The JOSTENT SelfX Biliary Stent consists of a self-expanding Nitinol stent mounted on a catheter delivery system. The stent will be available in lengths of 44 and 68 mm and diameters of 6, 8, and 10 mm. The delivery system has a usable length of 75 cm and is compatible with 0.035" diameter guidewires and 7F introducers.

AI/ML Overview

The provided text describes a 510(k) summary for the JOSTENT® SelfX Biliary Stent, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with strict acceptance criteria and performance metrics against a defined ground truth.

Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in this document. The submission is primarily based on performance data from bench and biocompatibility testing to show equivalence, rather than a clinical study evaluating specific performance criteria against a ground truth.

Here's an attempt to address your request based on the available information, noting where information is not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence, formal "acceptance criteria" for clinical performance as might be seen in a de novo clinical trial are not explicitly stated in this summary. The "performance data" mentioned refers to bench and biocompatibility testing. The "reported device performance" is essentially the finding of substantial equivalence based on these tests and comparison to predicate devices.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Summary of Findings)
Material Equivalence: Stent material is comparable to currently marketed Nitinol Biliary stents.	The stent material is substantially equivalent to currently marketed Nitinol Biliary stents.
Catheter Material Equivalence: Catheter materials are comparable to currently marketed stent delivery systems and PTA catheters.	The catheter materials are substantially equivalent to currently marketed stent delivery systems and PTA catheters.
Dimensional Equivalence: Range of device lengths and diameters are comparable to currently marketed Biliary stent/catheter systems.	The range of device lengths and diameters are equivalent to currently marketed Biliary stent/catheter systems.
Deployment Mechanism Equivalence: Deployment mechanism is similar to predicate devices.	The JOSTENT SelfX is constrained within an outer catheter and is deployed in the biliary tree by retracting the outer catheter until the stent is unconstrained (implying similar mechanism to predicate).
Biocompatibility: Device demonstrates appropriate biocompatibility.	Demonstrated through biocompatibility testing.
Mechanical Performance (Bench): Device meets mechanical performance standards (e.g., radial force, flexibility, fatigue resistance).	Demonstrated through bench testing.
Safety and Effectiveness: Data demonstrates safety and effectiveness (as inferred through equivalence).	The safety and effectiveness of the JOSTENT SelfX has been demonstrated through the data collected in bench and biocompatibility testing. Conclusion: Substantially equivalent to predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable/not provided for a "test set" in the context of clinical performance. The document refers to "bench and biocompatibility testing," which would have their own sample sizes for material and mechanical tests, but these are not specified.
Data Provenance: Not applicable for clinical data. Bench and biocompatibility testing data would typically be generated in a lab setting, details of which are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as there is no clinical "test set" for which ground truth was established by experts in this 510(k) summary. The submission relies on equivalence to devices already accepted as safe and effective.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring expert adjudication is described.

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 physical stent system, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance would not be relevant.

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

Not applicable. This device is a physical stent system, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for a clinical ground truth. The "ground truth" for this 510(k) relies on the established safety and effectiveness of the predicate devices and the demonstration of equivalence through non-clinical (bench and biocompatibility) data.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/algorithm. For the bench and biocompatibility testing, specific sample sizes would have been used for different tests (e.g., number of stents tested for radial force, number of samples for material characterization), but these details are not provided in the summary.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/algorithm, there is no corresponding ground truth to be established.

Summary

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JOMED

MAR 31 2003

510K) Summary of Safety and Effectiveness

Date Prepared:	January 23, 2003
Submitter Name:	JOMED AG
Submitter Address:	AmpthauptstrassePostlachCH-8222 BeringenSwitzerland
Contact Person:	Rudi OttVice President Regulatory and Clinical Affairs
Phone Number:	41 52 674 8505
Fax Number:	41 52 674 8404
Device Trade Name:	JOSTENT® SelfX
Device Common Name:	Biliary Stent
Device ClassificationName and Class:	Biliary Catheter; Class II
Predicate Devices:	Guidant DYNALINK™ Biliary Self Expanding Stent System (K002143)Guidant OTW MEGALINK™ SDS Biliary Stent System (K001222)Peripheral AVE Biliary Stent System (K983008)Cordis Long Medium PALMAZ-SCHATZ Balloon Expandable Stent (K964688)

Device Description:

Intended Use:

The JOSTENT SelfX is intended for use in the palliation of malignant strictures in the biliary tree.

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510(k) Summary (cont'd)

Device Technological Characteristics and Comparison to Predicate Device:

The JOSTENT SelfX is constrained within an outer catheter and is deployed in the biliary tree by retracting the outer catheter until the stent is unconstrained.

The stent material is substantially equivalent to currently marketed Nitinol Biliary stents and the catheter materials are substantially equivalent to currently marketed stent delivery systems and PTA catheters.

The range of device lengths and diameters are equivalent to currently marketed Biliary stent/catheter systems.

Performance Data:

The safety and effectiveness of the JOSTENT SelfX has been demonstrated through the data collected in bench and biocompatibility testing.

Conclusion:

The JOSTENT SelfX is substantially equivalent to the claimed predicate devices and other currently marketed biliary stent systems.

K030053 Premarket Notification [510(k)] Number

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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 resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

MAR 3 1 2003

Ms. Terry Schultz Regulatory Affairs Manager JOMED Inc. 15330 Avenue of Science, Suite 200 SAN DIEGO CA 92128

Re: K030053

Trade/Device Name: JOSTENT® SelfX Biliary Stent Regulation Number: 21 CFR $876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: March 21, 2003 Received: March 24, 2003

Dear Ms. Schultz:

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 marufacturing 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 -- Ms. Terry Schultz

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 above is added to your labeling, as described.

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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 Schultz, M.D.

Daniel 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 (if known): K030053

Device Name: JOSTENT® SelfX Biliary Stent

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

The JOSTENT SelfX Biliary Stent is intended for use in the palliation of malignant strictues in the biliary tree.

Prescription Use V Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)

David A. Ingram

(Division Sim Division in aboutinglys. roceminal and Radiotogram Covi 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.