EXPEL APD DRAINAGE CATHETER SYSTEM

K141335 · Boston Scientific Corp · FGE · Oct 17, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K141335
• Device Name: EXPEL APD DRAINAGE CATHETER SYSTEM
• Applicant: Boston Scientific Corp
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Oct 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The drainage catheter is intended to provide percutaneous drainage of abscess fluid and biliary collections. The drainage catheter is intended to provide external and internal percutaneous drainage of the biliary system.

Device Story

Expel™ drainage catheters are nonvascular, single-lumen catheters with distal drainage holes and proximal hubs; used for percutaneous drainage of fluid collections in body cavities. Catheters are inserted by physicians using percutaneous access; indwelling for up to 90 days. Distal ends feature radiopaque marker bands and tapered tips; shafts have graduation markings and hydrophilic coatings. APDL models include a distal locking pigtail activated by a proximal Twist-Loc™ hub; APD/Large Capacity models feature distal J-tip geometry and non-locking hubs. Accessories include cannulas, trocars, dilators, guidewires, and connecting tubes to assist placement and fluid management. Output is the drainage of fluid, which aids in managing abscesses or biliary obstructions. Benefits include minimally invasive fluid removal.

Clinical Evidence

Bench testing only. Testing included catheter tensile strength, tip robustness, pigtail retention, resistance to deformation/kinking, flow recovery, leakage resistance, chemical/MRI compatibility, accessory compatibility, sterile barrier integrity, shelf life, sterilization, and biocompatibility.

Technological Characteristics

Nonvascular, single-lumen catheter; 6-26 French OD; 15-45 cm length. Materials include hydrophilic coating, radiopaque marker bands. Features distal locking pigtail (APDL) or J-tip (APD). Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous drainage of abscess fluid, biliary collections, or internal/external biliary system drainage.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Flexima™ APD™ All Purpose Drainage Catheter Set (K944290)
• Flexima™ Biliary Drainage Catheter with RO Marker (K023870)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration<br><b>Indications for Use</b> | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
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| 510(k) Number (if known)<br>K141335 | |
| Device Name | Expel™ Drainage Catheter with Twist-Loc™ Hub Biliary Drainage Catheter<br>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) | |
| | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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.

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## 510(k) Summary
Per 21 CFR §807.92

Per 21 CFR §807.92

| Submitter's Name<br>and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311<br>USA | Predicate Devices | Flexima™ APD™ All Purpose Drainage Catheter Set<br>(K944290, 08-Dec-1994) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name<br>and Information | Matt Beauchane<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | Flexima™ Biliary Drainage Catheter with RO Marker<br>(K023870, 20-Dec-2002) |
| Date Prepared | 03-Sep-2014 | Intended Use /<br>Indications for<br>Use | Expel™ Drainage Catheter APD Drainage Catheter,<br>Expel™ Drainage Catheter with Twist-Loc™ Hub APDL<br>Drainage Catheter,<br>Expel™ Drainage Catheter with Twist-Loc™ Hub APDL<br>Drainage Catheter Kit,<br>Expel™ Large Capacity Drainage Catheter APD Large<br>Capacity Drainage Catheter :<br>The drainage catheter is intended to provide percutaneous<br>drainage of abscess fluid and biliary collections. |
| Proprietary<br>Names | Single Product Configurations<br>Expel™ Drainage Catheter APD Drainage Catheter<br>Expel™ Drainage Catheter with Twist-Loc™ Hub APDL<br>Drainage Catheter<br>Expel™ Large Capacity Drainage Catheter APD Large<br>Capacity Drainage Catheter<br>Expel™ Drainage Catheter with Twist-Loc™ Hub Biliary<br>Drainage Catheter<br>Kit Configurations<br>Expel™ Drainage Catheter with Twist-Loc™ Hub APDL<br>Drainage Catheter Kit<br>Expel™ Drainage Catheter with Twist-Loc™ Hub Biliary<br>Drainage Catheter Kit | | Expel™ Drainage Catheter with Twist-Loc™ Hub<br>Biliary Drainage Catheter,<br>Expel™ Drainage Catheter with Twist-Loc™ Hub<br>Biliary Drainage Catheter Kit:<br>The drainage catheter is intended to provide external and<br>internal percutaneous drainage of the biliary system. |
| Common Name | Diagnostic Biliary Catheter | Device<br>Description | Expel™ drainage catheters are nonvascular intervention<br>catheters that consist of a single lumen tube with drainage<br>holes in the distal region and a proximal hub. The<br>catheters are inserted using percutaneous access to<br>provide internal and/or external drainage of fluid collections<br>in body cavities. They can be long-term indwelling devices<br>not to exceed 90 days in the body. |
| Classification | Classification: Class II<br>Regulation: 21 CFR 876.5010<br>Product Code: FGE<br>Classification Panel: Gastroenterology/Urology | | Expel™ APD™, APDL, and APD Large Capacity families<br>differentiate the available French sizes, distal shape<br>geometries, and hub types. These families contain the<br>widest range of products with catheter outer diameters<br>ranging from 6 to 26 French, and working lengths ranging<br>from 15 to 45 cm. The distal ends of the catheters contain<br>drainage holes, an adjacent radiopaque marker band, and<br>a tapered tip. The catheter shafts have graduation<br>markings with numeric values and a hydrophilic coating<br>distally. Expel™ APDL family has a distal locking pigtail<br>and 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 |
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| 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

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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.