(178 days)
Not Found
No
The summary describes a mechanical stent and delivery system with electrocautery, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts, which is a therapeutic intervention.
No
This device is a therapeutic device (stent and delivery system) used for drainage of pancreatic pseudocysts, not for diagnosing conditions.
No
The device description clearly details physical components including a stent, catheter, handle with manual controls, and connections to an electrosurgical unit, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The AXIOS™ Stent and Electrocautery-Enhanced Delivery System is a device used within the body (in vivo) to facilitate the drainage of pancreatic pseudocysts. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a procedure to drain a pseudocyst, not to perform a diagnostic test on a sample.
- Device Description: The description details a stent and a delivery system for implantation, not equipment for analyzing biological samples.
Therefore, the AXIOS™ Stent and Electrocautery-Enhanced Delivery System is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AXIOS™ Stent and Electrocautery-Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris. The stent is intended for implantation up to 60 davs and should be removed upon confirmation of pseudocyst 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 deploving 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
EUS, Fluoroscopy
Anatomical Site
Pancreatic pseudocysts, Gastric or bowel wall, 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)
The proposed AXIOS Stent and Electrocautery-Enhanced Delivery System successfully passed all pre-defined product specifications for the tests performed. Bench tests were performed including: Deployed Stent Saddle Length, Deployed Stent Saddle Outer Diameter, Deployed Stent Flange Width, Stent Pull-out Force, Stent (Saddle) Radial Strength -in compression & expansion, Deployment Force, Implant Anchor Function- Retention (tensile), Magnetic Resonance Testing, Fatigue Testing, Delivery System Working Length, Catheter Extension, Nose Lock Hold Force, Slider Lock Hold Force, Nose Lock Cycling, Slider Lock Cycling, Distal Pusher Catheter to Distal Nose Joint Strength, Pusher Catheter to Hypotube Joint Strength, Outer Sheath to Hypotube Joint Strength, Pusher Hypotube to Handle Joint Strength, Outer Sheath Hypotube to Handle Joint Strength, Distal Pusher to Proximal Pusher Catheter Joint Strength, Outer Sheath to Handle Torque Strength, Luer to Nose Joint Strength, Tracking Force. All tests passed.
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.
0
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April 15, 2021
Boston Scientific Corporation Aparna Philip Regulatory Affairs Specialist II 100 Boston Scientific Way Marlborough, MA 01752
Re: K203132
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: March 15, 2021 Received: March 16, 2021
Dear Aparna Philip:
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.
1
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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (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,
Je An -S Digitally signed
by Je An -S
Je Hi An, Ph.D. 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203132
Device Name
AXIOSTM Stent and Electrocautery-Enhanced Delivery System
Indications for Use (Describe)
The AXIOS™ Stent and Electrocautery-Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris. The stent is intended for implantation up to 60 davs 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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K203132 Page 1 of 5
SECTION 5: 510(K) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Primary Contact: Aparna Philip Regulatory Affairs Specialist II Telephone: 508-382-0259 E-mail: Aparna.Philip@bsci.com
Date Prepared: October 16, 2020
2. Device:
Trade Name:
Device Common Name:
Classification Name: Regulation Number:
Product Code: Classification:
3. Predicate Device
Trade Name:
510(k) Number: Device Common Name:
Classification Name:
Regulation Number:
Product Code:
Classification:
AXIOSTM Stent and Electrocautery-Enhanced Delivery System Pancreatic drainage stent and delivery system & endoscopic electrosurgery device Pancreatic Drainage Stent and Delivery System 21CFR 876.5015 21CFR 876.4300 PCU/KNS Class II
AXIOSTM Stent and Electrocautery-Enhanced Delivery System & AXIOS Stent and Delivery System K181905 Pancreatic drainage stent and delivery system & endoscopic electrosurgery device Pancreatic drainage stent and accessories and endoscopic electrosurgery accessories 21CFR 876.5015 21CFR 876.4300 PCU/ KNS Class II
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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 deploving 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 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 9 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 | ||
| O | ||
| 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 working channel | ||
| Delivery system is luer-locked to the proximal end of the biopsy port of the endoscope | ||
| Electrosurgical Unit or Generator | Select an electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2. Recommended electrosurgical units or generators include: ERBE VIO 300D ERBE ICC 200 ERBE VIO 300S 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 | Stent lumen diameter and short flow path/conduit to ⇒Facilitate passive efficient pseudocyst drainage | |
| 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 Electrocautery-Enhanced Delivery System- Main Features
5
6
5. Indications for Use:
The AXIOS Stent and Electrocautery-Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst resolution.
6. Technological Characteristics
The proposed AXIOS Stents (6 mm x 8 mm and 8 mm x 8 mm) and Electrocautery-Enhanced Delivery System retains similar performance compared to the predicate AXIOS Stent (10 mm x 10 mm) despite the dimensional differences of the stent and delivery system. The intended use, and over all mode of operation remains identical to the predicate AXIOS Stent and Electrocautery-Enhanced Delivery system cleared via K181905.
7. Performance Data
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.
| Table 5-2 Summary of Bench Tests and Results | |
|---|---|
| Test | Results (Pass/ Fail) |
| AXIOS Stent | |
| Deployed Stent Saddle Length | Pass |
| Deployed Stent Saddle Outer Diameter | Pass |
| Deployed Stent Flange Width | Pass |
| Stent Pull-out Force | Pass |
| Stent (Saddle) Radial Strength -in compression & expansion | Pass |
| Deployment Force | Pass |
| Implant Anchor Function- Retention (tensile) | Pass |
| Magnetic Resonance Testing | Pass |
| Fatigue Testing | Pass |
| AXIOS 9 Fr. Electrocautery-Enhanced Delivery System | |
| Delivery System Working Length | Pass |
| Catheter Extension | Pass |
| Nose Lock Hold Force | Pass |
| Slider Lock Hold Force | Pass |
| Nose Lock Cycling | Pass |
| Slider Lock Cycling | Pass |
| Distal Pusher Catheter to Distal Nose Joint Strength | Pass |
| Pusher Catheter to Hypotube Joint Strength | Pass |
| Outer Sheath to Hypotube Joint Strength | Pass |
| Pusher Hypotube to Handle Joint Strength | Pass |
| Outer Sheath Hypotube to Handle Joint Strength | Pass |
7
| Distal Pusher to Proximal Pusher Catheter Joint Strength | Pass |
|---|---|
| Outer Sheath to Handle Torque Strength | Pass |
| Luer to Nose Joint Strength | Pass |
| Tracking Force | Pass |
Conclusion
The information Boston Scientific Corporation provided in this submission demonstrates that the proposed AXIOS 6 mm x 8 mm x 8 mm x 8 mm Stent and Electrocautery-Enhanced Delivery System is substantially equivalent to the currently cleared AXIOS 10 mm x 10 mm Stent and Electrocautery-Enhanced Delivery System K181905.