AXIOS Stent with Electrocautery Enhanced Delivery System

K150692 · Boston Scientific Corp · PCU · Aug 5, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150692
• Device Name: AXIOS Stent with Electrocautery Enhanced Delivery System
• Applicant: Boston Scientific Corp
• Product Code: PCU · Gastroenterology, Urology
• Decision Date: Aug 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5015
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AXIOS Stent with Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 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 resolution.

Device Story

Device facilitates endoscopic drainage of pancreatic pseudocysts; consists of a self-expanding Nitinol stent preloaded in an electrocautery-enhanced delivery system. Used in clinical settings by physicians; delivery system connects to an off-the-shelf electrosurgical generator (80-120 Watts) to create an access tract via pure cutting current. Once the tract is created, the stent is deployed in a two-stage process (distal flange first, then proximal) to secure the conduit between the pseudocyst and the stomach or duodenum. The stent acts as an access port for endoscopes to perform debridement, irrigation, and cystoscopy. Stent remains implanted for up to 60 days before removal. Benefits include reduced device exchanges during access and precise anatomical targeting.

Clinical Evidence

Prospective multi-center, single-arm clinical study evaluated safety and effectiveness. 100% technical success in stent implantation and removal. 83.3% overall clinical success. 100% stent patency at 60 days. 90% of subjects free from major complications; 93.3% experienced no serious adverse events related to the device or procedure. No unanticipated events related to electrocautery use.

Technological Characteristics

Fully-covered, self-expanding braided Nitinol stent; delivery system includes a fine wire (0.006" SS) electrocautery element. Compatible with 0.035" guidewires and echoendoscopes with ≥ 3.7mm working channels. Connects to standard electrosurgical units (IEC 60601-1-2/60601-2-2 compliant). Sterilized via EO. MR conditional. Bench testing per ISO 10555-1 and ISO 594-1.

Indications for Use

Indicated for symptomatic patients with pancreatic pseudocysts ≥ 6cm in size, ≥ 70% fluid content, and 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

• Xlumena, Inc. AXIOS Stent and Delivery System (K140561 and K123250)
• Wilson-Cook Medical, Inc. Wilson-Cook Cystotome (K022595)

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

August 5, 2015

Boston Scientific Corporation Carole Sykes V.P. Clinical and Regulatory Affairs 453 Ravendale Drive, Suite H Mountain View, CA 94043

Re: K150692

> Trade/Device Name: AXIOS™ Stent with Electrocautery 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: April 29, 2015 Received: June 24, 2015

Dear Carole Sykes,

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.

Sincerelv vours.

# Herbert P. Lerner -S

for 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

#### K150692

Device Name

AXIOS Stent with Electrocautery Enhanced Delivery System

Indications for Use (Describe)

The AXIOS Stent with Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 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 resolution.

| | 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)

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# 510(K) SUMMARY

| Date Prepared: | March 17, 2015 |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Boston Scientific Corp. |
| Address: | 453 Ravendale Drive, Suite H, Mountain View, CA 94043 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Carole Sykes<br>VP Clinical and Regulatory Affairs |
| Trade Name/Proprietary<br>Name: | AXIOS Stent with Electrocautery Enhanced Delivery System |
| Class: | II |
| Common Name: | Pancreatic drainage stent and delivery system and endoscopic<br>electrosurgery device |
| Classification/Name: | Pancreatic drainage stent and accessories<br>and endoscopic electrosurgery accessories |
| Regulation: | 21 CRF 876.5015 / 21 CFR 876.4300 |
| Product Code: | PCU / 78KNS |
| Predicate Devices (Legally<br>marketed devices to which<br>substantial equivalence is<br>claimed): | Xlumena, Inc. AXIOS Stent and Delivery System<br>K140561 and K123250<br>Wilson-Cook Medical, Inc. Wilson-Cook Cystotome<br>K022595 |

#### I. Device Description:

The AXIOS Stent with Electrocautery Enhanced Delivery System is intended for the endoscopic placement of a flexible. MR conditional, fully-covered, self-expanding braided Nitinol stent for transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts. The AXIOS Stent with Electrocautery Enhanced Delivery System is comprised of two main components: (1) AXIOS Stent and (2) Electrocautery Enhanced Deliverv System.

The subject premarket notification describes modifications to the cleared AXIOS Delivery System to add electrocautery to facilitate precise access to anatomic targets as well as the staged placement of the currently cleared AXIOS Stent. The AXIOS Stent with Electrocautery Enhanced Delivery System incorporates the same identical implantable stent that is preloaded within the current AXIOS Delivery System (K123250). Both the AXIOS Stent and Delivery System were originally cleared under 510(k) K123250 and most recently under 510(k) K140561.

As with the non-cautery AXIOS devices, the Electrocautery Enhanced AXIOS Delivery System is compatible with commercially-available 0.035-inch endoscopic guidewires and intended to be used in the gastrointestinal tract in conjunction with commercially

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available echoendoscopes. The Electrocautery Enhanced Delivery System has been modified to connect 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 used 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.

### II. Indications for Use:

The AXIOS™ Stent with Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 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 resolution.

### III.Summary of Technological Characteristics of the Proposed Device Compared to the Predicate Device:

The AXIOS Stent with Electrocautery Enhanced Delivery System is substantially equivalent to the legally marketed predicate devices identified in Table 1. The AXIOS Stent with Electrocautery Enhanced Delivery System is substantially equivalent in terms of intended use / indications for use, technological characteristics and principles of operation to the predicate AXIOS Stent and Delivery System which was cleared by FDA in 510(k)s K123250 and K140561, and the Wilson-Cook Medical Cystotome cleared by FDA in 510(k) K022595.

## Table 1. Comparison of AXIOS Stent with Electrocautery Enhanced Delivery System with Predicate Devices

| Feature | SUBJECT DEVICE<br>AXIOS Stent with<br>Electrocautery Enhanced<br>Delivery System | PRIMARY PREDICATE<br>DEVICE<br>Xlumena AXIOS Stent<br>with (non-cautery) Delivery<br>System | REFERENCE PREDICATE<br>DEVICE<br>Wilson-Cook Medical<br>Wilson-Cook Cystotome |
|------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| 510(k)<br>Number | K150692 | K140561 and K123250 | K022595 |

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| Feature | SUBJECT DEVICE<br>AXIOS Stent with<br>Electrocautery Enhanced<br>Delivery System | PRIMARY PREDICATE<br>DEVICE<br>Xlumena AXIOS Stent<br>with (non-cautery) Delivery<br>System | REFERENCE PREDICATE<br>DEVICE<br>Wilson-Cook Medical<br>Wilson-Cook Cystotome | | | | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Indications for<br>Use | To facilitate transgastric or<br>transduodenal endoscopic<br>drainage of symptomatic<br>pancreatic pseudocysts ≥<br>6cm in size, with ≥ 70%<br>fluid content that are<br>adherent to the gastric or<br>bowel wall. Once placed,<br>the AXIOS Stent functions<br>as an access port allowing<br>passage of standard and<br>therapeutic endoscopes to<br>facilitate debridement,<br>irrigation and cystoscopy.<br>The stent is intended for<br>implantation up to 60 days<br>and should be removed<br>upon confirmation of<br>pseudocyst resolution. | Same | For use as an electrosurgical<br>accessory to cannulate the<br>transgastric or transduodenal<br>wall and into a pancreatic<br>pseudocyst that is visibly<br>bulging into the gastrointestinal<br>tract. | | | | |
| Class | II | Same | Same | | | | |
| Classification/<br>Regulation<br>Name | Pancreatic drainage stent<br>and accessories<br>and endoscopic<br>electrosurgery accessories | Pancreatic drainage stent and<br>accessories | Endoscopic electrosurgery<br>accessories | | | | |
| Regulation<br>Number | 21CFR 876.5015<br>21CFR 876.4300 | 21CFR 876.5015 | 21CFR 876.4300 | | | | |
| Product Code | PCU and 78KNS | PCU | 78KNS | | | | |
| Outer Catheter<br>Length | 138 cm | Same | 165 CM | | | | |
| Inner Catheter<br>Sheath<br>Diameter | 9 Fr with preloaded Stent | Same | 5 Fr with 0.038" needle knife | | | | |
| Guidewire<br>Compatibility | 0.035" | Same | Same | | | | |
| Endoscope<br>Compatibility | Compatible with 3.7 mm<br>diameter or larger working<br>channel | Same | Same | | | | |
| Placement Site | Transgastric or<br>transduodenal wall and into<br>a pancreatic pseudocyst | Same | Same | | | | |
| Pseudocyst<br>Size | ≥ 6cm in size | Same | > 4cm in size | | | | |

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| Feature | SUBJECT DEVICE<br>AXIOS Stent with<br>Electrocautery Enhanced<br>Delivery System | PRIMARY PREDICATE<br>DEVICE<br>Xlumena AXIOS Stent<br>with (non-cautery) Delivery<br>System | REFERENCE PREDICATE<br>DEVICE<br>Wilson-Cook Medical<br>Wilson-Cook Cystotome |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mode of<br>Access or<br>Operation | Electrosurgically punctures hole<br>at the placement site.<br>Fine wire electrocautery<br>element (0.006" SS wire);<br>electrosurgically active wire<br>using pure cutting current to<br>access pseudocyst. After<br>access, deploy the AXIOS<br>Stent using a two stage<br>process. Distal stent flange<br>first followed by the<br>proximal flange. | Access path at placement site<br>is created using conventional<br>access tools. After access,<br>deploy the AXIOS Stent<br>using a two stage process.<br>Distal stent flange first<br>followed by the proximal<br>flange. | Electrosurgically punctures hole<br>at the placement site. Needle<br>0.038" knife tip;<br>electrosurgically active knife<br>using pure cutting current to<br>access pseudocyst. Enlarge<br>incision with a cauterizing<br>diathermic ring and 10 Fr outer<br>catheter. Utilizes a 0.035" wire<br>for placement of a stent or<br>drainage kit via compatible<br>endoscope. |
| Stent<br>Deployment<br>Mechanism | Deployed via handle<br>controls. Distal stent flange<br>first followed by the<br>proximal flange. | Same | N/A |
| Cutting<br>Current | 80-120 Watts | N/A | 80-120 Watts |
| Sterilization<br>Method | EO | EO | EO |

### IV. Summary of the Nonclinical Tests Performed:

testing performed includes: Nonclinical Bench -Performance, Biocompatibility. Electromagnetic Compatibility / Electrical Safety, and Animal Testing. The nonclinical test results demonstrate that the modified device continues to meet product design specifications.

### 1. Bench Performance

Bench performance testing was conducted for the AXIOS Stent with Electrocautery Enhanced Delivery System to demonstrate that the modified delivery system continues to meet the requirements of the product design specification and perform in accordance with its intended use. There have been no design or material changes to the AXIOS Stent; it is identical to the AXIOS Stent cleared in K123250 and K140561. The bench performance testing was conducted for the modifications to the Electrocautery Enhanced Delivery System Catheter and Handle only and included the following testing:

- RF Compatibility / Safety ●
- Tensile Strength testing ●
- Unsheathing Force (Distal Flange)
- Effect of Retainer (Stent Retention Force) ●

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- Design Validation Testing
- Transportation and Conditioning Testing
- Shelf Life and Package Testing
- Magnetic Resonance testing was confirmed via ASTM F2052-14, ASTM F2213-06, . ASTM F2182-11a and ASTM F2119-13.

Where applicable, performance testing was conducted in accordance with the following standards:

- . ISO 10555-1:2013 - Sterile, single-use intravascular catheters Part 1. General requirements
- ISO 594-1:1986 Conical Fittings with a 6% (Luer) taper for syringes, needles ● and certain other medical equipment – Part 1 : General Requirements

Design Verification testing included assessment of device dimensions, stent deployment and tensile testing of the applicable joints. The AXIOS Stent with Electrocautery Enhanced Delivery System was tested for design validation attributes. AXIOS Systems were evaluated in an ex vivo simulated use model for performance to the product specification. Based on the results of the bench performance testing, the modified Electrocautery Enhanced Delivery Systems meets the product design specification and performance requirements for its proposed intended use.

The AXIOS Stent with Electrocautery Enhanced Delivery System was evaluated in an Ex-Tissue Model to measure the comparative thermal effects of the AXIOS Vivo Electrocautery Enhanced Delivery System (11F) vs. the 10F Cook Cystotome on porcine tissue. In all tissue samples, the Electrocautery Enhanced Delivery System caused statistically significant less thermal damage to the tissue as compared to the Cystotome.

### 2. Biocompatibility

To verify the biocompatibility of the AXIOS Stent with Electrocautery Enhanced Delivery System the Company conducted biocompatibility testing pursuant to ISO 10993-1:2009 and FDA's Draft Guidance Document Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (2013)". Biocompatibility testing was conducted in accordance with the GLP regulations (21 CFR, Part 58).

The Electrocautery Enhanced Delivery System (Hot AXIOS Delivery System) is an "external communicating device" in contact with tissue for limited duration (<24 hour) during pseudocyst access and stent implant procedures. Based on these characteristics, the following biocompatibility tests were performed: Cytotoxicity - ISO MEM Elution Method, L-929 Cells, Sensitization - ISO Guinea Pig Maximization Study, Irritation - ISO Intracutaneous Reactivity in Rabbits and Systemic (Acute) Toxicity - ISO Systemic Toxicity in Mice. There have been no changes to the AXIOS Stent design or materials; it is identical to the AXIOS Stent cleared in 510(k)s K123250 and K140561, therefore no new biocompatibility testing is warranted. Based on the test results, the Electrocautery Enhanced Delivery System is

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biocompatible for the intended use.

#### Electromagnetic Compatibility and Electrical Safety 3.

The AXIOS Stent with Electrocautery Enhanced Delivery System (Hot AXIOS Device) was evaluated by Intertek NA, for conformance to the IEC 60601 family of standards. All completed testing passed the acceptance criteria as outlined in IEC 60601-1, 60601-1-6, 60601-2-2, 60601- 2-18, and ISO 14971 and as specified in the Final Study Reports provided by Intertek NA, Inc.

#### 4. Animal

The safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System (Hot AXIOS) during transmural endoscopic access and drainage of a simulated pancreatic pseudocyst and the biliary tract was evaluated. The study evaluated the safety and performance of the AXIOS Stent with Electrocautery Enhanced Delivery System when performing a simulated endoscopic drainage procedure in a porcine model using the 06x08mm and 20x10mm stent models.

Cautery access and stent deployment using the AXIOS Stent with Electrocautery Enhanced Delivery System were compared to standard techniques as represented by access with the commercially available Cystotome (Cook Medical, Limerick Ireland) and the placement of an 20x10mm Stent with Electrocautery Enhanced Delivery System (the Electrocautery Enhanced Delivery System was not energized). A direct comparison of tissue heat affects and healing were evaluated post cautery access and AXIOS Stent placement. Effectiveness of the Electrocautery Enhanced Delivery System to access the target anatomy and deliver the AXIOS stent (device performance) was also assessed.

The study animals were survived for one (1) month after stent implantation followed by stent removal. Study animals were survived another 7 days after stent removal for histopathological evaluation. Histological evaluation of the heat affects and healing of the implant site was performed.

Access using cautery was successfully achieved and stents were successfully deployed in all animals. None of the stents migrated from the original position and all stents remained patent during the implant period (1 month). The tissue surrounding the stent implant sites was healthy in all animals. The gross and histological evaluation of the tissues treated with either the control (AXIOS without cautery) or test device (AXIOS with Electrocautery Enhanced Delivery System) showed excellent healing between the two luminal structures (bile duct or jejunum and stomach). Thermal heat effects were not apparent grossly or histologically within the tissues evaluated in the AXIOS Electrocautery Enhanced Delivery System treated animals.

#### V. Summary of Clinical Tests Performed:

A prospective multi-center, single-arm clinical study was conducted to demonstrate the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for

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endoscopic transenteric drainage of pancreatic pseudocysts. The AXIOS Stent with Electrocautery Enhanced Delivery System is intended for the endoscopic ultrasonography (EUS) guided creation of an internal drainage conduit between the pancreatic pseudocyst and the stomach or duodenum. The AXIOS Electrocautery Enhanced Delivery System is designed to facilitate the creation of the access tract using electrosurgery while minimizing device exchanges for pseudocyst access. The design and manufacturing of AXIOS Stent remains unchanged.

Safety was evaluated as freedom from major complications with regard to stent placement and removal. Stent migration and tissue response for the period up to seven days after stent removal were also evaluated. Pseudocyst resolution and AXIOS device performance were evaluated to characterize effectiveness.

The study group consisted of symptomatic subjects who provided consent and were treated with the AXIOS Stent with Electrocautery Enhanced Delivery System.

Effectiveness: AXIOS Stents were placed in subjects with no intra-operative complications. AXIOS stent patency was confirmed with drainage visualized for all stents placed. In subjects treated PP, 100% of AXIOS devices remained in position at 30 or 60 days, and 81.1% of stent lumens remained patent at 30 days and 100% at 60 days. The AXIOS stent was successfully implanted in all study subjects (100%). Successful removal of the AXIOS stent was achieved in all subjects (100%) in which endoscopic removal PP was attempted. Overall clinical success was achieved in 83.3% of subjects.

Safety: Study results demonstrated that there were no unanticipated events related to the use of the device. Ninety percent (90%) of subjects were from major complications. Ninetythree percent (93.3%) of subjects experienced no serious adverse events related to the device or index procedure. Serious adverse events deemed related to the AXIOS device or the index procedure was the same type of events as those generally associated with endoscopic pancreatic pseudocyst drainage with commercially available stents and delivery systems. Conclusion:

The AXIOS Stent design and construction is optimized for controlled placement, maintaining patency, preventing migration and easy removal. Once placed, the stent provides a large diameter conduit and the bi-flange design secures access to the pseudocyst. The stent is provided fully covered to minimize tissue ingrowth.

The Electrocautery Enhanced Delivery System was used for access in 100% of patients and performed as intended in all cases. There were no adverse events or unanticipated adverse device effects attributed to electrocautery use.

The study of the AXIOS Stent with Electrocautery Enhanced Delivery System demonstrated the system to be predictable and easy to use. There were no intraoperative adverse events during AXIOS Stent placement and two during removal (both were minor bleeding not requiring transfusion). There were no unanticipated complications or new risks related to the

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implantation and removal of the AXIOS Stent. The AXIOS Stent with Electrocautery Enhanced Delivery System is deployed using electrocautery in conjunction with current strategies and techniques for clinical assessment and treatment. In conclusion, the AXIOS Stent with Electrocautery Enhanced Delivery System is safe and effective for the endoscopic transenteric drainage of pancreatic pseudocysts.

### VI. Substantial Equivalence:

Based on the results of the Bench Performance, Biocompatibility, Electromagnetic Compatibility / Electrical Safety and Animal testing, as well as clinical evaluations, the AXIOS Stent with Electrocautery Enhanced Delivery System is substantially equivalent to the currently cleared AXIOS Stent and Delivery System which was cleared by FDA in 510(k)s K123250 and K140561, and the Wilson-Cook Medical Cystotome cleared by FDA in 510(k) K022595. In regard to intended use/indication for use, technological characteristics, and principles of operation the modifications do not affect the performance or function of the device. The minor differences in the design between the modified and cleared devices do not raise any new types of safety or effectiveness questions as confirmed by non-clinical and clinical testing. Therefore, the AXIOS Stent with Electrocautery Enhanced Delivery System is substantially equivalent to the previously cleared predicate devices.

#### VII. Conclusions:

Boston Scientific concludes that based on the results of the Bench Performance, Biocompatibility, Electromagnetic Compatibility / Electrical Safety, Animal and Clinical Testing, that the modified AXIOS Stent with Electrocautery Enhanced Delivery System is substantially equivalent to the predicate devices.