(252 days)
The AXIOS Stent and Delivery System & AXIOS Stent and Electrocautery Enhanced Delivery System are 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.
The AXIOS Stent is a flexible, MR conditional, fully-covered self-expanding braided nitinol stent, which comes preloaded into the 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.
Non-Cautery Enhanced 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.
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 Sten. 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.
The provided text describes a 510(k) submission for the AXIOS Stent and Delivery System. The focus of this submission is to reinstate a passivation/etching manufacturing step that had previously been removed. Because the change involves reinstating a prior manufacturing step and the device is being claimed as substantially equivalent to previously cleared versions, the performance data presented is primarily bench testing to confirm that the reinstation of this step does not negatively impact the device's performance or safety.
Here's the breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" values in a quantitative format for each test. Instead, it states that the device "successfully passed all pre-defined product specifications and is equivalent to the predicate passivated AXIOS stent for the tests performed." This implies that the acceptance criteria for each test were met, resulting in a "Pass" outcome.
| Test | Reported Device Performance (Pass/Fail) | Acceptance Criteria (Implied) |
|---|---|---|
| Deployed Stent Saddle Length | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Deployed Stent Saddle Outer Diameter | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Deployed Stent Flange Width | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Corrosion Testing via ASTM Standard F2129 | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Stent Fatigue | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Stent Radial Strength – in expansion & in compression | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Stent Deployment Force | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Biocompatibility Testing (Cytotoxicity test on finished stent) | Pass | Confirmed manufacturing change did not impact toxicity; equivalent to predicate device |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each bench test conducted (e.g., number of stents tested for fatigue, corrosion, etc.). It only lists the types of tests performed.
The data provenance is from bench testing performed to verify design and validation requirements after reinstating a manufacturing step. The document does not specify if these tests were conducted internally by Boston Scientific or by an external laboratory. It does not refer to patient data (retrospective or prospective), as this submission is focused on a manufacturing change for an already cleared device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission concerns bench testing of a physical device for manufacturing changes, not diagnostic or interpretive tasks requiring expert ground truth establishment.
4. Adjudication method for the test set
Not applicable. This submission concerns bench testing of a physical device, not a diagnostic study requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for a medical device (stent and delivery system), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This submission is for a medical device (stent and delivery system), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" would be the pre-defined product specifications and performance characteristics of the predicate device. The tests were designed to verify that the modified device met these engineering and material standards. For example, for "Deployed Stent Saddle Length," the ground truth would be the specified design length within allowable tolerances.
8. The sample size for the training set
Not applicable. This submission focuses on bench testing a physical device after a manufacturing change, not on training a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a machine learning algorithm in this submission.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 25, 2019
Boston Scientific Corporation Kayla Mackey Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K181905
Trade/Device Name: AXIOS Stent and Delivery System, 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: February 25, 2019 Received: February 26, 2019
Dear Kayla Mackey:
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. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino -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 | Form Approved: OMB No. 0910-0120 |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| 510(k) Number ( if known ) | |
| Unknown K181905 | |
| Device Name | |
| AXIOS Stent and Delivery System | |
| AXIOS Stent and Electrocautery Enhanced Delivery System | |
| Indications for Use (Describe) | |
| The AXIOS Stent and Delivery System & AXIOS Stent and Electrocautery Enhanced Delivery System are 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) | |
| 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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| FORM FDA 3881 (7/17) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
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SECTION 5. 510(K) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Kayla Mackey Regulatory Affairs Specialist Telephone: 508-683-4534 Fax: 508-683-5939
Date Prepared: July 13, 2018
2. Device:
Trade Name:
Device Common Name: Classification Name:
Regulation Number:
Product Code:
Classification:
AXIOS™ Stent and Electrocautery-Enhanced Delivery System Pancreatic drainage stent and delivery system & endoscopic electrosurgical unit and accessories Pancreatic drainage stent and delivery system and endoscopic electrosurgical unit and accessories 21CFR 876.5015 21CFR 876.4300 PCU/ KNS Class II
Trade Name: AXIOSTM Stent and Delivery System Device Common Name: Pancreatic drainage stent and delivery system Classification Name: Pancreatic drainage stent and delivery system Regulation Number: 21CFR 876.5015 Product Code: PCU Classification: Class II
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-
- Predicate Device
| Trade Name: | AXIOST™ Stent and Electrocautery-EnhancedDelivery System & AXIOSTM Stent |
|---|---|
| 510(k) Number: | K153088/ K163272 |
| Device Common Name: | Pancreatic drainage stent and delivery system &endoscopic electrosurgical unit and accessories |
| Classification Name: | Pancreatic drainage stent and delivery systemand endoscopic electrosurgical unit andaccessories |
| Regulation Number: | 21CFR 876.501521CFR 876.4300 |
| Product Code: | PCU/ KNS |
| Classification: | Class II |
| Trade Name: | AXIOSTM Stent and Delivery System |
| 510(k) Number: | K153088 |
| Device Common Name: | Pancreatic drainage stent and delivery system |
| Classification Name: | Pancreatic drainage stent and delivery system |
| Regulation Number: | 21CFR 876.5015 |
| Product Code: | PCU |
4. Device Description
AXIOS Stent:
The AXIOS Stent is a flexible, MR conditional, fully-covered self-expanding braided nitinol stent, which comes preloaded into the 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.
Non-Cautery Enhanced 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.
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 Sten. The AXIOS Electrocautery Enhanced Delivery System is designed to be used in the gastrointestinal tract with
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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 AXIOS Stent and Electrocautery Enhanced Delivery System.
| Component/Design | Feature Description |
|---|---|
| Catheter | • Provided sterile, for single-patient use• Working length:138 cm Electrocautery EnhancedDelivery System139 cm Non-cautery DeliverySystem• Outer Diameter 10.8 Fr• Fluoroscopy: AXIOS Stent is containedbetween two (2) Platinum IridiumMarkers |
| Handle | • Staged delivery system for precise stentplacement⇒Two (2)-step release of each flange,including a full "stop"⇒Lock-out after the release of the firstflange, preventing unintendeddeployment of the second flange |
| Guidewire CompatibilityEndoscope Compatibility | 0.035" insulated guidewires• Compatible with 3.7 mm diameter orlarger working channel• Delivery system is luer-locked to theproximal end of the biopsy port of theendoscope |
| AXIOS Stent Design | • Bi-flange or double anchor for Staged andPrecise 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 flowpath/conduit to⇒Facilitate passive efficient drainage |
| ⇒Facilitate passage of endoscopictools 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 |
| 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 |
Table 5-1: AXIOS Stent and Delivery System- Main Features
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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.
6. Technological Characteristics
The proposed AXIOS Stent is equivalent to the predicate AXIOS stent. A manufacturing change was made to remove the passivation/etching manufacturing step. This change was documented internally. The purpose of this 510(k) is to reinstate this manufacturing step. There are no changes to the delivery system for either the electrocautery-enhanced version or the non-electrocautery enhanced version. The stent dimensions and materials, intended use, delivery system, and mode of operation remains identical to the predicate AXIOS Stent and Electrocautery Enhanced Delivery system and AXIOS Stent and Delivery System cleared via K153088 & K163272.
7. Performance Data
Bench Testing:
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The proposed passivated AXIOS Stent successfully passed all pre-defined product specifications and is equivalent to the predicate passivated AXIOS stent for the tests performed. There are no changes to the delivery system or the stent dimensions for the current AXIOS stents. Below is a summary of the tests performed to show the proposed device satisfied all design verification and validation requirements.
| Test | Results (Pass/ Fail) | |
|---|---|---|
| 1 | Deployed Stent Saddle Length | Pass |
| 2 | Deployed Stent Saddle Outer Diameter | Pass |
| 3 | Deployed Stent Flange Width | Pass |
| 4 | Corrosion Testing via ASTM Standard F2129 StandardTest Method for Conducting Cyclic PotentiodynamicPolarization Measurements to Determine the CorrosionSusceptibility of Small Implant Devices | Pass |
| 5 | Stent Fatigue | Pass |
| 6 | Stent Radial Strength –in expansion & in compression | Pass |
| 7 | Stent Deployment Force | Pass |
8. Biocompatibility Testing:
The proposed AXIOS Stent is equivalent to the predicate AXIOS stent. A manufacturing change was made to remove the passivation/etching manufacturing step. This change was documented internally. The purpose of this 510(k) is to reinstate this manufacturing step. There are no changes to the delivery system for either the electrocautery-enhanced version of the non-electrocautery enhanced version. The predicate biocompatibility testing conducted per EN ISO 10993-1 continues to be representative of the proposed AXIOS stent and delivery systems. Boston Scientific did conduct a Cytotoxicity test on the finished stent as a screening test to ensure the manufacturing change did not impact the toxicity of the device.
Conclusion
The purpose of this 510(k) is to reinstate the passivation/etching manufacturing step for the AXIOS stents. The manufacturing change to the passivation/etching step has been reinstated and remains identical to the predicate AXIOS device cleared via K153088 and K163272. The information Boston Scientific Corporation provided in this submission demonstrates that the proposed AXIOS Stent is substantially equivalent to the currently cleared AXIOS Stents cleared via K153088 & K163272.
§ 876.5015 Pancreatic drainage stent and delivery system.
(a)
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.(b)
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.