(49 days)
The AXIOS™ Stent and Delivery System is indicated for use to facilitate transenteric 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.
The AXIOS™ Stent and Delivery System is an endoscopic device designed to deliver a fully-covered stent between a pancreatic pseudocyst and the gastrointestinal tract. The AXIOS™ Stent is a flexible, MR compatible, fully-covered self-expanding Nitinol stent preloaded within the AXIOS Delivery System. The AXIOS™ Delivery System is compatible with endoscopes equipped with a 3.7mm diameter or larger working channel. The AXIOS Stent and Delivery System is provided sterile, disposable and intended for use during a single patient procedure. The AXIOS Stent and Delivery System are sterilized by a validated method of sterilization via Ethylene Oxide (EO).
The provided document is limited to a 510(k) summary for the AXIOS™ Stent and Delivery System. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than detailed clinical studies with acceptance criteria, performance metrics, and human reader evaluations typical for AI/ML-based diagnostic devices.
Therefore, the information required to populate most of the sections of your request (acceptance criteria, detailed study design with sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML models) is not present in this document.
However, I can extract information related to non-clinical testing and the overall conclusion about device performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Confirmed biocompatible, non-toxic, and safe for temporary implantation (in accordance with FDA guidance "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices," dated May 1, 1995 (G95-1)). |
| Device Function/Specifications | Verified that the device meets product specifications, performance characteristics, and requirements established by special controls for a pancreatic drainage stent and accessories. |
| Performance Levels | Test results established that the specified performance levels were achieved. |
| Risk Mitigation | Mitigations for anticipated risks were met through standard test methods, available guidances, and recognized technical requirements. |
| Comparison to Predicate | As safe, as effective, and performs as well as or better than the predicate AXIOS Stent and Delivery System (K123250). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes non-clinical bench testing and biocompatibility testing, not human clinical trials or AI/ML model performance evaluation with test sets derived from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. Ground truth, in the context of expert consensus for AI/ML, is not relevant to this type of device submission. The "ground truth" here is implied by predefined engineering specifications and regulatory standards met through non-clinical laboratory testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically for clinical outcome or diagnostic agreement, which is not described for this non-clinical submission.
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. An MRMC study is not mentioned as this is a medical device for drainage, not an AI-based diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a hardware medical device; the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical testing, the "ground truth" was established by predetermined product specifications, performance characteristics, regulatory standards, and recognized consensus standards (e.g., for biocompatibility and sterilization). The direct comparison was against the predicate device (AXIOS™ Stent and Delivery System K123250) for substantial equivalence.
8. The sample size for the training set
- Not Applicable. This document does not pertain to an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set for an AI/ML model is described.
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XLumena, Inc. AXIOS™ Stent and Delivery System
K140561 Page 1 of 2 Special 510(k) Page 26 of 47.
APR 2 3 2014
510(K) SUMMARY
510(k) Owner: Xlumena, Inc. 453 Ravendale Drive, Suite H Mountain View, California 94043 Phone: (650) 961-9900
| Contact: | Jane Beggs |
|---|---|
| Fax: (650) 961-9900 |
Date Prepared: 04 March 2014
Proprietary Name: AXIOS™ Stent and Delivery System
Common Name: Pancreatic drainage stent and delivery system 21 CFR 876.5015 Regulation: Regulation Name: Pancreatic drainage stent and accessories Regulatory Class: = Product Code: PCU
AXIOS™ Stent and Delivery System (K123250) Predicate Device:
Device Description: The AXIOS™ Stent and Delivery System is an endoscopic device designed to deliver a fully-covered stent between a pancreatic pseudocyst and the gastrointestinal tract.
The AXIOS™ Stent is a flexible, MR compatible, fully-covered self-expanding Nitinol stent preloaded within the AXIOS Delivery System.
The AXIOS™ Delivery System is compatible with endoscopes equipped with a 3.7mm diameter or larger working channel. The AXIOS Stent and Delivery System is provided sterile, disposable and intended for use during a single patient procedure.
The AXIOS Stent and Delivery System are sterilized by a validated method of sterilization via Ethylene Oxide (EO). The validation was conducted in accordance with recognized consensus standards.
Indications for Use: The AXIOS™ Stent and Delivery System is indicated for use to facilitate transenteric 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.
001 Page 26 of 47
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Principles of Operation: The AXIOS Delivery System is placed into the stomach through an endoscope that is passed through the patient's mouth and into an area of the stomach adjacent to the target pseudocyst. After creating a small opening in the wall of the stomach and a small opening in the pseudocyst, the physician positions the compressed stent across both openings, releases the stent and removes the delivery system. Once expanded, the stent allows the contents of the pseudocyst to drain into the stomach. When the pseudocyst has drained and decreased in size, the physician can use standard endoscopic tools to remove the AXIOS Stent.
Summary of Technological Characteristics: Comparison of materials used in the manufacture of the predicate and subject devices notes that the optional hydrophilic coating to be the only difference. The design and other technological characteristics are the same. No change was made to the AXIOS stent.
Determination of Substantial Equivalence: Substantial equivalence is supported through comparison with the predicate device: The AXIOS Stent and Delivery System. The subject device has the same intended use, utilizes the same principles of operations and fundamental scientific technology as that of the predicate device. No change was made to the AXIOS stent.
Non-clinical testing included biocompatibility testing, which was conducted in accordance with the FDA guidance entitled, "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices," dated May 1, 1995 (G95-1); as well as an comparison of tracking force with the predicate device.
Non-clinical testing confirmed the modified AXIOS Stent and Delivery Catheter is biocompatible, non-toxic and safe for temporary implantation. Bench testing of device function verified that the device meets product specifications, performance characteristics and requirements established by special controls for a pancreatic drainage stent and accessories.
Conclusions Drawn from Testing: Test results established that the specified performance levels were achieved and mitigations for anticipated risks were met through standard test methods, available guidances and recognized technical requirements. In conclusion, the modified device is as safe, as effective and performs as well as or better than the predicate AXIOS Stent and Delivery System.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2014
Xlumena, Inc. Jane Beggs VP, Regulatory and Clinical Affairs 453 Ravendale Drive, Suite H Mountain View, CA 94043
Re: K140561
Trade/Device Name: AXIOS™ Stent and Delivery System Regulation Number: 21 CFR§ 876.5015 Regulation Name: Pancreatic drainage stent and delivery system Regulatory Class: II Product Code: PCU Dated: March 21, 2014 Received: March 24, 2014
Dear Jane Beggs,
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.
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Page 2 - Jane Beggs
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
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
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INDICATIONS FOR USE STATEMENT 7
510(k) Number (if known): K140561
Device Name:
AXIOS™ Stent and Delivery System
Indications for Use:
The Xlumena AXIOS™ Stent and 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR ·
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert I
Page 1 of 1
§ 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.