AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System

K153088 · Boston Scientific Corporation · PCU · Dec 11, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K153088
• Device Name: AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
• Applicant: Boston Scientific Corporation
• Product Code: PCU · Gastroenterology, Urology
• Decision Date: Dec 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5015
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AXIOS Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥6cm in size, and symptomatic Walled Off Necrosis ≥6cm in size, with ≥70% fluid content, that are adherent to the gastric or bowel wall. Once placed, the AXIOS stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or Walled Off Necrosis resolution.

Device Story

AXIOS Stent and Delivery System facilitates endoscopic drainage of pancreatic pseudocysts and Walled Off Necrosis. Device consists of a nitinol, silicone-covered, bi-flange stent preloaded in a delivery catheter. Two versions: non-cautery and electro-cautery enhanced. Electro-cautery version connects to standard electrosurgical units for tissue puncture. Operated by physicians during endoscopic procedures using echoendoscopes (≥3.7mm channel). Stent creates a large-diameter access lumen between the GI tract and the fluid collection, allowing for drainage, irrigation, and endoscopic debridement. Stent remains in place for up to 60 days before removal. Benefits include secure tissue apposition, reduced migration risk, and creation of a stable conduit for therapeutic intervention.

Clinical Evidence

No new clinical data required. Safety and effectiveness previously established via IDEs G110068 and G130266. Evidence for indication update based on clinical consensus article: Banks, Peter A., 'Classification of acute pancreatitis- 2012: revision of the Atlanta classifications by international consensus' (Gut 2013).

Technological Characteristics

Stent: Nitinol (nickel-titanium) with silicone covering. Delivery system: 10.8 Fr outer diameter, 139cm/138cm length. Energy: Electrosurgical (80-120 Watts) for cautery version. Connectivity: Compatible with standard electrosurgical units (IEC 60601-1-2, IEC 60601-2-2) and 0.035-inch guidewires. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for patients with symptomatic pancreatic pseudocysts or Walled Off Necrosis ≥6cm in size, with ≥70% fluid content, that are adherent to the gastric or bowel wall, requiring transgastric or transduodenal endoscopic drainage.

Regulatory Classification

Identification

A pancreatic drainage stent is a prescription device that consists of a self-expanding, covered, metallic stent, intended for placement to facilitate transmural endoscopic drainage of pancreatic pseudocysts. This stent is intended to be removed upon confirmation of pseudocyst resolution. This device may also include a delivery system.

Special Controls

In combination with the general controls of the FD&C Act, the AXIOS Stent and Delivery System is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) The device and elements of the delivery device that may contact the patient must be demonstrated to be biocompatible. (2) Performance data must demonstrate the sterility of patient-contacting components of the device. (3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the requested shelf life. (4) Non-clinical testing data must demonstrate that the stent and delivery system perform as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Deployment testing of the stent and delivery system must be conducted under simulated use conditions. (ii) Removal force testing must be conducted. The removal force testing must demonstrate that the stent can be safely removed, and that the stent will remain in place when subjected to forces encountered during use. (iii) Expansion force testing must be conducted. The expansion force must demonstrate that the forces exerted by the stent will not damage the tissue surrounding the stent. (iv) Compression force testing must be conducted. The compression force must demonstrate that the stent will withstand the forces encountered during use. (v) Dimensional verification testing must be conducted. (vi) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use. (vii) Fatigue testing must be conducted. Material strength must demonstrate that the stent will withstand forces encountered during use. (viii) Corrosion testing must be conducted. Corrosion resistance must demonstrate that the stent will withstand conditions encountered during use. (5) Non-clinical testing must evaluate the compatibility of the stent in a magnetic resonance (MR) environment. (6) Well-documented clinical experience must demonstrate safe and effective use, and capture any adverse events observed during clinical use. (7) Labeling must include the following: (i) Appropriate instructions, warnings, cautions, limitations, and information related to the safe use of the device, including deployment of the device, maintenance of the drainage lumen, and removal of the device. (ii) A warning that the safety and patency of the stent has not been established beyond the duration of the documented clinical experience. (iii) Specific instructions and the qualifications and clinical training needed for the safe use of the device, including deployment of the device, maintenance of the drainage lumen, and removal of the device. (iv) Information on the patient population for which the device has been demonstrated to be effective. (v) A detailed summary of the clinical experience pertinent to use of the device. (vi) A detailed summary of the device technical parameters. (vii) A detailed summary of the device- and procedure-related complications pertinent to use of the device. (viii) An expiration date/shelf life.

Predicate Devices

• AXIOS Stent and Delivery System (K152572)
• AXIOS Stent and Electro-cautery Enhanced Delivery System (K150692)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 11, 2015

Boston Scientific Corporation Ashley Santos Regulatory Affairs Manager 100 Boston Scientific Way Marlborough, MA 01752

Re: K153088

> Trade/Device Name: AXIOS Stent and Delivery System and AXIOS Stent and Electro-cautery Enhanced Delivery System Regulation Number: 21 CFR§ 876.5015 Regulation Name: Pancreatic drainage stent and delivery system Regulatory Class: II Product Code: PCU. KNS Dated: October 21, 2015 Received: October 26, 2015

Dear Ashley Santos,

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.

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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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,

# Benjamin R. Fisher -S

Benjamin R. 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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## Indications for Use

#### 510(k) Number (if known) Unknown K153088

#### Device Name

AXIOS Stent and Delivery System and AXIOS Stent and Electro-cautery Enhanced Delivery System

#### Indications for Use (Describe)

The AXIOS Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥6cm in size, and symptomatic Walled Off Necrosis ≥6cm in size, with ≥70% fluid content, that are adherent to the gastric or bowel wall. Once placed, the AXIOS stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or Walled Off Necrosis resolution.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div style="display:flex; align-items:center;"> <span> <b> <span style="font-size: 20px;">☑</span> </b> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"> <span> <b> <span style="font-size: 20px;">☐</span> </b> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## SECTION 5 510(k) SUMMARY

## 510(k) SUMMARY

## 1. SUBMITTER:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Primary Contact: Ashley Santos Sr. Regulatory Affairs Manager Telephone: [phone] Fax: [phone]

Secondary Contact: Jennifer Kimball Director, Regulatory Affairs Telephone: [phone] Fax: [phone]

Date Prepared: December 8, 2015

#### 2. DEVICE:

| Name of Device: | AXIOS Stent and Delivery System |
|----------------------|-----------------------------------------------|
| Common Name: | Pancreatic drainage stent and delivery system |
| Classification Name: | Pancreatic drainage stent and accessories |
| Regulation Number: | 21 CRF 876.5015 |
| Product Code: | PCU |
| Classification: | Class II |

| Name of Device: | AXIOS Stent and Electrocautery Enhanced Delivery System |
|----------------------|----------------------------------------------------------------------------------------|
| Common Name: | Pancreatic drainage stent and delivery system & endoscopic<br>electrosurgery device |
| Classification Name: | Pancreatic drainage stent and accessories and endoscopic<br>electrosurgery accessories |
| Regulation Number: | 21 CRF 876.5015 / 21 CFR 876.4300 |
| Product Code: | PCU/ KNS |
| Classification: | Class II |

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## 3. PREDICATE DEVICE:

| Name of Device: | AXIOS Stent and Delivery System |
|----------------------|-------------------------------------------------------------------------------------|
| 510(k) Number: | K152572 |
| Common Name: | Pancreatic drainage stent and delivery system |
| Classification Name: | Pancreatic drainage stent and accessories |
| Regulation Number: | 21 CRF 876.5015 |
| Product Code: | PCU |
| Classification: | Class II |
| Name of Device: | AXIOS Stent and Electro-cautery Enhanced Delivery System |
| 510(k) Number: | K150692 |
| Common Name: | Pancreatic drainage stent and delivery system & endoscopic electrosurgery device |
| Classification Name: | Pancreatic drainage stent and accessories and endoscopic electrosurgery accessories |
| Regulation Number: | 21 CRF 876.5015 / 21 CFR 876.4300 |
| Product Code: | PCU/ KNS |
| Classification: | Class II |

## 4. DEVICE DESCRIPTION:

The main features of the AXIOS Stent and Delivery System and the AXIOS Stent and Electrocautery Enhanced Delivery System are discussed below and presented in Table 5 - 1 . There have been no changes to the AXIOS Stent or the delivery systems; it is identical to the stent and delivery systems cleared in 510(k) K152572 and K150692.

## AXIOS Stent:

The AXIOS Stent and Delivery System is designed to secure the apposition of tissue, minimize stent displacement and create a large access/drainage lumen.

## AXIOS Non-Cautery Delivery System:

The stent is preloaded within the AXIOS delivery catheter. The Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The Delivery System is designed to be used in the gastrointestinal tract in conjunction with commercially available echoendoscopes with a 3.7 mm diameter or larger working channel and is compatible with commercially-available 0.035-inch insulated endoscopic guidewires.

## AXIOS Electro-Cautery Enhanced Delivery System:

The stent is preloaded onto the AXIOS delivery catheter. The Electro-cautery Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The Electro-cautery Enhanced Delivery System is designed to be used in the gastrointestinal tract in conjunction with commercially available echoendoscopes with a 3.7 mm diameter or larger working channel and is compatible with commercially-available 0.035-inch insulated endoscopic guidewires.

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The Electro-cautery Enhanced Delivery System connects with an off-the shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2. The generator must be installed and put into service according to the EMC information provided in the generator manufacturer's guidance and declaration for electromagnetic compatibility.

Cables and patient return electrodes that are specified by generator manufacturer must be use for connection. The AXIOS Stent with Electrocautery Enhanced Delivery System is provided sterile, disposable and intended for single use. The Electrocautery Enhanced AXIOS Delivery System is IEC compliant.

| Component/Design | Feature Description |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter | Provided sterile, for single-patient use Working Length:<br>139cm Non-cautery Delivery System 138cm Electro-cautery Enhanced Delivery System Outer Diameter 10.8 Fr Fluoroscopy: AXIOS stent is contained between two (2) |
| Handle | Staged delivery system for precise stent placement ⇒ Two (2)-step release of each flange, including a full "stop" ⇒ Lock-out after the release of the first flange, preventing unintended deployment of the second flange |
| Guidewire<br>Compatibility | 0.035" insulated guidewires |
| Endoscope<br>Compatibility | Compatible with 3.7 mm diameter or larger working channel Delivery system is luer-locked to the proximal end of the biopsy port of the endoscope |
| | <b>AXIOS Stent</b> |
| AXIOS Stent Design | Bi-flange or double anchor for Staged and Precise positioning Flange/anchor designed to: ⇒ hold tissue layers in apposition ⇒ prevent migration MR conditional Provided sterile, for single-patient use |
| AXIOS Stent Lumen | Large stent lumen diameter and short flow path/conduit to ⇒ Facilitate passive efficient drainage ⇒ Facilitate passage of endoscopic tools for assessment and treatment |
| AXIOS Stent Material | Nitinol (Nickel-Titanium) ⇒ Shape memory and superelasticity for controlled placement and optimal deployment ⇒ Corrosion resistant and biocompatible |
| AXIOS Stent Covering | Fully covered with Silicone ⇒ Well tolerated by surrounding tissue to minimize tissue ingrowth ⇒ Provides leak protection and minimizes tissue ingrowth allowing for atraumatic stent removal |

Table 5-1: AXIOS Stent and Delivery System - Main Features

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| AXIOS Stent Visualization | The Stent is delivered constrained within a delivery system and deployed under visualization ⇒ EUS confirmation of first flange deployment ⇒ Direct endoscopic or EUS viewing of second flange deployment ⇒ Radiopacity of Nitinol allows fluoroscopy of deployed stent |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

## 5. INDICATIONS FOR USE:

The AXIOS Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥6cm in size, and symptomatic Walled Off Necrosis ≥6cm in size, with ≥70% fluid content, that are adherent to the gastric or bowel wall. Once placed, the AXIOS stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement. irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or Walled Off Necrosis resolution.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6. PREDICATE DEVICE:

There are no differences in the technological characteristics between the proposed device and the predicate AXIOS Stent with Delivery System (K152572) and AXIOS Stent with Electro-cautery Enhanced Delivery System (K150692). The purpose of this Traditional 510(k) is to request clarification to the AXIOS indication for use. The physical device will remain unchanged from the predicates K152572 and K150692, but the revision to the indication requires a change to the product labeling. All other design specifications remain unchanged. Tables 5-2 and 5-3 include a technological comparison of the proposed device against the predicate device.

| Table 5-2: AXIOS and Delivery System Technological Comparison | | |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Subject Device<br>AXIOS Stent and Delivery System | Primary Predicate AXIOS Stent and<br>Delivery System K152572 |
| Intended Use /<br>Indications<br>for Use | The AXIOS Stent is indicated for<br>use to facilitate transgastric or<br>transduodenal endoscopic drainage<br>of symptomatic pancreatic<br>pseudocysts $≥6cm$ in size, and<br>symptomatic Walled Off Necrosis<br>$≥6cm$ in size, with $≥70%$ fluid<br>content, that are adherent to the<br>gastric or bowel wall. Once placed,<br>the AXIOS stent functions as an<br>access port allowing passage of<br>standard and therapeutic endoscopes<br>to facilitate debridement, irrigation<br>and cystoscopy. The stent is<br>intended for implantation up to 60<br>days and should be removed upon<br>confirmation of pseudocyst or<br>Walled Off Necrosis resolution. | To facilitate transgastric or<br>transduodenal endoscopic drainage<br>of symptomatic pancreatic<br>pseudocysts $≥ 6cm$ in size, with $≥ 70%$ fluid content that are adherent<br>to the gastric or bowel wall. Once<br>placed, the AXIOS Stent functions<br>as an access port allowing passage<br>of standard and therapeutic<br>endoscopes to facilitate<br>debridement, irrigation and<br>cystoscopy. The stent is intended<br>for implantation up to 60 days and<br>should be removed upon<br>confirmation of pseudocyst<br>resolution. |
| Outer Catheter Length | 139 cm | Same |
| Outer Catheter Shaft | 10.8 Fr | Same |

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| Inner Catheter Sheath | 9 Fr with preloaded Stent | Same |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Guidewire | 0.035” | Same |
| Endoscope | Compatible with 3.7 mm | Same |
| Placement Site | Transgastric or transduodenal wall<br>and into a pancreatic pseudocyst or<br>Walled Off Necrosis | Transgastric or transduodenal wall<br>and into a pancreatic pseudocyst |
| Pseudocyst/Walled | ≥ 6cm in size | Same |
| Mode of Access or<br>Operation | Access path at placement site is<br>createdusing conventional access<br>tools. After access, deploy the<br>AXIOS Stent using a two stage<br>process. Distal stent flange first<br>followed by the proximal flange. | Same |
| Stent Deployment<br>Mechanism | Deployed via handle controls. Distal<br>stent flange first followed by the<br>proximal flange. | Same |
| Sterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) |

| Characteristic | Subject Device AXIOS Stent with<br>Electro-cautery Enhanced Delivery<br>System | Primary Predicate Device AXIOS<br>Stent with Electro-cautery<br>Enhanced Delivery<br>System(K150692) |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications<br>for Use | The AXIOS Stent is indicated for<br>use to facilitate transgastric or<br>transduodenal endoscopic drainage<br>of symptomatic pancreatic<br>pseudocysts ≥6cm in size, and<br>symptomatic Walled Off Necrosis<br>≥6cm in size, with ≥70% fluid<br>content, that are adherent to the<br>gastric or bowel wall. Once placed,<br>the AXIOS stent functions as an<br>access port allowing passage of<br>standard and therapeutic endoscopes<br>to facilitate debridement, irrigation<br>and cystoscopy. The stent is<br>intended for implantation up to 60<br>days and should be removed upon<br>confirmation of pseudocyst or<br>Walled Off Necrosis resolution. | To facilitate transgastric or<br>transduodenal endoscopic drainage<br>of symptomatic pancreatic<br>pseudocysts ≥ 6cm in size, with ≥<br>70% fluid content that are adherent<br>to the gastric or bowel wall. Once<br>placed, the AXIOS Stent functions<br>as an access port allowing passage<br>of standard and therapeutic<br>endoscopes to facilitate<br>debridement, irrigation and<br>cystoscopy. The stent is intended<br>for implantation up to 60 days and<br>should be removed upon<br>confirmation of pseudocyst<br>resolution. |
| Outer Catheter Length | 138 cm | Same |
| Outer Catheter Shaft | 10.8 Fr | Same |
| Guidewire | 0.035" | Same |
| Endoscope | Compatible with 3.7 mm | Same |
| Placement Site | Transgastric or transduodenal wall<br>and into a pancreatic pseudocyst or<br>Walled Off Necrosis | Transgastric or transduodenal wall<br>and into a pancreatic pseudocyst |
| Pseudocyst/Walled | > 6cm in size | Same |

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| Mode of Access or<br>Operation | Electrosurgically punctures hole at the placement site. After access, deploy the AXIOS Stent using a two stage process. Distal stent flange first followed by the proximal flange. | Same |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Stent Deployment<br>Mechanism | Deployed via handle controls. Distal stent flange first followed by the proximal flange. | Same |
| Cutting Current | 80-120 Watts | Same |
| Sterilization | Ethylene Oxide (EO) | Same |

## 7. PERFORMANCE DATA:

#### Non-Clinical Testing:

No performance data was required for this submission.

#### Clinical Data:

The published clinical guidelines identified in the "Classification of acute pancreatitis- 2012: revision of the Atlanta classification and definitions by international consensus", was the basis for requesting the revision to the indication for use. BSC is requesting to clarify the AXIOS indication for use to align with the "fluid collection" classifications identified in this clinical article. The safety and effectiveness of the AXIOS stent when used for drainage of encapsulated pancreatic collections >6cm in size, with >70% fluid content/ <30% necrotic material that are adherent to the gastric or bowel wall, which includes symptomatic pancreatic pseudocysts and symptomatic Walled Off Necrosis has been established via IDEs G110068 and G130266. Therefore, no additional clinical data is required to support the revision to this indication for use statement.

#### 8. CONCLUSION:

The revised indication for use that Boston Scientific Corporation is requesting for the proposed AXIOS Stent with Delivery System and AXIOS Stent with Electro-cautery Enhanced Delivery System is to align with the "fluid collection" definitions identified in the "Classification of acute pancreatitis- 2012: revision of the Atlanta classification and definitions by international consensus". The revised indication for use does not raise new questions of safety and effectiveness. The safety and effectiveness of the proposed AXIOS Stent with Delivery System and AXIOS Stent with Electro-cautery Enhanced Delivery System has been established.

Banks, Peter A., "Classification of acute pancreatitis- 2012: revision of the Atlanta classifications by international consensus" published in Gut 2013, Volume 62, pgs. 102-111.