(144 days)
No
The summary describes a mechanical stent and delivery system with electrocautery, and there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is a stent delivery system and stent used to drain the gallbladder in patients with acute cholecystitis, which directly treats a medical condition.
No
The device is indicated for facilitating endoscopic drainage of the gallbladder and acts as a stent, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components including a stent, catheter, handle with manual controls, and a connection to an electrosurgical unit. This indicates it is a hardware device, not software-only.
Based on the provided information, the AXIOS Stent and Electrocautery Enhanced Delivery System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "facilitate transgastric or transquodenal endoscopic drainage of the gallbladder." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a stent and a delivery system designed for placement within the gastrointestinal tract. It is a physical implant and a tool for delivering that implant.
- Mechanism of Action: The device works by creating a drainage pathway and maintaining its patency. This is a mechanical and structural function within the body.
- Lack of In Vitro Testing: The description and performance studies focus on clinical outcomes in patients, not on testing samples (like blood, urine, or tissue) outside of the body.
- Anatomical Site: The device is used within the gastrointestinal tract and gallbladder, which are internal anatomical sites.
IVDs are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. The AXIOS system does not perform such examinations. It is a therapeutic device used for drainage.
N/A
Intended Use / Indications for Use
The AXIOS Stent and Electrocautery-Enhanced Delivery System (10 mm x 10 mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15 mm x 10 mm Stent) is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery.
Product codes
QXH
Device Description
The AXIOS Stent and Electrocautery-Enhanced Delivery system is designed to help facilitate the transgastric or transduodenal endoscopic drainage of the gallbladder. The AXIOS Stent remains identical to the stents cleared previously per K220112.
The AXIOS Stent is a flexible, magnetic resonance conditional, fully covered, self-expanding, braided nitinol stent, which comes preloaded into the delivery system. The AXIOS stent is designed with two flanges, one 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 (Figure 1), The stent is fully covered with silicone to prevent leakage, discourage tissue in-growth within the nitinol woven braid, and facilitate removal.
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 chamel 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic ultrasonography (EUS)
Anatomical Site
Gallbladder (transgastric or transduodenal)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians familiar with endoscopic ultrasonography and who have received training for AXIOS Stent placement techniques.
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)
Nonclinical/Bench Studies:
- Study Type: Performance Testing
- Sample Size: Not specified for each test, but quantities sufficient to conduct tests (e.g., "Test stents").
- Key Results: All performance tests (Deployed Stent Saddle Length, Deployed Stent Saddle Outer Diameter, Deployed Stent Flange Width, Stent Pull-Out Force, Stent (Saddle) Radial Strength – Compression & Expansion, Deployment (Unsheathing) Force, Implant Anchor Function – Retention (Tensile), Magnetic Resonance Testing, Fatigue Testing, Corrosion Testing, Delivery System Working Length, Slider lock hold force testing, Nose lock hold force, Nose/slide lock cycling, Joint Strength Testing, Luer to Nose Joint Strength, Outer Sheath to Handle Torque Strength, Tracking Force) passed their respective acceptance criteria.
Clinical Study (Pivotal Study):
- Study Type: Single-arm pivotal study
- Sample Size: 30 subjects (ITT cohort), 28 subjects (Treated/Per Protocol (PP) cohorts)
- Key Results:
- Primary Effectiveness Endpoints:
- Initial analysis (ITT, 2 non-recipients censored at 60 days): Mean days to resolution of AC = 5.30 ± 14.90 days. Upper bound of 97.8% CI (10.78 days) was greater than performance goal of 3.5 days, thus failed.
- Additional analysis (ITT, regardless of implantation): Mean days to resolution of AC = 1.60 ± 1.50 days. Upper bound of 97.8% CI (2.15 days) was less than performance goal of 3.5 days, thus met hypothesis.
- Treated/PP cohorts: Mean days to resolution of AC = 1.39 ± 0.92 days. Upper bound of 97.8% CI (1.74 days) was less than performance goal of 3.5 days, thus met hypothesis.
- Secondary Effectiveness Endpoint (Rate of re-interventions):
- ITT patients: 16.7% (5/30), upper bound of 99.7% CI (42.0%) was less than performance goal of 46.2%, thus met hypothesis.
- Treated/PP patients: 14.3% (4/28), upper bound of 99.7% CI (40.2%) was less than performance goal of 46.2%, thus met hypothesis.
- Additional Endpoints:
- Stent patency at stent removal visit: 100.0% (22/22)
- Technical stent placement success: 93.3% (28/30)
- Technical stent removal success: 100% (19/19)
- Recurrence of acute cholecystitis symptoms: 10.0% (3/30)
- Mean cumulative hospital days: 8.0 ± 6.9 days
- Primary Effectiveness Endpoints:
Meta-Analysis of Clinical Literature:
- Study Type: Systematic review and meta-analysis
- Sample Size: 17 articles, encompassing 713 patients (for overall analysis across outcomes)
- Key Results (Meta-analysis Point Estimate (95% CI)):
- Technical Success: 97.0% (95.1%, 98.5%)
- Clinical Success: 92.0% (89.2%, 94.3%)
- Recurrent Cholecystitis: 1.8% (0.4%, 4.2%)
- Procedure Related AEs: 12.0% (8.5%, 16.0%)
- Overall AEs: 22.7% (17.5%, 28.4%)
- Re-interventions: 10.3% (2.6%, 22.1%)
Randomized Controlled Trial (Teoh AY, Kitano M, Itoi T, et al. (DRAC 1)):
- Study Type: Prospective, multi-centered randomized controlled trial comparing EUS-GBD (AXIOS stent) vs. PT-GBD.
- Sample Size: 39 patients in EUS-GBD group, 40 patients in PT-GBD group.
- Key Results (AXIOS (LAMS) specific):
- Technical Success: 97.4% (86.5%, 99.9%)
- Clinical Success: 92.3 % (79.1%, 98.4%)
- Recurrent Cholecystitis: 2.6% (0.1%, 13.5%)
- Procedure Related AEs: 12.8% (4.3%, 27.4%)
- Overall AEs: 25.6% (13.0%, 42.1%)
- Re-interventions: 2.6% (0.1%, 13.5%)
- Compared to PT-GBD:
- No significant differences in technical success (p=0.494), clinical success (p=1), or 30-day mortality (p=0.675).
- Significantly reduced 30-day adverse events (12.8% vs 47.5%, p=0.001) and 1-year adverse events (25.6% vs 77.5%, p
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM (10 MM X 10 MM STENT); AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM (15 MM X 10 MM STENT)
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Gallbladder drainage stent and delivery system. A gallbladder drainage stent is a prescription device intended to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder. This device may also include a delivery system.
NEW REGULATION NUMBER: 21 CFR 876.5016
CLASSIFICATION: Class II
PRODUCT CODE: QXH
BACKGROUND
DEVICE NAME: AXIOS Stent and Electrocautery-Enhanced Delivery System (10 mm x 10 mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15 mm x 10 mm Stent)
SUBMISSION NUMBER: DEN230019
DATE DE NOVO RECEIVED: March 27, 2023
SPONSOR INFORMATION:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, Massachusetts 01752
INDICATIONS FOR USE
The AXIOS Stent and Electrocautery-Enhanced Delivery System (10 mm x 10 mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15 mm x 10 mm Stent) is indicated as follows:
The AXIOS Stent and Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transquodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery.
LIMITATIONS
1
The sale, distribution, and use of the AXIOS Stent and Electrocautery-Enhanced Delivery System (10 mm x 10 mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15 mm x 10 mm Stent are restricted to prescription use in accordance with 21 CFR 801.109.
Placement of the AXIOS Stent should be performed by physicians familiar with endoscopic ultrasonography and who have received training for AXIOS Stent placement techniques.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS. PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The AXIOS Stent and Electrocautery-Enhanced Delivery system is designed to help facilitate the transgastric or transduodenal endoscopic drainage of the gallbladder. The AXIOS Stent remains identical to the stents cleared previously per K220112.
The AXIOS Stent is a flexible, magnetic resonance conditional, fully covered, self-expanding, braided nitinol stent, which comes preloaded into the delivery system. The AXIOS stent is designed with two flanges, one 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 (Figure 1), The stent is fully covered with silicone to prevent leakage, discourage tissue in-growth within the nitinol woven braid, and facilitate removal.
Image /page/1/Figure/6 description: The image shows two views of a medical stent labeled as "Figure 1: AXIOS(TM) Stent". On the left, the stent is viewed from the side, showing its hourglass shape with labels indicating "Flange Diameter", "Saddle Length", and "Lumen Diameter". On the right, the stent is viewed head-on, revealing its circular structure and the "Drainage Lumen" in the center.
Figure 1: AXIOS M Stent
2
| Description | Stent Size | Delivery | ||
|---|---|---|---|---|
| Lumen | ||||
| Diameter | Saddle | |||
| Length | Flange | |||
| Diameter | System | |||
| Outer | ||||
| Diameter | ||||
| AXIOS Stent and Electrocautery-Enhanced | ||||
| Delivery System | ||||
| (10mm x 10mm Stent) | 10 mm | 10 mm | 21 mm | 10.8 Fr |
| AXIOS Stent and Electrocautery-Enhanced | ||||
| Delivery System | ||||
| (15mm x 10mm Stent) | 15 mm | 10 mm | 24 mm | 10.8 Fr |
The following stent sizes are included in this submission:
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 chamel 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.
Image /page/2/Figure/4 description: The image shows a medical device with several labeled parts. The device includes components such as a 'Luer Lock,' 'Catheter Lock,' 'Stent Lock,' 'Safety Clip,' and 'Monopolar Plug.' The labels point to specific areas of the device, providing a clear understanding of its structure and function.
Figure 2: Electrocantery Enhanced AXIOS Delivery System Handle
3
Image /page/3/Picture/0 description: The image shows a medical device, possibly an endoscope or a similar instrument used for minimally invasive procedures. The device has a long, flexible tube extending from a handle with controls. The handle appears to have a grip and adjustment mechanisms, suggesting it is used to manipulate the distal end of the tube for navigation and operation within the body.
Figure 3: Electrocantery Enhanced AXIOSTM Delivery System
SUMMARY OF NONCLINICAL/BENCH STUDIES
The performance of the AXIOS Stent and Delivery System was evaluated using the testing described in Table 1 below.
| Test | Purpose | Method | Acceptance Criteria | Results |
|---|---|---|---|---|
| Deployed Stent | ||||
| Saddle Length | Verify dimensions of | |||
| deployed stent | Measure | |||
| deployed stent | Deployed Stent Saddle | |||
| Length (inside flange | ||||
| to inside flange) | ||||
| @37°C | ||||
| $\geq$ 8.5 mm ≤ 13 mm | ||||
| For both the | ||||
| AXIOS 10 mm x 10 | ||||
| mm | ||||
| AXIOS 15 mm x 10 | ||||
| mm | Pass | |||
| Deployed Stent | ||||
| Saddle Outer | ||||
| Diameter | Verify dimensions of | |||
| deployed stent | Measure | |||
| deployed stent | Deployed Stent Saddle | |||
| Outer Diameter @37°C | ||||
| AXIOS 10mm x 10 mm | ||||
| stent: $\geq$ 8 mm | Pass | |||
| Test | Purpose | Method | Acceptance Criteria | Results |
| AXIOS 15mm x 10mm | ||||
| stent: ≥ 13 mm | ||||
| Deployed Stent | ||||
| Flange Width | Verify dimensions of | |||
| deployed stent | Measure | |||
| deployed stent | Deployed Flange | |||
| Width @ 37°C | ||||
| AXIOS 10 mm x 10 | ||||
| mm: ≥ 3 mm | ||||
| AXIOS 15 mm x 10 | ||||
| mm: ≥ 3 mm | Pass | |||
| Stent Pull-Out Force | Verify stent will remain in | |||
| place when pull-out force is | ||||
| applied | Deploy stent into | |||
| test fixture. Pull | ||||
| stent until either | ||||
| stent flange slips | ||||
| through orifice. | AXIOS 10 mm x 10 | |||
| mm: ≥ 2.54 N | Pass | |||
| Stent (Saddle) Radial | ||||
| Strength – | ||||
| Compression & | ||||
| Expansion | Verify expansion strength | |||
| of the compressed stent | ||||
| meets product specification | Compress stent | |||
| using force | ||||
| gauge. Measure | ||||
| force at 50% | ||||
| reduction of | ||||
| original stent | ||||
| diameter. | AXIOS 10mm x 10 mm | |||
| and 15 mm x10 mm: | ||||
| Stent (Saddle) Radial | ||||
| Strength – in | ||||
| compression @ 37°C ≥ | ||||
| 0.06 N/mm of length @ | ||||
| 50% Ø. |
AXIOS 10 mm x 10
mm and 15 mm x 10
mm: Stent (Saddle)
Radial Strength – in
expansion @ 37°C ≥
0.02 N/mm of
length @ 50% Ø. | Pass |
| Deployment
(Unsheathing) Force | Verify force needed to
deploy stent | Measure
deployment
force of stent
using force
gauge. | AXIOS 10 mm x 10
mm: Stent Deployment
Force
≤ 40 N
(AXIOS) 15 mm x 10
mm stent: Stent
Deployment Force ≤ 40
N | Pass |
| Implant Anchor
Function – Retention
(Tensile) | Verify force needed to
achieve apposition of distal
flange to target structure | Measure force to
pull stent
through
simulated test
fixture | AXIOS 10 mm x 10
mm: ≥ 2 N
(AXIOS) 15 mm x 10
mm stent ≥ 2 N | Pass |
| Magnetic Resonance
Testing | Verify stent will not
prevent ability to use MRI | Testing per
ASTM F2182,
ASTM 2119, | The stent should not
prevent the ability of the
physician to use | Pass |
| Test | Purpose | Method | Acceptance Criteria | Results |
| | | ASTM F2052,
ASTM F2213,
ASTM F2503 | Magnetic Resonance
Imaging on the patient | |
| Fatigue Testing | Ensure stent remains intact
throughout the period of
use | Test stents in
fatigue tester
with off-axis
displacement of
2 mm | The stent must remain
intact after 940,000
translation (distal flange
with respect to proximal
flange) cycles. | Pass |
| Corrosion Testing | Evaluate corrosion
resistance of stent | Test in
accordance with
ASTM F2129 | The metal stent and
stent covering must
show corrosion
resistance when
subjected to an in vitro
corrosive environment
equivalent to sixty days | Pass |
| Delivery System
Working Length | Verify working length of
delivery device | Measure length
of device | Working Length (distal
point of the handle to
distal end of the catheter
tip) ≤ 138 cm | Pass |
| Slider lock hold force
testing | Evaluate performance of
lock under compressional
and torsional forces | Measure
displacement of
catheter after
applying 5 lbf of
compression/ten
sion to locked
proximal hub | Lock hold force ≥ 22 N | Pass |
| Nose lock hold force | Evaluate performance of
lock under compressional
and torsional forces | Measure
displacement of
catheter after
applying 5 lbf of
compression/ten
sion to locked
proximal hub | Lock hold force ≥ 22 N | Pass |
| Nose/slide lock
cycling | Inspect function of
nose/slide lock feature | Lock and unlock
nose/slide lock
for a
predetermined
number of cycles | Nose lock must function
after 6 cycles; slide lock
must function after 4
cycles | Pass |
| Joint Strength Testing | Verify joint strength meets
design requirements | Test methods per
EN ISO 10555-1 | Per EN ISO 10555-1,
the device shall meet
specific minimum force | Pass |
| Luer to Nose Joint
Strength | Verify peak tensile force of
luer to nose joint | Load delivery
system into test | Luer to Nose Joint
Strength ≥ 22 N | Pass |
| Test | Purpose | Method | Acceptance Criteria | Results |
| | | setup and apply
force until luer
to nose joint
fails. Record
peak force. | | |
| Outer Sheath to
Handle Torque
Strength | Verify ability of AXIOS
catheter to withstand torque
when the device is rotated
360° | Rotate device
handle 360
degrees
clockwise while
holding
proximal end of
handle assembly. | The catheter system
must withstand a
minimum of 1 full turn. | Pass |
| Tracking Force | Verify tracking force of
outer sheath through a 3.7
mm working channel | Load catheter
into stomach
model and
measure force
when tip of
sheath exits
model | Track force $≤$ 8.83 N | Pass |
Table 1. Performance Testing for AXIOS Stent and Delivery System
4
5
6
BIOCOMPATIBILITY/MATERIALS
The AXIOS Stent is defined as an implanted, tissue/bone contacting device with a contact duration greater than 30 days. Biocompatibility was evaluated in accordance with ISO 10993-1, Biological evaluation of medical devices and FDA Guidance: Use of International Standard 1SO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The following biocompatibility endpoints were evaluated:
- Cytotoxicity .
- Sensitization .
- Irritation .
- Acute Systemic Toxicity .
- Genotoxicity .
- . Implantation
The AXIOS Delivery Device is defined as an externally communicating, tissue/bone contacting device with a contact duration less than 24 hours. The following biocompatibility endpoints were evaluated:
- . Cytotoxicity
- Sensitization .
- Intracutaneous reactivity .
- Material mediated pyrogenicity .
- . Acute systemic toxicity
The provided biocompatibility data help demonstrate the biocompatibility of the device.
7
SHELF LIFE/STERILITY
The AXIOS Stent and Delivery System are single use devices that are sterilized with ethylene oxide. The sterilization methods, location, and packaging integrity information are the same as referenced in K220112 and K192043. Sterilization data on a new, alternative sterilization cycle was also provided. The new sterilization method was found acceptable.
SUMMARY OF CLINICAL INFORMATION
Clinical data from a single-arm pivotal study (from G170190) and data from literature sources were leveraged to help evaluate the safety and effectiveness of the AXIOS Stent and Delivery System.
PIVOTAL STUDY DATA
In the pivotal study (A Multicenter, Prospective Study of (endoscopic ultrasound) EUS-Guided Transluminal Gallbladder Drainage in Patients with Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage), thirty subjects who are at high risk or unsuitable for surgery were enrolled with grade I or II Acute Cholecystitis received an AXIOS stent for drainage of the gallbladder as an alternative to percutaneous cholecystostomy. The AXIOS stent was removed between 30 and 60 days unless AXIOS stent removal was not medically indicated.
Primary Effectiveness Endpoints
- . Symptom resolution:
- o temperature 3.5 days cannot be rejected and thus the endpoint has failed.
The two patients who did not receive an AXIOS stent were followed until resolution of Acute Cholecystitis. We also evaluated the Primary Effectiveness Endpoint using the observed days to Acute Cholecystitis resolution regardless of AXIOS stent implantation. For this additional analysis, 1.60±1.50 days to resolution of Acute Cholecystitis for the 30 ITT patients with 97.8% one-sided confidence interval of [0.0, 2.15] was observed. Since the upper bound of the 97.8% confidence interval of the mean days to resolution of Acute Cholecystitis was 2.15 days. which is less than the Performance Goal of 3.5 days, this analysis rejects the null hypothesis in favor of the alternative hypothesis that days to resolution of Acute Cholecystitis is less than 3.5 days.
For the treated/per-protocol cohorts (N=28), both the Primary and additional analyses vielded the same results of 1.39±0.92 days to resolution of Acute Cholecystitis (one-sided 97.8% confidence interval [0.0, 1.74]).
Since the upper bound of the 97.8% confidence interval (1.74 days) is less than the Performance Goal of 3.5 days, the null hypothesis is rejected in favor of the alternative hypothesis that days to resolution of Acute Cholecystitis is