The LifeStent Turbo consists of a balloon expandable stent that is provided on an over-the-wire delivery system. The LifeStent Turbo is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, open lattice design is made by laser cutting an open lattice design into a stainless steel tube. The stent is available in lengths of 12 mm, 18 mm, and 25mm and diameters of 5mm and 6mm.

AI/ML Overview

Here's an analysis of the provided documents regarding the acceptance criteria and study for the Edwards Lifesciences LifeStent Turbo Biliary Stent System:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Performance Characteristic	Reported Device Performance
Mechanical Performance	Deployment Testing	Performed in a manner substantially equivalent to the predicate device.
	Dimensional Testing	Performed in a manner substantially equivalent to the predicate device.
	Compression Force Testing	Performed in a manner substantially equivalent to the predicate device.
	Balloon Performance Testing	Performed in a manner substantially equivalent to the predicate device.
	Stent Deformation Testing	Performed in a manner substantially equivalent to the predicate device.
	Tensile Strength Testing (delivery system joints)	Performed in a manner substantially equivalent to the predicate device.
Material Properties	Materials	Identical or substantially equivalent to the predicate device.
Biocompatibility	Biocompatibility	Identical or substantially equivalent to the predicate device.
Sterilization	Method of Sterilization	Identical or substantially equivalent to the predicate device.
Packaging	Packaging	Identical or substantially equivalent to the predicate device.
Intended Use	Palliation of malignant strictures in the biliary tree	Same intended use as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The provided documents do not specify a sample size for a test set. The performance data section (Section 11) states that "Edwards Lifesciences completed bench testing" for various mechanical properties. This implies laboratory testing rather than clinical study with human or animal subjects acting as a "test set" in the common sense for medical devices involving diagnosis or treatment effectiveness.

The data provenance is bench testing, which is laboratory-based and therefore doesn't have a country of origin or a retrospective/prospective designation in the same way clinical data would.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided in the document. The "tests" mentioned are physical and mechanical bench tests, not clinical evaluations requiring expert interpretation or ground truth establishment in a diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. As mentioned above, the tests are mechanical bench tests, not evaluations requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is bench testing, not a clinical study involving human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone study was not done. This device is a physical medical device (stent and delivery system), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the bench testing would be the engineering specifications and established performance characteristics of the predicate device. The goal was to demonstrate "substantial equivalence" of the new device's engineering and performance properties to the predicate device.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This is a physical device, and the concept of a "training set" is usually relevant for AI/machine learning models. The stent itself is not a learning algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided. As explained above, the device is not an AI system, and therefore, there is no "training set" or corresponding ground truth establishment in that context.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of Edwards Lifesciences. The logo consists of a square graphic on the left and the company name "Edwards Lifesciences" on the right. The text is in a serif font and appears to be in black ink.

MAR 2 2 2005

510(k) Summary

K050627
Page 1 of 2

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: 949-250-3630 E-Mail: kevin_drisko@edwards.com

3. Date Prepared:

March 3, 2005

4. Device Trade Name:

LifeStent Turbo Biliary Stent System

5. Device Common Name:

Biliary Stent

6. Device Classification Name:

Biliary Catheter (78 FGE), Class II

7. Predicate Devices:

LifeStent LP SDS Billiary Stent System (K023248, K041370)

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Image /page/1/Picture/1 description: The image shows the logo for Edwards Lifesciences. The logo consists of a square graphic on the left and the text "Edwards Lifesciences" on the right. The text is in a serif font and is black. The graphic is a square with a grid pattern and the letter E in the center.

510(k) Summary (continued)

K050627
Page 2 of 2

8. Device Description:

The LifeStent Turbo consists of a balloon expandable stent that is provided on an over-the-wire The LifeStent Turbo ochales of a bancon one manently implanted device used to cathere that aoto as a donvoly byetem structed by tissue of an impinging tumor. The flexible, maintain patchoy of a major bile decesser cutting an open lattice design into a stainless steel tube. banoon expandation of this made by labor 6 hills. 18 mm, and 25mm and diameters of 5mm and 6mm.

9. Intended Use:

The LifeStent Turbo 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, compression force testing, balloon performance testing, stent deformation 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 device cited in item 7 above.

12. Conclusion:

Since the LifeStent Turbo has the same intended use, same 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/2 description: The image shows the seal of the U.S. Department of Health & Human Services. 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 emblem that resembles a stylized eagle or bird-like figure with three curved lines representing its body and wings.

MAR 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kevin Drisko Senior Manager, Regulatory Affairs Edwards Lifesciences LLC One Edwards Way IRVINE CA 92614

Re: K050627

K050627
Trade/Device Name: Edwards Lifesciences LifeStent Turbo Biliary Stent System
Trade/Device Name: Edwards Frade/Don Number: 21 CFR §876.5010 Regulation Names: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: March 10, 2005 Received: March 11, 2005

Dear Mr. Drisko:

We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section >10(K) prematise includent (for the indications for the indications for referenced above and have determined in devices marketed in interstate commerce
use stated in the enclosure) to legally marketed previoes marketed in interstate shat use stated in the enclosure) to legally markets areast analyments, or to devices that
prior to May 28, 1976, the enactment date of the Medical Device Amendments prior to May 28, 1976, the enatment date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal controls provisions o have been reclassified in accordance with the pive, subject to the general controls provisions of the
Act (Act). You may, therefore, market the seneral controls provisions o Act (Act). You may, therefore, market the devices and works.
Act and the limitations described below. The general controls provisions of the Actinelude Act and the limitations described below. The genetar confisions of them of the more
requirements for annual registration, listing of devices, good manufacturing practice, la requirements for annual beganding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that his device The Office of Device Evaluation has delemined in the proposed aboling and that such use could cause
will be used for an intended use not identify of the Act, the Act, the Act will be used for an intended use not identified in the proposed and the following limitation must
ham. Therefore, in accordance with Section 5 1 (i)(1)(E) of the Act, the fo narm. Therefore, in according 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 Furthermore, the indication for bithing use and other promotional materials, in close
pouch, box, and carton labels, instructions for use, and in hold mini pouch, box, and carton labors, mistrations 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
four device in the form to be Fristing major regulations affecting y If your device is classified (see above) into either class in (Special Control) of eries (
may be subject to additional controls. Existing major regulations affecting your d rr Jour be subject to additional controls. Existing major regulations from the collection
in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA m in the Code of Federal Regulations, True 21, 31.
announcements concerning your device in the Federal Register.

announce advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA's issuance of a substante coccummance of the Act or any
FDA has made a determination that your device complies with all FDA has made a determination that your device comples. You must comply with all
Federal statutes and regulations administered by other Federal openities (21 CFR Part 807); Federal statutes and regulations administered by other registration and listing (21 CFR Part 807);
the Act's requirements, including, but not limited to: registration as set the Act's requirements, including but not limited to: Teglirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as set fo labeling (21 CFR Part 801); good manufacturing practice to accordent as a comments.
systems (QS) regulation (21 CFR Part 820); and if applicable; the electronic product radia systems (QS) regulation (21 CFR Fart 020), and 1847-141-144-141-14-11-11-1000-1050.
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 proceed to the market. This The FDA finding of substantial equivalence of your device to proceed to the market. This results in a classification for your device as described in your Setion 510(k) premarket
letter will allow your obegin marketing your device as described in your labeline. letter will allow you to begin marketing your device as associated by our labeling.
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.
The Act. In and the started by Sep these limitations are modified in any way Please note that the above labeling Ilmitations are required by Bocker. Se ( ( from the device's labeling.

If you desire specific information about the application of other labeling requirements to your device If you desire specific information about the apprication of other 1900) 594-4616. Also, please note (21 CFR Part 801), please contact the United Communes at (501) for Parl 807.97).
the regulation entitled, "Misbranding by reference to premarket notification in the Division the regulation entitled, "Misbranding by responsibilities inderstine Act from the Division
You may obtain other general information on your responsibilities number You may obtain other general information on "Onsumer Assistance at its toll-free number
of Small Manufacturers, International, and Consumer Assistance at its toll-free number of Small Manufacturers, International its Internet address (600) 050 = fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

NAGTM

Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number: K050627

Device Name: Edwards Lifesciences LifeStent Turbo Biliary Stent System

FDA's Statement of the Indications for Use for device:

I Dri s Career in
The Edwards LifeStent Turbo Biliary Stent System is indicated for use in the palliation
in the provinces and any a in the biliary tree I he Edwards Enesciences Enoblems) in the biliary tree.

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Nancy Cropton

(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

Regulation Number and Section

§ 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.