MODIFICATION TO INTRASTENT

K992816 · Intratherapeutics, Inc. · FGE · Oct 15, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992816
• Device Name: MODIFICATION TO INTRASTENT
• Applicant: Intratherapeutics, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Oct 15, 1999
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

IntraStent™ is a balloon-expandable stainless steel stent with an open lattice design; intended for palliative treatment of malignant neoplasms in the biliary tree. Device is provided unmounted; physician manually crimps stent onto a noncompliant PTA balloon catheter. Upon balloon inflation, stent expands to conform to duct inner luminal surface; retains expanded state upon balloon deflation. Used in clinical settings by physicians. Benefits include mechanical support to maintain biliary patency in malignant strictures. Safety/effectiveness for vascular use not established.

Clinical Evidence

Bench testing only. Performance characteristics verified against predicate ITI Stent (K980290 & K991929). Pyrogenicity testing performed on a lot-to-lot basis supports nonpyrogenic claim.

Technological Characteristics

Balloon-expandable stent; 316L stainless steel; open lattice design; laser-cut slots/apertures; 4-7 mm expanded diameter. Sterilization: Ethylene oxide. Provided unmounted for manual crimping onto PTA balloon catheter.

Indications for Use

Indicated for palliative treatment of malignant neoplasms in the biliary tree in patients requiring biliary stenting.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ITI Stent (K980290)
• Cordis Corporation PALMAZ™ (K905720)
• PALMAZ-SCHATZ™ (K911581)
• PERFLEX™ Balloon-Expandable Biliary Stent (K964688, K980653)

Reference Devices

• ITI Stent (K991929)

Submission Summary (Full Text)

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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 Drive<br>St. Paul, MN 55112 |
|-------------------|-----------------------------------------------------------------------------------------------------------|
| Official Contact: | Cathy Yohnk<br>Senior Clinical /Regulatory Affairs Specialist<br>Tel. [phone] Fax [phone] |

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 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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html" .

Sincerely yours,

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