The LifeStent LP 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. This 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 expanded diameters of 4.0, 5.0, 6.0 mm at stent lengths of 18, 36, and 56 mm.

AI/ML Overview

The provided text describes the 510(k) summary for the LifeStent LP SDS Biliary Endoprosthesis, outlining its characteristics, intended use, and substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance metrics, or any specific study results as would be typically found in clinical trials or performance testing reports for AI/ML devices.

The document is a regulatory submission demonstrating substantial equivalence of a medical device (a biliary stent) to previously approved predicate devices, not an AI/ML product. Therefore, many of the requested categories for AI/ML device studies (such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable or present in this context.

Here's an attempt to answer the questions based on the available information, noting where the information is not present or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence based on in vitro tests and comparison to predicate devices, rather than predefined acceptance criteria for clinical efficacy or AI performance metrics.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Summary)
Material Properties: Identical to predicate devices	Identical material properties (316L stainless steel).
Performance Properties: Similar to predicate devices	Similar performance properties demonstrated through in vitro tests: Deployment, expansion force, compression force, dimensions, corrosion susceptibility, visual appearance, balloon performance, expansion damage, and balloon tensile strength.
Biocompatibility: Equivalent to predicate devices	Stated as substantially equivalent.
Method of Sterilization: Identical to predicate devices	Identical sterilization methods.
Packaging: Identical to predicate devices	Identical packaging.
Intended Use: Same as predicate devices	Intended for palliation of malignant neoplasms in the biliary tree, same as predicate devices.

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

This information is not provided in the document. The submission references "in vitro tests" but does not specify the sample sizes (e.g., number of stents tested), the specific test protocols, or the origin of any data (as it's in vitro, geographic provenance is less relevant than for patient data).

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

This information is not applicable as the document describes a physical medical device and in vitro performance testing, not an AI/ML device requiring expert-established ground truth from medical images or patient data.

4. Adjudication Method Used for the Test Set

This information is not applicable as the document describes in vitro performance testing of a physical medical device, not an AI/ML device with an adjudicated test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

This information is not applicable. An MRMC study is typically for evaluating the impact of an AI/ML device on human reader performance. This document concerns a physical device (stent) and its in vitro performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable. This document evaluates a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the in vitro performance tests, the "ground truth" would be established by the measurement standards and specifications for the physical properties of the stent and its delivery system (e.g., precise dimensions, force measurements, materials analysis). This is inherent to engineering and material science testing, rather than medical ground truth like pathology or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/ML device that requires a training set.

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

This information is not applicable as this is not an AI/ML device that requires a training set.

Summary

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FEB 1 1 2003

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Image /page/0/Picture/2 description: The image shows the logo for ORBUS MEDICAL TECHNOLOGIES INC. The logo consists of a stylized eye symbol on the left, followed by the word "ORBUS" in a bold, sans-serif font. Below "ORBUS" is the text "MEDICAL TECHNOLOGIES INC." in a smaller, sans-serif font, with a line separating it from the word "ORBUS" above.

CORPORATE NW 35 FORT LAUDERDALE FI ORIDA 33309 954/730-0711 954/730-7601 ww.orgusmt.com

XIII: 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:	September 27, 2002
4. Device Trade Name:	LifeStent LP SDS Biliary Endoprosthesis
5. Device Common Name:	Biliary stent
6. Device Classification:	Biliary Catheter (78 FGE)
7. Predicate Devices:	IntraStent DoubleStrut ParaMount XS Biliary EndoprosthesisPALMAZ CORINTHIAN Transhepatic Biliary Stent and DeliverySystemPALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018"Delivery SystemOTW MEGALINK SDS Biliary Stent System

8. Description:

9. Intended Use:

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

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 LP 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 LifeStent LP SDS Biliary Endoprosthesis, comprised of the Ø 4-7 mm LifeStent and the Ultraverse catheter (K964881, K010169, K012913), 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).

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form, with three wavy lines forming the body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2003

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

Re: K023248

Trade/Device Name: 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: January 16, 2003 Received: January 17, 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 (OS) 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

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):_K023248

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 use for the palliation of malignant neoplasms in the biliary tree.

Perscription Use(Per 21 CFR 801.109)	OR	Over-the-Counter Use
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Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K023248
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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.