(30 days)
Not Found
No
The description focuses on the mechanical and material properties of a ureteral access sheath and dilator, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is described as a conduit for passage of other devices, not as a device that performs a therapeutic function itself.
No
The device is described as a conduit for instruments during ureteroscopy procedures and its performance studies focus on mechanical strength and biocompatibility, not on diagnosis.
No
The device description explicitly states it consists of physical components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- BiFlex Evo Function: The description clearly states the BiFlex Evo is a "conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures." It's a tool used within the body during a surgical procedure to facilitate the use of other instruments.
- No Mention of Testing Samples: The description does not mention the device being used to analyze or test any biological samples.
The BiFlex Evo is an invasive surgical device used to access and work within the ureter.
N/A
Intended Use / Indications for Use
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.
Product codes
KNY
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.
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
Prescription Use
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
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.
Tests performed: 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.
Key Metrics
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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)
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
| 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)
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510 (k) Summary
A. Submitter Information
| Submitter's Name: | PROMEPLA SAM |
|---|---|
| Address | 9 Avenue Albert II |
| 98000 Monaco | |
| MONACO (Principality of) | |
| Contact Person | Alexandre Bareille |
| Regulatory 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:
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.
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.