ENDOXANE

K971509 · Novatech SA · NWA · Aug 21, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971509
• Device Name: ENDOXANE
• Applicant: Novatech SA
• Product Code: NWA · General, Plastic Surgery
• Decision Date: Aug 21, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

INDICATIONS ARE LISTED ACCORDING TO THEIR FREQUENCY : -TRACHEOBRONCIAL TUNORS' -TRACHEAL STENDSIS WITH SCARRING BRONCIAL STANQSIS AFTER SURGICAL ANASTOMOTIC, ANASTOHOSES RESECTIONS OR PULMONARY THANSPLANTATION THE STENDSES HAVE AS A COMMON CHARACTERISTIC THE IMPORTUNIE IN THE EXTENSIC CEMPRESSION OR THE COLLAPSE OF THE CARTILAGENS MALL. INDICNATION ATHARS FOCUSES ON AN ENDOSCORIC THERAPEUTIC ACCIENCY AND Lies a IT CONCERNS A RESECTION (LASER, CRYO, THERMO COGULATION) OR CHATAL. " THE SWENT INSERTEDN IS INDICATED ID THE EWOOSCOPIC RESECTICA 15 15-CONFLETTE IN CARR OF A PERSISTENT EXTRINGIC COMPRESSION OR IF THE LUMEN OF THE ADMANY IS INSUPEICIENT. THE MOST FREQUENT LOCALICAS ARF TRACENAL. THE LEBET MAIN BRONCHUS IS THE SECOND LOCATION FOLLOWED JY THE RIGHT MAIN BRONCHUS.

Device Story

ENDOXANE (Dumon Stent) is a non-armed, medical-grade silicone tube used as a tracheal/bronchial prosthesis. Designed for endoscopic insertion by physicians to maintain airway patency in cases of extrinsic compression or cartilaginous wall collapse. Features external stubs to prevent migration by anchoring between cartilaginous rings; surface coating minimizes mucus adhesion and tissue trauma. Stent regains round shape after insertion. Used in clinical settings following endoscopic resection or dilation. Benefits include improved airway lumen, reduced risk of migration, and facilitated secretion evacuation.

Clinical Evidence

Evidence based on a published study in 'The Journal of Bronchology' (1996) involving 1,500 stent placements. Reported outcomes include no observed cases of compression, even in serious tumors (e.g., osteosarcoma). Stents regained round shape within two days. Complications were reported as uncommon, including migration (9.5%) and obstruction by secretions.

Technological Characteristics

Medical-grade silicone (polysiloxane) construction. Features external stubs for anti-migration. Surface treated with a proprietary coating to reduce roughness, prevent tissue adhesion, and facilitate mucus flow. Available in multiple shapes (standard, pediatric, Y-stent, hourglass). Non-armed design.

Indications for Use

Indicated for patients with tracheobronchial tumors, tracheal stenosis with scarring, or bronchial stenosis following surgical anastomotic resections or pulmonary transplantation. Applicable when endoscopic resection is incomplete, extrinsic compression persists, or airway lumen is insufficient.

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

• ENDOXANE Stent (Bryan Corporation) (K4894380)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, which is a common symbol associated with medicine and healthcare.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2005

Mr. Bruno Ferreyrol Regulatory Affairs Office Novatech S.A. Avenu du Vent des Dames Z1 des Paluds 13685 Aubagne France

Re: K971509

Trade/Device Name: ENDOXANE® Regulation Number: 878.3720 Regulation Name: Prosthesis, tracheal, non-expandable, silicone Regulatory Class: 2 Product Code: NWA Dated: April 23, 1997 Received: April 25, 1997

Dear Mr. Ferreyrol:

This letter corrects our substantially equivalent letter of August 21, 1997.

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.

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## Page 2 - Mr. Bruno Ferreyrol

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/dsmaldsmamain.html.

Sincerely yours,

Sincerely yours,
Mark N Wilkerson

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

Enclosure: Indication for use statement for K971509.

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Page

i(10(k) Number (if known): K971509

Device Name: ENDOXANF

Indic

MBICATIONS ARE LISTED ACCORDING TO THEIR FREQUENCY : -TRACHEOBRONCIAL TUNORS'

-TRACHEAL STENDSIS WITH SCARRING

BRONCIAL STANQSIS AFTER SURGICAL ANASTOMOTIC, ANASTOHOSES RESECTIONS OR PULMONARY THANSPLANTATION

THE STENDSES HAVE AS A COMMON CHARACTERISTIC THE IMPORTUNIE IN THE EXTENSIC CEMPRESSION OR THE COLLAPSE OF THE CARTILAGENS MALL. INDICNATION ATHARS FOCUSES ON AN ENDOSCORIC THERAPEUTIC ACCIENCY AND Lies a IT CONCERNS A RESECTION (LASER, CRYO, THERMO COGULATION) OR CHATAL. " THE SWENT INSERTEDN IS INDICATED ID THE EWOOSCOPIC RESECTICA 15 15-CONFLETTE IN CARR OF A PERSISTENT EXTRINGIC COMPRESSION OR IF THE LUMEN OF THE ADMANY IS INSUPEICIENT. THE MOST FREQUENT LOCALICAS ARF TRACENAL. THE LEBET MAIN BRONCHUS IS THE SECOND LOCATION FOLLOWED JY THE RIGHT MAIN BRONCHUS.

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

Concurrence of CORH, Office of Device Evaluation 100E1

Mark N. Millan

(Division Sign-Off)
Division of General Restorative Devices

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| 510(k) Number | K971459 |

OR

7997-37

CZZ6Z3Z77B

Over The-Counter Use

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(Optional Formal 1-2-96)

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Image /page/3/Picture/0 description: The image shows the logo for Novatech. The logo is in black and white, with the word "NOVATECH" in large, bold letters. Below the word "NOVATECH" is the phrase "NEW BIOTECHNOLOGY FOR LIFE" in smaller letters. A white curved line is below the word "NOVATECH".

ﻌﺎ

K 971509

## 510(k) Summary

Date of Application :

April 23td, 1997

Applicant/Manufacturer Address :

Telephone Number :

Fax Number :

网

Name of Contact Person:

NOVATECH S.A. Avenue du Vent des Dames ZI des Paluds 13685 Aubagne France

(33) 442 82 92 92

(33) 442 82 92 27

Bruno FERREYROL Executive Director

Certification
N 460002 - ISO 9002

NOVATECH S.A. Avenue du Vent des Dames Z.1. les Paluds 13685 AUBAGNE - FRANCE TFL. (33) 04 42 82 92 92 - FAX. [phone]

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The proprietary name or trade name of our medical device is ENDOXANE ¯ ¯ he more common name of this device is an endo tracheal and endo bronchial stent, or Dumon Stent.

The Food and Drug Administration considers this device as a Class III - Tracheal Prosthesis.

The legally marketed device that we have cited for comparison is the ENDOXANE ® Stent, the same as ours, which was sold by our sole United States distributor, the Bryan Corporation (510K # K 4894380).

The device description can be found in Section IV Description of Device. In short, the ENDOXANE® is an endoscopy stent made of silicone. This stent, the most fitted in the world, is presented as a silicone tube with stubs allowing to avoid any movement. The non armed polysiloxane is covered with a new coating especially designed in order to keep its' flexibility which facilitates tolerance and evacuation of secretions.

A well-adapted ENDOXANE® does not move and cough reflexes are inhibited by reflex center saturation. The stubs prevent a direct contact between the stent surface and the mucus membrane and distribute the pressures among the small surfaces.

The main characteristics of ENDOXANE ® Stents can be divided into three main categories :

- 1. Histo compatibility : The medical grade silicone used for the manufacturing of ENDOXANE® is perfectly compatible during prolonged contact with trachea bronchial tissues.
- 2. Anti-encrustation and Anti-adhesion : NOVATECH has designed a new coating which guarantees high quality treatment of the surface favoring an easy flow of mucus. The surface is homogeneous and has a very fine grain. The parameter roughness is very weak. Furthermore, the surface treatment used avoids any tissue coloring and facilitates the positioning as well as the removal process. The extremities of the stents are manufactured according to a patented system which considerably reduces the risks of "mechanic" accumulation of mucus. The sides allows being non traumatic as no obstacle of mucus flow can be detected.
- 3. Anti-Migration System : All types of ENDOXANE® stents benefit from an exclusive and patented maintaining system. A perfect adhesion is assured by stubs found on the outer surface giving support to the surface and interpolating between the cartilaginous rings. This configuration prevents possible risks of stent migration if the size is well chosen.

The main indications according to their frequency are :

- 1. tracheobronchial tumors
- 2. Tracheal stenosis with scarring
- 3. Bronchial stenosis after surgical anastomotic, anastomoses resections or pulmonary transplantation.

These stenoses have, as a common characteristic, the importance of the extrinsic compression or the collapse of the cartilingeous wall. The indication always focuses on an endoscopic therapeutic action, whether is concerns a resection or dilation. The stent insertion is indicated if the endoscopic resection is incomplete, in case of a persistent extrinsic compression, or if the lumen is insufficient. The most frequent locations are tracheal. The left main bronchus is the second location, followed by the right main bronchus.

Our medical device has the same technological characteristics as the predicate device being that the two devices are the same. The only technological advancement that differs between the two devices is the new coating that we created in 1996. We have also developed three new shapes of the ENDOXANE Stents, each one with its particular use. The ENDOXANE BB Pediatric Stent was created in 1994 and is equipped with two lines of stubs opposite each other to facilitate the passage through the vocals cords. The ENDOXANE Y Stent is basically the same stent as Bryan Corporation but we added new dimension which are 15-12-12. This model is still used for carina pathologies associated with trachea and bronchus compression. The third new shape is the ENDOXANE ST Stent (hourglass shape) which is perfectly adapted to post intubation benion stenosis.

The conclusion that one can reach concerning our stents is best stated in the study published in "The Journal of Bronchology" (3:6-10, 1996) about the placing of 1500 stents (Cavalière, Diaz, Dumon, Vergnon). Not a single case of compression was observed, even in cases of the most serious tumors (osteosarcoma, for example). In all of the cases of extreme compression, the stent that was oval shaped at the outset regained its round shape in less than two days. "Complications were uncommon, usually easily manage, and rarely life threatening. The main complications were emigration (9.5%)n obstruction by secretions.