The LifeStent XL SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter that acts as the delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is inserted percutaneously to the diseased site, and supplied mounted onto a PTA balloon catheter, available with expanded diameters of 8.0 and 9.0mm at stent lengths of 17, 27, 37mm.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Orbus LifeStent XL SDS Biliary Endoprosthesis, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative performance acceptance criteria for the new device itself. The "performance data" section primarily lists types of in vitro tests conducted to show equivalence. Therefore, the table below reflects what can be inferred from the document regarding "acceptance" in the context of a 510(k) submission, which is often about demonstrating equivalence rather than meeting pre-defined numerical thresholds for novel performance claims.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices	The LifeStent XL SDS Biliary Endoprosthesis performs in a manner substantially equivalent to the predicate devices.
Deployment Characteristics	In vitro tests were conducted covering deployment.
Corrosion Susceptibility	In vitro tests were conducted covering corrosion susceptibility.
Visual Appearance	In vitro tests were conducted covering visual appearance.
Balloon Performance	In vitro tests were conducted covering balloon performance.
Expansion Damage	In vitro tests were conducted covering expansion damage.
Balloon Tensile Strength	In vitro tests were conducted covering balloon tensile strength.
Same Intended Use as Predicate	The device has the "same intended use" as the predicate (palliation of malignant neoplasms in the biliary tree).
Similar Material Properties to Predicate	The device has "similar material properties" to the predicate.
Similar Performance Properties to Predicate	The device has "similar performance properties" to the predicate (as demonstrated by the in vitro tests).
Similar Packaging to Predicate	The device has "similar packaging" to the predicate.
Similar Sterilization Methods to Predicate	The device has "similar sterilization methods" to the predicate.

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

Test Set Sample Size: The document does not specify the sample size used for any of the in vitro tests.
Data Provenance: The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned. However, since these are described as "in vitro tests" conducted by "Orbus protocols," it implies laboratory testing rather than human clinical trials.

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

Number of Experts: This information is not provided as the document discusses in vitro tests rather than expert-adjudicated clinical data.
Qualifications of Experts: Not applicable, as expert ground truth establishment for a test set is not described.

4. Adjudication Method for the Test Set

Adjudication Method: None described. The evaluation appears to be based on the direct results of in vitro engineering and materials tests, rather than a process requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission is a 510(k) for a medical device (stent), not an AI/software device that would typically involve a multi-reader study. The focus is on physical and performance characteristics compared to predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This device is a physical medical device (stent), not a software algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: For the in vitro tests mentioned, the "ground truth" would be established by engineering specifications, material standards, and experimental measurements compared against pre-defined acceptance criteria or performance of predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the typical clinical sense, but rather objective measurement and comparison.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set."

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

Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device submission.

Summary

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MAR 1 6 2004

Orbus Medical Techno

510(k) Notification 310(x) x 20-40 mm LifeStent XL SDS Biliary Endoprosthesis

510(k) Statement

1.	Submitter:	Orbus Medical Technologies, Inc5363 NW 35th AveFort Lauderdale, Florida 33309Phone: (954) 730-0711Fax: (954) 730-7601
2.	Contact:	Jim ClossickDirector of Quality Assurance and Regulatory Affairs
3.	Date Prepared:	3/1/04
4.	Device Trade Name:	LifeStent XL SDS Biliary Endoprosthesis
5.	Device Common Name:	Biliary stent
6.	Device Classification:	Biliary Catheter (78 FGE)
7	Prodicate Devices:	LifeStent SDS Biliary Endoprosthesis

Description: 8.

The LifeStent XL SDS Biliary Endoprosthesis consists of a balkon expandable stert which provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheren attacter acts as the delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, ballon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The sent is discosed site, and supplied mounted onto a PTA balloon catheter, inserted percutancously to the diseased site, and supplied mounted only a 1 TX banoon catices, movies with expanded diameters of 8.0 and 9.0mm at stent lengths of 17, 27, 37mm.

Intended Use: 9.

The LifeStent XL SDS Biliary Endoprosthesis are intended for the palliation of malignant neoplasms in the biliary tree.

Technological Characteristics: 10.

Comparisons of the rew and predicate devices were designed to show that the technication Comparisons of the 1.ew and predicate aconect were and interest and and packaging are identical or substantially equivalent.

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K040550
Page 2 of 2
Orbus Medical Technologies

510(k) Notification Ø 8,9 x 20-40 mm LifeStent XL SDS Biliary Endoprosthesis

Performance Data: 11.

Orbus protocols ensure that the LifeStent XL SDS Biliary Endoprosthesis perform in a manner Orous protocols ensure that the Enootent ILE SDS Bring in vitro tests such as deployment, substantially equivalent 10 the prodicate devices corrosion susceptibility, visual appearance, balloon performance, expansion damage, and balloon tensile strength.

Conclusion 12.

Since the LifeStent XL SDS Biliary Endoprosthesis, comprised of the Ø 8-12 mm LifeStent (K023121) and the Opti-Plast XT catheter (K941706), thas the same intended use, it may material properties, similar performance properties, packaging, and sterlization methods, it may be considered substantially equivaled proportion proportion in (7). These devices are a be considered substantary equivalent to the predicate device in (1)
Iine extension to the LifeStent SDS Biliary Endoprosthesis previously cleared per K023308 and K033212.

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Image /page/2/Picture/1 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. Inside the circle is an abstract image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 2004

Mr. Jim Clossick Director of Quality Assurance and Regulatory Affairs Orbus Medical Technologies 5363 NW 35th Avenue FT LAUDERDALE FL 33309

Re: K040550

Trade/Device Name: Orbus LifeStent XL SDS Biliary Endoprosthesis Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: March 1, 2004 Received: March 2, 2004

Dear Mr. Clossick:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave fevewed your boother in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the energians and of the Medical Device Amendments, or to devices that prov to way 20, 1778, the onadance with the provisions of the Federal Food, Drug, and Cosmetic have been reculssined in accerative the device, subject to the general controls provisions of the Act (Act). Tou may, mercessed manlow. The general controls provisions of the Act include Act and the inmunities described octor. - the geof 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 1115 Office of De rice Evanualion the contified in the proposed labeling and that such use could cause will oc used for an mended ass not researce $13(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 I untilere, the marbation for ostructions for use, and other promotional matcrials, in close proximity to the trade name, of a similar point size, and in bold print.

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Page 2 - Mr. Jim Clossick

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (seculove) this time) and regulations affecting your device can be found inay be subject to additional connous: "Existing major 10g 80g. 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 FICA has made a determination that your device complies with other requirements of the Act or any FDA has made a decemination that your and read by other Federal agencies. You must comply with all Federal statues and regulations administration and listing (21 CFR Part 807); the Act s requirements, merading, vanufacturing practice requirements as set forth in the quality labeling (21 CFR Part 001), good max 200; and if applicable, the electronic product radiation systems (QB) rogations 531-542 of the Act); 21 CFR 1000-1050.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device The FDA Inding Of substantal equivalence or your device to proceed to the market. This results in a classified for 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 5 13(i)(1)(E) of the Act. Fleast note that the above mooning mentare 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 If you desire specific monitation about are applicance at (301) 594-4616. Also, please note (21 CFR Part 807); produced and by reference to premarket notification'' (21 CFR Part 807.97). The regulation other general information on your responsibilities under the Act from the Division Tou may other generers, International, and Consumer Assistance at its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

David C. Schultz, M.D.

Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number: K040550

Device Name: Orbus LifeStent XL SDS Biliary Endoprosthesis

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

The Orbus LifeStent XL SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.

Prescription Use (Per 21 CFR 801.109) ાર

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Carolyn Y Newland for N.C.B.

Reproductive, Abdominal 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.