ROCAMED ROCAUS PLATINUM

K120160 · Promepla Sam · KNY · May 14, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K120160
• Device Name: ROCAMED ROCAUS PLATINUM
• Applicant: Promepla Sam
• Product Code: KNY · Gastroenterology, Urology
• Decision Date: May 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

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.

Device Story

The ROCAMED RocaUS Platinum is a sterile, single-use ureteral access sheath designed to facilitate urological procedures. It consists of a flexible, coil-reinforced sheath and a semirigid dual-lumen dilator with a tapered distal tip. The device is inserted over a guidewire into the urinary tract; once positioned, the dilator is removed, leaving the sheath in place to serve as a conduit for endoscopes and other instruments. The dual-lumen dilator allows for the simultaneous insertion of guidewires and injection of fluids. The device is used by physicians in a clinical setting. The hydrophilic coating and flexible construction are intended to ease insertion and reduce patient trauma. The device is radiopaque to assist in visualization during placement.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Flexible coil-reinforced sheath; semirigid dual-lumen dilator. Materials: Sheath (Pebax, SST, PTFE); Dilator (LDPE with BaSO4). Features: Hydrophilic coating, radiopaque, tapered atraumatic tip, luer lock connections. Sizes: 10/12 and 12/14 FR. Sterile, single-use. Mechanical device; no software or electronics.

Indications for Use

Indicated for use as a conduit for endoscopes and urological instruments during ureteroscopy procedures, allowing for guidewire and fluid insertion.

Regulatory Classification

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).

Predicate Devices

• AMCI UroPass Ureteral Access Sheath (K051593)
• Boston Scientific Navigator Access Sheath Set II (K030956)

Submission Summary (Full Text)

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# 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.

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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<br>Platinum | AMCI UroPass<br>Ureteral Access<br>Sheath | BSCI Navigator Access<br>Sheath Set II |
| 510(k) Number | | K051593 | K030956 |
| Product Code,<br>Regulation #,<br>Name | KNY<br>21 CFR 876.5130,<br>Urological catheter and<br>accessories. | KNY<br>21 CFR 876.5130,<br>Urological catheter and<br>accessories. | KOG<br>21 CFR 876.1500,<br>Endoscope and<br>Accessories<br><br>GBM<br>21 CFR 876.5130,<br>Urological catheter and<br>accessories. |
| Manufacturer | Promepla SAM | Gyrus ACMI | Boston Scientific |
| Intended Use | The ROCAMED<br>RocaUS Platinum is<br>intended to be a<br>conduit for passage of<br>endoscopes and other<br>urological devices for<br>the purpose of<br>performing<br>ureteroscopy<br>procedures. The dual<br>working lumen dilator<br>with luer lock<br>connections allows the<br>user to insert<br>guidewires and fluids. | The UroPass Ureteral<br>Access Sheath is<br>intended to be a<br>conduit for the passage<br>of endoscopes and<br>other urological<br>devices for the purpose<br>of performing<br>diagnostic and surgical<br>procedures such as<br>nephrostomy,<br>cystoscopy, or<br>ureteroscopy, in the<br>urinary tract. | The UASS II is<br>indicated for use in<br>endoscopic procedures<br>to facilitate the<br>passage of<br>endoscopes, urological<br>instruments and for the<br>injection of fluids into<br>the urinary tract<br>antegrade and/or<br>retrograde access. |
| Reuse Status | Disposable. For single<br>patient use only | Disposable. For single<br>patient use only | Disposable. For single<br>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<br>Media | Yes | Yes | Yes |
| Proximal End Funnel | Yes | Yes | Yes |

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## 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.

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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

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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 [phone] or [phone] 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

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## 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.