RUSCH POLYFLEX STENT KIT

K013266 · Rusch Intl. · NYT · Nov 27, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K013266
• Device Name: RUSCH POLYFLEX STENT KIT
• Applicant: Rusch Intl.
• Product Code: NYT · General, Plastic Surgery
• Decision Date: Nov 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Airway complications such as anastomosis and stenosis, Trachea-esophageal fistula, Stenosis of the central airways (such as trachea and main bronchus), and strictures due to tumors (Trachea and main bronchus).

Device Story

Rüsch Polyflex Stent Kit is a tracheal prosthesis designed to maintain airway patency. The device consists of a medical-grade silicone tube with an embedded braided polyester reinforcement. It is supplied with an insertion kit containing an introducer sleeve, stent loader, soft positioner, and blue stopper. The stent is placed into the trachea or main bronchus to treat strictures, fistulas, or stenosis. The device is intended for use by clinicians in a medical setting. It functions as a mechanical support to prevent airway collapse or obstruction, thereby improving patient breathing and airway function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Tracheal prosthesis composed of medical-grade silicone with braided polyester reinforcement. Supplied with insertion accessories (introducer sleeve, stent loader, soft positioner, blue stopper). Non-sterile and sterile versions available. Features indicator markings on the stent.

Indications for Use

Indicated for patients with airway complications including anastomosis, stenosis, tracheo-esophageal fistula, and strictures due to tumors in the trachea and main bronchus.

Regulatory Classification

Identification

The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

Predicate Devices

• Boston Scientific Ultraflex (K013266)
• Schneider Wall Stent (K013266)
• Cook Gianturco-Wallace Tracheobronchial 2 Stent (K013266)
• Bryan Dumon Tracheal Bronchial Stent (K013266)
• Hood Tracheal Bronchial Stent (K013266)
• Hood Westaby Stent (K013266)

Submission Summary (Full Text)

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**RUSCH.**
INTERNATIONAL
Group Regulatory Affairs
A Subsidiary of Teleflex Incorporated (USA)

K013266

Tall Pines Park Jaffrey, NH 03452 [phone] FAX [phone] or 6108

# NOV 2 7 2001

# 510 (k) Summary

### Submitter Name, Address, and Date of Submission. 1.

Miss Karenann J. Brozowski Group Regulatory Affairs Director Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452

[phone] Telephone: [phone] Facsimile:

Contact: Same as above

# Name of the Device, Common, Proprietary (if Known), and 2. Classification.

Classification Name: Tracheal Prosthesis

Common Name: Tracheal Bronchial Stent

Proprietary Name: Rüsch Polyflex Stent Kit

# Identification of the legally marketed device to which the 3. submitter claims equivalence.

The Rusch Polyflex Stent is substantially equivalent to the Boston Scientific Ultraflex®, Schneider Wall Stent, the Cook Gianturco-Wallace Tracheobronchial "2" Stent, and Bryan Dumon Tracheal Bronchial Stent-,Hood Tracheal Bronchial Stent, and Hood Westaby Stent

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# page 2

#### Description of the Device. 4 .

The Rusch Polyflex Stent Kit consists of a medical silicone file Rusch folyrica beene core along with the components Suppored by insert the device into the human body. These required to inocre one he Introducer Sleeve, the Stent Loader, Soft Positioner, and Blue Stopper.

This amendment changes the material of the Insertion ffirs amending to adds indicator markings to the stent and provides for a non-sterile version.

### Intended Use of the Device. 5 .

The indications for use for the Polyflex Stent Kit are as follows:

Airway complications such as anastomosis ans stenosis, Trachea-esophageal fistula, Stenosis of the central ridence obsphagetee trachea and main bronchus), and arrways (Such as trictures due to tumors (Trachea and main bronchus) .

## Summary of Technological Characteristics. 6.

The following technological characteristics are the same as fic for equivalent to the predicate device, the Boston Scientific Ultraflex® and the Schneider Wall Stent. The primary material of the Rüsch Polyflex Stent is medical grade silicone surrounding the braided polyester woven seenforcement. This is equivalent to the proprietary polymer surrounding the superalloy braided monofilament metal reenforcement of the Schneider Stent. moth Stents are supplied with Stent insertion accessories, which allow for placement of the Stent into the body.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2006

Boston Scientific Corporation % Ms. Angela Byland Manager, Regulatory Affairs Cardiovascular Two Scimed Place Maple Grove, Minnesota 55311-1566

Re: K013266

Trade/Device Name: Rusch Polyflex Stent Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: NYT Dated: September 27, 2001 Received: October 1, 2001

Dear Ms. Byland:

This letter corrects our substantially equivalent letter of November 27, 2001.

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) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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

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Page 2 - Ms. Angela Byland

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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Huber Lemur

L. Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(K) Number (if known): < 0 / 3266

Device Name:Rusch Polyflex Stent Kit

Indications For Use:

Compression or strictures due to tumors (trachea and main bronchus) Stenosis of the central airways (such as trachea and main bronchus) Tracheo Esophageal fistula

Airway complications such as-anastomosis and stenosis

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use. (Per 21 CFR 801.109)

::

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Susan Walk

(Division Sim-( +) Division of Coral, Restorative and Neurological Jevices

100(k) Number: K013266