(89 days)
Not Found
No
The description focuses on the mechanical and electrical components of a stent and delivery system, with no mention of AI or ML capabilities.
Yes
The device is described as facilitating endoscopic drainage and allowing passage of therapeutic endoscopes for debridement, irrigation, and cystoscopy, which are all therapeutic actions.
No
The device is a stent and delivery system designed to facilitate endoscopic drainage of pancreatic pseudocysts and walled-off necrosis, acting as an access port for therapeutic procedures, not for diagnostic purposes.
No
The device description clearly details a physical stent and a delivery system, which are hardware components. There is no mention of software being the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The AXIOS Stent and Electrocautery Enhanced Delivery System is a medical device used for a surgical procedure (endoscopic drainage) within the body. It is an implantable device designed to facilitate drainage and access to pancreatic pseudocysts and walled-off necrosis.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is mechanical and electrical, facilitating drainage and access.
Therefore, the description clearly indicates a device used for a therapeutic procedure within the body, not for in vitro diagnostic testing of samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
PCU, KNS
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy, EUS confirmation, Direct endoscopic viewing
Anatomical Site
transgastric or transduodenal (gastrointestinal tract)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing: The proposed AXIOS Stent and Electrocautery Enhanced Delivery System successfully passed all pre-defined product specifications for the tests performed. Tests included: Deployed Stent Saddle Length, Deployed Stent Saddle Outer Diameter, Deployed Stent Flange Width, Stent Pull-out Force (tensile), Stent (Saddle) Radial Strength - in expansion, Stent (Saddle) Radial Strength - in compression, Tracking Force, Stent Fatigue, Stent Deployment Force, Implant Anchor Function- Retention (tensile), MR Testing. All tests resulted in "Pass".
Animal Testing: The safety and performance of the proposed AXIOS Stent and Electrocautery Enhanced Delivery System was evaluated in animal models. The proposed device performed as intended and did not raise any new issues of safety or performance.
Clinical Literature Review: Clinical data was collected through a clinical literature review which evaluated the performance of larger diameter metal stents (≥20mm) for treatment of Walled off Pancreatic Necrosis. The conclusion of the analysis demonstrated that the clinical success of the larger diameter stents was similar to the success rates offered in the IDE for the 10mm and 15mm stent sizes. In addition, there was no increased risk for stent migration as the stent flange diameter was increased to compensate for the increased stent lumen diameter. The larger stent lumen diameter enhances drainage of Walled off Necrosis and can also ease the of passage of associated endoscopic devices. The clinical literature, referenced in this submission, did not identify any new risks associated with larger diameter metal stents.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. The symbol is composed of three curved lines that form the shape of a head and body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 18, 2017
Boston Scientific Corporation Kayla Mackey Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K163272
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: November 18, 2016 Received: November 23, 2016
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Charles Viviano -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
2
Indications for Use
510(k) Number (if known) Unknown K163272
Device Name
AXIOS 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 ≥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) |
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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: Kayla Mackey Regulatory Affairs Specialist Telephone: 508-683-4534 Fax: 508-683-5939
Secondary Contact: Ashley Santos Regulatory Affairs Manager Telephone: 508-683-4359 Fax: 508-683-5939
Date Prepared: November 18, 2016
2. Device:
| 2. Device | |
|---|---|
| Trade Name: | AXIOS™ Stent and Electrocautery-Enhanced |
| Delivery System | |
| Device Common Name: | Pancreatic drainage stent and delivery system & |
| endoscopic electrosurgery device | |
| Classification Name: | Pancreatic drainage stent and accessories and |
| endoscopic electrosurgery accessories | |
| Regulation Number: | 21CFR 876.5015 |
| 21CFR 876.4300 | |
| Product Code: | Primary Code: PCU |
| Secondary Code: KNS | |
| Classification: | Class II |
| 3. Predicate Device | |
| Trade Name: | AXIOS™ Stent and Electrocautery-Enhanced |
| Delivery System | |
| 510(k) Number: | K153088 |
| Device Common Name: | Pancreatic drainage stent and delivery system &
endoscopic electrosurgery device | |
|----------------------|----------------------------------------------------------------------------------------|--|
| Classification Name: | Pancreatic drainage stent and accessories and
endoscopic electrosurgery accessories | |
| Regulation Number: | 21CFR 876.5015
21CFR 876.4300 | |
4
Product Code:
Classification:
Primary Code: PCU Secondary Code: KNS Class II
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.
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. 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 Enhanced Delivery System Outer Diameter 10.8 Fr Fluoroscopy: AXIOS Stent is contained between two (2) Platinum Iridium Markers Electrocautery Tip for precise cutting Monopolar 750VP or 1500Vp-p Rated Accessory Voltage IEC 60601-1 compliant |
| 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 Compatibility | 0.035” insulated guidewires |
| Endoscope Compatibility | Compatible with 3.7 mm diameter or larger |
Table 5-1: AXIOS Stent and Electrocautery Enhanced Delivery System- Main Features
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| working channel Delivery system is luer-locked to the proximal end of the biopsy port of the endoscope | |
|---|---|
| Electrosurgical Unit or Generator | Compliant to IEC 60601-1-2 and IEC 60601-2-2 o ERBE VIO 300D o ERBE ICC 200 o ERBE VIO 300S o ERBE VIO 200D |
| 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 |
| 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.
6
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 (20mm x 10mm) and Electocautery Enhanced Delivery System is identical to the predicate AXIOS Stent (15mm x 10mm) and Electrocautery Enhanced Delivery System with the exception of the stent size. The proposed AXIOS Stent has a stent lumen diameter of 20 mm and a stent flange diameter of 29 mm. There are no changes to the delivery system. The intended use, electrocautery enhanced delivery system, and mode of operation remains identical to the predicate AXIOS Stent and Electrocautery Enhanced Delivery system cleared via K153088.
7. Performance Data
Bench Testing:
The proposed AXIOS Stent and Electrocautery Enhanced Delivery System successfully passed all pre-defined product specifications for the tests performed. 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 | Stent Pull-out Force (tensile) | Pass |
| 5 | Stent (Saddle) Radial Strength -in expansion | Pass |
| 6 | Stent (Saddle) Radial Strength -in compression | Pass |
| 7 | Tracking Force | Pass |
| 8 | Stent Fatigue | Pass |
| 9 | Stent Deployment Force | Pass |
| 10 | Implant Anchor Function- Retention (tensile) | Pass |
| 11 | MR Testing | Pass |
Animal Testing:
The safety and performance of the proposed AXIOS Stent and Electrocautery Enhanced Delivery System was also evaluated in animal models. The proposed device performed as intended and did not raise any new issues of safety or performance.
Clinical Literature Review:
Clinical data was collected through a clinical literature review which evaluated the performance of larger diameter metal stents (≥20mm) for treatment of Walled off Pancreatic Necrosis. The conclusion of the analysis demonstrated that the clinical success of the larger diameter stents was similar to the success rates offered in the IDE for the 10mm and 15mm stent sizes. In addition,
7
there was no increased risk for stent migration as the stent flange diameter was increased to compensate for the increased stent lumen diameter. The larger stent lumen diameter enhances drainage of Walled off Necrosis and can also ease the of passage of associated endoscopic devices. The clinical literature, referenced in this submission, did not identify any new risks associated with larger diameter metal stents. In conclusion, BSC believes that the safety and effectiveness of a larger diameter metal stent like the proposed AXIOS 20mm Stent is comparable to the currently cleared AXIOS Stents.
Conclusion
The information Boston Scientific Corporation provided in this submission demonstrates that the proposed AXIOS 20 mm Stent and Electrocautery Enhanced Delivery System is substantially equivalent to the currently cleared AXIOS Stent and Electocautery Enhanced Delivery System K153088.