The LifeStent SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter which 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 supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon inflation. The systems are available with an expanded diameter of 8.0 mm at stent lengths of 18 mm.

AI/ML Overview

This document describes a 510(k) submission for the Orbus Medical Technologies LifeStent SDS Biliary Endoprosthesis, specifically an 8 x 18/20 mm size, as a line extension to a previously cleared device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria in a clinical study.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not present specific quantitative acceptance criteria or reported device performance in the format of a table as it pertains to clinical outcomes. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance data mentioned are primarily from in-vitro tests designed to show that the new device performs "in a manner substantially equivalent to the predicate devices."

Acceptance Criteria Category	Reported Device Performance (Focus of 510(k))
Premarket Review Approach	Demonstration of substantial equivalence to predicate devices.
Functional Equivalence	"Performs in a manner substantially equivalent to the predicate devices during in vitro tests."
Material Equivalence	"Identical material properties" to predicate devices.
Performance Properties	"Similar performance properties" to predicate devices. (Based on in-vitro tests described below)
Packaging & Sterilization	"Identical packaging, and sterilization methods" to predicate devices.
Intended Use	"Same intended use" as predicate devices: palliation of malignant neoplasms in the biliary tree.

In-vitro tests performed (as listed in "11. Performance Data"):

Deployment
Expansion force
Compression force
Dimensions
Corrosion susceptibility
Visual appearance
Balloon performance
Expansion damage
Balloon tensile strength

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

The provided document does not describe a clinical study with a "test set" of patient data. The performance data mentioned are from in-vitro tests (laboratory tests) of the device itself, not from human subjects. Therefore, information on sample size for a test set, country of origin, or retrospective/prospective nature of data is not applicable to this 510(k) summary.

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

This is not applicable. The submission focuses on substantial equivalence based on technical comparisons and in-vitro performance, not on establishing ground truth for a test set of clinical cases.

4. Adjudication Method for the Test Set

This is not applicable as no clinical test set is described.

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. This submission relies on demonstrating substantial equivalence through non-clinical data.

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

This question is typically relevant for AI/software devices. The LifeStent SDS Biliary Endoprosthesis is a physical medical device (a stent and delivery system). Therefore, the concept of "standalone performance" in the context of an algorithm is not applicable here. The performance evaluated relates to the physical and mechanical properties of the device itself.

7. The Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) typically applies to diagnostic or treatment effect studies involving patient data. For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is based on:

Engineering specifications and design documents of the predicate devices.
Measurement results from in-vitro tests of the new device and, presumably, comparative data or established ranges from the predicate devices.
Established material properties of 316L stainless steel.

8. The Sample Size for the Training Set

The provided document does not describe a "training set" as would be used for machine learning or AI. The development and testing of this device are based on engineering principles and in-vitro testing, not statistical training on a data set.

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

This is not applicable as there is no "training set" in the context of an AI/ML algorithm.

Summary

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Orbus Medical Technologies

Ø 8 x 18/20 mm LifeStent SDS Biliary Endoprosthesis

510(k) Summary

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:	October 1, 2003
4.	Device Trade Name:	LifeStent SDS Biliary Endoprosthesis
5.	Device Common Name:	Biliary stent
6.	Device Classification:	Biliary Catheter (78 FGE)
7.	Predicate Devices:	LifeStent SDS Biliary Endoprosthesis

8. Description:

510(k) Notification

9. Intended Use:

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

11 - 11 - 11 -

10. Technological Characteristics:

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.

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11. Performance Data:

Orbus protocols ensure that the LifeStent SDS Biliary Endoprosthesis performs in a manner substantially equivalent to the predicate devices during in vitro tests such as deployment, expansion force, compression force, dimensions, corrosion susceptibility, visual appearance, balloon performance, expansion damage, and balloon tensile strength.

12. Conclusion

Since the [8 x 18 mm] LifeStent SDS Biliary Endoprosthesis, comprised of the Ø 6-10 mm LifeStent (K010107) and the Opti-Plast XT catheter (K941706), has the same intended use, identical material properties, similar performance properties, packaging, and sterilization methods, it may be considered substantially equivalent to the predicate devices cited in (7). These devices are a line extension to the LifeStent SDS Biliary Endoprosthesis previously cleared per K023308.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2003

Mr. Jim Clossick Director of Quality Assurance and Regulatory Affairs Orbus Medical Technologies 5363 NW 35th Avenue Fort Lauderdale, Florida 33309

Re: K033212

Trade/Device Name: Orbus LifeStent SDS Biliary Endoprosthesis Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: October 2, 2003 Received: October 3, 2003

Dear Mr. Clossick:

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. Jim Clossick

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,

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

Enclosure

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Page 1 of 1

510(k) Number: K033212

Device Name: Orbus LifeStent SDS Biliary Endoprosthesis

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

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

Prescription Use 1 (Per 21 CFR 801.109)

Over-the-Counter Use __________________

David A. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 10(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.