The LifeStent LP SDS Biliary Endoprosthesis consists of a balloon expandable stent which is mounted onto a transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The permanently implanted device used to maintain patency of a lumen compromised 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 supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon. The systems are available with an expanded diameter of 5.0 mm at stent lengths of 18, 36 and 56mm.

AI/ML Overview

The provided 510(k) notification for the Orbus LifeStent LP SDS Biliary Endoprosthesis focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria through a dedicated clinical study with defined acceptance criteria. Therefore, several of the requested sections (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set details) are not applicable or cannot be extracted from this specific document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Substantial equivalence to predicate devices in:	The device performs in a manner substantially equivalent to the predicate devices during in vitro tests.
- Materials	Explicitly stated that technical characteristics such as materials are "identical or substantially equivalent."
- Performance properties (in vitro: deployment, flexibility, visual appearance, balloon performance, expansion damage, balloon tensile strength)	Orbus protocols ensure the device performs equivalently to predicate devices in these in vitro tests. Specific results for these properties are not provided but are stated to be equivalent.
- Biocompatibility	Explicitly stated that technical characteristics such as biocompatibility are "identical or substantially equivalent."
- Method of sterilization	Explicitly stated that technical characteristics such as method of sterilization are "identical or substantially equivalent."
- Packaging	Explicitly stated that technical characteristics such as packaging are "identical or substantially equivalent."
- Intended Use	The device has the "same intended use" as the predicate device (palliation of malignant neoplasms in the biliary tree).
- Technological Characteristics	"Comparisons of the new and predicate devices were designed to show that the technical characteristics... are identical or substantially equivalent."

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

Sample Size for Test Set: Not applicable. This submission relies on in vitro testing and comparison to predicate devices, not a clinical test set with human data.
Data Provenance: Not applicable. The performance data described is from "Orbus protocols" for "in vitro tests."

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

Not applicable. No ground truth was established by experts for a test set in the context of this submission. The "ground truth" here is the performance of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication was used.

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 medical stent, not an AI diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is a medical stent, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established performance and safety profile of the predicate devices, as demonstrated through their prior FDA clearance and the company's internal in vitro testing protocols. There is no external "ground truth" (e.g., pathology, outcomes data) generated for this specific submission; rather, the device is considered substantially equivalent to already-cleared devices that presumably have such data supporting their original clearances.

8. The Sample Size for the Training Set

Not applicable. This submission does not involve a training set for an algorithm.

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

Not applicable. This submission does not involve a training set for an algorithm.

Summary

{0}------------------------------------------------

JUN 2 5 2004

510(k) Notification

0 5 x 18, 36 and 56mm LifeStent LP SDS Biliary Endoprosthesis

Orbus Medical Technologies

K041370
Page 1 of 2

510(k) Summary

Orbus Medical Technologies, Inc Submitter: 1 . 5363 NW 35th Ave Fort Lauderdale, Florida 33309 Phone: (954) 730-0711 Fax: (954) 730-7601
Jim Clossick Contact: 2. Director of Quality Assurance and Regulatory Affairs
Date Prepared: May 19, 2004 3.
LifeStent LP SDS Biliary Endoprosthesis Device Trade Name: 4.
Device Common Name: Biliary stent ડ.
Biliary Catheter (78 FGE) Device Classification: 6.
LifeStent LP SDS Biliary Endoprosthesis Predicate Devices: 7.

Description: 8.

The LifeStent LP SDS Biliary Endoprosthesis consists of a balloom expandable stent which is The LifeStone LF-SDG Dinesous transluminal angioplasty (PTA) balloon catheter which provided intounced onto a permanently implanted device used to maintain patency acts as the delrvery often." 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 supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and supplied mounted by balloon. The systems are available with an expanded diameter of 5.0 mm at stent lengths of 18, 36 and 56mm.

Intended Use: 9.

The LifeStent LP SDS Biliary Endoprosthesis is intended for the pailiation of malignant neoplasms in the biliary tree.

Technological Characteristics: 10.

Comparisons of the new and predicate devices were designed to show that the technical characteristics such as materials, performance properties, biocompatibility, method of sterilization, and packaging are identical or substantially equivalent.

{1}------------------------------------------------

510(k) Notification

Ø 5 x 18, 36 and 56mm LifeStent LP SDS Biliary Endoprosthesis

Orbus Medical Technologies

Performance Data: 11.

K041370
Page 2 of 2

Orbus protocols ensure that the LifeStent LP SDS Biliary Endoprosthesis performs in a manner Orous protocols ensure that the EneSteate devices during in vitro tests such as deployment, substantially cquiralent to the predicato assistentibility, visual appearance, balloon performance, expansion damage, and balloon tensile strength.

Conclusion 12.

Since the [5 x 18, 36 and 56mm] LifeStent LP SDS Biliary Endoprosthesis, comprised of the 04-Since the [ X 18, 30 and Johning Enestein 2F SDS Dinater have the same intended use, similar 7 min LifeStein (K025121) and the 11:11:12 - oddinitial packaging and sterilization methods, it may be considered substantially equivalent to the predicate devices cited in (VII). These devices It hay be considered substantially officient to the president is previously cleared per K023248.

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or progress.

JUN 2 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K.041370

K041370
Trade/Device Name: Orbus LifeStent LP SDS Biliary Endoprosthesis Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: May 20, 2004 Received: May 24, 2004

Dear Mr. Clossick:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) prematically equivalent (for the indications for referenced above and have decemined the devices marketed in interstate commerce
use stated in the enclosure) to legally marketed predicate or to devices that use stated in the enclosuly thanked processor in the Medical Device Amendments, or to devices that proof to May 28, 1970, the enactinent date of the Federal Food. Drug, and Cosmetic have been reclassified in accordance with the provisions of the general controls provisions of the Act (Act). You may, ulerclore, market the actrols provisions of the Act include Act and the fimilations described below. The general velies, 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 I he Office of Device Evaluation has development of the proposed labeling and that such use could cause will be used for an intended use not racintried in the propose and 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 Furthermore, the indication for offiary use mass or promotional materials, in close pouch, box, and career lare, of a similar point size, and in bold print.

{3}------------------------------------------------

Page 2 - Mr. Jim Clossick

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (sec above) into einer ciar regulations affecting your device and be found may be subject to additions, 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 Please be advised that FDA 's Issualice of a substance of the other requirements of the Act or any
FDA has made a determination that your device complies with other requireme FDA has made a decemination that your devices of agencies. You must comply with all
Federal statutes and regulations administered by other Federal CCP Part 807); Federal statures and regulations administerial 07 June 1 egistration and listing (21 CFF Part 807); the Act S requirements, merialing, but not more mirements as set forth in the quality labeling (21 CFR Part 801), good manazavi.amg from if applicable, the electronic product radiation systems (QB) regalates (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 The PDA Initing Of substantan equivals in the reason of proceed to the marked. This results in a classification 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 513(i)(1)(E) of the Act. Flease 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 to If you desire specific information as a micro of Compliance at (301) 594-4616. Also, please note (21 CFR Part 801), prease connate the Onremarket notification'' (21 CFR Part 807.97).
the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Pa You may obtain other general information on your responsibilities under the Act from the Division Tou may other other gener gener 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,

Thos. J. Phinizy

Donnaea Tillman, Ph.D. Acting Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_ I of 1

510(k) Number: K041370

Device Name: Orbus LifeStent LP SDS Biliary Endoprosthesis

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

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

Prescription Use _ i (Per 21 CFR 801.109)

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Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Amit Lynn

(Division Sign-Off) Division of Reproduct and Radiological Dev 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.