(302 days)
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No
The summary describes a mechanical stent and delivery system with no mention of AI or ML capabilities.
Yes
The device is indicated for the drainage of symptomatic pancreatic pseudocysts and facilitates debridement, irrigation, and cystoscopy, which are therapeutic interventions.
No
The device is a stent and delivery system designed for therapeutic drainage of pancreatic pseudocysts. While it may allow access for "additional diagnostic or therapeutic procedures," its primary function is not diagnostic.
No
The device description clearly states that the AXIOS Stent and Delivery System consists of a catheter-based delivery system and an implantable stent, which are physical hardware components.
Based on the provided information, the AXIOS Stent and Delivery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to facilitate the drainage of pancreatic pseudocysts and provide access for therapeutic procedures. This is a direct intervention on the patient's body.
- Device Description: The device is an implantable stent and a delivery system used to place the stent within the body.
- Mechanism of Action: The stent functions as a conduit for drainage and access, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
The AXIOS Stent and Delivery System is a therapeutic medical device used for a surgical/interventional procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
PCU
Device Description
The AXIOS Stent and Delivery System consists of two major components, the catheter-based delivery system and the implantable stent. The stent is a flexible, fully-covered. self-expanding Nitinol stent, which is preloaded within the catheter-based delivery system. The system is intended to cannulate the transgastric or transduodenal wall into a pancreatic pseudocyst for endoscopic drainage. The stent serves as a conduit for passive drainage of pseudocyst contents directly into the GI tract. The large lumen diameter provides a short path and may allow secure access to the pseudocyst interior for additional diagnostic or therapeutic procedures. An endosonographic exam is performed to locate the pancreatic pseudocyst, measure the size, assess the fluid content, and evaluate wall adherence of the pseudocyst. Once the endosonographic exam is complete, an access tract is created using conventional access tools. The stent and delivery system is then inserted into the endoscope and the stent is delivered. The AXIOS Stent is designed with a duplicate "anchor" or "flange" on each end to achieve tissue apposition and prevent migration. The stent is radiopaque and is fully covered with silicone to prevent leakage, minimize tissue in-growth, and facilitate removal. The large diameter is intended to facilitate efficient drainage. The AXIOS Stent will be provided in two lumen diameters and one length (10mm and 15mm lumen diameter, 10mm length). The AXIOS Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The AXIOS Delivery System is sized to fit within commercially available echoendoscopes with a working channel of 3.7 mm diameter or larger. The Delivery System catheter is 138 cm in working length and attached directly to the endoscope handle. The AXIOS Delivery System requires an access site of at least 10 Fr. The AXIOS Stent and Delivery System is provided sterile, disposable and intended for use during a single patient procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Endoscopic ultrasonography (EUS), abdominal CT, abdominal ultrasound, MRI
Anatomical Site
Pancreatic pseudocysts, transgastric or transduodenal wall
Indicated Patient Age Range
18 and 75 years old
Intended User / Care Setting
Physicians familiar with endoscopic ultrasonography and endoscopic stent placement techniques.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Feasibility Clinical Study:
- Study Type: Non-randomized feasibility clinical study.
- Sample Size: 15 subjects.
- Data Source: Single site, Tokyo Medical University. Results published in April 2012 in "Gastrointestinal Endoscopy" (retrospective case series).
- Key Results:
- Technical success (ability to deploy, implant, and remove the AXIOS stent): All stents deployed and removed without difficulty.
- Clinical success (pseudocyst resolution through implantation period and follow-up at 1, 3, and 6 months): Pseudocyst resolved in all subjects.
- Stents implanted for 8-82 days and patent at removal.
Pivotal Clinical Study:
- Study Type: Prospective, multi-center, single-arm study under an IDE.
- Sample Size: 33 subjects enrolled at seven sites.
- Safety Evaluation: Evaluated with regard to stent placement, stent migration, and tissue response for up to 7 days after stent removal.
- Effectiveness Measurement: Pseudocyst resolution (at least 50% reduction in size) and device performance. Telephone follow-up at 3 and 6 months post removal.
- Key Effectiveness Results:
- 90.9% of subjects had successful stent placement (30 of 33 procedures, ITT population).
- 93.1% of subjects (27 of 29) had stent lumens that were patent at stent removal (Per-Protocol population).
- 96.6% of stents (28 of 29) were successfully removed using standard endoscopic tools (Per-Protocol population). One was inadvertently dislodged.
- Clinical success (at least 50% decrease in pseudocyst size at time of stent removal) was observed for 86.2% (25 of 29 pseudocysts, Per-Protocol population).
- Mean pseudocyst diameter decreased from a baseline of 9.0 cm to 3.1 cm at 30 days (29 subjects), and 1.6 cm at 60 days (10 subjects).
- Key Safety Results:
- Freedom from major complications safety outcome met if 85% of subjects are free of major complications through 1 week post-removal visit.
- Overall Safety (freedom from major complications): 84.8% (28/33) for ITT subjects, and 86.2% (25/29) for Per-Protocol subjects.
- 45 adverse events reported among 33 subjects (29 post-index procedure, 16 post-removal).
- 5 subjects with major complications (2 probably device-related, 3 probable procedure-related).
- 25 serious adverse events (SAEs) occurred among 16 of 33 ITT subjects (48.5%).
- 7 SAEs (21.2%) were related to the procedure or device among ITT subjects.
- No life-threatening events were determined to be related to the procedure or device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Technical success (placement and removal): 90.9% (30/33) ITT, 96.7% (29/30) mITT
- Stent Lumen Patency: 93.1% (27/29) Per-Protocol
- Clinical Success (at least a 50% decrease in pseudocyst size): 86.2% (25/29) Per-Protocol
- Overall Effectiveness: 86.2% (25/29) Per-Protocol
- Freedom from Major Complications (Overall Safety): 84.8% (28/33) ITT, 86.2% (25/29) Per Protocol.
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.
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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.
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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).
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§ 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
DE NOVO CLASSIFICATION REQUEST FOR XLUMENA AXIOS STENT AND DELIVERY SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Pancreatic drainage stent and delivery system. 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.
NEW REGULATION NUMBER: 21 CFR 876.5015
CLASSIFICATION: II
PRODUCT CODE: PCU
BACKGROUND
DEVICE NAME: AXIOS STENT AND DELIVERY SYSTEM
SUBMISSION NUMBER: K123250
DATE OF DE NOVO: FEBRUARY 19, 2013
- CONTACT: XLUMENA, INC. Jane beggs, VP Regulatory and Clinical Affairs 453 RAVENSDALE DRIVE SUITE H MOUNTAIN VIEW, CA 94043
REQUESTER'S RECOMMENDED CLASSIFICATION: II
INDICATIONS FOR USE
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.
1
LIMITATIONS
The sale, distribution, and use of the AXIOS Stent and Delivery System is limited to prescription use only.
The AXIOS Stent has been shown to be MR Conditional and can be scanned safely under the following conditions:
- · Static magnetic field of 3-Tesla or less
- · Maximum spatial gradient magnetic field of 720 Gauss/cm or less
- · Maximum whole body averaged specific absorption rate (SAR) or 2-W/kg for 15 minutes of scanning.
The safety of the delivery system has not been evaluated in the MR environment, and, therefore, the delivery system should not be used within the MR environment.
Limitations on device use are also achieved through the following statements included in the Instructions for Use:
Placement of the AXIOS™ Stent should be performed by physicians familiar with endoscopic ultrasonography and endoscopic stent placement techniques.
The AXIOS Stent implantation should not exceed 60 days.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The AXIOS Stent and Delivery System consists of two major components, the catheter-based delivery system and the implantable stent, as shown in Figure 1 below. The stent is a flexible, fully-covered. self-expanding Nitinol stent, which is preloaded within the catheter-based delivery system.
The system is intended to cannulate the transgastric or transduodenal wall into a pancreatic pseudocyst for endoscopic drainage. The stent serves as a conduit for passive drainage of pseudocyst contents directly into the GI tract. The large lumen diameter provides a short path and may allow secure access to the pseudocyst interior for additional diagnostic or therapeutic procedures.
An endosonographic exam is performed to locate the pancreatic pseudocyst, measure the size, assess the fluid content, and evaluate wall adherence of the pseudocyst. Once the endosonographic exam is complete, an access tract is created using conventional access tools. The stent and delivery system is then inserted into the endoscope and the stent is delivered.
2
Image /page/2/Figure/0 description: Figure 1 shows the AXIOS Stent and Delivery System. The image shows the handle, catheter, sheathed AXIOS stent, and deployed AXIOS stent. The catheter is a long, thin tube that is used to deliver the stent to the target location. The sheathed AXIOS stent is the stent before it has been deployed, and the deployed AXIOS stent is the stent after it has been deployed.
Stent
As shown in Figure 2 below, the AXIOS Stent is designed with a duplicate "anchor" or "flange" on each end to achieve tissue apposition and prevent migration. The stent is radiopaque and is fully covered with silicone to prevent leakage, minimize tissue in-growth, and facilitate removal. The large diameter is intended to facilitate efficient drainage.
The AXIOS Stent will be provided in two lumen diameters and one length, for a total of two different stent models, to accommodate the various anatomy and cyst content. The stent sizes are provided in Table 1 below.
| Table 1: AXIOS Stent Sizes | ||
|---|---|---|
| Catalog Number | AXS-10-10 | AXS-15-10 |
| Stent Lumen Diameter (mm) | 10 | 15 |
| Stent Length (mm) | 10 | 10 |
hla 1. A VIOC Stant Siz
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Delivery System
The AXIOS Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The AXIOS Delivery System is sized to fit within commercially available echoendoscopes with a working channel of 3.7 mm diameter or larger. The Delivery System catheter is 138 cm in working length and attached directly to the endoscope handle. The AXIOS Delivery System requires an access site of at least 10 Fr.
The AXIOS Stent and Delivery System is provided sterile, disposable and intended for use during a single patient procedure.
Refer to the instructions for use for complete information for stent deployment and removal, including a list of warnings, precautions and contraindications.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The materials for the stent and delivery device are listed in Tables 2 and 3 below:
| Component
Name | Material | Patient
Contact |
|-------------------|--------------------------------------------|--------------------|
| Stent | Nitinol (Nickel-Titanium) | Direct |
| Covering | Silicone (b)(4) Trade Secret | Direct |
| Stent Covering | Silicone (b)(4) Trade Secret/CCI | Direct |
| Stent Lubricant | Silicone Lubricant (b)(4) Trade Secret/CCI | Direct |
Table 2: Stent Materials
Table 3: Delivery System Materials
| Component Name | Material | Patient
Contact |
|-------------------------------------------------|-------------------------|--------------------|
| Catheter | (b)(4) Trade Secret/CCI | Direct |
| RO Marker | | |
| Catheter
(b)(4) Trade Secret/CCI | | |
| Outer Sheath
(b)(4) Trade Secret/CCI | | |
| Outer Sheath Coating
(b)(4) Trade Secret/CCI | | |
| Nose Cone
(b)(4) Trade Secret/CCI | | None |
| Handle
(b)(4) Trade Secret/CCI | | |
4
| Winged Luer, | (b)(4) Trade Secret/CCI | |
|---|---|---|
The stent is classified as an implanted device with tissue contact for an extended duration (>30 days). In accordance with ISO10993-1, Biological evaluation of medical devices, the following tests were performed on the stent:
- Cytotoxicity ●
- Sensitization ●
- Implantation ●
- Sub-chronic toxicity ●
- Genotoxicity ●
- Acute systemic toxicity ●
- Irritation ●
The (b)(4) Trade Secret/CCI lubricant was not a part of the biocompatibility studies, since this lubricant was added subsequent to the biocompatibility testing and after the completion of the clinical study. In order to assess the biocompatibility of the final, finished, sterilized device, with the (b)(4) Trade s ere cellubricant, the following additional testing and information was provided:
- Device master file (b)(4) Trade Secret/con ●
- 6-month animal study of two different stent lubricants to evaluate local tissue ● response
- Toxicological risk assessment of ethyltriacetoxysilane, a component of ●
- Cytotoxicity testing of the AXIOS stent (b)(4) Trade Secret/CCI coating ●
- Biocompatibility testing reports of the (b)(4) Trade Secret/CCI ●
- (4) Trade Secretce 0 product profile for comparison .
- Summary of OUS adverse events of the AXIOS stent with the (b)(4) Trade Secret/CCI ●
- Toxicological risk assessment of the AXIOS stent with the (6)(4) Trade Secretect coating
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The delivery system is classified as an externally communicating device, with tissue contact for limited duration ( 70% fluid content that are adherent to the bowel wall, the probable benefits outweigh the probable risks for the AXIOS Stent and Delivery System. The device provides substantial benefits and the risks can be mitigated by the use of general controls and the identified special controls.
20
CONCLUSION
The de novo for the AXIOS Stent and Delivery System is granted and the device is classified under the following:
Product Code: PCU Device Type: Pancreatic drainage stent and delivery system Class: II Regulation: 21 CFR 876.5015