(191 days)
The Edwards Lifesciences LifeStent NT18 Self-Expanding Biliary Stent and Delivery System is indicated for use in the palliative treatment of patients with malignant biliary strictures.
The Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System is designed to deliver a self-expanding stent to the biliary tree via a sheathed delivery system to provide palliative treatment for malignant strictures. The Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System is comprised of the following:
- An implantable self-expanding nickel-titanium alloy (nitinol) stent. The stent is available in 6mm to 8mm diameters, and a variety of lengths.
- A 6Fr delivery system available in 75cm and 120cm usable lengths.
The Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System products are supplied sterile and are "single-use only" devices.
The provided text is a 510(k) summary for the Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and performing a study against them in the way a new, high-risk device might.
Therefore, many of the requested elements are not applicable or cannot be extracted from this specific type of regulatory submission. This 510(k) summary describes bench testing to show equivalence to existing devices, not clinical performance against acceptance criteria in humans.
Here's a breakdown of what can be inferred or directly stated from the document, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in the typical sense for clinical performance. Instead, it states that "The results indicate that the Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System performed in a manner substantially equivalent to the predicate devices cited in item 7 above."
The performance data listed are categories of bench tests, not specific clinical outcomes with pre-defined success/failure thresholds.
| Performance Characteristic (Type of Test) | Reported Device Performance |
|---|---|
| Deployment Testing | Substantially equivalent to predicate devices |
| Expansion Force Testing | Substantially equivalent to predicate devices |
| Compression Force Testing | Substantially equivalent to predicate devices |
| Dimensional Testing | Substantially equivalent to predicate devices |
| Corrosion Testing | Substantially equivalent to predicate devices |
| Tensile Strength Testing (Applicable joints of delivery system) | Substantially equivalent to predicate devices |
2. Sample Size for Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document only mentions "bench testing," implying a set of devices/components were tested in a lab setting, but not the number.
- Data Provenance: The nature of "bench testing" means the data is generated in a laboratory setting, not from human subjects. Therefore, country of origin is not relevant in the context of patient data, and it's inherently "prospective" in terms of the tests being run on the device samples.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. This relates to clinical studies with subjective interpretations (e.g., radiology images). For bench testing of device mechanics, "ground truth" is typically objective measurement against engineering specifications or comparative performance to known devices. Engineers or lab technicians would perform these tests.
4. Adjudication Method:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving multiple human readers interpreting data. This document describes bench testing.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No. This type of study assesses human reader performance with and without AI assistance. The submission describes a medical device (stent and delivery system), not an AI algorithm for interpretation, and the studies mentioned are bench tests, not clinical MRMC studies.
6. Standalone (Algorithm Only) Performance Study:
- No. As noted above, this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
- Objective Engineering Specifications / Comparative Device Performance: For the bench tests performed, the "ground truth" would be objective measurements (e.g., force, dimensions, corrosion resistance) compared against predetermined engineering specifications or directly compared to the performance of the predicate devices.
8. Sample Size for Training Set:
- Not applicable. There is no "training set" in the context of this device. A training set is relevant for machine learning algorithms.
9. How Ground Truth for Training Set Was Established:
- Not applicable. See point 8.
{0}------------------------------------------------
K024303 1 of 2
Image /page/0/Picture/2 description: The image shows a logo with a large letter 'E' superimposed on a grid-like background. The letter 'E' is white and appears to be the focal point of the design. Below the logo, the word 'Edwards' is written in a serif font. The overall design is simple and professional, suggesting a corporate or business identity.
510(k) Summary
1. Submitter's Name and Address:
Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614
2. Contact:
Kevin Drisko Senior Manager, Regulatory Affairs Edwards Lifesciences LLC Phone: (949) 250-2416 Fax: (949) 250-3630 E-mail: kevin_drisko@edwards.com
3. Date Prepared:
December 23, 2003
4. Device Trade Name:
Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System
5. Device Common Name:
Biliary Stent (self-expanding)
6. Device Classification Name:
Biliary Catheter (78 FGE), Class II
7. Predicate Devices:
Cordis S.M.A.R.T.TM Nitinol Stent Transhepatic Biliary System (K001843) Cordis Precise™ Nitinol Stent Transhepatic Biliary System (K010445) Cordis Precise™ Nitinol Stent Transhepatic Biliary System (6F) (K012993) Cordis S.M.A.R.T.TM Control™ Nitinol Stent Transhepatic Biliary System (K021898)
{1}------------------------------------------------
Image /page/1/Figure/1 description: The image shows a stylized letter "E" inside of a circle. The letter and circle are white, and they are set against a gray, textured background. The background appears to be made up of small squares, giving it a pixelated or mosaic-like appearance.
510(k) Summary (continued)
8. Device Description:
The Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System is designed to deliver a self-expanding stent to the biliary tree via a sheathed delivery system to provide palliative treatment for malignant strictures. The Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System is comprised of the following:
- An implantable self-expanding nickel-titanium alloy (nitinol) stent. The stent is . available in 6mm to 8mm diameters, and a variety of lengths.
- A 6Fr delivery system available in 75cm and 120cm usable lengths. .
The Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System products are supplied sterile and are "single-use only" devices.
9. Intended Use:
The Edwards LifeStent™ NT18 Self-Expanding Billary Stent and Delivery System is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
10. Technological Characteristics:
Comparisons of the new and predicate devices show that the technical characteristics such as materials, performance properties, biocompatibility, method of sterilization, and packaging are identical or substantially equivalent.
11. Performance Data:
Edwards Lifesciences completed bench testing such as deployment testing, expansion force testing, compression force testing, dimensional testing, corrosion testing, as well as tensile strength testing on applicable joints of the delivery system. The results indicate that the Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System performed in a manner substantially equivalent to the predicate devices cited in item 7 above.
12. Conclusion:
Since the Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System has the same intended use, identical material properties, similar performance properties, packaging and sterilization methods, it may be considerd substantially equivalent to the predicate devices cited in item 7 above.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The symbol in the center appears to be three stylized human profiles facing to the right, stacked on top of each other. The text around the perimeter is not fully legible but seems to be part of an organization's name. The logo has a simple, clean design with a focus on the human profiles.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2003
Mr. Kevin Drisko Senior Manager, Regulatory Affairs Edwards Lifesciences, LLC One Edwards Way Irvine, California 92614
Re: K024303
Trade/Device Name: Edwards LifeStent NT18 Self-Expanding Biliary Stent and Delivery System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: April 3, 2003 Received: April 4, 2003
Dear Mr. Drisko:
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.
{3}------------------------------------------------
Page 2 - Mr. Kevin Drisko
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, MD. Director Office of Device Evaluation Center for Devices and Radiological Health
{4}------------------------------------------------
Page _ 1 of 1
510(k) Number (if known): K024303
Device Name: LifeStent NT18 Self-Expanding Biliary Stent and Delivery System
FDA's Statement of the Indications For Use for device:
The Edwards Lifesciences LifeStent NT18 Self-Expanding Biliary Stent and Delivery System is indicated for use in the palliative treatment of patients with malignant biliary strictures.
Prescription Use_"_ OR (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Nancy C. Brandon
510(k) Nun
§ 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.