The BiFlex Evo 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 Evo 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

This document is a 510(k) summary for a medical device called "Bi-Flex Evo," a ureteral access sheath. It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

Analysis of the provided text reveals that this document focuses on a physical medical device (a urological catheter/sheath) and its mechanical performance, biocompatibility, and sterilization, rather than an AI-powered diagnostic or imaging device.

Therefore, most of the requested information regarding acceptance criteria and studies for an AI/ML-based medical device (such as sample size for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, etc.) is not applicable to this submission.

The document discusses "bench testing" to demonstrate mechanical strength and "biocompatibility" testing, which are standard for physical medical devices.

Here's the relevant information that can be extracted from the document, along with explanations for why other requested information is not present:

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

The document states: "All bench testing results confirmed that the products described in this submission met the necessary specification." However, it does not explicitly list the quantitative acceptance criteria for these tests (e.g., specific tensile strength values, burst pressures, etc.) nor the exact numerically reported performance results. It only provides a qualitative statement of meeting specifications.

Table of Acceptance Criteria and Reported Device Performance (as inferred):

Acceptance Criteria Category	Reported Device Performance
Mechanical Strength	"adequate mechanical strength for their intended use." "met the necessary specification."
Biocompatibility	"has been confirmed in accordance with ISO 10993."
Sterilization	"has conducted sterilization validation in accordance with recognized industry standards."
Material Change (LDPE to Polyurethane)	"allow a safer introduction thanks to the increased flexibility of its tapered tip." "does not affect the intended use of the device or alter the fundamental scientific technology of the device."
Printed Marks	"allowing an easier visualization of penetration depth and thus a safer insertion into patient."

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

Not Applicable. This pertains to a physical device, not an AI model. "Test set" in this context would refer to the number of physical units tested. The document does not specify the number of devices used for bench testing, biocompatibility, or sterilization validation. Data provenance (country, retrospective/prospective) is not relevant for this type of device testing as it's not based on patient data.

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. Ground truth in the context of AI/ML refers to labels for data. For a physical device, performance is evaluated against engineering specifications and international standards, not expert consensus on data interpretation.

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

Not Applicable. This refers to methods for establishing ground truth for data labeling, which is not relevant for a physical medical device's performance testing.

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

Not Applicable. MRMC studies are used to evaluate diagnostic imaging systems, often in conjunction with AI. This is a physical device (ureteral access sheath), not an imaging system or AI diagnostic tool.

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

Not Applicable. This refers to AI algorithm performance. This device is a physical instrument.

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

The "ground truth" for a physical device like this is its adherence to engineering specifications, material properties, and performance standards (e.g., mechanical strength, biocompatibility, sterility) as defined by established industry and regulatory guidelines (e.g., ISO, FDA guidance documents). There is no "expert consensus" on imaging or clinical outcomes data for its function.

8. The sample size for the training set

Not Applicable. This refers to AI model training data.

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

Not Applicable. This refers to AI model training data ground truth.

Summary of Device Performance/Compliance (as per 510(k) Summary):

The manufacturer conducted bench testing to demonstrate that the Bi-Flex Evo Ureteral Access Sheath:

Provides adequate mechanical strength for its intended use.
Meets necessary specifications for performance.
Is biocompatible in accordance with ISO 10993.
Has validated sterilization processes in accordance with recognized industry standards.
The material change in the dilator (LDPE to Polyurethane) provides increased flexibility for safer introduction and does not affect the intended use or fundamental scientific technology.
The addition of printed marks aids in visualization of penetration depth for safer insertion.

The conclusion is that the Bi-Flex Evo is substantially equivalent to its predicate device (Bi-Flex Ureteral Access Sheath K140441) and is safe and effective for its intended use.

Summary

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September 7, 2018

Promepla Sam Alexandre Bareille Regulatory Affairs Manager 9 Avenue Albert II MC 98000 Monaco

Re: K182144 Trade/Device Name: Bi-Flex Evo Regulation Number: 21 CFR& 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: KNY Dated: July 9, 2018 Received: August 8, 2018

Dear Alexandre Bareille:

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.

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.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mark R. Kreitz -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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Indications for Use

510(k) Number (if known) K182144

Device Name Bi-Flex Evo

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510 (k) Summary

A. Submitter Information

Submitter's Name:	PROMEPLA SAM
Address	9 Avenue Albert II98000 MonacoMONACO (Principality of)
Contact Person	Alexandre BareilleRegulatory Affairs Manager
Contact Person's email:	alb@promepla.com
Contact Person's Number	(377) 979-842-44
Contact Person's Fax	(377) 920-561-50
Submission date	July 09, 2018

B. Device Name

Trade Name of the Device:	Bi-Flex Evo
Common Name:	Accessories, Catheter, G-U
Regulation Number:	876.5130
Regulation Name:	Urological catheter and accessories
Regulation Class:	II
Product Code:	KNY
Panel:	Gastroenterology/Urology
Official Contact Person:	Alexandre Bareille

C. Predicates Devices

Nº	Product name	Manufacturer	510(k) number
1	Bi-Flex Ureteral Access Sheath	PROMEPLA SAM	K140441

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D. Device Description:

E. Indications for Use:

The Bi-Flex EVO 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 and Performance Data:

The changes are modifying the material of the dilator from LDPE to Polyurethane to be able to allow a safer introduction thanks to the increased flexibility of its tapered tip. In addition, the Bi-Flex Evo has marks printed on the dilator, allowing an easier visualization of penetration depth and thus a safer insertion into patient.

In support of this 510(k) premarket notification, Promepla SAM has conducted bench testing to demonstrate that Bi-flex Evo Ureteral Access Sheath provide adequate mechanical strength for their intended use.

All bench testing results confirmed that the products described in this submission met the necessary specification.

In addition, the biocompatibility of the devices has been confirmed in accordance with ISO 10993, and the company has conducted sterilization validation in accordance with recognized industry standards.

A list of the tests performed to support substantial equivalence is provided below:

Sterilization Validation; -
-Biocompatibility:
-Device verification and validation;

The results of these evaluations demonstrate that the Bi-Flex Evo are safe and effective when used in accordance with their intended use and labeling.

G. Conclusion

Promepla SAM has demonstrated that the proposed Bi-Flex Evo Ureteral Access Sheaths are substantially equivalent to Promepla SAM's currently marketed Bi-Flex Ureteral Access Sheath (K140441) and that the Bi-Flex Evo are safe and effective when used in accordance with their intended use and labeling

The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.

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.