(363 days)
The VIABIL Biliary Endoprosthesis is indicated for the treatment of malignant biliary strictures.
The VIABIL Biliary Endoprosthesis is a flexible, selfexpanding stent-graft that is radially compressed and secured onto the distal end of a delivery catheter. The catheter provides a means for implanting the VIABIL Biliary Endoprosthesis at the target site in the biliary tract. There are two principle components of the device: the Biliary Endoprosthesis and the Delivery Catheter. Two catheter lengths are available: a 75 cm working length catheter for percutaneous delivery of the endoprosthesis, and a 195 cm working length catheter for endoscopic delivery. The endoprosthesis is available in two diameters (8 mm and 10 mm), and four nominal lengths (4 cm, 6 cm, 8 cm, and 10 cm).
The provided text is a Premarket Notification Summary for the VIABIL Biliary Endoprosthesis, and thus focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or showing device performance against such criteria. As such, the information typically found in a study proving acceptance criteria for a new device is not fully present.
However, based on the provided text, here's an attempt to extract and infer the requested information, with notable limitations due to the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define specific numerical acceptance criteria (e.g., success rates, patency rates, complication rates) with corresponding target values. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" assessment is qualitative, stating that the device is "substantially equivalent" to predicates.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety: Device is as safe as legally marketed predicate devices. | Preclinical in vivo testing confirmed the safety in terms of delivery, deployment, functionality, and biological response. Clinical study demonstrated safety. Substantially equivalent to predicate. |
| Effectiveness: Device is as effective as legally marketed predicate devices for the intended use (treatment of malignant biliary strictures). Performance characteristics (e.g., patency, reduction of stricture) are comparable to predicates. | Preclinical in vivo testing confirmed efficacy. Clinical study demonstrated effectiveness. Substantially equivalent to predicate. |
| Technological Characteristics: Device has similar technological characteristics to predicate devices. | The VIABIL Biliary Endoprosthesis is a stent-graft made of nitinol, similar to predicate covered stents and nitinol stents. |
| Reliability: Device components and delivery system perform reliably. | Preclinical in vitro testing demonstrated the reliability of the endoprosthesis and delivery catheter. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document simply states "The results of the clinical study with the VIABIL Biliary Endoprosthesis demonstrated the safety and effectiveness of the device..." It does not specify the sample size of the clinical study.
- Data Provenance: The document does not specify the country of origin for the clinical study data or whether it was retrospective or prospective. It only mentions "clinical testing" and a "clinical study." The comparison to a "historical control" suggests that the predicate device's data was used retrospectively for comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. As this is a medical device for treatment, the "ground truth" would likely be based on clinical outcomes assessed by treating physicians and follow-up imaging, rather than expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study, as typically described for AI systems evaluating human reader improvement with AI assistance, was not performed or mentioned. The clinical study was likely a standard clinical trial for a medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to this device. The VIABIL Biliary Endoprosthesis is a physical medical device (a stent-graft), not an algorithm or AI system. Therefore, "standalone" algorithm performance is not a relevant concept for this product. The device's performance is intrinsically linked to its implantation by a human operator.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the device's performance would primarily be:
- Clinical Outcomes: Regarding safety (e.g., adverse events, complications) and effectiveness (e.g., successful stent deployment, patency of the biliary tract, relief of stricture, patient survival). This would be derived from patient follow-up data.
- Historical Control Data: For comparison, the performance of the predicate device based on its historical clinical outcomes likely served as a benchmark for equivalence.
8. The Sample Size for the Training Set
This question is not applicable to this device. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device undergoes design, manufacturing, and preclinical testing, followed by clinical studies.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" for a physical medical device in this context.
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VIABIL Biliary Endoprosthesis Premarket Notification
se 1/2
Ko14215
Tab J
DEC 1 9 2002
Premarket Notification Summary
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- Applicant Name, Address: W.L. Gore & Associates, Inc. 3450 W. Kiltie Lane P.O. Box 500 Flagstaff, AZ 86002-0500 Contact Person: Jacqueline Kalbach (928)864-3731 Date of Summary: December 20, 2001 2. Classification Name: Biliary catheter Common or Usual Name: Biliary stent Trade or Proprietary Name: VIABIL™ Biliary Endoprosthesis
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- Device Predicates: Microvasive Modified Biliary Wallstent®, Wallstent® Biliary Transhepatic Endoprosthesis with Unistep™ Plus Delivery System. Cordis S.M.A.R.T.TM Nitinol Stent Transhepatic Biliary System. Cordis S.M.A.R.T.™ Nitinol Stent Endoscopic Biliary System, Wilson-Cook ST-2 Soehendra Tannenbaum® Biliarv Stent
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- Device Description: The VIABIL Biliary Endoprosthesis is a flexible, selfexpanding stent-graft that is radially compressed and secured onto the distal end of a delivery catheter. The catheter provides a means for implanting the VIABIL Biliary Endoprosthesis at the target site in the biliary tract. There are two principle components of the device: the Biliary Endoprosthesis and the Delivery Catheter. Two catheter lengths are available: a 75 cm working length catheter for percutaneous delivery of the endoprosthesis, and a 195 cm working length catheter for endoscopic delivery. The endoprosthesis is available in two diameters (8 mm and 10 mm), and four nominal lengths (4 cm, 6 cm, 8 cm, and 10 cm).
TM GORE, VIABIL, and designs are trademarks of W.L. Gore & Associates
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22
KU14215
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- Intended Use: The VIABIL Biliary Endoprosthesis is indicated for the treatment of malignant biliary strictures.
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- Technological Characteristics: Similar to the Microvasive Modified Biliary Wallstent® (i.e., a covered stent), the VIABIL Biliary Endoprosthesis is a stent-graft. The stent is made of nitinol, the same material used in the Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System and Cordis S.M.A.R.T.™ Nitinol Stent Endoscopic Biliary System devices.
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- Assessment of Performance Data: Preclinical in vitro testing, preclinical in vivo testing, and clinical testing have demonstrated that the VIABIL Biliary Endoprosthesis is substantially equivalent to its predicate device.
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- Conclusion: Preclinical in vitro testing has demonstrated the reliability of the VIABIL Biliary Endoprosthesis and its delivery catheter. Preclinical in vivo testing has cofirmed the safety and efficacy of the VIABIL Biliary Endoprosthesis in terms of delivery and deployment, functionality, and biological response. The results of the clinical study with the VIABIL Biliary Endoprosthesis demonstrated the safety and effectiveness of the device for endoscopic and percutaneous approaches. The comparison to the historical control demonstrated the substantial equivalence of the VIABIL Biliary Endoprosthesis to its predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DFC 1 9 2002
Ms. Jacqueline Kalbach Regulatory Affairs Associate W.L. Gore and Associates, Inc. 3450 West Kiltie Lane FLAGSTAFF AZ 86001
Re: K014215
Trade/Device Name: VIABIL™ Biliary Endoprosthesis Regulation Number: 21 CFR $876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: September 26, 2002 Received: September 27, 2002
Dear Ms. Kalbach:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
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)(1)(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.
Furthermore, the indication for biliary use must be prominently displayed in all labeling, 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.
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Page 2 .- Ms. Jacqueline Kalbach
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); 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.
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 above is added to your labeling, as described.
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.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Daniel G. Schultz, M.D.
Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K014215
Device Name: VIABIL™ Biliary Endoprosthesis
FDA's Statement of the Indications for Use for device:
The VIABIL™ Biliary Endoprosthesis is indicated for the treatment of malignant biliary strictures.
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
David H. Sypman
(Division Sign-Off) Division of Reproductive, and RadioIngical Devices 510(x) Number_
§ 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.