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.

AI/ML Overview

This document describes a 510(k) premarket notification for the JFil® Ureteral Stents, not a study evaluating an AI device. As such, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance) is not applicable to this submission.

The document focuses on demonstrating substantial equivalence of the JFil® Ureteral Stents to legally marketed predicate devices based on intended use, technological characteristics, and performance data from bench and biocompatibility testing. The data provided only refers to in-vitro testing of a physical medical device, not an AI model.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study evaluating an AI device's performance based on the provided text.

Summary

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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

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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.

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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) 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

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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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K212868 Page 1 of 4

510 (k) Summary

1. Submitter Information

510 (k) submitter:	ROCAMED SAM
Address:	9 Avenue Albert II98000 MonacoMONACO (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.

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4. Device Description

Designation	Ø (Fr)	Length(cm)	Presenceof 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 & PredicateTrade name(Applicant)	Device underevaluationJFil® UreteralStents(Rocamed)	Primary Predicate- K030503Polaris™ LoopUreteral Stents(BostonScientific)	Secondary Predicate- K173734 RocaJJSoft 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

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K212868
Page 3 of 4

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Intended UseConditions	-Surgical suitein a hospitalenvironment- Medical facilities-Under asepticconditions(clothing, sterilesurgical gloves,and a controlledatmosphere)	The use conditions for thedevice are a surgical suitein a hospital environment.Ureteral stents are handledby surgeons under asepticconditions (clothing, sterilesurgical gloves, and acontrolled atmosphere).They will be placed for alength of time specified bythe urologist surgeon.	- Surgical suite in ahospital environment- Medical facilities- Under asepticconditions(clothing, sterilesurgical gloves,and a controlledatmosphere)
Prescription of use	Sale by or on theorder of a physician	Sale by or on the orderof a physician	Sale by or on theorder 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)	816	1610/12/14/18 /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
Suturematerial	Polypropylene	Polypropylene	Polypropylene
GuidewireCompatibility	0.035"	0.038"	0.035"
Ink Mark	No	Yes	Yes
Shelf-life	3 Years	Unknown	3 Years
Radiopacity	Yes	Yes	Yes
Placement	Placed usingendoscopictechniques	placement endoscopicallyorfluoroscopically	Placed usingendoscopictechniques
Indwelling time	14 days	14 days	6 days

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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.

Regulation Number and Section

§ 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).