APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, 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 Cateter System, vanSonnenberg
Device Facts
| Record ID | K211934 |
|---|---|
| Device Name | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, 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 Cateter System, vanSonnenberg |
| Applicant | Boston Scientific Corporation |
| Product Code | FAD · Gastroenterology, Urology |
| Decision Date | Nov 10, 2022 |
| Decision | SESK |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4620 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
To provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collection. 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.
Device Story
Percutaneous drainage catheter system; provides constant, unobstructed fluid drainage from internal accumulations to external/internal collection sites. Input: radiological guidance for placement. Operation: catheter inserted percutaneously; secured via pigtail/J-style tip (internal) or suture/adhesive (external). Features: hydrophilic coating (Glidex) for friction reduction; optional biocompatible dissolving tip (Temp-Tip) to facilitate guidewire placement, then dissolves to maximize lumen diameter. Used in clinical settings by physicians. Output: fluid drainage. Benefits: stable, effective drainage of loculated fluid collections.
Clinical Evidence
Bench testing only. Performance testing included radio frequency heating (ASTM F2182), displacement force (ASTM F2052), and image artifact evaluation (ASTM F2119). Additional testing included simulated shipping, packaging integrity, accelerated/real-time aging, and bacterial endotoxin testing (AAMI ST72:2019).
Technological Characteristics
Materials: Flexima (Tecoflex polyurethane) or Percuflex (ELVAX 460 ethylene vinyl acetate copolymer). Radiopaque additives: bismuth subcarbonate or radiopacifier. Features: hydrophilic coating, optional dissolving tip. MR compatible. Sterilization: not specified. Form factor: drainage catheter with pigtail/J-tip.
Indications for Use
Indicated for percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, mediastinal collections, and intra-abdominal fluid collections (cysts, pseudocysts, bilomas, hematomas, seromas, urinomas).
Regulatory Classification
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.
Predicate Devices
- Hydrogel Coated Percuflex Drainage Catheters (K924608)
- Modified (Flexima) Hydrogel Coated Drainage Catheters (K944290)
Related Devices
- K251019 — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G · Bioteque Corporation · Dec 22, 2025
- K200103 — BIOTEQ Drainage Catheter Set (One Step Type) · Bioteque Corporation · Oct 9, 2020
- K210419 — BIOTEQ Drainage Catheter BT-PDS-series · Bioteque Corporation · Apr 13, 2022
- K093392 — MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS · Navilyst Medical, Inc. · Dec 31, 2009
- K152069 — Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter · Navilyst Medical, Inc. · Sep 24, 2015
Submission Summary (Full Text)
{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) | |
|--------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-size: 16px;">☑</span> 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) | |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
#### 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) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
#### 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) | |
|------------------------------------------------------------------------------------------------------|--------------------------------------------|
| <span style="text-decoration: underline;"><b>Prescription Use</b></span> (Part 21 CFR 801 Subpart D) | <div style="display:inline-block;">☒</div> |
| <span style="text-decoration: underline;"><b>Over-The-Counter Use</b></span> (21 CFR 801 Subpart C) | <div style="display:inline-block;">☐</div> |
#### 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) |
|-------------------------------------------------|
|-------------------------------------------------|
| <span style="text-decoration: underline;">X</span> 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<br>Usual name | Regulation<br>Number | Regulation<br>Name | Product Code | Product Code<br>Name | Regulatory<br>Class |
|-------------------------|-------------------------|---------------------------------------------------------|--------------|-------------------------------|---------------------|
| Drainage<br>Catheter | 21 CFR Part<br>876.5090 | Suprapubic<br>urological<br>catheter and<br>accessories | FFA | Tube, Drainage,<br>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<br>Flexima™ APDL Drainage Catheter System Kit<br>Flexima™ APDL Drainage Catheter System Kit with Dissolving Tip<br>Flexima™ APDL Drainage Catheter System with Dissolving Tip<br>Flexima™ APD™ Drainage Catheter System<br>Flexima™ APD™ Drainage Catheter System Kit<br>Flexima™ APD™ Drainage Catheter System with Dissolving Tip<br>Flexima™ APD™ Drainage Catheter System Kit with Dissolving Tip<br>Flexima™ QuickStick™ Drainage Catheter System<br>vanSonnenberg™ Drainage Catheter System | To provide percutaneous<br>drainage of abscess fluid,<br>biliary, nephrostomy, urinary,<br>pleural empyemas, lung<br>abscesses, and mediastinal<br>collection. |
| vanSonnenberg Sump Catheter System<br>vanSonnenberg Sump Catheter System Kit | For use as a percutaneously<br>placed drain for intra-<br>abdominal fluid collections.<br>Such conditions include<br>abscesses, cysts,<br>pseudocysts, bilomas,<br>hematomas, seromas,<br>urinomas, or any loculated<br>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<br>Near Passive Implants During Magnetic Resonance<br>Imaging | ASTM F2182 | -11a |
| Measurement of Magnetically Induced Displacement<br>Force on Medical Devices in the Magnetic Resonance<br>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.
