(255 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a ureteral catheter, with no mention of AI or ML capabilities.
No
The device is a non-therapeutic ureteral catheter used for diagnostic and interventional procedures, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "flushing procedures for diagnostics".
No
The device description clearly outlines physical components like a flexible tube, stylet, and connector, indicating it is a hardware medical device, not software-only.
Based on the provided information, the RocaTub ureteral catheter is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body for drainage, opacification, and flushing procedures related to the urinary tract. IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The description details a physical catheter designed for insertion into the ureter. This is consistent with an in vivo medical device, not an in vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or the analysis of biological samples outside the body, which are hallmarks of IVD devices.
Therefore, the RocaTub ureteral catheter is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The RocaTub ureteral catheter is intended for use during ureteral catheterization for drainage, opacification of the upper urinary tract (retrograde ureteropyelography) and flushing procedures or interventional endourology procedures (stone management, stricture management) on adults.
Product codes
EYB
Device Description
The Rocamed RocaTub Catheters consist of a flexible tube, tapered, perforated and with position marks. It is radio-opaque and hydrophilic coated. The device includes a stylet for easing insertion into the patient if needed and a connector for syringe for flushing procedures. The device is offered in various sizes, from 4 to 7 Fr in 80cm length, and with various tip shapes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper urinary tract
Indicated Patient Age Range
adults
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
Bench testing was conducted to demonstrate that the RocaTub Ureteral Catheter provide adequate mechanical strength for their intended use. All bench testing results confirmed that the products described in this submission met the necessary specification. Performance testing has been done according to FDA-recognized standards or guidance document: EN 1618:1997 Catheters Other than Intravascular Catheters - Test Methods For Common Properties, ASTM F640-12 Standard Test Methods for Determining Radiopacity for Medical Use, ASTM D412A:2015 A quide to Polymeric Geomembranes: A Practical Approach.
In addition, the biocompatibility of the devices has been confirmed in accordance with ISO 10993, and the company has conducted sterilization adoption in accordance with recognized industry standards. The RocaTub ureteral catheter has a validated shelf life of 2 years.
Tests performed:
- Sterilization Validation
- Biocompatibility
- Device verification and validation
- Transportation adoption Validation
- Shelf life adoption Validation
The results of these evaluations demonstrate that the RocaTub Ureteral Catheter are safe and effective when used in accordance with their intended use and labeling.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
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April 23, 2020
Promepal Sam Mohamed Rekik QRA Manager 9 Avenue Albert II Monaco, 98000 MONACO
Re: K192183
Trade/Device Name: RocaTub Ureteral Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and accessories Regulatory Class: Class II Product Code: EYB Dated: March 13, 2020 Received: March 23, 2020
Dear Mohamed Rekik:
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.
1
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. 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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 Purva Pandya Acting 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indications for Use
510(k) Number (if known) K192183
Device Name RocaTub Ureteral catheter
Indications for Use (Describe)
The RocaTub ureteral catheter is intended for use during ureteral catheterization for drainage, opacification of the upper urinary tract (retrograde ureteropyelography) and flushing procedures or interventional endourology procedures (stone management, stricture management) on adults.
| 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
K192183 Page 1 of 4
Submitter: Promepla SAM RocaTub Ureteral catheter Traditional 510(k)
510 (k) Summary
A. Submitter Information
| Submitter's Name: | PROMEPLA SAM |
|---|---|
| Address | 9 Avenue Albert II |
| 98000 Monaco | |
| MONACO (Principality of) | |
| Contact Person | Mohamed REKIK |
| QRA Manager | |
| Contact Person's email: | mr@promepla.com |
| Contact Person's Number | (377) 979-842-44 |
| Contact Person's Fax | (377) 920-561-50 |
| Submission date | April 17th, 2020 |
B. Device Name
| Trade Name of the Device: | RocaTub Ureteral Catheter |
|---|---|
| Common Name: | Catheter, Ureteral, Gastro-Urology |
| Classification Name: | Urological catheter and accessories |
| Device Class: | 2 |
| Panel: | Gastroenterology/Urology |
| Product Code | EYB |
| Classification Regulation | 21 CFR 876.5130 |
| Official Contact person | Mohamed REKIK |
C. Predicate Device
| Nº | Product name | Manufacturer | 510(k) number |
|---|---|---|---|
| 1 | Ureteric catheters | Coloplast corp | K182122 |
D. Device Description:
The Rocamed RocaTub Catheters consist of a flexible tube, tapered, perforated and with position marks. It is radio-opaque and hydrophilic coated. The device includes a stylet for easing insertion into the patient if needed and a connector for syringe for flushing procedures. The device is offered in various sizes, from 4 to 7 Fr in 80cm length, and with various tip shapes.
| Reference | Diameter
(Fr) | Length
(cm) | Designation of the product |
|------------|------------------|----------------|--------------------------------------------------------------------|
| ROTA4200ST | 4 | 80 | ROCATUB CATHETER - 2 EYES - Straight/Open distal tip - 80 cm - 4Fr |
4
| ROTA5200ST | 5 | 80 | ROCATUB CATHETER - 2 EYES - Straight/Open distal tip - 80 cm - 5Fr |
|---|---|---|---|
| ROTA6200ST | 6 | 80 | ROCATUB CATHETER - 2 EYES - Straight/Open distal tip - 80 cm - 6Fr |
| ROTA7200ST | 7 | 80 | ROCATUB CATHETER - 2 EYES - Straight/Open distal tip - 80 cm - 7Fr |
| ROTG4000ST | 4 | 80 | ROCATUB CATHETER - NO EYES - Straight/Open distal tip - 80 cm - 4Fr |
| ROTG5000ST | 5 | 80 | ROCATUB CATHETER - NO EYES - Straight/Open distal tip - 80 cm - 5Fr |
| ROTG6000ST | 6 | 80 | ROCATUB CATHETER - NO EYES - Straight/Open distal tip - 80 cm - 6Fr |
| ROTG7000ST | 7 | 80 | ROCATUB CATHETER - NO EYES - Straight/Open distal tip - 80 cm - 7Fr |
| ROTH4000ST | 4 | 80 | ROCATUB CATHETER - NO EYES - Curved/Open distal tip - 80 cm - 4Fr |
| ROTH5000ST | 5 | 80 | ROCATUB CATHETER - NO EYES - Curved/Open distal tip - 80 cm - 5Fr |
| ROTH6000ST | 6 | 80 | ROCATUB CATHETER - NO EYES - Curved/Open distal tip - 80 cm - 6Fr |
| ROTH7000ST | 7 | 80 | ROCATUB CATHETER - NO EYES - Curved/Open distal tip - 80 cm - 7Fr |
E. Indications for Use:
The RocaTub ureteral catheter is intended for use during ureteral catheterization for drainage, opacification of the upper urinary tract (retrograde ureteropyelography) and flushing procedures for diagnostics or interventional endourology procedures (stone management, stricture management) on adults.
F. Summary of Non-Clinical Performance Testing:
In support of this 510(k) premarket notification, Promepla SAM has conducted bench testing to demonstrate that the RocaTub Ureteral Catheter provide adequate mechanical strength for their intended use.
All bench testing results confirmed that the products described in this submission met the necessary specification. Performance testing has been done according to FDA-recognized standards or guidance document: EN 1618:1997 Catheters Other than Intravascular Catheters - Test Methods For Common Properties, ASTM F640-12 Standard Test Methods for Determining Radiopacity for Medical Use, ASTM D412A:2015 A quide to Polymeric Geomembranes: A Practical Approach.
In addition, the biocompatibility of the devices has been confirmed in accordance with ISO 10993, and the company has conducted sterilization adoption in accordance with recognized industry standards. The RocaTub ureteral catheter has a validated shelf life of 2 years.
A list of the tests performed to support substantial equivalence is provided below:
- -Sterilization Validation;
- -Biocompatibility;
- -Device verification and validation
- Transportation adoption Validation; -
- Shelf life adoption Validation. -
The results of these evaluations demonstrate that the RocaTub Ureteral Catheter are safe and effective when used in accordance with their intended use and labeling.
5
G. Comparison of Technological Characteristics:
The RocaTub Ureteral Catheters are substantially equivalent to Coloplast currently marketed the Ureteric Catheters, regarding to the intended use, design and sterilization process.
| Product Name | RocaTub Ureteral
Catheter | Ureteric Catheters |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K192183 | K182122 |
| Product Code | EYB | EYB |
| Regulation Name | Ureteral Catheter | Ureteral Catheter |
| Manufacturer | PROMEPLA SAM | Coloplast Corp |
| Intended Use | RocaTub catheters are
intended for use during
ureteral catherization,
drainage, opacification of
the upper urinary tract
(retrograde
ureteropyelography) and
flushing procedures | The Ureteric Catheters for
retrograde
ureteropyelography are
intended for injection of
contrast medium or saline
during endourological
procedures |
| Diameter | From 4 Fr to 7 Fr | From 5 Fr to 7Fr |
| Disposable | YES | YES |
| Sterile | YES | YES |
| Stylet for ease of insertion | YES | YES |
| Suitable for use with a
guidewire | YES | YES |
| Connection with a syringe | YES | YES |
| Material | Thermoplastic Polyurethane | Polyether block amide |
| Tip shape | Straight or open distal tip | Straight or open distal tip |
| Side eyes | With or without | With or without |
| Ink Marks | YES | YES |
| Hydrophilic coating | YES | NO |
| Type of sterilization | Ethylene oxide | Ethylene oxide |
6
Submitter: Promepla SAM RocaTub Ureteral catheter Traditional 510(k)
*Green Boxes means that the characteristics are the same between the subject device and the predicate.
H. Conclusion
Promepla SAM has demonstrated that the proposed RocaTub Ureteral Catheter are substantially equivalent to Coloplast currently marketed the Ureteric Catheters, cleared under premarket notification number K182122. The differences do not affect the performances and the safety of the patient as biocompatibility tests have been performed to ensure that the raw material used are biocompatible. An analysis of material sheets/safety data sheets has been performed as well as a risk analysis. Plus, the RocaTub Ureteral Catheter have a hydrophilic coating which when activated allow to insert more easily the device into the patient than the predicate device. So, the RocaTub Ureteral Catheter are safe and effective as the corresponding predicate device when used in accordance with their intended use and labeling.