(90 days)
The Boussignac/ Vygon Endotracheal Tube is indicated for airway management. The insufflation canals permit the delivery of intermittent jet ventilation and the administration of oxygen during tracheobronchial suctioning procedures. They also provide a supplemental means for administering oxygen during bronchoscopies. In these ventilatory modes, the main lumen serves as a channel for the elimination of expired gases. When the insufflation port is capped, The Boussignac/ Vygon Endotracheal Tube can function as a standard tracheal tube with ventilation occurring through the main lumen. The Boussignac/ Vygon Endotracheal Tube is intended for oral/nasal intubation.
The monitoring/irrigation lumens may be used for monitoring airway pressure, for irrigation of a patient's tracheobronchial tree, to aid in the removal of accumulated secretions, for sampling tracheal gases, for anesthetizing the trachea, or for introducing suitable medication in accordance with standard medical practice.
The Boussignac/ Vygon Endotracheal Tube is a standard endotracheal tube available in pediatric and adult use. The tube design includes a Magill curve, a tip, printed depth markings (in one centimeter increments), a low-pressure cuff (adult models only) and self-sealing valve with attached pilot balloon for cuff inflation/deflation. The tube also features a radiopaque line to assist in radiographic visualization. The device, including featured characteristics listed above, conforms to ISO 5361: Anesthetic and Respiratory Equipment – Tracheal Tubes and Connectors.
The tube has a main lumen and eight (8) separate canals, or "capillaries", embedded in the tube wall. For adult models, six (6) of these canals are used for gas insufflation, two (2) for pressure control, CO2 monitoring, or irrigation, and as in any endotracheal tube, one (1) for pressure control. CO2 monitoring, or irrigation. For the uncuffed pediatric model, six (6) of the imbedded canal is reserved for gas insufflation, while two (2) are used for pressure control, CO2 monitoring, or irrigation.
The provided text is a 510(k) summary for the Boussignac/Vygon Endotracheal Tube. It does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to the request.
The document primarily focuses on establishing substantial equivalence to predicate devices, providing a device description, intended use, and comparison to existing products. It mentions "Performance testing was presented" and "Clinical publications were presented" but does not elaborate on the details or results of these tests.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets them based on the provided text.
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510(k) Summary
Vygon. S.A
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal in accordance with the Sale Medical Devices Fred (0.1.2.1.2017) The following summary of safety and effectiveness information is provided:
Submitted by A.
Vygon, S.A. 5-11. Rue Adeline 95440 Ecouen France Telephone: (33) 1 39 92 63 63 Contact: Michel Hanania. Regulatory Affairs/Quality Assurance Manager Date Prepared: March 11, 2004.
B. Device Name
Trade or Proprietary Name: Boussignac/ Vygon Endotracheal Tube
Endotracheal Tube Common or Usual Name:
Tracheal Tube Classification Name:
C. Predicate Devices
The subject device is substantially equivalent to the Mallickrodt Hi-Lo® Jet Tracheal Tube (K802505). and the Vygon's Double Lumen Tracheal Tube (K960795).
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Device Description D.
I he Boussignac/ V ygon Endorracheal Tube is a standard endotracheal tube available in I he boussignat? Fygon Enaon activent and adult use. The tube design includes a Magill curve, a tip, printed depth markings (in one centimeter increments), a low-pressure cuff (adult models only) and self-sealing valve with attached pilot balloon for cuff inflation detlation. The tube also features a radiopaque line to assist in radiographic innation. The device, including featured characteristics listed above, conforms to ISO cisualization: The Gevice, motary Equipment – Tracheal Tubes and Connectors.
The tube has a main lumen and eight (8) separate canals, or "capillaries", embedded in the The ture has a main fument and eight (5) of these canals are used for gas insufflation, two (2) for pressure control. CO2 monitoring, or irrigation, and as in any endotracheal tube, one (1) for pressure control. CO2 monitoring, on the uncuffed pediatric model, six (6) of the imbedded canal is reserved for gas insufflation, while two (2) are used for pressure control, CO2 monitoring, or irrigation.
Intended l'se E.
The Boussignac/ Vygon Endotracheal Tube is indicated for airway management. The insullation canals permit the delivery of intermittent jet ventilation and the administration of oxygen during tracheobronchial suctioning procedures. They also provide a or oxygen daministering oxygen during bronchoscopies. In these ventilatory suppliciteman means for arres as a channel for the elimination of expired gases. When the modes, the main famen set res abussignac/ Vygon Endotracheal Tube can function as a misumation port is oupport to allation occurring through the main lumen. The Boussignac/ Vygon Endotracheal Tube is intended for oral/nasal intubation.
The monitoring/irrigation lumens may be used for monitoring airway pressure, for irrigation of a patient's tracheobronchial tree, to aid in the removal of accumulated secretions, for sampling tracheal gases, for anesthetizing the trachea, or for introducing suitable medication in accordance with standard medical practices.
Comparison to Predicate Devices F.
As was established in this submission, the subject device is substantially equivalent to its rs was obtablished the Mallinckrodt Hi-Lo® Jet Tracheal Tube (K802505), and the Vygon's Double Lumen Tracheal Tube (K960795), cleared by the agency for commercial distribution in the United States.
The subject device has substantially equivalent indications for use as the Mallinckrodt Hi-I no Jet Tracheal Tube, being indicated for airway management via oral/nasal intubation.
The subject device is composed of the same materials as one or more of the predicate devices, all of which are established as safe for their application in the subject device.
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The subject device encompasses design features which are substantially equivalent to those of The subject device encompasses design Trached Tube, including a standard 1 5mm offered by the MaillineKfodd 71-L0 - Jer 77dt inflation, low-pressure cuff adult models and connector, a pilot balloon and valve for can innelled tip, depth markings, a main luments) uncutted pediatic models, a facilopaque mic and overs and insufflation lumen(s).
for the evacuation of expired gases and mucosal secretions, and insufflation lumen(s).
The subject device provides functions equivalent to those provided by the Mallinskrodt Hi-I he subject device proviture the delivery of intermittent jet ventilation and the administration of oxygen during tracheobronchial suctioning procedures, providing a administration of oxygen during tracheroervann and ing bronchoscopies, and when the insufflation port is capped, both devices may also function as standard trached tubes with insuitiation port is capped, ood devices may and oring irrigation lumens may be ventilation occurring unough the main rains of a patient's trackeobronchial tree, to
used for monitoring airway pressure, for irrigation of a patient's tracked as an used for monitoning an way pressure, for intrigation and and eases, for ansthetizing
aid in the removal of accumulated secretions, for sampling traches modical aid in the removal of accumulated secretions, for sumpling with standard medical practices.
Further, the subject device is packaged and labeled in a manner substantially equivalent to its predicate device. the Mallinckrodt Hi-Lo® Jet Tracheal Tube.
Summary of Non-Clinical Tests G.
Performance testing was presented.
Summary of Clinical Tests H.
Clinical publications were presented.
Conclusions of Non-Clinical and Clinical Tests I.
Performance testing and clinical publications were presented.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2004
Ms. Laetitia Bernard Excaelia, Inc. 45900 Parsippany Court Temecula CA 92592
Re: K040657
Trade/Device Name: Boussignac Vygon Endotracheal Tube Regulation Number: 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated on Submission: March 11, 2004 Date Received in ODE: March 12, 2004
Dear Ms. Bernard:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection be clevice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to regary to regary the Medical Device Ameridments, or to commence prior to May 20, 1976, the exact ance with the provisions of the Federal Food, Drug, devices mat have occh rechassinou in accessfire approval of a premarket approval application (PMA). and Cosmetic Act (Fee) market the device, subject to the general controls provisions of the Act. The r ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of assisted, 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 If your device is classifica (see above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA w may be subject to such additional controller Entisting and to 898. In addition, FDA may be found in the Code of I castal stegeming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that PDA s issuated of a babbains and other requirements of the Act that FDA has made a delerimiation administered by other Federal agencies. You must of ally rederal statutes and regulations and uding, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, necesses,
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 – Ms. Laetitia Bernard
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21) CFR (2000) (2005) (2005) (21) (2005-100) (21 CFR 1000-1050, This forth in the quality systems (QS) regulation (2F CJ R P & 050, 21 CFR 1000-1050. This
product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050. product radiation control provisions (SCCRONS 551 e as described in your Section 510(k)
letter will allow you to begin marketing your device of your device to a letter will allow you to begin man kening your activelence of your device to a legally
premarket notification. The FDA finding of substantial equive add thus, nermits vour d premarket notification. The FDA inding of substantal equivalies of your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
ron of the many of the many 1941 164 - Also - mass note the regulation enti If you desire specific advice for your device on our necesses note the regulation entitled,
contact the Office of Compliance at (301) 594-4646. Also, please note the regulat contact the Office of Complailed at (501) 574-10 10. Tree Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). "Misbranding by reference to premarket notification (C) < et Act from the Division of Small other general information on your responsibilities and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-areanain html Manufacturers, International and Consumer Piositiatio and Consumers of the main.html.
Sincerely yours,
Ques
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Draft Labeling V.
Indications for Use A.
510(k) Number (if known): K040657
Boussignac/ Vygon Endotracheal Tube Device Name:
Indications for Use:
The Boussignac/ Vygon Endotracheal Tube is indicated for airway management. The I he Boussignal? I ygon Endorfacile I ace 15 minutent jet ventilation and the administration of
insufflation canals permit the delivery of intermittent jet worlds a surpleme insufflation canals permit the denvery of internations. They also provide a supplemental oxygen during tracheooronicular succioining procedures. In these ventilatory modes, the main
means for administering oxygen during bronchoscopies. In these ventify institutio means for administering oxygen during of expired gases. When the insufflation port is lumen serves as a chamel for the emilitation of express gasson as a standard tracheal tube with capped. The Boulssignal - Trgon Endortached. The Boussignac/ Vygon Endotracheal Tube is intended for oral/nasal intubation.
The monitoring/irrigation lumens may be used for monitoring airway pressure, for impling I he monitoring/irrigation inflicts may be ased for the of accumulated secretions, for sampling in a patient s tracheooronemal tree, to are in the reaches, or for introducing suitable medication in accordance with standard medical practice.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR
Over-The-Counter Use
Aus Taylor
(Division Sign-Off
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number:
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).