(27 days)
No
The device description and performance studies focus on the mechanical properties and delivery system of a self-expanding stent, with no mention of AI or ML.
Yes
The stent is permanently implanted to maintain patency of a bile duct obstructed by a tumor, directly addressing a medical condition (malignant strictures) for palliation.
No
Explanation: The device, a self-expanding stent, is used for the palliation of malignant strictures in the biliary tree, which is a therapeutic purpose to maintain patency, not to diagnose a condition.
No
The device description clearly states it consists of a physical, permanently implanted stent and a delivery catheter, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "palliation of malignant strictures (neoplasms) in the biliary tree." This describes a therapeutic intervention performed within the body to treat a physical condition.
- Device Description: The device is a "self-expanding stent" that is "permanently implanted device used to maintain patency of a major bile duct." This is a medical device designed for internal placement and structural support.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The description of the LifeStent FlexStar XL Biliary Stent System does not involve any such testing of specimens.
Therefore, the LifeStent FlexStar XL Biliary Stent System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LifeStent FlexStar XL Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Product codes
FGE
Device Description
The LifeStent FlexStar XL Biliary Stent System consists of a self-expanding stent that is provided loaded into an over the wire catheter that acts as a delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging turnor. The flexible, self-expanding stent is made by laser cutting an open lattice design into a nitinol tube. The subject device is supplied in lengths of 100mm, 120mm and 150mm and diameters of 6mm and 7mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Edwards Lifesciences completed bench testing such as deployment testing, dimensional testing, as well as tensile strength testing on applicable joints of the delivery system. The results indicate that the system performed in a manner substantially equivalent to the predicate devices cited in item 7 above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LifeStent FlexStar Self-Expanding Biliary Stent System (K053404), ev3 Protégé GPS Self-Expanding Nitinol Stent (K042204)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for Edwards Lifesciences. The logo consists of the company name, "Edwards Lifesciences", in a serif font. To the left of the name is a stylized graphic, possibly representing the letter "E" or a medical device.
CONFIDENTIAL May not be reproduced without written permission fro Edwards Lifesciences
510(k) Summary
1. Submitter's Name and Address:
Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614
2. Contact:
- Kevin Drisko Sr. Regulatory Manager Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 Phone: 949-250-2416 FAX: 949-250-2303 E-Mail: kevin drisko@edwards.com
3. Date Prepared:
February 23, 2006
4. Device Trade Name:
LifeStent FlexStar XL Biliary Stent System
5. Device Common Name:
Biliary Stent
6. Device Classification Name:
Biliary Catheter (78 FGE), Class II
7. Predicate Devices:
LifeStent FlexStar Self-Expanding Biliary Stent System (K053404) ev3 Protégé GPS Self-Expanding Nitinol Stent (K042204)
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Image /page/1/Picture/0 description: The image shows the logo for Edwards Lifesciences. The logo consists of a stylized letter "E" on the left, followed by the text "Edwards Lifesciences" in a clear, sans-serif font. The text is aligned horizontally and is easy to read.
510(k) Summary (continued)
8. Device Description:
The LifeStent FlexStar XL Biliary Stent System consists of a self-expanding stent that is provided loaded into an over the wire catheter that acts as a delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging turnor. The flexible, self-expanding stent is made by laser cutting an open lattice design into a nitinol tube. The subject device is supplied in lengths of 100mm, 120mm and 150mm and diameters of 6mm and 7mm.
9. Intended Use:
The LifeStent FlexStar XL Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
10. Technological Characteristics:
Comparisons of the subject 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, dimensional testing, as well as tensile strength testing on applicable joints of the delivery system. The results indicate that the system performed in a manner substantially equivalent to the predicate devices cited in item 7 above.
12. Conclusion:
Since the LifeStent FlexStar XL Billary Stent System has the same intended use, similar materials, similar performance properties, packaging and sterilization methods, it may be considered substantially equivalent to the predicate device cited in item 7 above.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 23 2006
Mr. Kevin Drisko Senior Manager, Regulatory Affairs Edwards Lifesciences LLC One Edwards Way IRVINE CA 92614
Re: K060487
Trade/Device Name: LifeStent FlexStar XL Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: February 23, 2006 Received: February 24, 2006
Dear Mr. Drisko:
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). 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 -- Mr. Kevin Drisko
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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Susan Kuong
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number:_K060487
Device Name: LifeStent FlexStar XL Biliary Stent System
FDA's Statement of the Indications for Use for device:
The LifeStent FlexStar XL Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
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)
Janece Guadon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
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