(149 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a drainage catheter, with no mention of AI or ML capabilities.
No.
Therapeutic devices are generally defined as those that treat or cure a disease or medical condition. This device is explicitly described as a "drainage catheter" intended to "provide percutaneous drainage of abscess fluid and biliary collections" and "provide external and internal percutaneous drainage of the biliary system." While drainage can be part of a treatment regimen, the device itself is performing a mechanical function of fluid removal rather than actively treating or curing a disease at its source.
No
This device is a drainage catheter, intended for therapeutic purposes (draining fluid collections), not for diagnosis.
No
The device description clearly outlines physical components like catheters, tubes, hubs, and accessories, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide percutaneous drainage of abscess fluid and biliary collections. This is a therapeutic procedure, not a diagnostic test performed in vitro (outside the body) on specimens.
- Device Description: The device is a catheter designed for insertion into the body to drain fluids. This is a medical device used for treatment or management, not for analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (like blood, urine, tissue, etc.) to provide diagnostic information. The focus is on physically removing fluid from the body.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This drainage catheter does not fit that description.
N/A
Intended Use / Indications for Use
Expel™ Drainage Catheter APD Drainage Catheter, Expel™ Drainage Catheter with Twist-Loc™ Hub APDL Drainage Catheter, Expel™ Drainage Catheter with Twist-Loc™ Hub APDL Drainage Catheter Kit, Expel™ Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter : The drainage catheter is intended to provide percutaneous drainage of abscess fluid and biliary collections.
Expel™ Drainage Catheter with Twist-Loc™ Hub Biliary Drainage Catheter, Expel™ Drainage Catheter with Twist-Loc™ Hub Biliary Drainage Catheter Kit: The drainage catheter is intended to provide external and internal percutaneous drainage of the biliary system.
Product codes
FGE
Device Description
Expel™ drainage catheters are nonvascular intervention catheters that consist of a single lumen tube with drainage holes in the distal region and a proximal hub. The catheters are inserted using percutaneous access to provide internal and/or external drainage of fluid collections in body cavities. They can be long-term indwelling devices not to exceed 90 days in the body.
Expel™ APD™, APDL, and APD Large Capacity families differentiate the available French sizes, distal shape geometries, and hub types. These families contain the widest range of products with catheter outer diameters ranging from 6 to 26 French, and working lengths ranging from 15 to 45 cm. The distal ends of the catheters contain drainage holes, an adjacent radiopaque marker band, and a tapered tip. The catheter shafts have graduation markings with numeric values and a hydrophilic coating distally. Expel™ APDL family has a distal locking pigtail and a proximal Twist-Loc™ hub. Expel™ APD™ and APD Large Capacity families have a distal J-tip geometry and a proximal non-locking hub.
Expel™ Biliary drainage catheters are available in outer diameters of 8 to 14 French and lengths ranging from 20 to 40 cm. The distal end of the catheter contains drainage holes within a locking pigtail, an adjacent radiopaque marker band, and a tapered tip. The catheter shaft has additional drainage holes, graduation markings and numeric values, and a hydrophilic coating distally. The distal locking pigtail is activated by the proximal Twist-Loc™ hub.
The Expel™ drainage catheters come with a variety of accessories that aid in percutaneous access, device placement, device securement, and drainage fluid management. Accessories include:
- Cannulas
- Trocars
- Connecting Tubes
- Plugs / Caps
- Pigtail Straightener
- Facial Dilators
- Guidewires
- Dressing
- Catheter Cuff
- Introducers / Needles
- Cable Ties
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biliary system, abscess fluid and biliary collections (body cavities)
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)
The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Expel™ drainage catheter families, including packaging, met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
Bench testing included:
- Catheter OD
- Catheter Shaft Tensile Strength
- RO Marker Band Tensile Strength
- Hub to Shaft Tensile Strength
- Tip Tensile Strength
- Distal Tip Robustness
- Pigtail Retention (Curl Strength) / Removal Force
- Resistance to Deformation
- Kink Resistance
- Flow Recovery Post Kinking
- Resistance to Liquid Leakage
- Alcohol Compatibility
- MRI Compatibility
- Urine and Bile Compatibility
- Accessory to Catheter Connection Force
- Cannula to Catheter Compatibility
- Guidewire to Catheter/ Accessory Compatibility
- Large Capacity Catheter to Large Capacity Connecting Tube Compatibility
- Flexible Stiffening Cannula/Dilator Hub to Shaft Tensile Strength
- Large Capacity Stiffening Dilator ID to Metal Stiffening Cannula OD Compatibility
- Large Capacity Connecting Tube Hub to Shaft Tensile Strength
- Sterile Barrier Integrity
- Pouch Seal Strength
- Thermoformed Tray Visual
- Packaging Card Visual
- Shelf Life
- Sterilization
- Biocompatibility
- Coefficient of Friction
- Radiopacitv
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
Not Found
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three intertwined figures representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
Boston Scientific Corp Matt Beauchane Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566
Re: K141335 Trade/Device Name: Expel™ APD Drainage Catheter System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: FGE Dated: October 9, 2014 Received: October 10, 2014
Dear Matt Beauchane,
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P.
Lerner -S
for Benjamin Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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Type of Use (Select one or both, as applicable,
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510(k) Number (if known
K141335
The belines is intended to revise perculancous draines of absess fruid and biliary collections.
Indications for Use (Describe)
Device Name
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inte section and to requirements of the Pagerwork Reduction Act 1885.
ndications for Use
Food and Drug Administration
" ກອປການປະຊາທິປະຕິທິນ ປະເທດ ແລະ ຄຣນອໄຊຣາ່ນ ນຳ ຂຣອງພາ ແດງຜູ້ສາມາດງາມ
Department of Health and Human Services
Paperwork Reduction Act (PRA) Staff
Food and Drug Administration
Office of Chief Information Officer
PRASStaff@fda.hhs.gov
FOR FDA USE ONLY
(2) Over The-Counter Use (2) OFF The Counter C)
Form Approved: OMB. 0000-0120
interior Dete: January 31, 2017
| e PRA Statesment below. | ||
|---|---|---|
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known)
K141335 | |
| Device Name | Expel™ Drainage Catheter with Twist-Loc™ Hub Biliary Drainage Catheter
Expel™ Drainage Catheter with Twist-Loc™ Hub Biliary Drainage Catheter Kit |
| Indications for Use (Describe) | The drainage catheter is intended to provide external and internal percutaneous drainage of the biliary system. |
| Type of Use (Select one or both, as applicable) | |
| | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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:
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"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."
| FORM FDA 3881 (1/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740
EF |
| ---------------------- | ------------- | ---------------------------------------------- |
|---|
4
510(k) Summary
Per 21 CFR §807.92
Per 21 CFR §807.92
| Submitter's Name
and Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311
USA | Predicate Devices | Flexima™ APD™ All Purpose Drainage Catheter Set
(K944290, 08-Dec-1994) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and Information | Matt Beauchane
Regulatory Affairs Specialist
Phone: 763-494-1789
Fax: 763-494-2222
Email: matt.beauchane@bsci.com | | Flexima™ Biliary Drainage Catheter with RO Marker
(K023870, 20-Dec-2002) |
| Date Prepared | 03-Sep-2014 | Intended Use /
Indications for
Use | Expel™ Drainage Catheter APD Drainage Catheter,
Expel™ Drainage Catheter with Twist-Loc™ Hub APDL
Drainage Catheter,
Expel™ Drainage Catheter with Twist-Loc™ Hub APDL
Drainage Catheter Kit,
Expel™ Large Capacity Drainage Catheter APD Large
Capacity Drainage Catheter :
The drainage catheter is intended to provide percutaneous
drainage of abscess fluid and biliary collections. |
| Proprietary
Names | Single Product Configurations
Expel™ Drainage Catheter APD Drainage Catheter
Expel™ Drainage Catheter with Twist-Loc™ Hub APDL
Drainage Catheter
Expel™ Large Capacity Drainage Catheter APD Large
Capacity Drainage Catheter
Expel™ Drainage Catheter with Twist-Loc™ Hub Biliary
Drainage Catheter
Kit Configurations
Expel™ Drainage Catheter with Twist-Loc™ Hub APDL
Drainage Catheter Kit
Expel™ Drainage Catheter with Twist-Loc™ Hub Biliary
Drainage Catheter Kit | | Expel™ Drainage Catheter with Twist-Loc™ Hub
Biliary Drainage Catheter,
Expel™ Drainage Catheter with Twist-Loc™ Hub
Biliary Drainage Catheter Kit:
The drainage catheter is intended to provide external and
internal percutaneous drainage of the biliary system. |
| Common Name | Diagnostic Biliary Catheter | Device
Description | Expel™ drainage catheters are nonvascular intervention
catheters that consist of a single lumen tube with drainage
holes in the distal region and a proximal hub. The
catheters are inserted using percutaneous access to
provide internal and/or external drainage of fluid collections
in body cavities. They can be long-term indwelling devices
not to exceed 90 days in the body. |
| Classification | Classification: Class II
Regulation: 21 CFR 876.5010
Product Code: FGE
Classification Panel: Gastroenterology/Urology | | Expel™ APD™, APDL, and APD Large Capacity families
differentiate the available French sizes, distal shape
geometries, and hub types. These families contain the
widest range of products with catheter outer diameters
ranging from 6 to 26 French, and working lengths ranging
from 15 to 45 cm. The distal ends of the catheters contain
drainage holes, an adjacent radiopaque marker band, and
a tapered tip. The catheter shafts have graduation
markings with numeric values and a hydrophilic coating
distally. Expel™ APDL family has a distal locking pigtail
and a proximal Twist-Loc™ hub. Expel™ APD™ and APD |
5
6
| Device | Large Capacity families have a distal J-tip geometry and a |
|---|---|
| Description, cont. | proximal non-locking hub. |
Expel™ Biliary drainage catheters are available in outer diameters of 8 to 14 French and lengths ranging from 20 to 40 cm. The distal end of the catheter contains drainage holes within a locking pigtail, an adjacent radiopaque marker band, and a tapered tip. The catheter shaft has additional drainage holes, graduation markings and numeric values, and a hydrophilic coating distally. The distal locking pigtail is activated by the proximal Twist-Loc™ hub.
The Expel™ drainage catheters come with a variety of accessories that aid in percutaneous access, device placement, device securement, and drainage fluid management. Accessories include:
- Cannulas .
- Trocars .
- . Connecting Tubes
- Plugs / Caps ●
- Pigtail Straightener ●
- Facial Dilators ●
- Guidewires ●
- Dressing .
- Catheter Cuff ●
- Introducers / Needles ●
- Cable Ties
Comparison of Technological Characteristics
The Expel™ drainage catheter families are similar in fundamental design, function, device materials, sterilization, operating principle, intended use / indication for use and fundamental technology as the predicate devices, Flexima™ APD™ All Purpose Drainage Catheter Set and Flexima™ Biliary Drainage Catheter with RO Marker. The modifications from the predicate devices include:
- Modified hub designs .
- New catheter shaft material ●
- Addition of length graduation markings and radiopaque ● (RO) marker bands
- Extended sizes/platforms ●
- Modified packaging ●
Performance Data The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Expel™ drainage catheter families, including packaging, met the predetermined acceptance criteria
7
ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
- Catheter OD
- · Catheter Shaft Tensile Strength
- · RO Marker Band Tensile Strength
- Hub to Shaft Tensile Strength
- Tip Tensile Strength
- Distal Tip Robustness
- · Pigtail Retention (Curl Strength) / Removal Force
- · Resistance to Deformation
- · Kink Resistance
- Flow Recovery Post Kinking
- · Resistance to Liquid Leakage
- Alcohol Compatibility
- · MRI Compatibility
- · Urine and Bile Compatibility
- Accessory to Catheter
- Connection Force • Cannula to Catheter
- Compatibility
- · Guidewire to Catheter/ Accessory Compatibility
- · Large Capacity Catheter to Large Capacity Connecting Tube Compatibility
- · Flexible Stiffening Cannula/Dilator Hub to Shaft Tensile Strength
- · Large Capacity Stiffening Dilator ID to Metal Stiffening Cannula OD Compatibility
- · Large Capacity Connecting Tube Hub to Shaft Tensile Strength
- · Sterile Barrier Integrity
- · Pouch Seal Strength
- Thermoformed Tray Visual
- Packaging Card Visual
- · Shelf Life
- · Sterilization
- · Biocompatibility
- · Coefficient of Friction
- · Radiopacitv
Conclusion Boston Scientific has demonstrated that the modifications made for the Expel™ drainage catheter families are substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use / indication for use as the predicate devices, Flexima™ APD™ All Purpose Drainage Catheter Set and Flexima™ Biliary Drainage Catheter with RO Marker.