(448 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of the stents and catheters, with no mention of AI or ML algorithms for image analysis, diagnosis, or treatment planning.
Yes
The devices are intended to provide drainage and stenting, which are therapeutic actions aimed at treating a medical condition.
No
The devices described are stents and catheters intended for drainage and stenting of various anatomical sites (ureter, renal pelvis, bladder, biliary ducts, abscess). Their function is therapeutic (to provide drainage and maintain patency), not diagnostic (to identify or determine the nature of a disease or condition).
No
The device description clearly details physical components made of biocompatible copolymers and radiopaque resin, intended for physical placement within the body. It also mentions sterilization and physical performance testing. This is not a software-only device.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of these devices is to provide drainage and stenting within the body (ureter, renal pelvis, bladder, biliary ducts, abscess). This is a therapeutic or interventional purpose, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical characteristics and function of catheters and stents designed for internal placement and drainage. It does not describe reagents, instruments, or systems used for testing biological samples.
- Performance Studies: The performance studies focus on aspects like MR compatibility, material properties, and mechanical strength, which are relevant to the safety and function of an implanted or internally placed device. They do not involve evaluating the performance of a diagnostic test.
In summary, these devices are designed for direct medical intervention within the body, not for performing tests on samples outside the body, which is the core function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit:
The Ureteral Stent 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 externally.
Percuflex™ Nephroureteral Stent System:
The Percuffex Nephroureteral Stent is intended for use in Percutaneous Drainage to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent.
Amplatz Anchor™ Catheter System:
The Amplatz Anchor™ Catheter System is intended for use in applications of percutaneous drainage, particularly percutaneous nephrostomy, abscess or external biliary drainage.
Product codes (comma separated list FDA assigned to the subject device)
FAD, FGE
Device Description
The Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit is designed with the classic pigtail shape on each end and is intended to facilitate drainage internally from the renal pelvis to the bladder and stenting of the ureter without external access after placement. The ureteral stent systems contain a suture to adjust the pigtail shape or to remove the stent. These devices are constructed of a proprietary, biocompatible copolymer called Percuflex™ for patient comfort with a radiopaque resin throughout the catheter tube. Designated Percuflex™ Ureteral Stent Systems are also available with a proprietary Glidex™ hydrophilic material for the reduction of surface friction during placement or with a dissolving distal tip (Temp-Tip™). The dissolving tip internal diameter aids in placement, then dissolves soon after placement to allow a larger lumen for drainage.
The Percuflex™ Nephroureteral Stent System is also designed with the classic pigtail shape on each end and facilitates drainage from the internal ureteropelvic junction to the bladder with external access to the stent. The Nephroureteral Stent System also incorporates the Percuflex™ copolymer and a radiopaque resin throughout the catheter tube. Select models are available with a Temp-Tip™ which dissolves soon after placement. A suture is locked in place with a stopcock to retain the pigtail shape. A luer allows for connection to other drainage devices with a conical fitting.
The Amplatz Anchor™ Catheter System is designed with a unique locking Malecot diamond shape to facilitate percutaneous nephrostomy, abscess or external biliary drainage. The Amplatz Anchor™ Catheter Systems also incorporate the Percuflex™ copolymer and a radiopaque resin throughout the catheter tube. A suture is locked in place with a stopcock to retain the 2-winq design. A luer allows for connection to other drainage devices with a conical fitting.
These Percuflex™ Drainage Catheters and Stents are provided sterile, using 100% ethylene oxide (EO) gas sterilization, and are intended for hospital and single use only. Where long-term use is indicated, it is recommended not to exceed 90 days of indwelling time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteropelvic junction to the bladder, renal pelvis, ureter, percutaneous nephrostomy, biliary
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 (MR) compatibility information to the Directions for Use, including Radio Frequency Heating, Force Measurement, and Image Artifact. FDA guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment (December 11, 2014)" and standards ASTM F2182-11a, ASTM F2052-14, and ASTM F2119-07 were used.
Non-clinical performance testing was also performed to support cumulative internal changes to the devices through Boston Scientific's Design Control System, which meets 21 CFR Part 820 quality system requirements. These changes included a resin additive material supplier change and a tensile performance specification update.
For the resin additive material supplier change:
- A material evaluation was performed using Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Oxidative Induction Time (OIT), and Dynamic Contact Angle (DCA) analysis. Results showed that both supplied resins had the same thermal transition characteristics, material type (chemistry), and composition.
- Design Verification testing included Catheter Shaft Tensile, Column Strength, Kink Resistance, Removal Force, and Renal Coil Resistance-Stent Shaft >5F to assess finished device properties.
- Biocompatibility testing per ISO 10993-1 included: Cytotoxicity, Sensitization, Intracutaneous irritation testing, Material mediated pyrogenicity, Acute systemic toxicity testing, Genotoxicity testing Ames assay, Genotoxicity testing MLA, Muscle implantation 4-week study, Muscle implantation 13-week study A, and Toxicological Risk Assessment.
For the tensile performance specification update:
- Design verification testing was conducted on aged and unaged samples to demonstrate that the dissolving tip to shaft bond design output continues to meet the defined design input requirements after sterilization.
Conclusion: Based on the intended use, technological characteristics, and non-clinical performance data, the Percuflex™ Drainage Catheters and Stents are substantially equivalent to the predicate devices (K924608). The update to the Directions for Use with magnetic resonance compatibility information does not raise new questions of safety or effectiveness, and the subject devices are as safe and effective as the predicate devices.
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.
April 26, 2021
Boston Scientific Corporation Heidi Shearer Senior Regulatory Affairs Specialist Three Scimed Place Maple Grove, MN 55311
Re: K200260
Trade/Device Name: Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit, Percuflex™ Nephroureteral Stent System, Amplatz Anchor™ Catheter System Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD, FGE Dated: March 25, 2021 Received: March 26, 2021
Dear Heidi Shearer:
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 Percuflex Ureteral Stent System 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 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 medical devices and radiation-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). 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-device-advice-comprehensive-regulatoryassistance/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. 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
2
Indications for Use
510(k) Number (if known) K200260
Device Name
Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit, Percuflex™ Nephroureteral Stent System Amplatz Anchor™ Catheter System
Indications for Use (Describe)
Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit:
The Ureteral Stent 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 externally.
Percuflex™ Nephroureteral Stent System:
The Percuffex Nephroureteral Stent is intended for use in Percutaneous Drainage to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent.
Amplatz AnchorTM Catheter System:
The Amplatz Anchor™ Catheter System is intended for use in applications of percutaneous drainage, particularly percutaneous nephrostomy, abscess or external biliary drainage.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary - K200260
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: 763-255-0056 Fax: 763-494-2222 e-mail: Heidi.Shearer@bsci.com
Contact person name: Heidi Shearer Date Prepared: April 26, 2021
II. DEVICE INFORMATION
Tables 1 to 4 below summarize the relevant subject device information.
| Product Trade Name | Model Numbers |
|---|---|
| Percuflex ™ Ureteral Stent System | M001235490 |
| M001235500 | |
| M001235510 | |
| M001235520 | |
| M001235530 | |
| M001235570 | |
| M001235580 | |
| M001235590 | |
| M001235600 | |
| M001235610 | |
| M001245490 | |
| M001245500 | |
| M001245510 | |
| M001245520 | |
| M001245530 | |
| M001245570 | |
| M001245580 |
Table 1: Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit
4
510(k) Summary Percuflex Drainage Catheters and Stents
| Product Trade Name | Model Numbers |
|---|---|
| M001245590 | |
| M001245600 | |
| M001245610 | |
| Percuflex™ Ureteral Stent System Kit | M001245620 |
| M001245630 | |
| M001245640 | |
| M001245650 | |
| M001245660 | |
| M001245720 | |
| M001245730 | |
| M001245740 | |
| M001245750 | |
| M001245760 |
Table 2: Percuflex™ Nephroureteral Stent System
| Product Trade Name | Model Number |
|---|---|
| Percuflex™ Nephroureteral Stent System | M001221360 |
| M001221370 | |
| M001221380 | |
| M001221390 | |
| M001221400 | |
| M001221410 | |
| M001221420 | |
| M001221430 | |
| M001231360 | |
| M001231370 | |
| M001231380 | |
| M001231390 | |
| M001231400 | |
| M001231410 | |
| M001231420 | |
| M001231430 |
5
Table 3: Amplatz Anchor™ Catheter System
| Product Trade Name | Model Number |
|---|---|
| Amplatz Anchor™ Catheter System | M001221000 |
| Amplatz Anchor™ Catheter System | M001221010 |
| Amplatz Anchor™ Catheter System | M001221020 |
Table 4: Additional Device Information
| Common or
Usual name | Classification
Number | Classification
Name | Product Code | Product Code
Name | Regulatory
Class |
|--------------------------------|--------------------------|-------------------------------------|--------------|---------------------------------------------------------|---------------------|
| Ureteral Stent
System | 21 CFR Part
876.4620 | Ureteral stent | FAD | stent, ureteral | II |
| Nephroureteral
Stent System | 21 CFR Part
876.4620 | Ureteral stent | FAD | stent, ureteral | II |
| Biliary Catheter
System | 21 CFR Part
876.5010 | Biliary catheter
and accessories | FGE | stents, drains
and dilators for
the biliary ducts | II |
III. PREDICATE DEVICE IDENTIFICATION
Name of Predicate Device
Medi-Tech Ureteral Stent System, Nephroureteral Stent System, Amplatz Anchor System with Locking Malecot (K924608. Cleared 26-Jan-1994)
Predicate devices referenced above have not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Percuflex™ Ureteral Stent System and Percuflex™ Ureteral Stent System Kit is designed with the classic pigtail shape on each end and is intended to facilitate drainage internally from the renal pelvis to the bladder and stenting of the ureter without external access after placement. The ureteral stent systems contain a suture to adjust the pigtail shape or to remove the stent. These devices are constructed of a proprietary, biocompatible copolymer called Percuflex™ for patient comfort with a radiopaque resin throughout the catheter tube. Designated Percuflex™ Ureteral Stent Systems are also available with a proprietary Glidex™ hydrophilic material for the reduction of surface friction during placement or with a dissolving distal tip (Temp-Tip™). The dissolving tip internal diameter aids in placement, then dissolves soon after placement to allow a larger lumen for drainage.
The Percuflex™ Nephroureteral Stent System is also designed with the classic pigtail shape on each end and facilitates drainage from the internal ureteropelvic junction to the bladder with external access to the stent. The Nephroureteral Stent System also incorporates the Percuflex™ copolymer and a radiopaque resin throughout the catheter tube. Select models are available with a Temp-Tip™ which dissolves soon after placement. A suture is locked in place with a stopcock to retain the pigtail shape. A luer allows for connection to other drainage devices with a conical fitting.
The Amplatz Anchor™ Catheter System is designed with a unique locking Malecot diamond shape to facilitate percutaneous nephrostomy, abscess or external biliary drainage. The Amplatz Anchor™ Catheter Systems also incorporate the Percuflex™ copolymer and a radiopaque resin throughout the catheter tube. A suture is locked in place with a stopcock to retain the 2-winq design. A luer allows for connection to other drainage devices with a conical fitting.
6
These Percuflex™ Drainage Catheters and Stents are provided sterile, using 100% ethylene oxide (EO) gas sterilization, and are intended for hospital and single use only. Where long-term use is indicated, it is recommended not to exceed 90 days of indwelling time.
Table 5, 6, and 7 below provide information on the differences between the Percuflex™ Drainage Catheters and Stents models, in relation to specific device features such as coating, dissolving tip, and the outside diameter and length dimensions.
| Product Trade Name | Product Labeled Features | Model Number | Dimensions
(OD/Length) |
|-----------------------------------------|------------------------------------------------------------------|--------------|---------------------------|
| Percuflex™ Ureteral
Stent System | Percuflex™ TempTip™ Ureteral Stent
System with Dissolving Tip | M001235490 | 8F/20cm |
| | | M001235500 | 8F/22cm |
| | | M001235510 | 8F/24cm |
| | | M001235520 | 8F/26cm |
| | | M001235530 | 8F/28cm |
| | | M001235570 | 10F/20cm |
| | | M001235580 | 10F/22cm |
| | | M001235590 | 10F/24cm |
| | | M001235600 | 10F/26cm |
| | | M001235610 | 10F/28cm |
| Percuflex™ Ureteral
Stent System | Percuflex™ Glidex™ HYDROGEL
COATING Ureteral Stent System | M001245490 | 8F/20cm |
| | | M001245500 | 8F/22cm |
| | | M001245510 | 8F/24cm |
| | | M001245520 | 8F/26cm |
| | | M001245530 | 8F/28cm |
| | | M001245570 | 10F/20cm |
| | | M001245580 | 10F/22cm |
| | | M001245590 | 10F/24cm |
| | | M001245600 | 10F/26cm |
| | | M001245610 | 10F/28cm |
| Percuflex™ Ureteral
Stent System Kit | Percuflex™ Glidex™ HYDROGEL
COATING Ureteral Stent System Kit | M001245620 | 8F/20cm |
| | | M001245630 | 8F/22cm |
| | | M001245640 | 8F/24cm |
| | | M001245650 | 8F/26cm |
| | | M001245660 | 8F/28cm |
| Product Trade Name | Product Labeled Features | Model Number | Dimensions
(OD/Length) |
| | | M001245720 | 6F/20cm |
| | | M001245730 | 6F/22cm |
| | | M001245740 | 6F/24cm |
| | | M001245750 | 6F/26cm |
| | | M001245760 | 6F/28cm |
Table 5: Percuflex™ Ureteral Stent System Device Features
7
Table 6: Percuflex™ Nephroureteral Stent System Device Features
| Product Trade Name | Product Labeled Features | Model Number | Dimensions
(OD/Length) |
|----------------------------------------------|-------------------------------------------------------------------------------------------|--------------|---------------------------|
| Percuflex™
Nephroureteral Stent
System | Percuflex™ Locking Pigtail
Nephroureteral Stent System | M001221360 | 8F/22cm |
| | | M001221370 | 8F/24cm |
| | | M001221380 | 8F/26cm |
| | | M001221390 | 8F/28cm |
| | Percuflex™ TempTip™ Locking Pigtail
Nephroureteral Stent System with
Dissolving Tip | M001221400 | 10F/22cm |
| | | M001221410 | 10F/24cm |
| | | M001221420 | 10F/26cm |
| | | M001221430 | 10F/28cm |
| | M001231360 | 8F/22cm | |
| | M001231370 | 8F/24cm | |
| | M001231380 | 8F/26cm | |
| | M001231390 | 8F/28cm | |
| | M001231400 | 10F/22cm | |
| | M001231410 | 10F/24cm | |
| | M001231420 | 10F/26cm | |
| | M001231430 | 10F/28cm | |
Table 7: Amplatz Anchor™ Catheter System Device Features
| Product Trade Name | Product Labeled Features | Model Number | Dimensions
(OD/Length) |
|---------------------------------|--------------------------------------------------------------------|--------------|---------------------------|
| Amplatz Anchor™ Catheter System | Amplatz Anchor™ Locking Malecot,
Amplatz Anchor Catheter System | M001221000 | 8F/30cm |
| | | M001221010 | 10F/30cm |
| | | M001221020 | 12F/30cm |
8
V. INDICATIONS FOR USE
Predicate and subject device Intended use and Indications for Use are the same.
| PercuflexTM Drainage Catheters and
| Stents | Indications for Use |
|---|---|
| PercuflexTM Ureteral Stent System and | |
| PercuflexTM Ureteral Stent System Kit | The Ureteral Stent 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. |
| PercuflexTM Nephroureteral Stent | |
| System | The Percuflex Nephroureteral Stent is intended for use in Percutaneous Drainage to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent. |
| Amplatz AnchorTM Catheter System | The Amplatz AnchorTM Catheter System is intended for use in applications of percutaneous drainage, particularly percutaneous nephrostomy, abscess or external biliary drainage. |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The Percuflex™ Drainage Catheters and Stents incorporate substantially equivalent design, function, packaging, sterilization process, materials, fundamental technology, indications for use, and operating principles as those featured in the predicate drainage devices (K924608). The difference from the legally marketed predicate device is the addition of Magnetic Resonance (MR) compatibility information to the Directions for Use.
Cumulative changes have been made to the devices internally through Boston Scientific's Design Control System, which meets the quality system requirements of 21 CFR Part 820. These changes include a resin additive material supplier change and tensile performance specification update.
The tensile performance specification update applies to the Percuflex™ TempTip™ Ureteral Stent System with Dissolving Tip and the Percuflex™ TempTip™ Locking Pigtail Nephroureteral Stent System with Dissolving Tip devices. This change updated the dissolving tip to catheter tensile strength performance specification.
VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
In order to support the addition of Magnetic Resonance Compatibility 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 (December 11, 2014) and the following standards were used to guide the generation of the non-clinical data:
9
| 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 |
In order to support the cumulative changes that have been made to the devices internally through Boston Scientific's Design Control System, the following non clinical performance testing was performed:
- · Resin additive material supplier change
- o A material evaluation consisted of Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Oxidative Induction Time (OIT), and Dynamic Contact Angle (DCA) analysis was performed. Results demonstrated that both supplied resins present the same thermal transition characteristics, material type (chemistry), and composition.
- o Design Verification testing including Catheter Shaft Tensile, Column Strength, Kink Resistance, Removal Force, and Renal Coil Resistance-Stent Shaft >5F was performed to assess these finished device properties.
- · The following biocompatibility testing was performed per ISO 10993-1:
-
Cytotoxicity
-
Sensitization
-
Intracutaneous irritation testing
-
Material mediated pyrogenicity
-
Acute systemic toxicity testing
-
Genotoxicity testing Ames assay
-
Genotoxicity testing MLA
-
Muscle implantation 4-week study
- Muscle implantation 13-week study A
-
Toxicological Risk Assessment
-
- · Tensile performance specification update
- o Design verification testing was conducted on aged and unaged samples to demonstrate the dissolving tip to shaft bond design output continues to meet the defined design input requirements after sterilization.
· CONCLUSION
Based on the intended use, technological characteristics, and non-clinical performance data provided, the Percuflex™ Drainage Catheters and Stents are substantially equivalent to the predicate devices (K924608). The Directions for Use update with magnetic resonance compatibility 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.