BI-FLEX URETERAL ACCESS SHEATH

K140441 · Promepla Sam · KNY · Jun 17, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140441
• Device Name: BI-FLEX URETERAL ACCESS SHEATH
• Applicant: Promepla Sam
• Product Code: KNY · Gastroenterology, Urology
• Decision Date: Jun 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Indications for Use

The Bi-Flex Ureteral Access Sheath 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

Bi-Flex Ureteral Access Sheath functions as conduit for endoscopes/urological instruments during ureteroscopy; consists of flexible, coil-reinforced sheath and semirigid dual-lumen dilator with tapered distal tip. Device inserted over guidewire; dilator removed, leaving sheath in place. Dual-lumen dilator features luer lock connections for guidewire/fluid insertion. Used in clinical urology settings by physicians. Radiopaque materials and hydrophilic coating facilitate navigation and placement. Benefits include safe, atraumatic access to urinary tract for diagnostic or therapeutic procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Flexible coil-reinforced sheath; semirigid dual-lumen dilator. Materials: LDPE+BaSO4 (dilator), Pebax-SST-PTFE (sheath). Features: hydrophilic coating, radiopaque, tapered atraumatic tip, luer lock connections. Sizes: 10/12 and 12/14 FR; lengths: 35 and 45 cm. Single-patient use; sterile.

Indications for Use

Indicated for patients undergoing ureteroscopy procedures requiring a conduit for the passage of endoscopes and other urological instruments, and for the insertion of guidewires and fluids.

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

• ROCAMED RocaUS Platinum (K120160)

Submission Summary (Full Text)

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Submitter . Promepla SAM

# JUN 1 7 2014

K140441 Pg. 1 of 3 Bi-Flex Ureteral Access Sheath Traditional 510 (k)

# 510 (k) Summary

# A. Submitter Information:

| Submitter's Name: | PROMEPLA SAM | |
|--------------------------|-----------------------------------|--|
| Address: | 9 Avenue Prince Albert II | |
| | "LE COPORI" | |
| | MC 98000 MONACO (Principality of) | |
| Contact Person: | Mohamed Rekik | |
| Contact Person's Number: | (377) 97984233 | |
| Contact Person's Fax: | (377) 92056150 | |
| Date of Preparation: | January 23, 2014 | |

#### B. Device Name:

| Trade Name: | Bi-Flex Ureteral Access Sheath | |
|-------------------------|--------------------------------|--|
| Common Name: | Ureteral Access Sheath | |
| Classification Name(s): | Accessories, Catheter, G-U | |
| Produce Code: | KNY | |
| CFR Reference: | 21 CFR 876.5130 | |

#### C. Predicate Device Name:

Trade Name:

ROCAMED RocaUS Platinum (K120160)

#### D. Device Description:

The Bi-Flex Ureteral Access Sheath 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 radiopaque and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR, and two lengths, 35 and 45 cm.

#### E. Intended Use:

The Bi-Flex Ureteral Access Sheath 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 Bi-Flex Ureteral Access Sheath 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 Bi-Flex Ureteral Access Sheath versus the predicate devices.

Section 5

.

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# Table 1

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

#

| | Proposed Device | Predicate Device |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Bi-Flex Ureteral Access<br>Sheath | ROCAMED RocaUS<br>Platinum |
| 510(k) Number | | |
| Product Code, 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. |
| Manufacturer | Promepla SAM | Promepla SAM |
| Intended Use | The Bi-Flex Ureteral<br>Access Sheath is<br>intended to be a conduit<br>for passage of<br>endoscopes and other<br>urological devices for the<br>purpose of performing<br>ureteroscopy procedures.<br>The dual working lumen<br>dilator with luer lock<br>connections allows the<br>user to insert guidewires<br>and fluids. | The ROCAMED RocaUS<br>Platinum is intended to be<br>a conduit for passage of<br>endoscopes and other<br>urological devices for the<br>purpose of performing<br>ureteroscopy procedures.<br>The dual working lumen<br>dilator with luer lock<br>connections allows the<br>user to insert guidewires<br>and fluids. |
| Reuse Status | Disposable. For single<br>patient use only | Disposable. For single<br>patient use only |
| Sterile | Yes | Yes |
| Lumen | 2 | 2 |
| Dilator Material | LDPE+BaSO4 | LDPE+BaSO4 |
| Sheath Material | Pebax-SST-PTFE | Pebax-SST-PTFE |
| X-Ray Opaque | Yes | Yes |
| Coil Reinforced | Yes | Yes |
| Fr Size | 10/12,12/14 | 10/12,12/14 |
| Length | 35, 45 cm | 35 cm |
| Guide wire Compatibility | 0.032", 0.035" | 0.032", 0.035" |
| Atraumatic Tip | Yes | Yes |
| Tapered Dilator | Yes | Yes |
| Radiopaque Marks | Yes | Yes |
| Hydrophilic Coating | Yes | Yes |
| Injection of Contrast Media | Yes | Yes |
| Proximal End Funnel | Yes | Yes |

Section 5

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# G. Performance Data:

Results of physical and functional testing support a determination of substantial equivalents for the Bi-Flex Ureteral Acces Sheath when compared to the predicate device.

The Bi-Flex Ureteral Access Sheath is substantially equivalent to devices currently market approved in terms of intended use, technology, principles of operation and materials.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### June 17, 2014

Promepla SAM Mohamed Rekik Quality Manager 9 Avenue Albert II, "Le Copori" MC 98000 MONACO

K140441 Re:

Trade/Device Name: Bi-Flex Ureteral Access Sheath Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY Dated: January 23, 2014 Received: February 21, 2014

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 for use sured in the enorther. 776, the enactment date of the Medical Device Amendments, or to conninered province 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). and Cosmetic rice, its (110) has the device, subject to the general controls provisions of the Act. The rou may, alores 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 If your device is blackling a 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 r least of advised that I Drin based that your device complies with other requirements of the Act that I DA has made a continegulations administered by other Federal agencies.

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Page 2 - Mohamed Rekik

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,

JoyceMDang-S

for

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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# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140441

Device Name Bi-Flex Ureteral Access Sheath

Indications for Use (Describe)

The Bi-Fies: Ureteral Access Sheath is intended to be a conduit for passage of endoscopes and other urological devices for the purpose The DPF fest Offerent Needs onean is the dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

THE FOR FOR FOR FOR FOR FOR FOR FOR FOR the first the rest Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

FORM FDA 3881 (1/14)

150 Publishing Services [phone]

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