(26 days)
The AXIOS Stent and Electrocautery Enhanced Delivery System is 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, 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 or walled-off necrosis resolution.
The AXIOS Stent is a flexible, MR conditional, fully-covered self-expanding braided nitinol stent, which comes preloaded into the 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 Sten. 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 contains information about the AXIOS Stent and Electrocautery-Enhanced Delivery System, specifically an FDA 510(k) summary for a new version of the device (K192043). However, it does not describe a clinical study that proves the device meets specific acceptance criteria based on human or expert evaluation. Instead, it describes bench testing against predefined product specifications to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested items (sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable or cannot be answered from the provided document as it does not detail a clinical performance study with human readers or AI.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes "pre-defined product specifications" for bench tests as the acceptance criteria. The device is reported to have met these criteria.
| Acceptance Criteria (Pre-defined Product Specifications) | Reported Device Performance (Results) |
|---|---|
| Deployed Stent Saddle Length | Pass |
| Deployed Stent Saddle Outer Diameter | Pass |
| Deployed Stent Flange Width | Pass |
| Stent Pull-out Force (tensile) | Pass |
| Stent (Saddle) Radial Strength - in compression & expansion | Pass |
| Deployment Force | Pass |
| Implant Anchor Function- Retention (tensile) | Pass |
| Magnetic Resonance Testing | Pass |
Regarding the other requested information:
- 2. Sample size used for the test set and the data provenance: This information is not provided in the document. The tests performed were bench tests on the device itself, not clinical tests on a patient population.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the bench tests would be the established product specifications for physical properties, not expert-derived medical diagnoses.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for clinical studies involving interpretation of medical images or patient outcomes, not for bench testing of device specifications.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was mentioned. The device is a medical stent and delivery system, not an AI diagnostic tool that assists human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical medical device, not a standalone AI algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench tests, the ground truth was the pre-defined product specifications for mechanical and physical properties of the device (e.g., specific dimensions, force resistance, MR compatibility).
- 8. The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI model that requires a training set.
- 9. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI model.
Summary from the document:
The provided text focuses on the technical characteristics and bench testing of a medical device (AXIOS Stent and Electrocautery-Enhanced Delivery System) to demonstrate substantial equivalence to a previously cleared predicate device. The "acceptance criteria" here refer to predefined product specifications for the physical device, and the "study" is a series of bench tests. No clinical studies involving human readers, AI, or patient outcomes for the purpose of establishing device performance against clinical acceptance criteria are described in this document.
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August 26, 2019
Boston Scientific Corporation Kayla Mackey Principal Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
K192043 Re:
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: Class II Product Code: PCU, KNS Dated: July 29, 2019 Received: July 31, 2019
Dear Kayla Mackey:
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.
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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.
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 medical devices and radiation-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.
Daniel G. Walter, Jr. Assistant Division 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) ו את המאמילים של המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המוזיקה המועד המועד המוע K192043
Device Name
AXIOS Stent and Electrocautery-Enhanced Delivery System
Indications for Use (Describe)
The AXIOS Stent and Electrocautery Enhanced Delivery System is 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, 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 or walled-off necrosis resolution.
| A BE AN AND A BRICA FREE A B A COLORIO COLLECT OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION O | A BRICH AN A BLACK AN A BE A BE A BE A BE A BE A BE A BE A BE A BE A BE A BE A BE A BE A BE A BE A BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE BE | ||
|---|---|---|---|
| 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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K192043 Page 1 of 4
SECTION 5. 510(K) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Primary Contact: Kayla Mackey Principal Regulatory Affairs Specialist Telephone: 508-683-4534 Fax: 508-683-5939
2. Device:
| Trade Name: | AXIOST™ Stent and Electrocautery-EnhancedDelivery System |
|---|---|
| Device Common Name: | Pancreatic drainage stent and delivery system &endoscopic electrosurgery device |
| Classification Name: | Pancreatic drainage stent and accessories andendoscopic electrosurgery accessories |
| Regulation Number: | 21CFR 876.501521CFR 876.4300 |
| Product Code: | PCU/ KNS |
| Classification: | Class II |
| 3. Predicate Device | |
| Trade Name: | AXIOS™ Stent and Electrocautery-EnhancedDelivery System & AXIOS Stent and DeliverySystem |
| 510(k) Number: | K181905 |
| Device Common Name: | Pancreatic drainage stent and delivery system &endoscopic electrosurgery device |
| Classification Name: | Pancreatic drainage stent and accessories andendoscopic electrosurgery accessories |
| Regulation Number: | 21CFR 876.501521CFR 876.4300 |
| Product Code: | PCU/ KNS |
| Classification: | Class II |
4. Device Description
AXIOS Stent:
The AXIOS Stent is a flexible, MR conditional, fully-covered self-expanding braided nitinol stent, which comes preloaded into the delivery system. The AXIOS stent is designed with two
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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 Sten. 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 AXIOS Stent and Electrocautery Enhanced Delivery System.
| Component/Design | Feature Description |
|---|---|
| Catheter | Provided sterile, for single-patient use Working length: 138 cm Electrocautery Enhanced Delivery System Outer Diameter 10.8 Fr Fluoroscopy: AXIOS Stent is contained between two (2) Platinum Iridium Markers Electrocautery Tip for precise cutting Monopolar 750VP or 1500Vp-p Rated Accessory Voltage IEC 60601-1 compliant |
| Handle | Staged delivery system for precise stent placement ⇒Two (2)-step release of each flange, including a full "stop" ⇒Lock-out after the release of the first flange, preventing unintended deployment of the second flange |
| Guidewire Compatibility | 0.035" insulated guidewires |
| Endoscope Compatibility | Compatible with 3.7 mm diameter or larger working channel Delivery system is luer-locked to the proximal end of the biopsy port of the endoscope |
| Electrosurgical Unit or Generator | Compliant to IEC 60601-1-2 and IEC 60601-2-2 ERBE VIO 300D |
| ○ ERBE ICC 200 ○ ERBE VIO 300S ○ ERBE VIO 200D | |
| AXIOS Stent Design | Bi-flange or double anchor for Staged and Precise positioning Flange/anchor designed to:⇒hold tissue layers in apposition⇒prevent migration MR Conditional Provided sterile, for single-patient use |
| AXIOS Stent Lumen | Large stent lumen diameter and short flow path/conduit to⇒Facilitate passive efficient drainage⇒Facilitate passage of endoscopic tools for assessment and treatment |
| AXIOS Stent Material | Nitinol (Nickel-Titanium)⇒Shape memory and superelasticity for controlled placement and optimal deployment⇒Corrosion resistant and biocompatible |
| AXIOS Stent Covering | Fully covered with Silicone⇒Well tolerated by surrounding tissue to minimize tissue ingrowth⇒Provides leak protection and minimizes tissue ingrowth allowing for atraumatic stent removal |
| AXIOS Stent Visualization | The Stent is delivered constrained within a delivery system and deployed under visualization⇒EUS confirmation of first flange deployment⇒Direct endoscopic or EUS viewing of second flange deployment⇒Radiopacity of Nitinol allows fluoroscopy of deployed stent |
Table 5-1: AXIOS Stent and Electrocautery Enhanced Delivery System- Main Features
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5. Indications for Use:
The AXIOS Stent is 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, 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
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for implantation up to 60 days and should be removed upon confirmation of pseudocyst or Walled Off Necrosis resolution.
6. Technological Characteristics
The proposed AXIOS Stent (15mm x 15mm) and Electocautery Enhanced Delivery System is identical to the predicate AXIOS Stent (15mm x 10mm) and Electrocautery Enhanced Delivery System with the exception of the stent saddle length. The proposed AXIOS Stent has a stent saddle length of 15 mm. The intended use and mode of operation remains identical to the predicate AXIOS Stent and Electrocautery Enhanced Delivery system cleared via K181905. The Electrocautery Enhanced Delivery System is identical to the predicate AXIOS 15x10mm Electrocautery Enhanced Delivery System except for two minor modifications to the stent deployment hub and the stent mounting length.
7. Performance Data
Bench Testing:
The proposed AXIOS Stent and Electrocautery Enhanced Delivery System successfully passed all pre-defined product specifications for the tests performed. Below is a summary of the tests performed to show the proposed device satisfied all design verification and validation requirements.
| Table 5-1 Summary of Bench Tests and Results | ||
|---|---|---|
| # | Test | Results (Pass/ Fail) |
| 1 | Deployed Stent Saddle Length | Pass |
| 2 | Deployed Stent Saddle Outer Diameter | Pass |
| 3 | Deployed Stent Flange Width | Pass |
| 4 | Stent Pull-out Force (tensile) | Pass |
| 5 | Stent (Saddle) Radial Strength -in compression & expansion | Pass |
| 6 | Deployment Force | Pass |
| 7 | Implant Anchor Function- Retention (tensile) | Pass |
| 8 | Magnetic Resonance Testing | Pass |
| # | Test | Results (Pass/ Fail) |
|---|---|---|
| 5 | Stent (Saddle) Radial Strength –in compression & expansion | Pass |
| 6 | Deployment Force | Pass |
| 7 | Implant Anchor Function- Retention (tensile) | Pass |
Conclusion
The information Boston Scientific Corporation provided in this submission demonstrates that the proposed AXIOS 15mm x 15mm Stent and Electrocautery Enhanced Delivery System is substantially equivalent to the currently cleared AXIOS 15mm x 10mm Stent and Electrocautery Enhanced Delivery System K181905.
§ 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.