AXIOS Stent and Electrocautery-Enhanced Delivery System

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September 7, 2022 Boston Scientific Corporation Ian Broome, M.S., RAC Senior Regulatory Affairs Specialist 200 Boston Scientific Way, Mail Stop M41 Marlborough, MA 01752 Re: K220112 > Trade/Device Name: AXIOS™ Stent and 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: August 5, 2022 Received: August 5, 2022 Dear Ian Broome: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, April Marrone, Ph.D., MBA Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220112 #### Device Name AXIOSTM Stent and Electrocautery-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 ≥ 6 cm in size, and symptomatic Walled Off Necrosis ≥ 6 cm in size, 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) | <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------| | □ Over-The-Counter Use (21 CFR 801 Subpart C) | |-----------------------------------------------| |-----------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Device: AXIOS™ Stent and Electrocautery-Enhanced Trade Name: Delivery System Device Common Name: Pancreatic drainage stent and delivery system & endoscopic electrosurgery device Classification Name: Pancreatic drainage stent and accessories & endoscopic electrosurgery accessories Regulation Number: 21 CFR 876.5015, 21 CFR 876.4300 Product Code: PCU/KNS Classification: Class II 3. Predicate Devices Trade Name: AXIOS™ Stent and Electrocautery-Enhanced Delivery System 510(k) Numbers: K181905, K192043 Device Common Name: Pancreatic drainage stent and delivery system & endoscopic electrosurgery device Pancreatic drainage stent and accessories and Classification Name: endoscopic electrosurgery accessories Regulation Number: 21 CFR 876.5015 21 CFR 876.4300 Product Code: PCU/KNS Classification: Class II {4}------------------------------------------------ ### 4. Device Description #### AXIOS™ Stent: The AXIOS™ Stent is a flexible, MR conditional, fully-covered, self-expanding braided nitinol stent, which comes preloaded into a delivery system. The AXIOS™ stent is designed with two flanges on each end to prevent migration and to enable tissue plane apposition and a "saddle" in between the flanges to span the tissue implant distance. #### Electrocautery-Enhanced Delivery System: The AXIOS™ Electrocautery-Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS™ Stent. The AXIOS™ Electrocautery-Enhanced Delivery System is designed to be used in the gastrointestinal tract 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. The Electrocautery-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 AXIOS™ Stent and Electrocautery-Enhanced Delivery System is provided sterile, disposable and intended for single use. Table 5-1 below discusses the main features of the AXIOSTM Stent and Electrocautery-Enhanced Delivery System. | Component/Design | Feature Description | |--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Catheter | Provided sterile, for single-patient use Working length: 138 cm Outer Diameter 10.8 Fr Fluoroscopy: AXIOS™ Stent is contained<br>between two (2) Platinum Iridium<br>Markers Electrocautery Tip for precise cutting (in<br>the Electrocautery-Enhanced Delivery<br>System only) Monopolar 750VP or 1500Vp-p<br>Rated Accessory Voltage<br>⇒ IEC 60601-1 compliant | | Handle | Staged delivery system for precise stent<br>placement<br>⇒Two (2)-step release of each flange,<br>including a full “stop”<br>⇒Lock-out after the release of the first<br>flange, preventing unintended<br>deployment of the second flange | | Guidewire Compatibility | 0.035" insulated guidewires | | Endoscope Compatibility | Compatible with 3.7 mm diameter or<br>larger working channel Delivery system is Luer-locked to the<br>proximal end of the biopsy port of the<br>endoscope | | Component/Design | Feature Description | | Suggested Electrosurgical Unit or<br>Generator (Electrocautery-Enhanced<br>Delivery System only) | Compliant to IEC 60601-1-2 and IEC 60601-2-2 ERBE VIO 300D ERBE ICC 200 ERBE VIO 300S ERBE VIO 200D | | AXIOST™ 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 | | AXIOST™ 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 | | AXIOST™ Stent Material | Nitinol (Nickel-Titanium) ⇒Shape memory and superelasticity for controlled placement and optimal deployment ⇒Corrosion resistant and biocompatible | | AXIOST™ 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 | | AXIOST™ 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 Nitol allows fluoroscopy of deployed stent | Table 5-1. AXIOS™ Stent and Electrocautery-Enhanced Delivery System - Main Features Component/Design Feature Description {5}------------------------------------------------ {6}------------------------------------------------ #### 5. Proposed Indications for Use The AXIOS™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pseudocysts ≥ 6 cm in size, and symptomatic Walled Off Necrosis ≥ 6 cm in size, 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. ### 6. Technological Characteristics The technological characteristics of the device remain unchanged from the predicates cleared in K181905 (the 10mm x 10 mm, 10mm and 20mm x 10mm stent sizes) and K192043 (the 15mm x 15mm stent size). # 7. Performance Data The devices' technological characteristics remain unchanged, therefore, no further performance testing was required. # 8. Clinical Data Summary Clinical data from a prospective, single arm, multi-center trial on the AXIOS™ Stent and Electrocautery-Enhanced Delivery System support the expanded indication for use and confirm the subject device's substantial equivalence, safety and effectiveness to the predicate. The trial was conducted per GCP and 21 CFR Parts 50, 56 and 812 under an approved Investigational Device Exemption. Patients with Walled Off Necrosis (WON) with greater than 30% necrotic material (as suggested by pre-operative imaging) were eligible for inclusion. The primary effectiveness endpoint was resolution of WON with endoscopic drainage (defined as radiographic decrease of WON size to < 3cm evaluated by CT scan or MRI within 60 days from AXIOS™ stent placement). The primary safety endpoint was AXIOS™ stent-related or WON drainage procedure-related serious adverse events (SAE). Forty patients enrolled in the study. Forty-five AXIOS™ stents were implanted in 40 subjects (some subjects had multiple WON). Post procedural radiographic evidence demonstrated successful resolution of WON in 97.5% (39/40) patients. Table 5-1 below shows the Primary Effectiveness Endpoint, Primary Safety Endpoint, and Additional Endpoints. | | ITT Subjects<br>(N=40) | |---------------------------------------------------------------------------------------------------------------------------|---------------------------------| | Primary Effectiveness Endpoint | | | Resolution of WON to ≤ 3 cm (assessed radiographically by CT scan<br>or MRI within 60 days from AXIOST™ stent placement)1 | 97.5% (39/40)<br>[86.8%, 99.9%] | | Primary Safety Endpoint | | | AXIOS™ stent related or WON drainage procedure related serious<br>adverse events | 7.5% (3/40)<br>[1.6%, 20.4%] | | Additional Endpoints | | | Reduction of WON-related symptoms Final WON assessment visit 6-month WON recurrence assessment visit Technical success | | | | 75.0% (30/40) | | | 85.3% (29/34) | | | | | Table 5-2. Primary Effectiveness and Safety Endpoints and Additional Endpoints | |--------------------------------------------------------------------------------| |--------------------------------------------------------------------------------| {7}------------------------------------------------ | Ο AXIOST™ stent placement | 100.0% (40/40) | |------------------------------------------------------------------------------------|---------------------------------| | Ο AXIOST™ stent removal | 100.0% (40/40) | | ● Drainage procedure time (min) | | | Ο Total | 22.6±11.3 (40)<br>(1.0, 51.0) | | Ο Initial AXIOSTM stent | 21.8±11.0 (40)<br>(1.0, 51.0) | | Ο Second AXIOSTM stent | 10.0±3.5 (3)<br>(8.0, 14.0) | | ● Resolution of WON by 6-month post-stent removal2 | | | Ο Resolution before AXIOST™ removal - not lost to 6-month follow-up (34/34) | 100.0% (40/40) | | Ο Resolution before AXIOST™ removal – lost to 6-month follow-up (6/6) | | | ● Time to WON resolution of ≤ 3 cm (days) | 34.1±16.8 (40)<br>(4.0, 100.0) | | ● Recurrence of WON from initial resolution to 6 months post-AXIOSTM stent removal | 0.0% (0/34) | | ● Stent lumen patency | | | Ο Drainage through AXIOST™ stent visualized from the stomach or bowel | | | ■ After stent placement | 100.0% (40/40) | | ■ Before stent removal | 65.0% (26/40) | | ● Visual confirmation of AXIOST™ stent lumen patency | | | Ο After stent placement | 100.0% (40/40) | | Ο Before stent removal | 97.5% (39/40) | | ● Fluoroscopy time per endoscopic procedure (min) | 4.6±6.1 (38)<br>(1.0, 33.0) | | ● Incidence of new organ failure from drainageprocedure to WON resolution 3 | 2.6% (1/39) | | ● Change of SF-12 score from baseline to: | | | Ο AXIOST™ stent removal 4 | 23.6±20.5 (37)<br>(-26.1, 67.2) | | Ο End of study 5 | 40.9±24.3 (27)<br>(-12.5, 81.3) | 1 One subject reached WON size <3cm 100 days after AXIOS™ stent placement. 2 All subjects (including those that were later lost to follow-up) had resolution of WON by 100 days after AXIOS™ stent placement and before AXIOS™ stent removal, i.e. by 6 month post-stent removal. 3 Organ failure assessment not collected for 1 subject. 4 SF-12 not collected for 3 subjects at time of stent removal. 5 SF-12 not collected for 7 subjects at 6-month WON assessment visit. The observed proportion of subjects who were positive for the Primary Safety Endpoint for the ITT cohort was 7.5% (3/40; 95% CI 1.6% to 20.4%). There were no unanticipated adverse device effects reported in this study. There were 49 adverse events (AEs) observed in 24 subjects since the beginning of the 49 adverse events, 36 were recorded as Serious Adverse Events (SAEs). Five AEs were related to the AXIOS™ stent and 7 AEs were related to a necrosectomy. There were no AEs related to the use of the Advanix™ 7Fr double pigtail plastic stent. Two (2) SAEs were reported as possibly AXIOSTMrelated or WON procedure-related and 4 SAEs were reported as related to necrosectomy. {8}------------------------------------------------ # 9. Conclusion Based on the clinical investigation results, technological characteristics, and prior nonclinical testing performed on the identical predicate device, the AXIOS™ Stent and Electrocautery-Enhanced Delivery System has been shown to be safe, effective, and substantially equivalent to the predicate device when 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, that are adherent to the gastric or bowel wall. In addition to the clinical evidence, labeling and other materials provided in this 510(k) premarket notification submission demonstrate compliance to the special controls prescribed in 21 CFR 876.5015.