(140 days)
Not Found
No
The description focuses on the mechanical and electrical components of the stent and delivery system, with no mention of AI, ML, or image processing for analysis or decision-making.
Yes
The device is implanted to facilitate debridement, irrigation, and cystoscopy for pancreatic pseudocysts, functioning as a direct treatment for the condition.
No
The device is indicated for facilitating endoscopic drainage and debridement of pancreatic pseudocysts, functioning as an access port and therapeutic tool, not primarily for diagnosis.
No
The device description clearly states it is comprised of a stent (hardware) and a delivery system (hardware) with electrocautery capabilities (hardware). It is a physical medical device used for a surgical procedure.
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 an access port for debridement, irrigation, and cystoscopy. This is a therapeutic and interventional procedure performed directly on the patient's body.
- Device Description: The device is a stent and a delivery system designed for implantation within the body. It is used in conjunction with endoscopes and electrosurgical units.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such examination of specimens.
The device is clearly designed for an in vivo (within the body) therapeutic and interventional application.
N/A
Intended Use / Indications for Use
The AXIOS Stent with Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6cm in size, with ≥ 70% fluid content 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 resolution.
Product codes (comma separated list FDA assigned to the subject device)
PCU, 78KNS
Device Description
The AXIOS Stent with Electrocautery Enhanced Delivery System is intended for the endoscopic placement of a flexible. MR conditional, fully-covered, self-expanding braided Nitinol stent for transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts. The AXIOS Stent with Electrocautery Enhanced Delivery System is comprised of two main components: (1) AXIOS Stent and (2) Electrocautery Enhanced Delivery System.
The subject premarket notification describes modifications to the cleared AXIOS Delivery System to add electrocautery to facilitate precise access to anatomic targets as well as the staged placement of the currently cleared AXIOS Stent. The AXIOS Stent with Electrocautery Enhanced Delivery System incorporates the same identical implantable stent that is preloaded within the current AXIOS Delivery System (K123250). Both the AXIOS Stent and Delivery System were originally cleared under 510(k) K123250 and most recently under 510(k) K140561.
As with the non-cautery AXIOS devices, the Electrocautery Enhanced AXIOS Delivery System is compatible with commercially-available 0.035-inch endoscopic guidewires and intended to be used in the gastrointestinal tract in conjunction with commercially available echoendoscopes. The Electrocautery Enhanced Delivery System has been modified to connect with an off-the- shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2. The generator must be installed and put into service according to the EMC information provided in the generator manufacturer's guidance and declaration for electromagnetic compatibility.
Cables and patient return electrodes that are specified by generator manufacturer must be used for connection.
The AXIOS Stent with Electrocautery Enhanced Delivery System is provided sterile, disposable and intended for single use. The Electrocautery Enhanced AXIOS Delivery System is IEC compliant.
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)
Nonclinical Bench -Performance, Biocompatibility. Electromagnetic Compatibility / Electrical Safety, and Animal Testing were performed.
Bench performance testing was conducted to demonstrate that the modified delivery system continues to meet the requirements of the product design specification and perform in accordance with its intended use. Testing included: RF Compatibility / Safety, Tensile Strength testing, Unsheathing Force (Distal Flange), Effect of Retainer (Stent Retention Force), Design Validation Testing, Transportation and Conditioning Testing, Shelf Life and Package Testing, and Magnetic Resonance testing (confirmed via ASTM F2052-14, ASTM F2213-06, . ASTM F2182-11a and ASTM F2119-13). Performance testing was conducted in accordance with ISO 10555-1:2013 and ISO 594-1:1986. The AXIOS Stent with Electrocautery Enhanced Delivery System was evaluated in an ex vivo simulated use model for performance to the product specification, and in an Ex-Tissue Model to measure the comparative thermal effects against the Cook Cystotome on porcine tissue, showing statistically significant less thermal damage.
Biocompatibility testing was conducted pursuant to ISO 10993-1:2009 and FDA's Draft Guidance Document Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (2013)", and GLP regulations (21 CFR, Part 58). Tests performed included Cytotoxicity (ISO MEM Elution Method, L-929 Cells), Sensitization (ISO Guinea Pig Maximization Study), Irritation (ISO Intracutaneous Reactivity in Rabbits), and Systemic (Acute) Toxicity (ISO Systemic Toxicity in Mice).
Electromagnetic Compatibility and Electrical Safety was evaluated by Intertek NA, for conformance to IEC 60601-1, 60601-1-6, 60601-2-2, 60601-2-18, and ISO 14971. All completed testing passed the acceptance criteria.
Animal Study: A porcine model was used to evaluate the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System during transmural endoscopic access and drainage of a simulated pancreatic pseudocyst and the biliary tract. The study evaluated the 06x08mm and 20x10mm stent models. Cautery access and stent deployment were compared to standard techniques (Cook Medical Cystotome and non-energized Electrocautery Enhanced Delivery System). 1-month survival after stent implantation, followed by stent removal and an additional 7-day survival for histopathological evaluation.
Key results: Acess using cautery was successfully achieved and stents were successfully deployed in all animals. None of the stents migrated, and all remained patent during the 1-month implant period. Tissue surrounding implant sites was healthy. Gross and histological evaluation showed excellent healing. Thermal heat effects were not apparent grossly or histologically in treated animals.
Clinical Study: A prospective multi-center, single-arm clinical study was conducted.
Sample Size: Not specified, "symptomatic subjects who provided consent and were treated with the AXIOS Stent with Electrocautery Enhanced Delivery System."
Key results: AXIOS Stents were placed with no intra-operative complications. Patency was confirmed with drainage visualized for all stents. In subjects treated PP, 100% of AXIOS devices remained in position at 30 or 60 days, and 81.1% of stent lumens remained patent at 30 days and 100% at 60 days. The AXIOS stent was successfully implanted in all study subjects (100%). Successful removal was achieved in all subjects (100%) where endoscopic removal PP was attempted. Overall clinical success was 83.3%.
Safety: No unanticipated events related to device use. Ninety percent (90%) of subjects were free from major complications. Ninety-three percent (93.3%) of subjects experienced no serious adverse events related to the device or index procedure. Observed SAEs were consistent with those generally associated with endoscopic pancreatic pseudocyst drainage.
The Electrocautery Enhanced Delivery System was used for access in 100% of patients and performed as intended in all cases. No adverse events or unanticipated adverse device effects attributed to electrocautery use.
No intraoperative adverse events during AXIOS Stent placement, and two during removal (minor bleeding not requiring transfusion). No unanticipated complications or new risks related to implantation and removal.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Success: 83.3%
Freedom from major complications: 90%
No serious adverse events related to device or index procedure: 93.3%
AXIOS devices remained in position at 30 or 60 days: 100%
Stent lumens remained patent at 30 days: 81.1%
Stent lumens remained patent at 60 days: 100%
Successful implantation: 100%
Successful removal: 100% (when attempted PP)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2015
Boston Scientific Corporation Carole Sykes V.P. Clinical and Regulatory Affairs 453 Ravendale Drive, Suite H Mountain View, CA 94043
Re: K150692
Trade/Device Name: AXIOS™ Stent with 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: April 29, 2015 Received: June 24, 2015
Dear Carole Sykes,
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/ResourcesforYou/Industry/default.htm.
Sincerelv vours.
Herbert P. Lerner -S
for 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K150692
Device Name
AXIOS Stent with Electrocautery Enhanced Delivery System
Indications for Use (Describe)
The AXIOS Stent with Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6cm in size, with ≥ 70% fluid content 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 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete time to review that dollows, Search existing data commons regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(K) SUMMARY
| Date Prepared: | March 17, 2015 |
|---|---|
| Submitter: | Boston Scientific Corp. |
| Address: | 453 Ravendale Drive, Suite H, Mountain View, CA 94043 |
| Phone: | (650) 868-4331 |
| Fax: | (650) 961-9901 |
| Contact Person: | Carole Sykes |
| VP Clinical and Regulatory Affairs | |
| Trade Name/Proprietary | |
| Name: | AXIOS Stent with Electrocautery Enhanced Delivery System |
| Class: | II |
| Common Name: | Pancreatic drainage stent and delivery system and endoscopic |
| electrosurgery device | |
| Classification/Name: | Pancreatic drainage stent and accessories |
| and endoscopic electrosurgery accessories | |
| Regulation: | 21 CRF 876.5015 / 21 CFR 876.4300 |
| Product Code: | PCU / 78KNS |
| Predicate Devices (Legally | |
| marketed devices to which | |
| substantial equivalence is | |
| claimed): | Xlumena, Inc. AXIOS Stent and Delivery System |
| K140561 and K123250 | |
| Wilson-Cook Medical, Inc. Wilson-Cook Cystotome | |
| K022595 |
I. Device Description:
The AXIOS Stent with Electrocautery Enhanced Delivery System is intended for the endoscopic placement of a flexible. MR conditional, fully-covered, self-expanding braided Nitinol stent for transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts. The AXIOS Stent with Electrocautery Enhanced Delivery System is comprised of two main components: (1) AXIOS Stent and (2) Electrocautery Enhanced Deliverv System.
The subject premarket notification describes modifications to the cleared AXIOS Delivery System to add electrocautery to facilitate precise access to anatomic targets as well as the staged placement of the currently cleared AXIOS Stent. The AXIOS Stent with Electrocautery Enhanced Delivery System incorporates the same identical implantable stent that is preloaded within the current AXIOS Delivery System (K123250). Both the AXIOS Stent and Delivery System were originally cleared under 510(k) K123250 and most recently under 510(k) K140561.
As with the non-cautery AXIOS devices, the Electrocautery Enhanced AXIOS Delivery System is compatible with commercially-available 0.035-inch endoscopic guidewires and intended to be used in the gastrointestinal tract in conjunction with commercially
4
available echoendoscopes. The Electrocautery Enhanced Delivery System has been modified to connect with an off-the- shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2. The generator must be installed and put into service according to the EMC information provided in the generator manufacturer's guidance and declaration for electromagnetic compatibility.
Cables and patient return electrodes that are specified by generator manufacturer must be used for connection.
The AXIOS Stent with Electrocautery Enhanced Delivery System is provided sterile, disposable and intended for single use. The Electrocautery Enhanced AXIOS Delivery System is IEC compliant.
II. Indications for Use:
The AXIOS™ Stent with Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6cm in size, with ≥ 70% fluid content 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 resolution.
III.Summary of Technological Characteristics of the Proposed Device Compared to the Predicate Device:
The AXIOS Stent with Electrocautery Enhanced Delivery System is substantially equivalent to the legally marketed predicate devices identified in Table 1. The AXIOS Stent with Electrocautery Enhanced Delivery System is substantially equivalent in terms of intended use / indications for use, technological characteristics and principles of operation to the predicate AXIOS Stent and Delivery System which was cleared by FDA in 510(k)s K123250 and K140561, and the Wilson-Cook Medical Cystotome cleared by FDA in 510(k) K022595.
Table 1. Comparison of AXIOS Stent with Electrocautery Enhanced Delivery System with Predicate Devices
| Feature | SUBJECT DEVICE
AXIOS Stent with
Electrocautery Enhanced
Delivery System | PRIMARY PREDICATE
DEVICE
Xlumena AXIOS Stent
with (non-cautery) Delivery
System | REFERENCE PREDICATE
DEVICE
Wilson-Cook Medical
Wilson-Cook Cystotome |
|------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| 510(k)
Number | K150692 | K140561 and K123250 | K022595 |
5
| Feature | SUBJECT DEVICE
AXIOS Stent with
Electrocautery Enhanced
Delivery System | PRIMARY PREDICATE
DEVICE
Xlumena AXIOS Stent
with (non-cautery) Delivery
System | REFERENCE PREDICATE
DEVICE
Wilson-Cook Medical
Wilson-Cook Cystotome | | | | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Indications for
Use | To facilitate transgastric or
transduodenal endoscopic
drainage of symptomatic
pancreatic pseudocysts ≥
6cm in size, with ≥ 70%
fluid content 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 resolution. | Same | For use as an electrosurgical
accessory to cannulate the
transgastric or transduodenal
wall and into a pancreatic
pseudocyst that is visibly
bulging into the gastrointestinal
tract. | | | | |
| Class | II | Same | Same | | | | |
| Classification/
Regulation
Name | Pancreatic drainage stent
and accessories
and endoscopic
electrosurgery accessories | Pancreatic drainage stent and
accessories | Endoscopic electrosurgery
accessories | | | | |
| Regulation
Number | 21CFR 876.5015
21CFR 876.4300 | 21CFR 876.5015 | 21CFR 876.4300 | | | | |
| Product Code | PCU and 78KNS | PCU | 78KNS | | | | |
| Outer Catheter
Length | 138 cm | Same | 165 CM | | | | |
| Inner Catheter
Sheath
Diameter | 9 Fr with preloaded Stent | Same | 5 Fr with 0.038" needle knife | | | | |
| Guidewire
Compatibility | 0.035" | Same | Same | | | | |
| Endoscope
Compatibility | Compatible with 3.7 mm
diameter or larger working
channel | Same | Same | | | | |
| Placement Site | Transgastric or
transduodenal wall and into
a pancreatic pseudocyst | Same | Same | | | | |
| Pseudocyst
Size | ≥ 6cm in size | Same | > 4cm in size | | | | |
6
| Feature | SUBJECT DEVICE
AXIOS Stent with
Electrocautery Enhanced
Delivery System | PRIMARY PREDICATE
DEVICE
Xlumena AXIOS Stent
with (non-cautery) Delivery
System | REFERENCE PREDICATE
DEVICE
Wilson-Cook Medical
Wilson-Cook Cystotome |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mode of
Access or
Operation | Electrosurgically punctures hole
at the placement site.
Fine wire electrocautery
element (0.006" SS wire);
electrosurgically active wire
using pure cutting current to
access pseudocyst. After
access, deploy the AXIOS
Stent using a two stage
process. Distal stent flange
first followed by the
proximal flange. | Access path at placement site
is created using conventional
access tools. After access,
deploy the AXIOS Stent
using a two stage process.
Distal stent flange first
followed by the proximal
flange. | Electrosurgically punctures hole
at the placement site. Needle
0.038" knife tip;
electrosurgically active knife
using pure cutting current to
access pseudocyst. Enlarge
incision with a cauterizing
diathermic ring and 10 Fr outer
catheter. Utilizes a 0.035" wire
for placement of a stent or
drainage kit via compatible
endoscope. |
| Stent
Deployment
Mechanism | Deployed via handle
controls. Distal stent flange
first followed by the
proximal flange. | Same | N/A |
| Cutting
Current | 80-120 Watts | N/A | 80-120 Watts |
| Sterilization
Method | EO | EO | EO |
IV. Summary of the Nonclinical Tests Performed:
testing performed includes: Nonclinical Bench -Performance, Biocompatibility. Electromagnetic Compatibility / Electrical Safety, and Animal Testing. The nonclinical test results demonstrate that the modified device continues to meet product design specifications.
1. Bench Performance
Bench performance testing was conducted for the AXIOS Stent with Electrocautery Enhanced Delivery System to demonstrate that the modified delivery system continues to meet the requirements of the product design specification and perform in accordance with its intended use. There have been no design or material changes to the AXIOS Stent; it is identical to the AXIOS Stent cleared in K123250 and K140561. The bench performance testing was conducted for the modifications to the Electrocautery Enhanced Delivery System Catheter and Handle only and included the following testing:
- RF Compatibility / Safety ●
- Tensile Strength testing ●
- Unsheathing Force (Distal Flange)
- Effect of Retainer (Stent Retention Force) ●
7
- Design Validation Testing
- Transportation and Conditioning Testing
- Shelf Life and Package Testing
- Magnetic Resonance testing was confirmed via ASTM F2052-14, ASTM F2213-06, . ASTM F2182-11a and ASTM F2119-13.
Where applicable, performance testing was conducted in accordance with the following standards:
- . ISO 10555-1:2013 - Sterile, single-use intravascular catheters Part 1. General requirements
- ISO 594-1:1986 Conical Fittings with a 6% (Luer) taper for syringes, needles ● and certain other medical equipment – Part 1 : General Requirements
Design Verification testing included assessment of device dimensions, stent deployment and tensile testing of the applicable joints. The AXIOS Stent with Electrocautery Enhanced Delivery System was tested for design validation attributes. AXIOS Systems were evaluated in an ex vivo simulated use model for performance to the product specification. Based on the results of the bench performance testing, the modified Electrocautery Enhanced Delivery Systems meets the product design specification and performance requirements for its proposed intended use.
The AXIOS Stent with Electrocautery Enhanced Delivery System was evaluated in an Ex-Tissue Model to measure the comparative thermal effects of the AXIOS Vivo Electrocautery Enhanced Delivery System (11F) vs. the 10F Cook Cystotome on porcine tissue. In all tissue samples, the Electrocautery Enhanced Delivery System caused statistically significant less thermal damage to the tissue as compared to the Cystotome.
2. Biocompatibility
To verify the biocompatibility of the AXIOS Stent with Electrocautery Enhanced Delivery System the Company conducted biocompatibility testing pursuant to ISO 10993-1:2009 and FDA's Draft Guidance Document Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (2013)". Biocompatibility testing was conducted in accordance with the GLP regulations (21 CFR, Part 58).
The Electrocautery Enhanced Delivery System (Hot AXIOS Delivery System) is an "external communicating device" in contact with tissue for limited duration (