EXPEL APD DRAINAGE CATHETER SYSTEM by BOSTON SCIENTIFIC CORP.

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

AI/ML Overview

This document is a 510(k) summary for the Expel™ APD Drainage Catheter System. It describes the device, its intended use, and its equivalence to predicate devices, supported by performance data from bench testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The Expel™ drainage catheter families, including packaging, met the predetermined acceptance criteria." However, specific numerical acceptance criteria values are not provided in the text. The table below lists the performance characteristics tested, but the actual pass/fail criteria and the quantitative reported performance are not detailed.

Acceptance Criteria Category	Reported Device Performance
Catheter OD	Met acceptance criteria
Catheter Shaft Tensile Strength	Met acceptance criteria
RO Marker Band Tensile Strength	Met acceptance criteria
Hub to Shaft Tensile Strength	Met acceptance criteria
Tip Tensile Strength	Met acceptance criteria
Distal Tip Robustness	Met acceptance criteria
Pigtail Retention (Curl Strength) / Removal Force	Met acceptance criteria
Resistance to Deformation	Met acceptance criteria
Kink Resistance	Met acceptance criteria
Flow Recovery Post Kinking	Met acceptance criteria
Resistance to Liquid Leakage	Met acceptance criteria
Alcohol Compatibility	Met acceptance criteria
MRI Compatibility	Met acceptance criteria
Urine and Bile Compatibility	Met acceptance criteria
Accessory to Catheter Connection Force	Met acceptance criteria
Cannula to Catheter Compatibility	Met acceptance criteria
Guidewire to Catheter/ Accessory Compatibility	Met acceptance criteria
Large Capacity Catheter to Large Capacity Connecting Tube Compatibility	Met acceptance criteria
Flexible Stiffening Cannula/Dilator Hub to Shaft Tensile Strength	Met acceptance criteria
Large Capacity Stiffening Dilator ID to Metal Stiffening Cannula OD Compatibility	Met acceptance criteria
Large Capacity Connecting Tube Hub to Shaft Tensile Strength	Met acceptance criteria
Sterile Barrier Integrity	Met acceptance criteria
Pouch Seal Strength	Met acceptance criteria
Thermoformed Tray Visual	Met acceptance criteria
Packaging Card Visual	Met acceptance criteria
Shelf Life	Met acceptance criteria
Sterilization	Met acceptance criteria
Biocompatibility	Met acceptance criteria
Coefficient of Friction	Met acceptance criteria
Radiopacity	Met acceptance criteria

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for each of the bench tests. It also does not provide any information regarding the country of origin of the data or whether it was retrospective or prospective, as this was likely a series of internal engineering bench tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The study involved bench testing of physical device properties, not clinical data requiring expert review for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving reader interpretations of data, not for bench testing of physical device characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance

No such study was conducted. This document describes the 510(k) clearance for a physical medical device (drainage catheter system), not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable, as the device is not an algorithm or software. It is a physical medical device.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" was established by engineering specifications and industry standards for device performance. Each test would have a defined acceptable range or passing condition that the device needed to meet. For example, a "Catheter Shaft Tensile Strength" test would have a minimum force required before breakage, which would be the ground truth for that specific test.

8. The Sample Size for the Training Set

This is not applicable. As this document describes the 510(k) for a physical medical device and its bench testing, there is no concept of a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for this type of device submission.

Summary

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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

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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

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CType of Use (Select one or both, as applicable,Large Capacity Drainage Catherer1.00% Dainer Catheter, AP Drime Cather with Twitter with Twitter with Twitter Prints of Straining CatedExpelly Mainteer with Twist-Loom Hild ADC Distinctit, This Preyer Mire Capsity Drisines Capsity Drimas Cathers APD510(k) Number (if knownK141335The belines is intended to revise perculancous draines of absess fruid and biliary collections.Indications for Use (Describe)Device Nameəsindən bir bəhri olan məhrəm bura nəqlər sənədlər məşğul və mərkəzi və mələn və mil: http://www.bandises.org.com/publish/subsitions/superiors in toən bulbuları şərədən vəq sının bir əğgəndə olan mərkəzi və qalınmışdır. Bu mürəlir. Bu və bir nə bir nə bir və bir və bir və bir və bir və bir və bir və bir və bir və bir vəA F F S A F S A S T A R A S UNIT N C COMITINC C - BALL SINT WO J B A F A F A F A F A F A F A F A F A F A F A F A F A F A F A F F F F F F( The quart Use And 21 CFR 21 CFR 800 Support Dof to a set buodses of baniupes for an norsed on to roubuo tour sem you you considerA WOJER SEE AЭЭРИЯЭГ ИАМИН ОНА НТТАЭН ТО ТИЭМ SERVICESinte section and to requirements of the Pagerwork Reduction Act 1885.ndications for UseFood and Drug Administration" ກອປການປະຊາທິປະຕິທິນ ປະເທດ ແລະ ຄຣນອໄຊຣາ່ນ ນຳ ຂຣອງພາ ແດງຜູ້ສາມາດງາມDepartment of Health and Human ServicesPaperwork Reduction Act (PRA) StaffFood and Drug AdministrationOffice of Chief Information OfficerPRASStaff@fda.hhs.govFOR FDA USE ONLY(2) Over The-Counter Use (2) OFF The Counter C)Form Approved: OMB. 0000-0120interior Dete: January 31, 2017e PRA Statesment below.

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)K141335
Device Name	Expel™ Drainage Catheter with Twist-Loc™ Hub Biliary Drainage CatheterExpel™ 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
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FORM FDA 3881 (1/14)	Page 1 of 1	PSC Publishing Services (301) 443-6740EF
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510(k) Summary

Per 21 CFR §807.92

Submitter's Nameand Address	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311USA	Predicate Devices	Flexima™ APD™ All Purpose Drainage Catheter Set(K944290, 08-Dec-1994)
Contact Nameand Information	Matt BeauchaneRegulatory Affairs SpecialistPhone: 763-494-1789Fax: 763-494-2222Email: matt.beauchane@bsci.com		Flexima™ Biliary Drainage Catheter with RO Marker(K023870, 20-Dec-2002)
Date Prepared	03-Sep-2014	Intended Use /Indications forUse	Expel™ Drainage Catheter APD Drainage Catheter,Expel™ Drainage Catheter with Twist-Loc™ Hub APDLDrainage Catheter,Expel™ Drainage Catheter with Twist-Loc™ Hub APDLDrainage Catheter Kit,Expel™ Large Capacity Drainage Catheter APD LargeCapacity Drainage Catheter :The drainage catheter is intended to provide percutaneousdrainage of abscess fluid and biliary collections.
ProprietaryNames	Single Product ConfigurationsExpel™ Drainage Catheter APD Drainage CatheterExpel™ Drainage Catheter with Twist-Loc™ Hub APDLDrainage CatheterExpel™ Large Capacity Drainage Catheter APD LargeCapacity Drainage CatheterExpel™ Drainage Catheter with Twist-Loc™ Hub BiliaryDrainage CatheterKit ConfigurationsExpel™ Drainage Catheter with Twist-Loc™ Hub APDLDrainage Catheter KitExpel™ Drainage Catheter with Twist-Loc™ Hub BiliaryDrainage Catheter Kit		Expel™ Drainage Catheter with Twist-Loc™ HubBiliary Drainage Catheter,Expel™ Drainage Catheter with Twist-Loc™ HubBiliary Drainage Catheter Kit:The drainage catheter is intended to provide external andinternal percutaneous drainage of the biliary system.
Common Name	Diagnostic Biliary Catheter	DeviceDescription	Expel™ drainage catheters are nonvascular interventioncatheters that consist of a single lumen tube with drainageholes in the distal region and a proximal hub. Thecatheters are inserted using percutaneous access toprovide internal and/or external drainage of fluid collectionsin body cavities. They can be long-term indwelling devicesnot to exceed 90 days in the body.
Classification	Classification: Class IIRegulation: 21 CFR 876.5010Product Code: FGEClassification Panel: Gastroenterology/Urology		Expel™ APD™, APDL, and APD Large Capacity familiesdifferentiate the available French sizes, distal shapegeometries, and hub types. These families contain thewidest range of products with catheter outer diametersranging from 6 to 26 French, and working lengths rangingfrom 15 to 45 cm. The distal ends of the catheters containdrainage holes, an adjacent radiopaque marker band, anda tapered tip. The catheter shafts have graduationmarkings with numeric values and a hydrophilic coatingdistally. Expel™ APDL family has a distal locking pigtailand a proximal Twist-Loc™ hub. Expel™ APD™ and APD

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Device	Large Capacity families have a distal J-tip geometry and a
Description, cont.	proximal non-locking 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

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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.

Regulation Number and Section

§ 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.