana Rasolofoniaina Regulatory Affairs Specialist 9 Avenue Albert II Monaco, Monaco 98000 Monaco
Re: K212868
Trade/Device Name: JFil® Ureteral Stents, JFil® ECO Kit Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: December 23, 2021 Received: December 29, 2021
Dear Tahiana Rasolofoniaina:
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 mav, 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.
2
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 (QS) 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,
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
3
Indications for Use
510(k) Number (if known) K212868
Device Name JFil® Ureteral Stents, JFil® ECO KIT
Indications for Use (Describe) The JFil® Ureteral Stents are used for temporary internal drainage of the ureteropelvic junction.
The stents may be placed using endoscopic techniques.
The stents are not intended as permanent indwelling devices, it is recommended that the indwelling time does not exceed 14 days.
Target population: adults only (greater than 21 years of age).
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
K212868 Page 1 of 4
510 (k) Summary
1. Submitter Information
| 510 (k) submitter: | ROCAMED SAM |
|---|---|
| Address: | 9 Avenue Albert II |
| 98000 Monaco | |
| MONACO (Principality of) | |
| Contact Person Name: | Tahiana Rasolofoniaina |
| Contact Title: | Regulatory Affairs Specialist |
| Contact Person's email: | tr@promepla.com |
| Contact Person's Number: | (+377) 979-842-44 |
| Preparation date: | January 25, 2022 |
2. Device Information
| Trade Name of the Device: | JFil® Ureteral Stents, JFil® ECO KIT |
|---|---|
| Common Name | Ureteral Stent |
| Classification Name: | Stent, Ureteral |
| Classification Regulation: | 21 CFR 876.4620 |
| Device Class: | II |
| Review Panel | Gastroenterology/Urology |
| Product Code | FAD |
3. Predicate Devices
| 510(k) number | K030503 | K173734 |
|---|---|---|
| Owner | Boston Scientific Corp. | Promepla SAM |
| Trade name of the Device | Polaris Loop Ureteral Stents | RocaJJ Soft Stents |
| 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 |
Both predicate devices have not been subjected to a design-related recall.
5
4. Device Description
The JFil® Ureteral Stents consist of a tube-like device that is inserted into the ureter to allow the passage of the urine in the treatment of ureteral injuries and ureteral obstructions. This polyurethane stent has a single loop on the proximal tip and a polypropylene-monofilament surgical thread on the distal tip. JFil stents are 6.0 or 7.0 French (Fr) in diameter and 8 or 16 cm in specified length. The stent is provided with a 63 cm length pusher and may include a Nitinol Guidewire in the kit. The pusher consists of a radio-opaque ring connected to a tubing, and is intended to allow pushing, placing, and releasing the stent inside the patient. This stents can only be used by trained professionals in a clinic or hospitals environment. The JFil Ureteral Stents are sterile and for single use only. The stents are also available in ECO-kits which do not include a guidewire. The stents can be removed cystoscopically by gently pulling on the surgical thread.
| Designation | Ø (Fr) | Length
(cm) | Presence
of guide | Designation of the product |
|-------------|--------|----------------|----------------------|---------------------------------------------|
| ROJV0608ST | 6 | 8 | Yes | JFil® - Ureteral Stent - 6Fr ; 8cm |
| ROJV0616ST | 6 | 16 | Yes | JFil® - Ureteral Stent - 6Fr ; 16cm |
| ROJV0708ST | 7 | 8 | Yes | JFil® - Ureteral Stent - 7Fr ; 8cm |
| ROJV0716ST | 7 | 16 | Yes | JFil® – Ureteral Stent – 7Fr ; 16cm |
| ROJV5708ST | 7 | 8 | No | JFil® ECO KIT - Ureteral Stent - 7Fr ; 8cm |
| ROJV5716ST | 7 | 16 | No | JFil® ECO KIT - Ureteral Stent - 7Fr ; 16cm |
The models are described in the table below:
5. Intended Use
The JFil® Ureteral Stents are used for temporary internal drainage of the ureteropelvic junction.
The stents may be placed using endoscopic techniques.
The stents are not intended as permanent indwelling devices, it is recommended that the indwelling time does not exceed 14 days.
Target population: adults only (greater than 21 years of age).
6. Comparison of The Technological Characteristics with Predicate Devices:
| Device & Predicate
Trade name
(Applicant) | Device under
evaluation
JFil® Ureteral
Stents
(Rocamed) | Primary Predicate
- K030503
Polaris™ Loop
Ureteral Stents
(Boston
Scientific) | Secondary Predicate - K173734 RocaJJ
Soft Ureteral Stents
(Promepla) |
|-------------------------------------------------|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Regulation Number | 876.4620 | 876.4620 | 876.4620 |
| Regulation Name | Stents, Ureteral | Stents, Ureteral | Stents, Ureteral |
| Product Code | FAD | FAD | FAD |
| Classification | Class II | Class II | Class II |
| Stent Type | Single J Stent | Single J Stent | Double J Stent |
6
| K212868 |
|---|
| Page 3 of 4 |
==============================================================================================================================================================================
| Intended Use
Conditions | -Surgical suite
in a hospital
environment
- Medical facilities
-Under aseptic
conditions
(clothing, sterile
surgical gloves,
and a controlled
atmosphere) | The use conditions for the
device are a surgical suite
in a hospital environment.
Ureteral stents are handled
by surgeons under aseptic
conditions (clothing, sterile
surgical gloves, and a
controlled atmosphere).
They will be placed for a
length of time specified by
the urologist surgeon. | - Surgical suite in a
hospital environment - Medical facilities
- Under aseptic
conditions
(clothing, sterile
surgical gloves,
and a controlled
atmosphere) |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription of use | Sale by or on the
order of a physician | Sale by or on the order
of a physician | Sale by or on the
order of a physician |
| Reuse Status | Single Use | Single Use | Single Use |
| Sterilization | Ethylene oxide (EO) | Ethylene oxide (EO) | Ethylene oxide
(EO) |
| Size (Fr) | 6/7 | 5/6/7/8 | 4,8/6/7/8 |
| Length (cm) | 8
16 | 16
10/12/14/18 /20/22/
24/26/28/30 | 24/26/28/30 |
| Stent type | Simple J | Simple J | Double J |
| Renal loop | Pigtail loop | Pigtail loop | Pigtail loop |
| Bladder loop | Suture thread | Suture loop | Pigtail loop |
| Suture
material | Polypropylene | Polypropylene | Polypropylene |
| Guidewire
Compatibility | 0.035" | 0.038" | 0.035" |
| Ink Mark | No | Yes | Yes |
| Shelf-life | 3 Years | Unknown | 3 Years |
| Radiopacity | Yes | Yes | Yes |
| Placement | Placed using
endoscopic
techniques | placement endoscopically
or
fluoroscopically | Placed using
endoscopic
techniques |
| Indwelling time | 14 days | 14 days | 6 days |
7
As evidenced by the above table, both the subject and the predicate devices have the same intended use, but the subject and predicate devices have different technological characteristics. However, these differences do not raise different questions of safety or effectiveness and the testing mentioned below showed that the subject is substantially equivalent with the predicates.
7. Performance Data
Performance Data - Bench
In support of this premarket notification, Rocamed conducted the following bench performance testing -
- Drainage capacity, Per ASTM F623-99, "Standard Performance Specification for Foley ● Catheter"
- Curl strength ●
- Tensile and elongation/yield strength
- . Shelf life validation
All bench testing results confirmed that the products described in this submission met the necessary specification.
Biocompatibility Testing
Biocompatibility of the subject stents was confirmed per ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The device met the requirements.
8. Conclusion
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicates.