(237 days)
The AXIOS™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, and symptomatic Walled Off Necrosis ≥ 6 cm in size, that are adherent to the gastric or bowel wall. Once placed, the AXIOS™ Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The Stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or Walled-Off Necrosis resolution.
The AXIOS™ Stent is a flexible, MR conditional, fully-covered, self-expanding braided nitinol stent, which comes preloaded into a delivery system. The AXIOS™ stent is designed with two flanges on each end to prevent migration and to enable tissue plane apposition and a "saddle" in between the flanges to span the tissue implant distance.
The AXIOS™ Electrocautery-Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS™ Stent. The AXIOS™ Electrocautery-Enhanced Delivery System is designed to be used in the gastrointestinal tract with commercially available echoendoscopes with a 3.7 mm diameter or larger working channel and is compatible with commercially available 0.035-inch insulated endoscopic guidewires.
The Electrocautery-Enhanced Delivery System connects with an off-the-shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2.
The AXIOS™ Stent and Electrocautery-Enhanced Delivery System is provided sterile, disposable and intended for single use.
The provided text is a 510(k) summary for a medical device (AXIOS™ Stent and Electrocautery-Enhanced Delivery System), establishing its substantial equivalence to a predicate device. It details the device's description, indications for use, and performance data from a clinical trial.
However, the request asks for information typically found in an AI/ML medical device submission, specifically concerning "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm's performance. The document describes a medical device (a stent and delivery system), not an AI/ML algorithm. Therefore, many of the requested fields are not applicable to the content provided (e.g., number of experts to establish ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training/test set sample sizes for an algorithm, etc.).
The "Performance Data" section in the document refers to a clinical trial evaluating the safety and effectiveness of the stent, not an AI/ML algorithm's performance.
Given this discrepancy, I will extract the relevant "performance data" provided for the stent and explain why other AI/ML-specific questions are not applicable to this document.
Acceptance Criteria and Study Proving Device Meets Criteria (Based on Provided Document)
This document describes the regulatory submission for a medical device: the AXIOS™ Stent and Electrocautery-Enhanced Delivery System. It is not an AI/ML-driven device, so the typical AI/ML-specific acceptance criteria and study design (like MRMC studies, ground truth establishment by experts for an algorithm, training/test sets for an algorithm, etc.) are not applicable here.
The "acceptance criteria" in this context would implicitly refer to demonstrating safety and effectiveness for its intended use, sufficient for FDA 510(k) clearance based on substantial equivalence to predicate devices, and in support of an expanded indication. The "study that proves the device meets the acceptance criteria" is the described clinical trial.
Here's the information extracted and contextualized based on the provided document:
1. Table of "Acceptance Criteria" (Clinical Endpoints) and Reported Device Performance
Note: These are not acceptance criteria for an AI/ML algorithm's performance but rather for the clinical efficacy and safety of a medical device (stent).
| Clinical Endpoint (Analogous to Acceptance Criteria) | Reported Device Performance (N=40 subjects) |
|---|---|
| Primary Effectiveness Endpoint: | |
| Resolution of WON to ≤ 3 cm (assessed radiographically by CT scan or MRI within 60 days from AXIOS™ stent placement) | 97.5% (39/40) [86.8%, 99.9% CI] |
| Primary Safety Endpoint: | |
| AXIOS™ stent related or WON drainage procedure related serious adverse events | 7.5% (3/40) [1.6%, 20.4% CI] |
| Additional Endpoints: | |
| Technical success (AXIOS™ stent placement) | 100.0% (40/40) |
| Technical success (AXIOS™ stent removal) | 100.0% (40/40) |
| Resolution of WON by 6-month post-stent removal | 100.0% (40/40) |
| Recurrence of WON from initial resolution to 6 months post-AXIOS™ stent removal | 0.0% (0/34) |
| Visual confirmation of AXIOS™ stent lumen patency (after stent placement) | 100.0% (40/40) |
| Visual confirmation of AXIOS™ stent lumen patency (before stent removal) | 97.5% (39/40) |
| Incidence of new organ failure | 2.6% (1/39) |
2. Sample Size and Data Provenance
- Sample Size (Clinical Trial): 40 patients (with 45 AXIOS™ stents implanted, as some subjects had multiple WON).
- Data Provenance: The document states "a prospective, single arm, multi-center trial." It does not specify the country of origin but implies a formal clinical investigation under an approved Investigational Device Exemption (IDE) per GCP and 21 CFR Parts 50, 56, and 812, which are U.S. regulations. Thus, it's a prospective, clinical trial data.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable (N/A): This is a clinical trial of a medical device (stent and delivery system), not an AI/ML algorithm requiring expert ground truth for image interpretation or similar AI-specific tasks. The "ground truth" here is the clinical outcome (WON resolution, adverse events), determined by medical professionals treating the patients and clinical assessments (radiographic imaging, physical exams) as part of the trial protocol.
4. Adjudication Method for the Test Set
- N/A: As this is a clinical trial, not an AI/ML algorithm's test set requiring human reader adjudication for performance metrics. Clinical endpoints are typically evaluated by blinded assessment where possible, and adverse events are adjudicated by a clinical events committee, but the specific details of that adjudication are not provided beyond the general statement of a "prospective, single arm, multi-center trial conducted per GCP."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No (N/A): An MRMC study is relevant for evaluating the impact of an AI/ML algorithm on human reader performance (e.g., radiologists interpreting images). This document describes a clinical trial of a physical medical device (stent), not an AI/ML algorithm.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- N/A: This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
- Clinical Outcomes and Radiographic Assessment: For the primary effectiveness endpoint, the "ground truth" was the "radiographic decrease of WON size to < 3cm evaluated by CT scan or MRI within 60 days from AXIOS™ stent placement." For safety, it was the occurrence of "AXIOS™ stent-related or WON drainage procedure-related serious adverse events." These are objective clinical and imaging-based measures.
8. The Sample Size for the Training Set
- N/A: This document does not describe the development or validation of an AI/ML algorithm, so there is no "training set" in that context. The "clinical investigation" described is for demonstrating the device's performance for regulatory clearance.
9. How the Ground Truth for the Training Set was Established
- N/A: As above, no AI/ML training set is described.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 7, 2022
Boston Scientific Corporation Ian Broome, M.S., RAC Senior Regulatory Affairs Specialist 200 Boston Scientific Way, Mail Stop M41 Marlborough, MA 01752
Re: K220112
Trade/Device Name: AXIOS™ Stent and Electrocautery-Enhanced Delivery System Regulation Number: 21 CFR§ 876.5015 Regulation Name: Pancreatic drainage stent and delivery system Regulatory Class: II Product Code: PCU, KNS Dated: August 5, 2022 Received: August 5, 2022
Dear Ian Broome:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
April Marrone, Ph.D., MBA Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
AXIOSTM Stent and Electrocautery-Enhanced Delivery System
Indications for Use (Describe)
The AXIOS™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, and symptomatic Walled Off Necrosis ≥ 6 cm in size, that are adherent to the gastric or bowel wall. Once placed, the AXIOS™ Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The Stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or Walled-Off Necrosis resolution.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ------------------------------------------------------------------------------------------------ |
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
| ----------------------------------------------- |
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K220112 Page 1 of 6
510(k) SUMMARY SECTION 1.
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Primary Contact: Ian Broome, M.S., RAC Senior Regulatory Affairs Specialist Telephone: (617) 517-4932
Date Summary Prepared:
6 September 2022
2. Device:
AXIOS™ Stent and Electrocautery-Enhanced Trade Name: Delivery System Device Common Name: Pancreatic drainage stent and delivery system & endoscopic electrosurgery device Classification Name: Pancreatic drainage stent and accessories & endoscopic electrosurgery accessories Regulation Number: 21 CFR 876.5015, 21 CFR 876.4300 Product Code: PCU/KNS Classification: Class II 3. Predicate Devices Trade Name: AXIOS™ Stent and Electrocautery-Enhanced Delivery System 510(k) Numbers: K181905, K192043 Device Common Name: Pancreatic drainage stent and delivery system & endoscopic electrosurgery device Pancreatic drainage stent and accessories and Classification Name: endoscopic electrosurgery accessories Regulation Number: 21 CFR 876.5015 21 CFR 876.4300 Product Code: PCU/KNS Classification: Class II
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4. Device Description
AXIOS™ Stent:
The AXIOS™ Stent is a flexible, MR conditional, fully-covered, self-expanding braided nitinol stent, which comes preloaded into a delivery system. The AXIOS™ stent is designed with two flanges on each end to prevent migration and to enable tissue plane apposition and a "saddle" in between the flanges to span the tissue implant distance.
Electrocautery-Enhanced Delivery System:
The AXIOS™ Electrocautery-Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS™ Stent. The AXIOS™ Electrocautery-Enhanced Delivery System is designed to be used in the gastrointestinal tract with commercially available echoendoscopes with a 3.7 mm diameter or larger working channel and is compatible with commercially available 0.035-inch insulated endoscopic guidewires.
The Electrocautery-Enhanced Delivery System connects with an off-the-shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2.
The AXIOS™ Stent and Electrocautery-Enhanced Delivery System is provided sterile, disposable and intended for single use. Table 5-1 below discusses the main features of the AXIOSTM Stent and Electrocautery-Enhanced Delivery System.
| Component/Design | Feature Description |
|---|---|
| Catheter | Provided sterile, for single-patient use Working length: 138 cm Outer Diameter 10.8 Fr Fluoroscopy: AXIOS™ Stent is containedbetween two (2) Platinum IridiumMarkers Electrocautery Tip for precise cutting (inthe Electrocautery-Enhanced DeliverySystem only) Monopolar 750VP or 1500Vp-pRated Accessory Voltage⇒ IEC 60601-1 compliant |
| Handle | Staged delivery system for precise stentplacement⇒Two (2)-step release of each flange,including a full “stop”⇒Lock-out after the release of the firstflange, preventing unintendeddeployment of the second flange |
| Guidewire Compatibility | 0.035" insulated guidewires |
| Endoscope Compatibility | Compatible with 3.7 mm diameter orlarger working channel Delivery system is Luer-locked to theproximal end of the biopsy port of theendoscope |
| Component/Design | Feature Description |
| Suggested Electrosurgical Unit orGenerator (Electrocautery-EnhancedDelivery System only) | Compliant to IEC 60601-1-2 and IEC 60601-2-2 ERBE VIO 300D ERBE ICC 200 ERBE VIO 300S ERBE VIO 200D |
| AXIOST™ Stent Design | Bi-flange or double anchor for Staged and Precise positioning Flange/anchor designed to: ⇒hold tissue layers in apposition ⇒prevent migration MR Conditional Provided sterile, for single-patient use |
| AXIOST™ Stent Lumen | Large stent lumen diameter and short flow path/conduit to ⇒Facilitate passive efficient drainage ⇒Facilitate passage of endoscopic tools for assessment and treatment |
| AXIOST™ Stent Material | Nitinol (Nickel-Titanium) ⇒Shape memory and superelasticity for controlled placement and optimal deployment ⇒Corrosion resistant and biocompatible |
| AXIOST™ Stent Covering | Fully covered with Silicone ⇒Well tolerated by surrounding tissue to minimize tissue ingrowth ⇒Provides leak protection and minimizes tissue ingrowth allowing for atraumatic stent removal |
| AXIOST™ Stent Visualization | The Stent is delivered constrained within a delivery system and deployed under visualization ⇒EUS confirmation of first flange deployment ⇒Direct endoscopic or EUS viewing of second flange deployment ⇒Radiopacity of Nitol allows fluoroscopy of deployed stent |
Table 5-1. AXIOS™ Stent and Electrocautery-Enhanced Delivery System - Main Features Component/Design Feature Description
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5. Proposed Indications for Use
The AXIOS™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pseudocysts ≥ 6 cm in size, and symptomatic Walled Off Necrosis ≥ 6 cm in size, that are adherent to the gastric or bowel wall. Once placed, the AXIOS™ Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The Stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or Walled-Off Necrosis resolution.
6. Technological Characteristics
The technological characteristics of the device remain unchanged from the predicates cleared in K181905 (the 10mm x 10 mm, 10mm and 20mm x 10mm stent sizes) and K192043 (the 15mm x 15mm stent size).
7. Performance Data
The devices' technological characteristics remain unchanged, therefore, no further performance testing was required.
8. Clinical Data Summary
Clinical data from a prospective, single arm, multi-center trial on the AXIOS™ Stent and Electrocautery-Enhanced Delivery System support the expanded indication for use and confirm the subject device's substantial equivalence, safety and effectiveness to the predicate. The trial was conducted per GCP and 21 CFR Parts 50, 56 and 812 under an approved Investigational Device Exemption.
Patients with Walled Off Necrosis (WON) with greater than 30% necrotic material (as suggested by pre-operative imaging) were eligible for inclusion. The primary effectiveness endpoint was resolution of WON with endoscopic drainage (defined as radiographic decrease of WON size to < 3cm evaluated by CT scan or MRI within 60 days from AXIOS™ stent placement). The primary safety endpoint was AXIOS™ stent-related or WON drainage procedure-related serious adverse events (SAE).
Forty patients enrolled in the study. Forty-five AXIOS™ stents were implanted in 40 subjects (some subjects had multiple WON). Post procedural radiographic evidence demonstrated successful resolution of WON in 97.5% (39/40) patients. Table 5-1 below shows the Primary Effectiveness Endpoint, Primary Safety Endpoint, and Additional Endpoints.
| ITT Subjects(N=40) | |
|---|---|
| Primary Effectiveness Endpoint | |
| Resolution of WON to ≤ 3 cm (assessed radiographically by CT scanor MRI within 60 days from AXIOST™ stent placement)1 | 97.5% (39/40)[86.8%, 99.9%] |
| Primary Safety Endpoint | |
| AXIOS™ stent related or WON drainage procedure related seriousadverse events | 7.5% (3/40)[1.6%, 20.4%] |
| Additional Endpoints | |
| Reduction of WON-related symptoms Final WON assessment visit 6-month WON recurrence assessment visit Technical success | |
| 75.0% (30/40) | |
| 85.3% (29/34) | |
| Table 5-2. Primary Effectiveness and Safety Endpoints and Additional Endpoints |
|---|
| -------------------------------------------------------------------------------- |
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| Ο AXIOST™ stent placement | 100.0% (40/40) |
|---|---|
| Ο AXIOST™ stent removal | 100.0% (40/40) |
| ● Drainage procedure time (min) | |
| Ο Total | 22.6±11.3 (40)(1.0, 51.0) |
| Ο Initial AXIOSTM stent | 21.8±11.0 (40)(1.0, 51.0) |
| Ο Second AXIOSTM stent | 10.0±3.5 (3)(8.0, 14.0) |
| ● Resolution of WON by 6-month post-stent removal2 | |
| Ο Resolution before AXIOST™ removal - not lost to 6-month follow-up (34/34) | 100.0% (40/40) |
| Ο Resolution before AXIOST™ removal – lost to 6-month follow-up (6/6) | |
| ● Time to WON resolution of ≤ 3 cm (days) | 34.1±16.8 (40)(4.0, 100.0) |
| ● Recurrence of WON from initial resolution to 6 months post-AXIOSTM stent removal | 0.0% (0/34) |
| ● Stent lumen patency | |
| Ο Drainage through AXIOST™ stent visualized from the stomach or bowel | |
| ■ After stent placement | 100.0% (40/40) |
| ■ Before stent removal | 65.0% (26/40) |
| ● Visual confirmation of AXIOST™ stent lumen patency | |
| Ο After stent placement | 100.0% (40/40) |
| Ο Before stent removal | 97.5% (39/40) |
| ● Fluoroscopy time per endoscopic procedure (min) | 4.6±6.1 (38)(1.0, 33.0) |
| ● Incidence of new organ failure from drainageprocedure to WON resolution 3 | 2.6% (1/39) |
| ● Change of SF-12 score from baseline to: | |
| Ο AXIOST™ stent removal 4 | 23.6±20.5 (37)(-26.1, 67.2) |
| Ο End of study 5 | 40.9±24.3 (27)(-12.5, 81.3) |
1 One subject reached WON size <3cm 100 days after AXIOS™ stent placement.
2 All subjects (including those that were later lost to follow-up) had resolution of WON by 100 days after AXIOS™ stent placement and before AXIOS™ stent removal, i.e. by 6 month post-stent removal.
3 Organ failure assessment not collected for 1 subject.
4 SF-12 not collected for 3 subjects at time of stent removal.
5 SF-12 not collected for 7 subjects at 6-month WON assessment visit.
The observed proportion of subjects who were positive for the Primary Safety Endpoint for the ITT cohort was 7.5% (3/40; 95% CI 1.6% to 20.4%).
There were no unanticipated adverse device effects reported in this study. There were 49 adverse events (AEs) observed in 24 subjects since the beginning of the 49 adverse events, 36 were recorded as Serious Adverse Events (SAEs). Five AEs were related to the AXIOS™ stent and 7 AEs were related to a necrosectomy. There were no AEs related to the use of the Advanix™ 7Fr double pigtail plastic stent. Two (2) SAEs were reported as possibly AXIOSTMrelated or WON procedure-related and 4 SAEs were reported as related to necrosectomy.
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9. Conclusion
Based on the clinical investigation results, technological characteristics, and prior nonclinical testing performed on the identical predicate device, the AXIOS™ Stent and Electrocautery-Enhanced Delivery System has been shown to be safe, effective, and substantially equivalent to the predicate device when indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6cm in size, and symptomatic Walled Off Necrosis ≥ 6cm in size, that are adherent to the gastric or bowel wall.
In addition to the clinical evidence, labeling and other materials provided in this 510(k) premarket notification submission demonstrate compliance to the special controls prescribed in 21 CFR 876.5015.
§ 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.