(216 days)
Not Found
No
The device description focuses on the materials and mechanical function of the catheters and stents, with no mention of AI or ML capabilities.
Yes
The device is intended to provide drainage and stenting within the body, which are therapeutic actions to treat medical conditions.
No
Explanation: The devices described are stents and catheters intended for drainage and stenting of the biliary and ureteral systems. Their purpose is therapeutic (to provide drainage and support), not to diagnose a disease or condition. The mention of "Magnetic Resonance Safety Information" refers to testing the device's compatibility with MR imaging, not using the device itself for diagnostic imaging.
No
The device description clearly details physical components made of Tecoflex Polyeurethane-based resin, including catheters, stents, and radiopaque markers. It also mentions sterilization and a hydrophilic coating, all indicative of a physical medical device, not software.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Flexima devices are catheters and stents intended for drainage and stenting within the body (biliary system, ureter, bladder, renal pelvis). They are physically placed inside the patient.
- Lack of Testing on Samples: There is no mention of the device being used to analyze samples taken from the body. Its function is to facilitate drainage and maintain patency of anatomical structures.
Therefore, the Flexima Ureteral Stent System and Flexima Biliary Catheter System are invasive medical devices used for therapeutic and drainage purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Flexima™ Ureteral Stent System and Flexima™ Ureteral Stent System Kit is intended to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally.
The Flexima™ Biliary Catheter System / Flexima™ Biliary Catheter System Kit / Flexima™ Biliary Catheter System with Radiopaque Marker / Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip / Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip and Radiopaque Marker are intended to provide external and internal percutaneous drainage of the biliary system.
Product codes (comma separated list FDA assigned to the subject device)
FAD, FGE
Device Description
The Flexima Biliary Catheters are constructed of Flexima, a Tecoflex Polyeurethane-based resin, and selected subfamilies also have a radiopaque marker (RO) made from 65%Tungsten. The radiopaque marker is located approximately 5mm proximal to the most proximal drainage hole to aid in proper placement of the catheter. Additionally, designated Flexima Biliary Catheters are available with a biocompatible, dissolving distal tip (Temp-Tip™). This dissolvable tip facilities tracking over a guidewire for percutaneous placement and dissolves within 24 hours of placement to provide a larger drainage lumen. These biliary catheters provide external and internal percutaneous drainage of the biliary system. Where long-term use is indicated, it is recommended that indwelling time not exceed 90 days.
The Flexima Ureteral Stent is also constructed of Tecoflex Polyeurethane-based resin. The pigtails on either end of the stent, are in opposite directions so that the proximal pigtail can form in the renal pelvis, while the distal pigtail forms in the bladder, to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally. The double pigtail stent prevents upward and downward movement. Also, where longterm use is indicated, this stent is recommended not to exceed 90 days of indwelling time.
The Flexima Biliary Catheters and Flexima Ureteral Stents are provided sterile, using 100% ethylene oxide (EO) gas sterilization, and are intended for hospital and single use only. These devices utilize Glidex™ Hydrophillic Coating for the reduction of surface friction during placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter, ureteropelvic junction, bladder, biliary system, renal pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was performed to support the addition of Magnetic Resonance Safety Information to the Directions for Use, including: Radio Frequency Heating, Force Measurement, and Image Artifact. The studies were guided by the FDA guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. Dec. 2014" and the following standards: ASTM F2182-11a for Radio Frequency Induced Heating, ASTM F2052-14 for Magnetically Induced Displacement Force, and ASTM F2119-07 for MR Image Artifacts from Passive Implants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains 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.
January 2, 2020
Boston Scientific Corporation Jois Zuniga-Gamboa Peripherical Interventional Regulatory Affairs Specialist Three Scimed Place Maple Grove, MN 55311
Re: K191446
Trade/Device Name: Flexima™ Biliary Catheter System Flexima™ Biliary Catheter System Kit Flexima™ Biliary Catheter System with Radiopaque Marker Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip FleximaTM Biliary Catheter System with Hydrophilic Dissolving Tip and Radiopaque Marker. Flexima™ Ureteral Stent System and Flexima™ Ureteral Stent System Kit Regulation Number: 21 CFR 876.4620 Regulation Name: Ureteral Stent Regulatory Class: Class II Product Code: FAD, FGE Dated: November 26, 2019 Received: December 4, 2019
Dear Jois Zuniga-Gamboa:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the
1
enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
2
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 (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica K. Nguyen, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K191446
Device Name
Flexima™ Ureteral Stent System and Flexima™ Ureteral Stent System Kit. Flexima™ Biliary Catheter System Kit / Flexima™ Biliary Catheter System with Radiopaque Marker / Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip / Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip and Radiopaque Marker.
Indications for Use (Describe)
The Flexima™ Ureteral Stent System and Flexima™ Ureteral Stent System Kit is intended to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally.
The Flexima™ Biliary Catheter System / Flexima™ Biliary Catheter System Kit / Flexima™ Biliary Catheter System with Radiopaque Marker / Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip / Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip and Radiopaque Marker are intended to provide external and internal percutaneous drainage of the biliary system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary
510(k) Summary Complying with 21 CFR 807.92
I. SUBMITTER INFORMATION
Submitter name: Boston Scientific Corporation
Submitter address: Three Scimed Place Maple Grove, MN 55311-1566 USA
Telephone: 763-494-2211 Fax: 763-494-2222 e-mail: JoisDayana.ZunigaGamboa@bsci.com
Contact person name: Jois Zuniga G. Date Prepared: December 11, 2019
II. DEVICE INFORMATION
Table 1, 2 and 3 as follows summarizes the relevant device information for the subject devices.
| Device Trade Name | Model Number |
|---|---|
| Flexima™ Biliary Catheter System | M001271540 |
| M001271550 | |
| M001271560 | |
| M001271570 | |
| M001271580 | |
| M001271590 | |
| M001271600 | |
| M001271610 | |
| M001271620 | |
| Flexima™ Biliary Catheter System Kit | M001271630 |
| M001271640 | |
| M001271650 | |
| M001271660 |
Table 1. Flexima™ Biliary Catheters Name of Devices
5
| Device Trade Name | Model Number |
|---|---|
| M001272600 | |
| M001272610 | |
| M001272620 | |
| Flexima™ Biliary Catheter System with Radiopaque Marker | M001272630 |
| M001272640 | |
| M001272650 | |
| M001272660 | |
| M001272670 | |
| M001281560 | |
| Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip | M001281570 |
| M001281580 | |
| M001281590 | |
| M001282610 | |
| Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip and | |
| Radiopaque Marker | M001282600 |
Table 2, Elexima™ Ureteral Stents Name of Devices
| Table 2. Flexima TM Ureteral Stents Name of Devices
| Device Trade Name | Model Number |
|---|---|
| FleximaTM Ureteral Stent System | M001274000 |
| M001274010 | |
| M001274020 | |
| M001274030 | |
| M001274040 | |
| M001274050 | |
| M001274060 | |
| M001274070 | |
| M001274080 | |
| M001274090 | |
| M001274100 | |
| M001274110 | |
| M001274120 | |
| M001274130 | |
| FleximaTM Ureteral Stent System Kit | M001274140 |
| M001274150 | |
| M001274160 | |
| M001274170 | |
| M001274180 | |
| M001274190 |
6
| Common or
Usual Name | Classification
Number | Classification
Name | Product
Code | Product
Code Name | Regulatory
Class |
|-------------------------------|--------------------------|----------------------------------------|-----------------|-------------------------------------------------------------|---------------------|
| Biliary Drainage
Catheters | 21 CFR Part
876.5010 | Biliary catheter
and
accessories | FGE | stents, drains
and dilators
for the biliary
ducts. | II |
| Ureteral Stent
Systems | 21 CFR Part
876.4620 | Ureteral stent | FAD | stent, ureteral | II |
III. PREDICATE DEVICE IDENTIFICATION
Name of Predicate Device
Flexima Biliary Catheter K023870 (Predicate for Flexima Biliary Catheters)
Flexima Drainage Catheters and Stents K944290 (Predicate for Flexima Ureteral Stents)
Predicate devices referenced above have not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Flexima Biliary Catheters are constructed of Flexima, a Tecoflex Polyeurethane-based resin, and selected subfamilies also have a radiopaque marker (RO) made from 65%Tungsten. The radiopaque marker is located approximately 5mm proximal to the most proximal drainage hole to aid in proper placement of the catheter. Additionally, designated Flexima Biliary Catheters are available with a biocompatible, dissolving distal tip (Temp-Tip™). This dissolvable tip facilities tracking over a guidewire for percutaneous placement and dissolves within 24 hours of placement to provide a larger drainage lumen. These biliary catheters provide external and internal percutaneous drainage of the biliary system. Where long-term use is indicated, it is recommended that indwelling time not exceed 90 days.
The Flexima Ureteral Stent is also constructed of Tecoflex Polyeurethane-based resin. The pigtails on either end of the stent, are in opposite directions so that the proximal pigtail can form in the renal pelvis, while the distal pigtail forms in the bladder, to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally. The double pigtail stent prevents upward and downward movement. Also, where longterm use is indicated, this stent is recommended not to exceed 90 days of indwelling time.
The Flexima Biliary Catheters and Flexima Ureteral Stents are provided sterile, using 100% ethylene oxide (EO) gas sterilization, and are intended for hospital and single use only. These devices utilize Glidex™ Hydrophillic Coating for the reduction of surface friction during placement.
7
Table 4 and Table 5 below provide information on the differences between the models, in relation to the outside diameter and length dimensions of the Flexima Biliary Catheters and Flexima Ureteral Stents respectively.
| Product Trade Name | Model Number | Dimensions
(OD/Length) | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-------------------------------------------------------------------------------------------|---------------------------------------------------------|---------------------------|------------|----------|------------|----------|------------|----------|------------|---------|------------|----------|------------|----------|------------|----------|---------------------------------------------------------------------|------------|---------|------------|----------|------------|----------|------------|----------|-------------------------------------------------------------------------------------------|------------|---------|------------|----------|
| Flexima™ Biliary Catheter System | M001271540 | 8F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001271550 | 10F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001271560 | 8F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001271570 | 10F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001271580 | 12F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001271590 | 14F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001271600 | 10F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001271610 | 12F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001271620 | 14F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Flexima™ Biliary Catheter System Kit | M001271630 | 8F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001271640 | 10F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001271650 | 8F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001271660 | 10F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Flexima™ Biliary Catheter System with Radiopaque Marker | M001272600 | 8F/35cm | M001272610 | 10F/35cm | M001272620 | 12F/35cm | M001272630 | 14F/35cm | M001272640 | 8F/35cm | M001272650 | 10F/35cm | M001272660 | 10F/35cm | M001272670 | 12F/35cm | Flexima™ Biliary Catheter System with Hydrophilic Dissolving
Tip | M001281560 | 8F/35cm | M001281570 | 10F/35cm | M001281580 | 12F/35cm | M001281590 | 14F/35cm | Flexima™ Biliary Catheter System with Hydrophilic Dissolving
Tip and Radiopaque Marker | M001282600 | 8F/35cm | M001282610 | 10F/35cm |
| | Flexima™ Biliary Catheter System with Radiopaque Marker | M001272600 | 8F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | M001272610 | 10F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | M001272620 | 12F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | M001272630 | 14F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | M001272640 | 8F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | M001272650 | 10F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | M001272660 | 10F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| M001272670 | | 12F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Flexima™ Biliary Catheter System with Hydrophilic Dissolving
Tip | M001281560 | 8F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001281570 | 10F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001281580 | 12F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001281590 | 14F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Flexima™ Biliary Catheter System with Hydrophilic Dissolving
Tip and Radiopaque Marker | M001282600 | 8F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | M001282610 | 10F/35cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Table 4. Flexima Biliary Catheters Dimensions
8
| Product Trade Name | Model Number | Dimensions
(OD/Length) |
|------------------------------------|--------------|---------------------------|
| Flexima™ Ureteral Stent System | M001274000 | 8F/20cm |
| | M001274010 | 8F/22cm |
| | M001274020 | 8F/24cm |
| | M001274030 | 8F/26cm |
| | M001274040 | 8F/28cm |
| | M001274050 | 10F/20cm |
| | M001274060 | 10F/22cm |
| | M001274070 | 10F/24cm |
| | M001274080 | 10F/26cm |
| | M001274090 | 10F/28cm |
| Flexima™ Ureteral Stent System Kit | M001274100 | 6F/20cm |
| | M001274110 | 6F/22cm |
| | M001274120 | 6F/24cm |
| | M001274130 | 6F/26cm |
| | M001274140 | 6F/28cm |
| | M001274150 | 8F/20cm |
| | M001274160 | 8F/22cm |
| | M001274170 | 8F/24cm |
| | M001274180 | 8F/26cm |
| | M001274190 | 8F/28cm |
Table 5. Flexima Ureteral Stents Dimensions
V.INDICATIONS FOR USE
Flexima Biliary Catheters
To provide external and internal percutaneous drainage of the biliary system.
Flexima Ureteral Stents
To provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally.
Predicate and subject device Intended use and Indications for Use are the same.
9
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
There are no differences in the technological characteristics between the predicate and subject devices. The Flexima Biliary Catheters and Flexima Ureteral Stents maintain the same fundamental scientific technology, indications for use and operating principles as the predicate devices - K023870 and K944290 respectively.
The purpose of this 510(k) submission is to receive clearance for the addition of MRI Magnetic Resonance information to the product directions for use (DFU).
VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
In order to support the addition of Magnetic Resonance Safety Information to the Directions for Use the following non-clinical performance testing was performed:
- . Radio Frequency Heating
- Force Measurement
- . Image Artifact
FDA guidance Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. Dec. 2014 and the following standards were used to guide the generation of the nonclinical data:
| Document Name | Document
Number | Document
Version |
|-----------------------------------------------------------------------------------------------------------------------|--------------------|---------------------|
| Measurement of Radio Frequency Induced
Heating Near Passive Implants During Magnetic
Resonance Imaging | ASTM F2182 | -11a |
| Measurement of Magnetically Induced
Displacement Force on Medical Devices in the
Magnetic Resonance Environment | ASTM F2052 | - 14 |
| Evaluation of MR Image Artifacts from Passive
Implants | ASTM F2119 | - 07 |
VIII. CONCLUSION
Based on the intended use, technological characteristics, and non-clinical performance data provided, the Biliary Drainage Catheters and the Ureteral Stent Systems are substantially equivalent to the predicate devices K944290 and K023870 respectively. The Directions for Use update with magnetic resonance safety information for the subject devices does not raise new questions of safety or effectiveness, and the subject devices are as safe and effective as the predicate devices.