MODIFICATION TO INTRASTENT by INTRATHERAPEUTICS, INC.

The IntraStent™ is a balloon expandable stainless steel stent with an open lattice design. The device is provided unmounted, to be manually crimped onto a noncompliant PTA balloon catheter for biliary stent expansion of choice by the physician. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, specifically the IntraStent™ Biliary Stent. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials.

Therefore, the study described is not a typical clinical study with acceptance criteria in the usual sense (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, the "acceptance criteria" here relate to demonstrating that the new device performs equivalently to existing devices through bench testing.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Meet same performance characteristics as predicate ITI Stent (K980290 & K991929)	Bench tests were performed to verify this. (Specific performance characteristics are not detailed in the summary, but implied to be equivalent).
Non-pyrogenic	Pyrogenicity testing performed on a lot-to-lot basis supports the claim.
Identical materials to predicate stents	Stated as identical materials (balloon expandable stainless steel stent with open lattice design, 316L stainless steel hypotube).
Identical indication for use as predicate stents	Stated as "as a palliative treatment for malignant neoplasms in the biliary tree," which is the same as the predicate devices.
Identical technological characteristics to predicate stents	Stated as having identical technological characteristics (e.g., laser-cut slots/apertures, cleaning, electro-polishing, packaging, sterilization method for the new device – ethylene oxide vs. CO60 for predicate Palmaz). Exception: new device is a smaller version allowing 4-7mm expanded diameter.

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

Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involves "bench tests" and "pyrogenicity testing on a lot to lot basis." For bench tests of medical devices like stents, this typically means a representative number of units from manufacturing lots are tested.
Data Provenance: Not specified. Bench testing is typically performed in a laboratory setting, and pyrogenicity testing would be performed on manufactured product lots. There is no mention of human clinical data or geographical origin.

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

This type of information is not applicable to this submission. The "ground truth" for substantial equivalence is the performance of the predicate devices. The validation is against engineering and material specifications and the performance of existing, approved devices, not against expert interpretation of data.

4. Adjudication Method for the Test Set

This is not applicable. There is no "test set" in the sense of clinical cases requiring adjudication by experts.

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

This is not applicable. This submission is for a physical medical device (biliary stent), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and AI assistance are irrelevant.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this submission is the established performance and characteristics of the legally marketed predicate devices (IntraTherapeutics, Inc. ITI Stent (K980290 & K991929) and Cordis Corporation PALMAZ™, PALMAZ-SCHATZ™, and PERFILEX™ Balloon-Expandable Biliary Stent (K905720, K911581, K964688, K980653)). The new device's performance is compared to these benchmarks through bench testing.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

This is not applicable.

Summary

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OCT 1 5 1999

510(k) Summary (Page 1 of 2)

Product Name: IntraStent™ Common Name: Biliary Catheter

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

Summary Preparation Date: August 19, 1999

This summary is provide in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission.

The product trade and common name are IntraStent™ and biliary catheter, respectively, This is a Class II product classified under 21 CFR §8768.5010 as a biliary catheter and accessories. Substantial equivalence* is claimed to IntraTherapeutics, Inc. ITI Stent (K980290) and Cordis Corporation PALMAZ™, PALMAZ-SCHATZ™, and PERFILEX™ Balloon-Expandable Biliary Stent (K905720, K911581, K964688, K980653).

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

Summary of technological characteristics: The modified IntraStent™ (models S12-12, S12-16, S12-26, S12-36, S12-56) provides a smaller version the ITI Stent (K980290 & K991929), allowing an expanded diameter of 4-7 mm. The IntraStent™ and predicate stents are balloon expandable stents fabricated by cutting an engineered 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 predicate Palmaz™ stent CO60. The IntraStent™ and predicate stents are provided unmounted, additionally the predicate Palmaz™ stent can be

*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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992816

510K Summary (Page 2 of 2)

provided premounted on a PTA balloon catheter. For the unmounted stent, the Palmaz™ stent offers a separate non-sterile 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 TTI Stent (K980290 & K991929). 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 PALMAZ™, PALMAZ-SCHATZ™, and PERFLEX™ Balloon-Expandable Biliary Stent as a palliative treatment for malignant strictures of the billiary 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/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three curved lines that resemble an abstract human figure. The lines are arranged in a way that suggests movement or flow. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1999

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

Re: K992816

IntraStent™ Biliary Stent Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: September 15, 1999 Received: September 16, 1999

Dear Ms. Yohnk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 -- Ms. Cathy Yohnk

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (300 above) and additional controls. Existing major regulations (Fremarks) Approval), it may of sale, of Federal Regulations, Title 21, Parts 800 to 895. alleting your do noves cant determination assumes compliance with the Current Good A substantially Cquirements, as set forth in the Quality System Regulation (QS) for Manufacturing Practice requarements, (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, the Food and Drag result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this further announcements collecting your submission does not affect any obligation you might have response to your promance nemes. of the Act for devices 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 predicate device The I DX midnig of subtainer equive and permits your device to proceed to the market. This letter will allow you to begin marketing 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 don't openio neema additionally 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 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 __ 1 of 1

510(k) Number (if known): K992816

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__________________________________________________________________________________________________________________________________________________________

Gimil A. Slayton
Division Sign. Off.

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 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.