(59 days)
The GORE® VIABIL® Short Wire Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree.
The GORE® VIABIL® Short Wire Biliary Endoprosthesis is a flexible endoprosthesis (stent) that is radially compressed and secured onto the distal end of a delivery catheter. The catheter provides a means for implanting the GORE® VIABIL® Short Wire Biliary Endoprosthesis at the target site in the biliary tract. The subject of this 510(k) pre-market notification is a modification to the catheter component of the endoscopic (GI) delivery system to include a guidewire exit port located near the distal end of the catheter which will allow use of a shorter length (minimum 260cm) guidewire enabling single user control of the guidewire during use. No changes have been made to the implanted endoprosthesis of the predicate GORE® VIABIL® Biliary Endoprosthesis device.
This document is a 510(k) premarket notification from the FDA, discussing the substantial equivalence of a new medical device, the GORE® VIABIL® Short Wire Biliary Endoprosthesis, to a previously marketed predicate device. As such, it focuses on demonstrating substantial equivalence rather than proving a device meets specific clinical performance acceptance criteria through a full-scale clinical study with human patients and outcomes data.
Therefore, the provided text does not contain the information requested for a detailed "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical performance or AI/human reader studies.
Specifically, the document states:
- "No animal studies were required to support this submission." (Page 7)
- "No clinical evaluations were required to support this submission." (Page 7)
The "Summary of Performance Testing" section (Page 6-7) refers to non-clinical testing primarily related to the device modification (a change to the catheter component for guidewire use). This testing aims to show that the modified device performs similarly to the predicate device in terms of engineering and material properties, rather than clinical efficacy.
Here's what can be extracted based on the provided text, and what is missing:
Information Present in the Document:
The document describes non-clinical performance testing conducted to ensure the modified device (GORE® VIABIL® Short Wire Biliary Endoprosthesis) is substantially equivalent to its predicate (GORE® VIABIL® Biliary Endoprosthesis K081184). The focus is on the catheter component modification to allow for a shorter guidewire.
Acceptance Criteria and Reported Device Performance (Non-Clinical):
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Simulated Use Deployment Testing | Tested. Device met established acceptance criteria. |
| Dimensional Testing | Tested. Device met established acceptance criteria. |
| Tensile/Bond Strength Testing | Tested. Device met established acceptance criteria. |
| Deployment Force | Tested. Device met established acceptance criteria. |
| Accessory Component Compatibility | Tested. Device met established acceptance criteria. |
| Deployment Accuracy | Tested. Device met established acceptance criteria. |
| Deployment Reliability | Tested. Device met established acceptance criteria. |
| Shelf Life Performance | Testing demonstrated the subject Viabil device met the established acceptance criteria for up to the intended device shelf life, consistent with the predicate Viabil device. |
| Biocompatibility (per ISO10993-1) | Testing confirmed the subject device, like the predicate device, is biocompatible for its intended use. Identical to predicate. |
| Device Packaging Acceptability | Packaging testing of the subject Viabil device in the predicate Viabil device packaging system confirmed that the packaging system was acceptable. |
| MR Safety (per FDA guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment) | Tested. Results included in device labeling. |
| Sterilization Method/SAL | Same as predicate (Ethylene Oxide/SAL of 10-6). |
Information NOT Present in the Document (and explicitly stated as not required):
The document explicitly states that no animal or clinical evaluations were required. Therefore, none of the following information, which would typically be found in a clinical study report for proving device efficacy or effectiveness, is available:
- Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used. The non-clinical tests were conducted on "representative sterile, aged samples."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance was not established as there was no clinical study.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is a physical endoprosthesis, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. For non-clinical tests, the "ground truth" would be engineering specifications and predicate device performance.
- The sample size for the training set: Not applicable. No machine learning/AI model was developed or trained.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
This 510(k) submission relies on a demonstration of substantial equivalence through non-clinical performance testing of a modified device component, rather than a clinical study proving new efficacy or safety. The acceptance criteria and performance data provided relate only to engineering, materials, and functional aspects of the device in a non-clinical setting, ensuring the modified device functions comparably to its predicate.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002
May 8, 2017
W.L. Gore & Associates, Inc. Barbara L. Smith, RAC Regulatory Associate 301 Airport Road Elkton, MD 21921
Re: K170740
Trade/Device Name: GORE® VIABIL® Short Wire Biliary Endoprosthesis Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE Dated: March 9, 2017 Received: March 10, 2017
Dear Barbara L. Smith:
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 and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for use in the vascular system have not been established
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Furthermore, the indication for biliary use must be prominently displayed in all labeline. including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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. 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 devicerelated 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.
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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.
Sincerely,
William H. Maisel -S
William H. Maisel, MD, MPH Director, Office of Device Evaluation (Acting) Deputy Center Director for Science Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
GORE® VIABIL® Short Wire Biliary Endoprosthesis
Indications for Use (Describe)
The GORE® VIABIL® Short Wire Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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7 510(K) SUMMARY [21 CFR 807.92]
510(k) Submitter
W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21921 Regulatory contact: Barbara L. Smith, RAC
Date Prepared
May 1, 2017
Device Names/Classification
| Device Name: | GORE® VIABIL® Short Wire Biliary Endoprosthesis |
|---|---|
| Common Name: | Biliary Stent |
| Classification Name: | Catheter, biliary, diagnostic |
| Classification: | 21CFR876.5010 – Class II |
| Product Code: | FGE |
Predicate Devices
- . K081184 GORE® VIABIL® Biliary Endoprosthesis
Device Description
The GORE® VIABIL® Short Wire Biliary Endoprosthesis is a flexible endoprosthesis (stent) that is radially compressed and secured onto the distal end of a delivery catheter. The catheter provides a means for implanting the GORE® VIABIL® Short Wire Biliary Endoprosthesis at the target site in the biliary tract. The subject of this 510(k) pre-market notification is a modification to the catheter component of the endoscopic (GI) delivery system to include a guidewire exit port located near the distal end of the catheter which will allow use of a shorter length (minimum 260cm) guidewire enabling single user control of the guidewire during use. No changes have been made to the implanted endoprosthesis of the predicate GORE® VIABIL® Biliary Endoprosthesis device.
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The sizes of the GORE® VIABIL® Short Wire Biliary Endoprosthesis device are the same as the predicate GORE® VIABIL® Biliary Endoprosthesis as noted in the following table.
| Endoprosthesis -Diameter (mm) x Length(cm) | Drainage HolesLocated at theHilar Region |
|---|---|
| 8 × 4 | No holes |
| 8 x 6 | No holes |
| 8 × 8 | No holes |
| 8 x 10 | No holes |
| 10 x 4 | No holes |
| 10 x 6 | No holes |
| 10 x 8 | No holes |
| 10 x 10 | No holes |
| 8 × 6 | Holes |
| 8 × 8 | Holes |
| 8 x 10 | Holes |
| 10 x 6 | Holes |
| 10 x 8 | Holes |
| 10 x 10 | Holes |
Indications for Use
The GORE® VIABIL® Short Wire Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree.
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Comparison of Technological Characteristics
The table below describes the similarities/differences between the catheter component of the subiect GORE® VIABIL® Short Wire Biliary Endoprosthesis and the catheter component of the predicate GORE® VIABIL® Biliary Endoprosthesis (K081184).
| Modified Device | Predicate Device | |
|---|---|---|
| GORE® VIABIL® Short Wire Biliary | GORE® VIABIL® Biliary | |
| Endoprosthesis | EndoprosthesisK081184 | |
| Indications for use | No change - Same as predicate | Intended for palliation of malignantstrictures in the biliary tree. |
| Endoprosthesis(Stent device) | No change - Same as predicate | ePTFE/FEP film tube supported byan FEP coated Nitinol stent. |
| DeploymentSystem | No change - Same as predicate | Pull-line style deployment using anePTFE zipper |
| Single port hub | Y-arm (dual port) catheter hub | |
| GI DeliveryCatheterComponent -Modified for usewith shorterguidewire | Dual lumen catheter tubing-Added guidewire exit port on cathetershaft; 2nd catheter hub port eliminated.Catheter material formulation changeto different durometer of samematerial type | Dual lumen catheter tubing-Guidewire exits from 2nd catheterhub port |
| Biocompatibility | Same as predicate | Biocompatible per ISO10993-1. |
| Device Packaging | • HDPE coil with modified connector• No change to sterile barrier | • HDPE coil and connector forphysical protection of devicewithin sterile barrier |
| Sterilizationmethod/SAL | Same as predicate | Ethylene Oxide/SAL of 10-6 |
| Labeling | Same as predicateMR safety informationUpdate to warning statements | Complies with applicable regulations &FDA guidance on MR safety |
Summary of Performance Testing
Non-Clinical
The device specific guidance document, FDA's Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents, was consulted in determining the appropriate testing for the subject catheter modification. Testing was conducted on representative sterile, aged samples. The test samples were subjected to simulated use deployment testing, dimensional testing, tensile/bond strength testing, deployment force, accessory component compatibility, deployment accuracy, and deployment reliability. Testing demonstrated the subject Viabil device met the established acceptance criteria for up to the intended device shelf life, consistent with the predicate Viabil device. Biocompatibility testing was conducted per ISO10993-1 and confirmed the subject device, like the predicate device, is biocompatible for its intended use. Packaging testing of the subject Viabil device in the predicate Viabil device packaging system confirmed that the packaging system
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was acceptable for the GORE® VIABIL® Short Wire Biliary Endoprosthesis device. MR Safety testing was conducted in recognition of FDA's guidance, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and the results included in the device labeling.
Animal study: No animal studies were required to support this submission.
Clinical
No clinical evaluations were required to support this submission.
Conclusion
Based on the information contained within this 510(k) premarket notification, W. L. Gore & Associates concludes that the subject GORE® VIABIL® Short Wire Biliary Endoprosthesis device is substantially equivalent to the predicate GORE® VIABIL® Biliary Endoprosthesis device in terms of indications for use, materials, biocompatibility, sterilization, packaging, labeling and performance.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.