(237 days)
Not Found
No
The summary describes a mechanical stent and its delivery system, with no mention of AI or ML capabilities.
Yes
The device is indicated for use to facilitate endoscopic drainage of symptomatic pancreatic pseudocysts and Walled Off Necrosis, and functions as an access port for debridement, irrigation, and cystoscopy. This directly addresses and treats a medical condition, qualifying it as a therapeutic device.
No
Explanation: The AXIOS™ Stent is a therapeutic device used to facilitate drainage of pancreatic pseudocysts and walled-off necrosis. It functions as an access port and aids in debridement and irrigation, but does not diagnose conditions.
No
The device description clearly details a physical stent and a delivery system, which are hardware components.
Based on the provided information, the AXIOS™ Stent is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- AXIOS™ Stent Function: The AXIOS™ Stent is a medical device designed for implantation to facilitate drainage of pancreatic pseudocysts and Walled Off Necrosis. It acts as an access port for endoscopic procedures and is a therapeutic device used within the body.
- Lack of Specimen Analysis: The description of the AXIOS™ Stent and its intended use does not involve the analysis of any specimens derived from the human body for diagnostic purposes.
Therefore, the AXIOS™ Stent falls under the category of an implantable medical device used for therapeutic and procedural purposes, not an In Vitro Diagnostic.
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 ≥ 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.
Product codes
PCU, KNS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
transgastric or transduodenal
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)
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
§ 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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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. 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,
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)
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ------------------------------------------------------------------------------------------------ |
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
| ----------------------------------------------- |
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K220112 Page 1 of 6
510(k) SUMMARY SECTION 1.
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Primary Contact: Ian Broome, M.S., RAC Senior Regulatory Affairs Specialist Telephone: (617) 517-4932
Date Summary Prepared:
6 September 2022
2. 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 |
| between two (2) Platinum Iridium | |
| Markers Electrocautery Tip for precise cutting (in | |
| the Electrocautery-Enhanced Delivery | |
| System only) 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 working channel Delivery system is Luer-locked to the | |
| proximal end of the biopsy port of the | |
| endoscope | |
| Component/Design | Feature Description |
| Suggested Electrosurgical Unit or | |
| Generator (Electrocautery-Enhanced | |
| 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