(116 days)
No
The 510(k) summary describes a mechanical device (sheath and dilator) for creating a conduit during urological procedures. There is no mention of any software, image processing, AI, or ML capabilities. The performance studies focus on physical and functional testing, not algorithmic performance.
No
The device is described as a conduit for urological procedural instruments, such as endoscopes and other urological devices, and is used to facilitate procedures rather than providing a direct therapeutic effect on a medical condition.
No
The device is described as a "conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures." Its function is to facilitate procedural instrument insertion, not to diagnose conditions.
No
The device description clearly outlines physical components (flexible sheath, semirigid dilator catheter) and materials, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures." This describes a surgical or procedural tool used within the body, not a device used to examine samples outside the body to diagnose a condition.
- Device Description: The description details a physical device (sheath and dilator) designed to create a passage for instruments. This aligns with a surgical/procedural device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVDs are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to facilitate a surgical procedure, not to perform diagnostic testing on a sample.
N/A
Intended Use / Indications for Use
The ROCAMED RocaUS Platinum is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.
Product codes
KNY, KOD
Device Description
The ROCAMED RocaUS Platinum is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopague and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Results of physical and functional testing support a determination of substantial equivalents for the ROCAMED RocaUS Platinum when compared to the predicate devices. The ROCAMED RocaUS Platinum is substantially equivalent to devices currently market approved in terms of intended use, technology, principles of operation and materials.
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
§ 876.5130 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
MAY 1 4 2012
K120160/S001
Submitter : Promepla SAM
RocaUS Sheath Traditional 510 (k)
510 (k) Summary
A. Submitter Information:
Submitter's Name: Address:
Contact Person: Contact Person's Number: Contact Person's Fax: Date of Preparation:
PROMEPLA SAM 9 Avenue Prince Albert II "LE COPORI" MC 98000 MONACO (Principality of) David Tripodi (377) 97984233 (377) 92056150 January 14, 2012
B. Device Name:
Trade Name: Common Name: Classification Name(s): Produce Code: CFR Reference:
ROCAMED RocaUS Platinum · Ureteral Access Sheath Accessories, Catheter, G-U KNY 21 CFR 876.5130
C. Predicate Device Name:
Trade Names:
AMCI UroPass Ureteral Access Sheath (K051593) Boston Scientific Navigator Access Sheath Set II (K030956)
D. Device Description:
The ROCAMED RocaUS Platinum is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopague and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR.
E. Intended Use:
The ROCAMED RocaUS Platinum is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.
F. Technological Characteristics Summary:
The ROCAMED RocaUS Platinum is flexible coil reinforced sheath with hydrophilic coating. The device can be inserted by placing the dilator/sheath assembly over a guidewire, inserting it into the patient and unclipping the dilator from the sheath and removing the sheath in place. The sheath allows for safe passage of endoscopes, injection of fluids and other related instruments.
Table 1 provides a comparison summary of the technological characteristics of the ROCAMED RocaUS Platinum versus the predicate devices.
1
Submitter . Promepla SAM
RocaUS Sheath Traditional 510 (k)
Table 1
Summary of Equivalence of the ROCAMED RocaUS Platinum to Predicate Devices
| Proposed Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| Product Name | ROCAMED RocaUS | ||
| Platinum | AMCI UroPass | ||
| Ureteral Access | |||
| Sheath | BSCI Navigator Access | ||
| Sheath Set II | |||
| 510(k) Number | K051593 | K030956 | |
| Product Code, | |||
| Regulation #, | |||
| Name | KNY | ||
| 21 CFR 876.5130, | |||
| Urological catheter and | |||
| accessories. | KNY | ||
| 21 CFR 876.5130, | |||
| Urological catheter and | |||
| accessories. | KOG | ||
| 21 CFR 876.1500, | |||
| Endoscope and | |||
| Accessories |
GBM
21 CFR 876.5130,
Urological catheter and
accessories. |
| Manufacturer | Promepla SAM | Gyrus ACMI | Boston Scientific |
| Intended Use | The ROCAMED
RocaUS Platinum is
intended to be a
conduit for passage of
endoscopes and other
urological devices for
the purpose of
performing
ureteroscopy
procedures. The dual
working lumen dilator
with luer lock
connections allows the
user to insert
guidewires and fluids. | The UroPass Ureteral
Access Sheath is
intended to be a
conduit for the passage
of endoscopes and
other urological
devices for the purpose
of performing
diagnostic and surgical
procedures such as
nephrostomy,
cystoscopy, or
ureteroscopy, in the
urinary tract. | The UASS II is
indicated for use in
endoscopic procedures
to facilitate the
passage of
endoscopes, urological
instruments and for the
injection of fluids into
the urinary tract
antegrade and/or
retrograde access. |
| Reuse Status | Disposable. For single
patient use only | Disposable. For single
patient use only | Disposable. For single
patient use only |
| Sterile | Yes | Yes | Yes |
| Lumen | 2 | 1 | 1 |
| Dilator Material | LDPE+BaSO4 | PTFE+ BaSO4 | PTFE+ BaSO4 |
| Sheath Material | Pebax-SST-PTFE | SST-PTFE | SST-PTFE |
| X-Ray Opaque | Yes | Yes | Yes |
| Coil Reinforced | Yes | Yes | Yes |
| Fr Size | 10/12,12/14 | 12/14 | 11/13, 13/15 |
| | | | |
| Length | 35 cm | 24, 38, 54 cm | 28, 36, 46 cm |
| Guide wire | 0.032", 0.035" | Yes | 0.035", 0.038" |
| Compatibility | | | |
| Atraumatic Tip | Yes | Yes | Yes |
| Tapered Dilator | Yes | Yes | Yes |
| Radiopaque Marks | Yes | Yes | Yes |
| Hydrophilic Coating | Yes | Yes | Yes |
| Injection of Contrast
Media | Yes | Yes | Yes |
| Proximal End Funnel | Yes | Yes | Yes |
2
K120160/S001
Submitter : Promepla SAM
i
RocaUS Sheath
Traditional 510 (k)
Dilator material is different from the predicate devices, LDPE instead of PTFE. It was selected instead of PTFE because it is slightly more flexible, which will ease insertion into the patient and reduce trauma.
G. Performance Data:
·
Results of physical and functional testing support a determination of substantial equivalents for the ROCAMED RocaUS Platinum when compared to the predicate devices. The ROCAMED RocaUS Platinum is substantially equivalent to devices currently market approved in terms of intended use, technology, principles of operation and materials.
3
Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Krista Johnson . Quality Group - Regulatory Affairs PROMEPLA SAM LE COPORI - 9 Avenue Prince Albert II MONACO MC 98000 MONACO
MAY 1 4 2012
Re: K120160 Trade/Device Name: ROCAMED RocaUS Platinum
Regulation Number: 21 CFR$ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY, KOD Dated: May 4, 2012 Received: May 7, 2012
Dear Ms. Johnson:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract hiability 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. 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 (reporting of medical
4
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin K-twke
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
5
K120160/S001
Submitter : Promepla SAM
RocaUS Sheath Traditional 510 (k)
Indications for Use Statement (K98-1)
| 510(k) Number (if known): | |
|---|---|
| --------------------------- | -- |
Device Name: ROCAMED RocaUS Platinum
Indication for use:
The ROCAMED RocaUS Platinum is intended to be a conduit.for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.
Prescription Use __ X (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE 6 CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Grant Barr for Benjamin Fisher
(Division Sign-Off)
actro-Ren.