(118 days)
K 4894380
Not Found
No
The summary describes a silicone stent and its intended use and performance, with no mention of AI or ML technology.
Yes
Explanation: The device is described as a stent used for therapeutic actions such as resection or dilation of tracheobronchial and tracheal stenoses, aiming to restore or maintain lumen patency.
No
The device is a silicone endoscopic stent used for therapeutic actions like resections or dilation in cases of tracheobronchial or tracheal stenosis, and it is explicitly stated that its indication focuses on "an endoscopic therapeutic action," not diagnosis.
No
The device description explicitly states that the ENDOXANE® is an endoscopy stent made of silicone, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for therapeutic intervention within the tracheobronchial tree (resection, dilation, stent insertion) to address physical obstructions like tumors and stenoses. This is a direct treatment of a physical condition.
- Device Description: The device is a physical silicone stent designed to be inserted into the airway to maintain patency. This is a medical device used for structural support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro to provide information for diagnosis, monitoring, or screening. The device itself is the treatment.
Therefore, the ENDOXANE® stent, as described, is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
-TRACHEOBRONCHIAL TUMORS
-TRACHEAL STENOSIS WITH SCARRING
BRONCHIAL STENOSIS AFTER SURGICAL ANASTOMOTIC, ANASTOHOSES RESECTIONS OR PULMONARY TRANSPLANTATION
THE STENOSES HAVE AS A COMMON CHARACTERISTIC THE IMPORTANCE IN THE EXTRINSIC COMPRESSION OR THE COLLAPSE OF THE CARTILAGENS WALL. INDICATION ALWAYS FOCUSES ON AN ENDOSCOPIC THERAPEUTIC EFFICIENCY AND WHETHER IT CONCERNS A RESECTION (LASER, CRYO, THERMO COAGULATION) OR DILATION. THE STENT INSERTION IS INDICATED IF THE ENDOSCOPIC RESECTION IS INCOMPLETE, IN CASE OF A PERSISTENT EXTRINSIC COMPRESSION OR IF THE LUMEN OF THE AIRWAY IS INSUFFICIENT. THE MOST FREQUENT LOCATIONS ARE TRACHEAL. THE LEFT MAIN BRONCHUS IS THE SECOND LOCATION FOLLOWED BY THE RIGHT MAIN BRONCHUS.
Product codes (comma separated list FDA assigned to the subject device)
NWA
Device Description
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:
- Histocompatibility: The medical grade silicone used for the manufacturing of ENDOXANE® is perfectly compatible during prolonged contact with trachea bronchial tissues.
- 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.
- 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 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 ENDOXANED 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trachea, Bronchus, Carina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
"Complications were uncommon, usually easily manage, and rarely life threatening. The main complications were emigration (9.5%) obstruction by secretions."
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 4894380
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3720 Tracheal prosthesis.
(a)
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.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
0
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.
1
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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.
2
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
| Labels | Values |
|---|---|
| 510(k) Number | K971459 |
OR
7997-37
CZZ6Z3Z77B
Over The-Counter Use
ર દ
(Optional Formal 1-2-96)
3
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. (33) 04 42 82 92 27
4
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 :
-
- Histo compatibility : The medical grade silicone used for the manufacturing of ENDOXANE® is perfectly compatible during prolonged contact with trachea bronchial tissues.
-
- 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.
-
- 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 :
-
- tracheobronchial tumors
-
- Tracheal stenosis with scarring
-
- 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.