(27 days)
No
The summary describes a mechanical stent and delivery system for draining pancreatic pseudocysts. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used to facilitate drainage of symptomatic pancreatic pseudocysts, serving a therapeutic purpose by addressing a medical condition.
No
The device is a stent and delivery system used for drainage of pancreatic pseudocysts. It facilitates a medical procedure rather than diagnosing a condition.
No
The device description clearly outlines a physical stent and a delivery system consisting of a catheter and handle with manual controls, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate endoscopic drainage of pancreatic pseudocysts and function as a port for further procedures. This is a therapeutic and interventional procedure performed directly on the patient's body.
- Device Description: The device is a stent and delivery system designed for implantation within the gastrointestinal tract. It is a physical device used to treat a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or conditions.
The device is a medical device used for a therapeutic intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AXIOS Stent and Delivery System is indicated for use to facilitate transqastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, with ≥ 70% fluid content that are adherent to the bowel wall. Once placed, the AXIOS Stent functions as a 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 resolution.
Product codes
PCU
Device Description
The AXIOS Stent and Delivery System is designed to secure the apposition of tissue, minimize stent displacement and create a large access/drainage lumen. The main features of the AXIOS Stent and Delivery System are presented in Table 2-1. There have been no changes to the AXIOS Stent or the delivery system; it is identical to the stent and delivery system cleared in 510(k) K140561.
The AXIOS Stent and Delivery System is provided sterile, disposable and intended for single patient use. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy, EUS (Endoscopic Ultrasound), Direct endoscopic viewing
Anatomical Site
Pancreatic pseudocysts, 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
The device modification involves changes to the Magnetic Resonance (MR) information, clinical information, and procedural instructions, supported by MR test data and clinical information submitted and cleared under K150692. No additional verification or validation activities were required to support the DFU changes. The MR data and clinical data that supported the proposed labeling modifications were also used to support the same labeling changes that were cleared for the AXIOS with Electrocautery Enhanced Delivery System per K150692.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an image of three stylized human profiles facing to the right, with a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2015
Boston Scientific Corporation Ashley Santos Regulatory Affairs Manager 453 Ravendale Drive. Suite H Mountain View, CA 94043
Re: K152572
Trade/Device Name: AXIOS Stent and Delivery System Regulation Number: 21 CFR§ 876.5015 Regulation Name: Pancreatic drainage stent and delivery system Regulatory Class: II Product Code: PCU Dated: September 4, 2015 Received: September 9, 2015
Dear Ashley Santos,
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.
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 (reporting of 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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
STATEMENT OF INDICATIONS FOR USE
510(k) NUMBER (IF KNOWN): K152572
DEVICE NAME: AXIOS Stent and Delivery System
INDICATIONS FOR USE:
The AXIOS Stent and Delivery System is indicated for use to facilitate transqastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, with ≥ 70% fluid content that are adherent to the bowel wall. Once placed, the AXIOS Stent functions as a 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 resolution.
Concurrence of CDRH, Office of Device Evaluations (ODE)
Prescription Use X (Per 21 CFR 901.109 OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
3
510(k) SUMMARY
AXIOS Stent and Delivery System
| Date Prepared: | October 2, 2015 |
|---|---|
| Manufacturer: | Boston Scientific Corporation |
| 453 Ravendale Drive, Suite H | |
| Mountain View, CA 94043 | |
| Contact: | Ashley Santos |
| Ashley.Santos@bsci.com | |
| Regulatory Affairs Manager (Marlborough, MA) | |
| Phone: 508-683-4359 | |
| Fax: 508-683-5939 | |
| Trade Name: | AXIOS Stent and Delivery System |
| Common Name: | Pancreatic Stent |
| Device Class: | Class II |
| Regulation: | 21 CFR 876.5015 |
| Product Code: | PCU |
| Review Panel: | Reproductive, Gastro-Renal and Urological Devices |
Predicate Device Information:
| Manufacturer | Name of Predicate Device | 510(k) # | Clearance Date |
|---|---|---|---|
| Boston Scientific* | AXIOS Stent and Delivery System | K140561 | April 23, 2014 |
| Boston Scientific* | AXIOS Stent with Electrocautery | ||
| Enhanced Delivery System | K150692 | August 8, 2015 |
*Manufacturer is now Boston Scientific Corporation through acquisition of Xlumena in April 2015.
Description:
The AXIOS Stent and Delivery System is designed to secure the apposition of tissue, minimize stent displacement and create a large access/drainage lumen. The main features of the AXIOS Stent and Delivery System are presented in Table 2-1. There have been no changes to the AXIOS Stent or the delivery system; it is identical to the stent and delivery system cleared in 510(k) K140561.
4
| 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 | |
| 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 | |
| AXIOS Stent | |
| 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 vand 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 2-1: AXIOS Stent and Delivery System - Main Features
The AXIOS Stent and Delivery System is provided sterile, disposable and intended for single patient use. 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.
5
Device Modification:
The AXIOS Stent with Delivery System Directions for Use (DFU) is being modified to align with the DFU of the AXIOS Stent with Electrocautery Delivery System that was cleared per K150692. The DFU modification involves changes to the Magnetic Resonance (MR) information, clinical information, and procedural instructions. These changes are supported by the MR test data and clinical information that was submitted and cleared per K150692. The patient implant card is also being revised to align with the AXIOS Stent with Electrocautery Delivery System language that was cleared per K150692.
Indications for Use:
Identical to the cleared AXIOS Stent and Delivery System (K140561) and the AXIOS Stent with Electrocautery Delivery System (K150692):
The AXIOS Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts > 6 cm in size. with > 70% fluid content that are adherent to the bowel wall. Once placed, the AXIOS Stent functions as a 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 resolution.
Substantial Equivalence Comparison:
There are no changes to the device in any way. The intended use/indication for use, technological characteristics, and principles of operation are the same as the predicate device. The minor changes to the DFU do not raise any new types of safety or effectiveness questions as confirmed by MR testing and a clinical trial. Therefore, the AXIOS Stent and Delivery System is substantially equivalent to the previously cleared predicate devices.
Summary of Verification & Validation Activities:
No additional verification or validation activities were required to support the DFU changes proposed in this submission for the AXIOS Stent with Delivery System. The MR data and clinical data that supported the proposed labeling modifications were also used to support the same labeling changes that were cleared for the AXIOS with Electrocautery Enhanced Delivery System per K150692.
Conclusion:
The modified DFU of the AXIOS Stent and Delivery System is substantially equivalent to the predicate devices.