INTRASTENT by INTRATHERAPEUTICS, INC.

The IntraStent™ is a balloon expandable stainless steel stent with an open attisce design. The device is provided unmounted, to be manually crimped onto a noncompliant PTA I he device is provided uninounced, to be manadis computer luminal surface and inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the IntraStent™ Biliary Catheter based on the provided 510(k) summary:

This device is not a typical AI/ML-enabled medical device, so many of the questions asked (like MRMC study, ground truth for training set, effect size of AI, etc.) are not applicable in this context. This is a physical medical device (a stent) and its submission focuses on demonstrating substantial equivalence to already marketed devices through bench testing and material comparisons.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Device Performance / How it's Met
Performance Equivalence	Meet the same performance characteristics as the predicate ITI Stent (K980290).	Bench tests were performed to verify that the IntraStent™ met the same performance characteristics as the predicate ITI Stent (K980290).
Material Equivalence	Identical in materials to predicate devices.	The IntraStent™ is "identical in materials" to the predicate ITI Stent and Cordis Corporation/Johnson & Johnson PALMAZ™, PALMAZ-SCHATZ™, and PERFLEX™ Balloon-Expandable Biliary Stents. (Implied by substantial equivalence claim).
Indication for Use	Identical in indication for use to predicate devices.	The IntraStent™ is "identical in... indication for use" to the predicate devices: "as a palliative treatment for malignant neoplasms in the biliary tree."
Technological Characteristics	Identical in technological characteristics to predicate devices.	The IntraStent™ is "identical in... technological characteristics" to the predicate devices. Both are balloon expandable, made from 316L stainless steel hypotubes with laser-cut slots, cleaned, electro-polished, packaged in double sterile barriers, and sterilized.
Sterility/Biocompatibility	Nonpyrogenic.	Pyrogenicity testing performed on a lot-to-lot basis supports the nonpyrogenic claim.

Study Information

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size for a "test set" in the context of clinical trials or AI/ML validation. The "test" mentioned refers to bench tests.
- Data Provenance: Bench testing data would be generated in a laboratory setting, likely in the US (where the company is based). It's a prospective generation of data specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML or clinical imaging studies (expert consensus) is not relevant here. The "ground truth" for bench testing is defined by engineering specifications and predicate device performance.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is for clinical or imaging review, not bench testing.
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 is a physical medical device (a stent), not an AI-enabled diagnostic or assistive system.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission is based on the established performance characteristics and design of predicate devices, combined with engineering specifications and bench testing results. The goal is substantial equivalence, meaning the new device performs as well as, or comparably to, already approved devices.
The sample size for the training set: Not applicable. This is not an AI/ML device where a "training set" in that sense would exist.
How the ground truth for the training set was established: Not applicable. See point 7.

Summary

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510(k) Summary (Page 1 of 2)

K991929

Product Name: IntraStent™ Common Name: Biliary catheter

Submitter's Name:	IntraTherapeutics, Inc, 651 Campus DriveSt. Paul, MN 55112
Official Contact:	Cathy YohnkSenior Clinical Research/Regulatory Affairs AssociateTel. 651-697-2003 Fax 651-697-2080

Summary Preparation Date: June 7, 1999

This summary is provide in compliance with section 513(I(X)(A) of the Act and This summary is provide in comphance with contained in this premarket notification submission.

The product trade and common name are IntraStent™ and biliary catheter, respectively.
Comments of the career of CAL CED 50768 5010 as a biliary cathercrand This is a Class II product classified under 21 CFR 88768.5010 as a biliary catheter and This is a Class II product classince ander is claimed to IntraTherapeuics, Inc. ITT Stent (K980290) and Cordis Corporation PALMAZ™, PALMAZ™, PALMAZ-SCHATZ™, and (K980290) and Cordis Corporation (KB05720, K911581, K964688, K980653).

The intended use is "as a palliative treatment for malignant neoplasms in the biliary tree".

Summary of technological characteristics: The IntraStent™ provides a line extension to Sundhaly of technological characteristics and predicate stents are balloon expandable the 111 Stein (1596290). The miracted series of slots/apertures into a 316L stainless steel hypotube. The IntraStent™ and predicate stent cuts are made with a laser. Both the IntraStent™ and predicate stents are cleaned, electro-polished, packaged in a double sterile barrier and sterilized. The IntraStent™ is ethylene oxide sterilized and the sterne "oarrier" and "stermzed: "The "madelem" and predicate stents are provided

*This document uses the term "substantial equivalence" as intended in 21 CFR 807.87, and not as defined in Title 36 of the US Code.

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510K Summary (Page 2 of 2)

unmounted, additionally the predicate Palmaz™ stent can be provided premounted on a PTA balloon catheter. For the unmounted stent, the Palmaz™ stent offers a separate nonsterile crimping tool while the ITI product does not. Both the IntraStent™ and predicate stents include use of manual compression using one's thumbs and forefingers to compress the stent onto the delivery balloon catheter.

Bench tests were performed to verify that the IntraStent™ met the same performance characteristics as the predicate ITI Stent (K980290). Pyrogenicity testing performed on a lot to lot basis supports the nonpyrogenic claim.

The IntraStent™ is substantially equivalent to the currently marketed ITI Stent and the Cordis Corporation/Johnson & Johnson PALMAZTM, PALMAZ-SCHATZ™, and PERFLEX™ Balloon-Expandable Biliary Stent as a palliative treatment for malignant strictures of the biliary tree. As demonstrated the IntraStent™ is identical in materials, indication for use and technological characteristics. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the IntraStent™ meets the requirements that are considered acceptable for the intended use.

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Image /page/2/Picture/2 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the left and has three lines representing its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 1999

Ms. Cathy Yohnk Ms. Cathy Yollik
Senior Clinical Research / Regulatory Affairs Associate IntraTherapeutics, Inc. 651 Campus Drive St. Paul, Minnesota 55112

K991929 Re: IntraStent™ Biliary Stent Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 8, 1999 Received: July 9, 1999

Dear Ms. Yohnk:

We have reviewed your Section 510(k) notification of intent to market the device referenced
we have the states and the besice is whetentially equivalent (for the indications We have reviewed your Section 510(k) notification of intention of the indications for use
above and we have detectived the device is substantially equivalent in interstate co above and we have determined the device is substanted in interstate commerce
stated in the enclosure) to legally marketed prodicate devices marketed in interstate comments, o stated in the enclosure) to legally marketed predical Device Amendments, or to devices that
prior to May 28, 1976, the enactment date of the Rederal Food. Drug, and Cosmetic prior to May 28, 1976, the enactment date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosm have been reclassified in accordance with the provisions of the general controls provisions of
Act (Act). You may, therefore, market the device, subject to the Act include Act (Act). You may, therefore, market the device, subject covinsions of the Act include
the Act and the limitations described below. The general controly provise, labeling, the Act and the limitations described below. The general of the states of the station of the subsidiary, and the supplied requirements against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this The Office of Device Evaluation nas detectimed that the proposed labeling and that such use
device will be used for an intended use not identified in the Act, the following device will be used for an intended use not lucinities an the Section 513 (i) (I) (E) of the Act, the following
could cause harm. Therefore, in accordance with Section of could cause harm. "Therororo, in accorder 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 billary use must be prominently displayed in all labeling, including Furthermore, the indication for unlary asc mast or promotional materials, in close pouch, box, and career labels, of a similar point size, and in bold print.

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Page 2 - Ms. Cathy Yohnk

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Fremarket Approval), it may of subject to sae of Federal Regulations, Title 21, Parts 800 to 895. allecting your device can be found in in assumes compliance with the Current Good A substantially oquivalent develments, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS Medical Devices. Gelleral regulation (FDA) will verify such assumptions. Failure to mspections, the Pood and Drag result in regulatory action. In addition, FDA may publish Comply with the GMI Togation inaly in the Federal Register. Please note: this itimel announcements concerning your averaission does not affect any obligation you might have
response to your premarket notification submission does not at Redict Rediction response to your premarket notification sector cevices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

The FDA finding of substantial equivalence of your device to a legally marketed predicated and The LDA inding of substantial oquridential of traits your device to proceed to the market. This resurts in a clussinoution for your device as described in your 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. I herefore, 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 11 you desire specific manen as as a many as a many and and stores), 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Susan Alpert, Ph.D., M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ l of 1

510(k) Number (if known): K991929

Device Name: IntraStent™ Biliary Stent

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

The IntraStent™ Biliary Stent is indicated as a palliative treatment for malignant neoplasms in the biliary tree.

Prescription Use / OR
(Per 21 CFR 801.109)

Over-The-Counter Use

Lit

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device ટાપ્ડા

510(k) Number K991929/5

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.