RUSCH POLYFLEX STENT KIT

K982614 · Rusch Intl. · NYT · Dec 4, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982614
• Device Name: RUSCH POLYFLEX STENT KIT
• Applicant: Rusch Intl.
• Product Code: NYT · General, Plastic Surgery
• Decision Date: Dec 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Rüsch Polyflex Stent Kit is a medical silicone stent with a polyester core; designed for placement in the trachea or main bronchus to treat airway complications, strictures, or fistulas. The kit includes insertion accessories: introducer sleeve, stent loader, soft positioner, and blue stopper. The device is used by clinicians to maintain airway patency in patients suffering from tumor-related compression or post-surgical stenosis. By providing structural support to the airway, the stent prevents collapse or occlusion, potentially improving patient respiratory function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical-grade silicone stent with braided polyester woven reinforcement. Supplied with insertion accessories (introducer sleeve, stent loader, soft positioner, blue stopper). Non-powered, mechanical device.

Indications for Use

Indicated for patients with airway complications including anastomosis and stenosis, tracheo-esophageal fistula, stenosis of the central airways (trachea and main bronchus), and compression or 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

• Schneider Wall Stent
• Cook Gianturco-Wallace Tracheobronchial "Z" Stent
• Bryan Dumon Tracheal Bronchial Stent
• Hood Tracheal Bronchial Stent
• Hood Westaby Stent

Submission Summary (Full Text)

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K98 26/4

Image /page/0/Picture/1 description: The image shows the date December 4, 1998. The month is abbreviated to DEC. The day is the number 4, and the year is 1998. The text is in a simple, sans-serif font.

Image /page/0/Picture/2 description: The image shows the logo for Rusch International Group Regulatory Affairs, a subsidiary of Teleflex Incorporated (USA). The logo is in black and white and features the word "RUSCH." in a bold, sans-serif font. Below the company name is the text "INTERNATIONAL Group Regulatory Affairs" in a smaller font. The text "A Subsidiary of Teleflex Incorporated (USA)" is located below the company's department name.

all Pines Park affrom NH 03452 03 532-7706 AX [phone] or 6108

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:

Same as above Contact:

## 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 Rüsch Polyflex Stent is substantially equivalent to the Schneider Wall Stent, the Cook Gianturco-Wallace Tracheobronchial "Z" Stent, and Bryan Dumon Tracheal Bronchial Stent-,Hood Tracheal Bronchial Stent, and Hood Westaby Stent

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#### Description of the Device. 4 .

The Rüsch Polyflex Stent Kit consists of a medical silicone supported by a polyester core along with the components required to insert the device into the human body. These components consist of the Introducer Sleeve, the Stent Loader, Soft Positioner, and Blue Stopper.

#### 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 airways(such as the trachea and main bronchus), and Compression or strictures due to tumors (Trachea and main bronchus) .

#### Summary of Technological Characteristics. 6.

The following technological characteristics are the same as or equivalent to the predicate device, the Schneider The primary material of the Rüsch Polyflex Stent Wallstent. is medical grade silicone surrounding the braided polyester woven reenforcement. This is equivalent to the proprietary polymer surrounding the superalloy braided monofilament metal reenforcement of the Schneider Stent. Both Stents are supplied with Stent insertion accessories, which allow for placement of the Stent into the body.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the top half of the logo.

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

Re: K982614

Trade/Device Name: Rusch Polyflex Stent Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: NYT Dated: October 22, 1998 Received: October 26, 1998

Dear Ms. Byland:

· This letter corrects our substantially equivalent letter of December 4, 1998.

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

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Page 2 - Ms. Angela Byland

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.

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,

Herbert Steiner no

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):_

Ocvice Name:_Rusch Polyflex Stent Kit

Indications For Use:

- Airway complicatins such as anastomosis and stenosis Compression or stricture due to
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- Compression or stricture due to tumors (trachea and main bronchus
Compression or stricture due to tumors (trachea and main bronchuse
Fracher-esophageal fistula - Tracheo-esophageal fistula
- e and of Sephagedi TISCulla
Stenosis of the central airways (such as trachea and main brondus)

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EEDEDI NEEDED)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Krascapiton Use OK Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Par 21 CER 801 1091 (Optional Formay 1-2-96) (Division S gn-Off Division of General Restorative Devices

510(k) Number