(506 days)
No
The document describes a physical medical device (drainage catheter) and its materials, intended use, and performance testing. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The guidance mentioned is radiological, which refers to imaging techniques used by a human operator for placement.
No
The device is a drainage catheter used to remove fluid collections from the body, which is a therapeutic function. However, the term "therapeutic device" in a medical context typically refers to devices that treat diseases or conditions directly through physical, chemical, or biological means, often implying a more active treatment than simple drainage. While drainage is a form of treatment, this device primarily facilitates the removal of unwanted substances rather than actively treating a disease or condition itself.
No
The device is a drainage catheter used for therapeutic purposes (draining fluid collections), not for diagnosing conditions.
No
The device description clearly details a physical catheter made of materials like polyurethane and EVA, designed for percutaneous drainage. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The description clearly states that this device is a drainage catheter used for the percutaneous drainage of fluid collections within the body. It is a tool for removing fluid directly from the patient.
- Intended Use: The intended use is to drain fluid from various anatomical sites, not to analyze samples of those fluids for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics of the catheter, its materials, and how it facilitates drainage. There is no mention of any components or processes related to analyzing biological samples.
The device is a therapeutic and interventional device used in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collection.
The vanSonnenberg™ Sump Catheter is designed for use as a percutaneously placed drain for intra-abdominal fluid collections. Such conditions include abscesses, cysts, pseudocysts, bilomas, seromas, urinomas, or any loculated fluid collection.
Product codes
FFA
Device Description
All Purpose Drainage catheters are designed to provide constant, unobstructed fluid drainage from various fluid accumulations to an external and/or internal collection sites and to ensure stability during treatment. These ends are met through the choice of drainage material and by incorporating a secure fixation method in the drainage site (internally by pig-tail or "J" style tips and externally, by means of suture or adhesive). Percutaneous placement is accomplished with radiological guidance.
The following All Purpose Drainage catheters are in scope of this submission:
-. APDL Drainage Catheter System
-. Flexima™ APDL Drainage Catheter System Kit
-. Flexima™ APDL Drainage Catheter System Kit with Dissolving Tip
-. Flexima™ APDL Drainage Catheter System with Dissolving Tip
- Flexima™ APD™ Drainage Catheter System .
- Flexima™ APD™ Drainage Catheter System Kit .
-. Flexima™ APD™ Drainage Catheter System with Dissolving Tip
-. Flexima™ APD™ Drainage Catheter System Kit with Dissolving Tip
-. Flexima™ QuickStick™ Drainage Catheter System
-. vanSonnenberg™ Drainage Catheter System - vanSonnenberg™ Sump Catheter System Kit .
-. vanSonnenberg™ Sump Catheter System
Select Boston Scientific All Purpose Drainage catheters are coated with a hydrophilic material, Glidex™ , for the reduction of surface friction during placement.
Some of these catheters are also available with a biocompatible, distal tip (Temp-Tip™). The tip's internal diameter allows the guidewire to direct the tip for accurate catheter placement; however, soon after placement, the Temp-Tip™ material dissolves, allowing the full diameter of the catheter lumen to contribute to site drainage.
All Purpose Drainage catheters are manufactured with one of two types of resins, Flexima or Percuflex.
- Flexima is a biocompatible polyurethane (Tecoflex) known for its flexibility, strength, and . kink resistance. Flexima comes in durometers ranging in Firm, Regular and Soft and uses a radiopacifier for visualization under fluoroscopy.
-. Percuflex is an ELVAX™ 460, ethylene vinyl acetate (EVA) copolymer for patient comfort. This material is available in firm (white in color) and regular (blue in color) durometers. The firmer durometers provide more pushability during device placement. A radiopaque additive, bismuth subcarbonate, incorporated throughout the catheter tube also aids radiopacity and percutaneous placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
fluoroscopy
Anatomical Site
intra-abdominal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Compatibility information to the Directions for Use. Tests included: Radio Frequency Heating, Force Measurement, and Image Artifact.
Additional tests were performed to support substantial equivalence to predicate devices: Simulated climatic conditioning and distribution followed by packaging integrity testing, Accelerated and real time aging followed by packaging integrity testing, Performance testing after aging, shipping and distribution in scope of K924608 and K944290, and BET assessment as recommended in AAMI ST72:2019, Bacterial endotoxins Test methods, routine monitoring, and alternatives to batch testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 for 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.
November 10, 2022
Boston Scientific Corporation Liz Johnston Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K211934
Trade/Device Name: APDL Drainage Catheter System, Flexima™ APDL Drainage Catheter System Kit, Flexima™ APDL Drainage Catheter System Kit with Dissolving Tip, Flexima™ APDL Drainage Catheter System with Dissolving Tip, Flexima™ QuickStickTM Drainage Catheter System, vanSonnenberg™ Sump Catheter System Kit, vanSonnenberg™ Sump Catheter System, vanSonnenberg™ Drainage Catheter System, Flexima™ APD™ Drainage Catheter System, Flexima™ APDTM Drainage Catheter System Kit, Flexima™ APD™ Drainage Catheter System with Dissolving Tip, Flexima™ APD™ Drainage Catheter System Kit with Dissolving Tip
Regulation Number: 21 CFR§ 876.5090 Regulation Name: Suprapubic urological catheter and accessories Regulatory Class: II Product Code: FFA Dated: October 13, 2022 Received: October 14, 2022
Dear Liz Johnston:
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 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
1
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). 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 -S
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
510(k) Number (if known) K211934
Device Name
APDL Drainage Catheter System, Flexima™ APDL Drainage Catheter System Kit, Flexima™ APDL Drainage Catheter System Kit with Dissolving Tip, Flexima™ APDL Drainage Catheter System with Dissolving Tip
Indications for Use (Describe)
To provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collection.
| 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) |
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
3
510(k) Number (if known) K211934
Device Name
Flexima™ QuickStick™ Drainage Catheter System
Indications for Use (Describe)
To provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collection.
| 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) |
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
4
510(k) Number (if known) K211934
Device Name
vanSonnenberg™ Sump Catheter System Kit, vanSonnenberg™ Sump Catheter System
Indications for Use (Describe)
The vanSonnenberg™ Sump Catheter is designed for use as a percutaneously placed drain for intra-abdominal fluid collections. Such conditions include abscesses, cysts, pseudocysts, bilomas, seromas, urinomas, or any loculated fluid collection.
| 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) |
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
5
510(k) Number (if known) K211934
Device Name
vanSonnenberg™ Drainage Catheter System
Indications for Use (Describe)
To provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collection.
| 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) | ☐ |
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
6
510(k) Number (if known) K211934
Device Name
Flexima™ APD™ Drainage Catheter System, Flexima™ APD™ Drainage Catheter System Kit, Flexima™ APD™ Drainage Catheter System with Dissolving Tip, Flexima™ APD™ Drainage Catheter System Kit with Dissolving Tip
Indications for Use (Describe)
To provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, and mediastinal collection.
| 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
7
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: 763-494-1676 Fax: 763-494-2222 e-mail: liz.johnston@bsci.com
Contact person name: Liz Johnston Date Prepared: November 10, 2022
II. DEVICE INFORMATION
Tables 1 to 4 below summarize the relevant subject device information.
| UPN | Product Description |
|---|---|
| M001271240 | Flexima™ APDL Drainage Catheter System |
| M001271310 | Flexima™ APDL Drainage Catheter System |
| M001271320 | Flexima™ APDL Drainage Catheter System |
| M001275080 | Flexima™ APDL Drainage Catheter System with Dissolving Tip |
| M001271330 | Flexima™ APDL Drainage Catheter System |
| M001271340 | Flexima™ APDL Drainage Catheter System |
| M001271350 | Flexima™ APDL Drainage Catheter System |
| M001271380 | Flexima™ APDL Drainage Catheter System |
| M001271390 | Flexima™ APDL Drainage Catheter System |
| M001271960 | Flexima™ APDL Drainage Catheter System Kit |
| M001271970 | Flexima™ APDL Drainage Catheter System Kit |
| M001271980 | Flexima™ APDL Drainage Catheter System Kit |
| M001271990 | Flexima™ APDL Drainage Catheter System Kit |
| M001275010 | Flexima™ APDL Drainage Catheter System |
| M001275030 | Flexima™ APDL Drainage Catheter System Kit |
| M001275090 | Flexima™ APDL Drainage Catheter System Kit with Dissolving Tip |
| M001281340 | Flexima™ APDL Drainage Catheter System with Dissolving Tip |
| M001281350 | Flexima™ APDL Drainage Catheter System with Dissolving Tip |
| M001281380 | Flexima™ APDL Drainage Catheter System with Dissolving Tip |
| M001281390 | Flexima™ APDL Drainage Catheter System with Dissolving Tip |
| M001245061 | APDL Drainage Catheter System |
| M001245071 | APDL Drainage Catheter System |
| M001245081 | APDL Drainage Catheter System |
| M001245060 | APDL Drainage Catheter System |
| M001245070 | APDL Drainage Catheter System |
Table 1: APDL Drainage Catheters
8
Table 2: APD Drainage Catheters
| UPN | Product Description |
|---|---|
| M001271250 | Flexima™ APDTM™ Drainage Catheter System |
| M001271260 | Flexima™ APDTM™ Drainage Catheter System |
| M001271270 | Flexima™ APDTM™ Drainage Catheter System |
| M001275060 | Flexima™ APDTM™ Drainage Catheter System with Dissolving Tip |
| M001271280 | Flexima™ APDTM™ Drainage Catheter System |
| M001271290 | Flexima™ APDTM™ Drainage Catheter System |
| M001271300 | Flexima™ APDTM™ Drainage Catheter System |
| M001271360 | Flexima™ APD™ Drainage Catheter System |
| M001271370 | Flexima™ APD™ Drainage Catheter System |
| M001275070 | Flexima™ APDTM™ Drainage Catheter System Kit with Dissolving Tip |
| M001281290 | Flexima™ APDTM™ Drainage Catheter System with Dissolving Tip |
| M001281300 | Flexima™ APDTM™ Drainage Catheter System with Dissolving Tip |
| M001281360 | Flexima™ APDTM™ Drainage Catheter System with Dissolving Tip |
| M001281370 | Flexima™ APDTM™ Drainage Catheter System with Dissolving Tip |
Table 3: Flexima Quickstick Drainage Catheters
| UPN | Product Description |
|---|---|
| M001271460 | FleximaTM QuickStickTM Drainage Catheter System |
| M001271470 | FleximaTM QuickStickTM Drainage Catheter System |
Table4: vanSonnenberg Drainage Catheters
| UPN | Product Description |
|---|---|
| M001245130 | vanSonnenberg™ Drainage Catheter System |
| M001245140 | vanSonnenberg™ Drainage Catheter System |
| UPN | Product Description |
|---|---|
| M001201000 | vanSonnenberg™ Sump Catheter System Kit |
| M001201050 | vanSonnenberg™ Sump Catheter System Kit |
| M001201060 | vanSonnenberg™ Sump Catheter System Kit |
| M001203000 | vanSonnenberg™ Sump Catheter System |
| M001203010 | vanSonnenberg™ Sump Catheter System |
| M001203020 | vanSonnenberg™ Sump Catheter System |
| M001203030 | vanSonnenberg™ Sump Catheter System |
| M001203070 | vanSonnenberg™ Sump Catheter System |
| M001213060 | vanSonnenberg™ Sump Catheter System with Dissolving Tip |
| M001213070 | vanSonnenberg™ Sump Catheter System with Dissolving Tip |
| M001273000 | vanSonnenberg™ Sump Catheter System |
| M001273010 | vanSonnenberg™ Sump Catheter System |
| M001273030 | vanSonnenberg™ Sump Catheter System |
| M001273040 | vanSonnenberg™ Sump Catheter System |
| M001273060 | vanSonnenberg™ Sump Catheter System Kit |
| M001273070 | vanSonnenberg™ Sump Catheter System Kit |
| M001273090 | vanSonnenberg™ Sump Catheter System Kit |
| M001273100 | vanSonnenberg™ Sump Catheter System Kit |
| M001273130 | vanSonnenberg™ Sump Catheter System |
| M001273180 | vanSonnenberg™ Sump Catheter System Kit |
| M001273190 | vanSonnenberg™ Sump Catheter System Kit |
| M001273210 | vanSonnenberg™ Sump Catheter System Kit |
9
| Common or
Usual name | Regulation
Number | Regulation
Name | Product Code | Product Code
Name | Regulatory
Class |
|-------------------------|-------------------------|---------------------------------------------------------|--------------|-------------------------------|---------------------|
| Drainage
Catheter | 21 CFR Part
876.5090 | Suprapubic
urological
catheter and
accessories | FFA | Tube, Drainage,
Suprapubic | II |
5: Additional Device Information
III. PREDICATE DEVICE IDENTIFICATION
Name of Predicate Device
K924608 Hydrogel Coated Percuflex Drainage Catheters K944290 Modified (Flexima) Hydrogel Coated Drainage Catheters
For devices that are manufactured with Flexima resin (Tecoflex), K944290 is the predicate. For devices that are manufactured from Percuflex resin. K924608 is the appropriate predicate.
These devices are Class II 21 CFR Part 876.4620, FAD (K924608), and Part 876.5090, FFA (K944290) with subsequent product codes of FAD, FGE, LJE. Predicate devices referenced above have not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
All Purpose Drainage catheters are designed to provide constant, unobstructed fluid drainage from various fluid accumulations to an external and/or internal collection sites and to ensure stability during treatment. These ends are met through the choice of drainage material and by incorporating a secure fixation method in the drainage site (internally by pig-tail or "J" style tips and externally, by means of suture or adhesive). Percutaneous placement is accomplished with radiological guidance.
The following All Purpose Drainage catheters are in scope of this submission:
- . APDL Drainage Catheter System
- . Flexima™ APDL Drainage Catheter System Kit
- . Flexima™ APDL Drainage Catheter System Kit with Dissolving Tip
- . Flexima™ APDL Drainage Catheter System with Dissolving Tip
- Flexima™ APD™ Drainage Catheter System .
- Flexima™ APD™ Drainage Catheter System Kit .
- . Flexima™ APD™ Drainage Catheter System with Dissolving Tip
- . Flexima™ APD™ Drainage Catheter System Kit with Dissolving Tip
- . Flexima™ QuickStick™ Drainage Catheter System
- . vanSonnenberg™ Drainage Catheter System
- vanSonnenberg™ Sump Catheter System Kit .
- . vanSonnenberg™ Sump Catheter System
Select Boston Scientific All Purpose Drainage catheters are coated with a hydrophilic material, Glidex™ , for the reduction of surface friction during placement.
Some of these catheters are also available with a biocompatible, distal tip (Temp-Tip™). The tip's internal diameter allows the guidewire to direct the tip for accurate catheter placement; however, soon after placement, the Temp-Tip™ material dissolves, allowing the full diameter of the catheter lumen to contribute to site drainage.
10
All Purpose Drainage catheters are manufactured with one of two types of resins, Flexima or Percuflex.
- Flexima is a biocompatible polyurethane (Tecoflex) known for its flexibility, strength, and . kink resistance. Flexima comes in durometers ranging in Firm, Regular and Soft and uses a radiopacifier for visualization under fluoroscopy.
- . Percuflex is an ELVAX™ 460, ethylene vinyl acetate (EVA) copolymer for patient comfort. This material is available in firm (white in color) and regular (blue in color) durometers. The firmer durometers provide more pushability during device placement. A radiopaque additive, bismuth subcarbonate, incorporated throughout the catheter tube also aids radiopacity and percutaneous placement.
Intended Use/Indications for Use: to provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collection.
V. INDICATIONS FOR USE
Predicate and subject device Intended use and Indications for Use are the same.
| Drainage Device | Indications for Use |
|---|---|
| APDL Drainage Catheter System | |
| Flexima™ APDL Drainage Catheter System Kit | |
| Flexima™ APDL Drainage Catheter System Kit with Dissolving Tip | |
| Flexima™ APDL Drainage Catheter System with Dissolving Tip | |
| Flexima™ APD™ Drainage Catheter System | |
| Flexima™ APD™ Drainage Catheter System Kit | |
| Flexima™ APD™ Drainage Catheter System with Dissolving Tip | |
| Flexima™ APD™ Drainage Catheter System Kit with Dissolving Tip | |
| Flexima™ QuickStick™ Drainage Catheter System | |
| vanSonnenberg™ Drainage Catheter System | To provide percutaneous |
| drainage of abscess fluid, | |
| biliary, nephrostomy, urinary, | |
| pleural empyemas, lung | |
| abscesses, and mediastinal | |
| collection. | |
| vanSonnenberg Sump Catheter System | |
| vanSonnenberg Sump Catheter System Kit | For use as a percutaneously |
| placed drain for intra- | |
| abdominal fluid collections. | |
| Such conditions include | |
| abscesses, cysts, | |
| pseudocysts, bilomas, | |
| hematomas, seromas, | |
| urinomas, or any loculated | |
| fluid collection. |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The All Purpose Drainage Catheters 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, K944290). The difference from the legally marketed predicate device is the addition of Magnetic Resonance (MR) compatibility information to the Directions for Use.
In addition, cumulative changes were implemented since the time the predicate (K924608 and K944290) 510(k)s were cleared such as a coating surfactant change, supplier color additive compound change, and resin additive supplier change.
11
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 nonclinical performance testing was performed:
- Radio Frequency Heating
- . Force Measurement
- Image Artifact
FDA quidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," issued May 20, 2021, and the following standards were used to guide the generation of the non-clinical 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 |
In addition, the following tests were performed to support substantial equivalence to the predicate devices:
- Simulated climatic conditioning and distribution followed by packaging integrity testing ●
- Accelerated and real time aging followed by packaging integrity testing .
- Performance testing after aging, shipping and distribution in scope of K924608 and ● K944290
- BET assessment as recommended in AAMI ST72:2019, Bacterial endotoxins Test methods, . routine monitoring, and alternatives to batch testing
Cumulative changes made to the devices since the clearance of the predicate (K924608 and K944290) were supported by leveraging prior testing and providing justification to support the changes.
VIII. CONCLUSION
Based on the intended use, technological characteristics, and non-clinical performance data and justifications provided, the All Purpose Drainage Catheters are substantially equivalent to the predicate devices (K924608, K944290). The Directions for Use update with magnetic resonance compatibility information for the subject devices and cumulative changes made to the device do not raise new questions of safety or effectiveness, and the subject devices are as safe and effective as the predicate devices.