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 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.

AI/ML Overview

The provided document is a 510(k) summary for the Bi-Flex Ureteral Access Sheath. It describes the device, its intended use, and its technological characteristics compared to a predicate device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish novel performance criteria.

Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, detailed study designs, sample sizes, expert qualifications, or ground truth establishment typically found in performance studies for new, non-substantially equivalent devices or AI/software as a medical device (SaMD) clearances.

This 510(k) submission primarily relies on physical and functional testing to support the claim of substantial equivalence.

Here's what can be extracted based on the provided text, while also noting what is not present:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as quantitative performance metrics with defined thresholds. The "acceptance criteria" for a 510(k) of this nature primarily revolve around demonstrating that the device is as safe and effective as the predicate device by meeting similar design and material specifications and passing standard physical and functional tests.
Reported Device Performance:
- "Results of physical and functional testing support a determination of substantial equivalents for the Bi-Flex Ureteral Access Sheath when compared to the predicate device." This is a high-level statement that general performance was found to be acceptable relative to the predicate. No specific numerical performance values are given.
- The document lists various technological characteristics of the proposed device, which can be interpreted as design specifications that the device met to be considered substantially equivalent to the predicate. These are listed in "Table 1: Proposed Device" column. The implicit "acceptance criterion" for each of these is that it matches or is comparable to the predicate device's characteristic.

Acceptance Criterion (Implicit)	Reported Device Performance (as listed in Table 1)
Product Name	Bi-Flex Ureteral Access Sheath
Product Code, Regulation #, Name	KNY, 21 CFR 876.5130, Urological catheter and accessories
Manufacturer	Promepla SAM
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.
Reuse Status	Disposable. For single patient use only
Sterile	Yes
Lumen	2
Dilator Material	LDPE+BaSO4
Sheath Material	Pebax-SST-PTFE
X-Ray Opaque	Yes
Coil Reinforced	Yes
Fr Size	10/12, 12/14
Length	35, 45 cm
Guide wire Compatibility	0.032", 0.035"
Atraumatic Tip	Yes
Tapered Dilator	Yes
Radiopaque Marks	Yes
Hydrophilic Coating	Yes
Injection of Contrast Media	Yes
Proximal End Funnel	Yes

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not specified. The document mentions "physical and functional testing" but does not detail the specific tests, sample sizes, or where these tests were conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not specified. This is not an AI/SaMD device where expert-established ground truth is typically required for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI/SaMD device for which an MRMC study would be conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a hardware medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable in the usual sense for clinical performance. The "ground truth" for this device's performance would be engineering specifications and standards for material properties, mechanical integrity, and biocompatibility, as confirmed through physical and functional testing.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it is not an AI/machine learning product.

9. How the ground truth for the training set was established:

Not applicable. This device does not involve a training set.

Summary of Study:

The study involved physical and functional testing of the Bi-Flex Ureteral Access Sheath. The details of these tests, including specific methodologies and quantitative results, are not provided in this 510(k) summary. The purpose of this testing was to demonstrate that the new device is substantially equivalent to the predicate device (ROCAMED RocaUS Platinum, K120160) by comparing their intended use, technology, principles of operation, and materials. The FDA's clearance of K140441 indicates that based on the submitted data, the agency agreed with the claim of substantial equivalence.

Summary

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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:

E. Intended Use:

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 AccessSheath	ROCAMED RocaUSPlatinum
510(k) Number
Product Code, Regulation #,Name	KNY21 CFR 876.5130,Urological catheter andaccessories.	KNY21 CFR 876.5130,Urological catheter andaccessories.
Manufacturer	Promepla SAM	Promepla SAM
Intended Use	The Bi-Flex UreteralAccess Sheath isintended to be a conduitfor passage ofendoscopes and otherurological devices for thepurpose of performingureteroscopy procedures.The dual working lumendilator with luer lockconnections allows theuser to insert guidewiresand fluids.	The ROCAMED RocaUSPlatinum is intended to bea conduit for passage ofendoscopes and otherurological devices for thepurpose of performingureteroscopy procedures.The dual working lumendilator with luer lockconnections allows theuser to insert guidewiresand fluids.
Reuse Status	Disposable. For singlepatient use only	Disposable. For singlepatient 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure, composed of three curved lines.

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 (800) 638-2041 or (301) 796-7100 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 (301) 433-6740

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Regulation Number and Section

§ 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.