(14 days)
The Edwards Lifesciences LifeStent FlexStar Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
The LifeStent FlexStar 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 20mm to 80mm and diameters of 6mm to 10mm.
The provided text describes a 510(k) premarket notification for the LifeStent FlexStar Biliary Stent System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing de novo performance criteria or conducting clinical trials to prove device performance against specific acceptance criteria.
Therefore, the document does not contain information regarding traditional acceptance criteria or a study designed to prove the device meets such criteria.
Instead, it focuses on demonstrating that the new device is substantially equivalent to predicate devices already on the market.
Here's a breakdown of why the requested information cannot be fully provided based on the input text:
1. A table of acceptance criteria and the reported device performance:
- Not applicable for a 510(k) submission based on substantial equivalence. The document states: "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." This indicates the tests were to show similarity, not to meet pre-defined performance acceptance criteria unique to this device against a new standard.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document only mentions "bench testing" without specifying sample sizes for these tests. Data provenance like country of origin or retrospective/prospective is not relevant to bench testing.
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. Bench testing does not involve establishing ground truth through expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for clinical studies or image interpretations, not bench testing of material properties.
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:
- Not applicable. This device is a physical medical implant (biliary stent), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. Bench testing for substantial equivalence evaluates physical and performance characteristics against a known predicate, not against a "ground truth" in the clinical sense.
8. The sample size for the training set:
- Not applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set or ground truth in this context.
Summary of available information related to performance:
- Type of Study: Bench testing to demonstrate substantial equivalence.
- Tests Performed: Deployment testing, dimensional testing, tensile strength testing on applicable joints of the delivery system.
- Conclusion: The results indicate that the system performed in a manner substantially equivalent to the predicate devices (LifeStent NT18 and LifeStent NT35 Self-Expanding Biliary Stent Systems).
- Key Argument for Approval: The device has the same intended use, similar materials, similar performance properties, packaging, and sterilization methods as the predicate devices.
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Ko5340f
CONFIDENTIAL May not be reproduced without written permissio Edwards Lifesciences
510(k) Summary
1. Submitter's Name and Address:
DEC 2 1 2005
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:
December 6, 2005
4. Device Trade Name:
LifeStent FlexStar Biliary Stent System
5. Device Common Name:
Biliary Stent
6. Device Classification Name:
Biliary Catheter (78 FGE), Class II
7. Predicate Devices:
LifeStent NT18 Self-Expanding Biliary Stent System (K024303) and LifeStent NT35 Self-Expanding Biliary Stent System (K042985).
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Image /page/1/Picture/1 description: The image shows the logo for Edwards Lifesciences. The logo consists of a graphic on the left and the text "Edwards Lifesciences" on the right. The text is in a serif font and is black. The graphic on the left is a complex design that is difficult to discern.
510(k) Summary (continued)
8. Device Description:
The LifeStent FlexStar 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 20mm to 80mm and diameters of 6mm to 10mm.
9. Intended Use:
The LifeStent FlexStar 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 Biliary 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 devices cited in item 7 above.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle symbol, composed of three curved lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2005
Mr. Kevin Drisko Senior Manager, Regulatory Affairs Edwards Lifesciences LLC One Edwards Way IRVINE CA 92614
Re: K053404
Trade/Device Name: Edwards Lifesciences LifeStent FlexStar Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: December 6, 2005 Received: December 7, 2005
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
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 described above is added to your labeling.
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), please contact the Office of Compliance at (301) 594-4616. 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,
Sincerely yours,
Qatula
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: K053404
Device Name: Edwards Lifesciences LifeStent FlexStar Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Edwards Lifesciences LifeStent FlexStar Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Opmil G. Seguram
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ____ 8053404
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.