(141 days)
Not Found
No
The device description and intended use focus on the physical characteristics and function of a standard tracheal tube, with no mention of AI or ML capabilities.
No
The device is an endotracheal tube used for maintaining an open airway and facilitating ventilation, which are supportive functions, not therapeutic in nature. It doesn't treat, cure, or prevent a disease.
No
The device is an endotracheal tube used for maintaining an open airway and ventilation, which are therapeutic functions, not diagnostic ones.
No
The device description clearly describes a physical, hardware-based tracheal tube with a cuff and wire reinforcement, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to maintain an open airway by being inserted into the trachea and attached to an anesthesia machine for ventilation. This is a direct intervention on the patient's body for therapeutic purposes (maintaining an airway and facilitating breathing).
- Device Description: The description details a physical device (tracheal tube) designed for insertion into the body to facilitate breathing. It describes its physical characteristics and function in maintaining an airway and preventing aspiration.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any tests on samples. It is a device used in the body for a physiological function.
Therefore, the LMA Fastrach™ ETT SU is a therapeutic medical device used for airway management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LMA Fastrach™ ETT SU is intended to be inserted through the patient's mouth into the trachea to maintain an open airway and is attached to the anesthesia machine after insertion into the patient. It is intended that the user will be able to inflate the device cuff and ventilate the patient.
Indications for Use:
The LMA Fastrach™ ETT SU is indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for kinking or occlusion of the tracheal tube, when the patient is in the prone position or where surgery of the head or neck is required following intubation.
Product codes
BTR
Device Description
The LMA Fastrach™ ETT SU is a straight, cuffed, wire-reinforced, single use tracheal tube with a Murphy Eye. The metal wire spiral reinforcement is to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery.
The plastic material and the spring allow the tube to be easily bent in all direction. The plastic material and the ophing crevent kinking or occlusion of the tube.
The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gasses are channeled through the tube and not allowed to escape, thus preventing loss of ventilation / or inspired oxygen and aspirated stomach contents from entering the lungs.
This reinforced tracheal tube is available in size 6, 6.5, 7.0, 7.5 and 8.0 mm only, and it is designed to be compatible with the LMA Fastrach™, LMA Fastrach™ LMA CTrach Airways.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea, mouth, head, neck
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)
Clinical evaluation data is shown in Section 6.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K991580, K860105, K990619, K032112
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
DEC 1 3 2005
2051993
The Laryngeal Mask Company Limited
LMA Fastrach™ ETT SU
510(K) SUMMARY
Submitter:
The Laryngeal Mask Company Limited PO Box 221, Mahe, Seychelles
US Agent for Submission And Contact Person:
Mr. Foster Boop LMA North America, Inc. 4660 La Jolla Village Drive Suite 900 San Diego, CA 92122 Phone: 858-587-4025
Date Prepared:
04 July 2005
Trade Name:
LMA Fastrach™ETT SU
Reinforced Tracheal Tube (Cuffed)
Common Name:
Device Type and Class:
Reinforced Tracheal Tube. Class II BTR, 21 CFR 868.5730
Predicate Device:
- Predicate 1: LMA Fastrach™ ETT already marketed in the USA under . K991580
- Predicate 2: Sheridan Spiral-Flex ETT already marketed in the USA under . K860105
- Predicate 3: Rusch Reinforced ETT already marketed in USA under . K990619
- Predicate 4: Portex reinforced ETT already marketed in the USA under ● K032112
Device Description:
The LMA Fastrach™ ETT SU is a straight, cuffed, wire-reinforced, single use tracheal tube with a Murphy Eye. The metal wire spiral reinforcement is to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery.
1
LMA Fastrach™ ETT SU
The Laryngeal Mask Company Limited
510(K) SUMMARY
The plastic material and the spring allow the tube to be easily bent in all direction. The plastic material and the ophing crevent kinking or occlusion of the tube.
The cuff is intended to provide a seal against the trachea, ensuring that The Cull 1s Intended to provied through the tube and not allowed to Inspiratory and expiratory gasses are atthus preventing loss of ventiation / escape to the patients "upper" direct" and aspirated stomach contents from entering the lungs.
This reinforced tracheal tube is available in size 6, 6.5, 7.0, 7.5 and 8.0 mm only, This reinforced trached tube is available in size of other fract and as the comment.
And it is designed to be compatible with the LMA Fastrach™, LMA Fastrach™ And it is coolig. LMA CTrach Airways.
Intended Use:
The LMA Fastrach™ ETT SU is intended to be used for oral intubation for arway management during anaesthesia. The product maybe used where the patient's management uunny anaesthoolar 11c froo atient is in the prone position so that a non-reinforced tracheal tube might become kinked.
Technological Characteristics of the Proposed Versus Prodicate Devices:
The proposed device is substantially equivalent to predicate 1 – LMA Fastrach™ ETT, in all aspects except the followings:
- Material. The proposed device is identical in material to the tubing . Material: The propossa Sheridan Spiral-Flex ETT, Predicate 3: Rusch Reinforced ETT and Predicate 4: Portex reinforced ETT.
- Sterile. The proposed device is a sterile single use device which is . Sterfic. The Predicate 4- Portex reinforced ETT and Predicate 2-Sheridan Spiral-Flex ETT.
- Cuff. The proposed device is identical in material and design to that of 1 Predicate 2- Sheridan Spiral-Flex ETT.
2
The Laryngeal Mask Company Limited
LMA Fastrach™ ETT SU
:
510(K) SUMMARY
Performance / Clinical Data:
Clinical evaluation data is shown in Section 6.
Conclusion:
Comparison of the proposed device to the predicate devices supports the Companson of the proposed device is substantially equivalent in safety and conclusion that the proposed - to existing legally marketed devices.
3
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
DEC 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Laryngeal Mask Company Limited C/O Mr. Foster Boop Director, Technical Affairs LMA North America, Incorporated 9360 Towne Centre Drive San Diego, California 92121
Re: K051993
Trade/Device Name: LMA Fastrach™ ETT Single Use Regulation Number: 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: December 2, 2005 Received: December 5, 2005
Dear Mr. Boop:
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 application (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 such 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.
4
Page 2 - Mr. Boop
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 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 begin 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) 276-0120. 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/industry/support/index.html.
Sincerely yours,
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
5
Indications for Use
510(k) Number (if known): K051993
LMA Fastrach™ ETT Single Use
The LMA Fastrach™ ETT SU is intended to be inserted through the patient's mouth into the trachea to maintain an open airway and is attached to the modif into the traction after insertion into the patient. It is intended andootherio machine the user will be able to inflate the device cuff and ventilate the patient.
Indications for Use:
Device Name:
The LMA Fastrach™ ETT SU is indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for intubation of the traonomist of the head or neck is required following intubation.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cune Egleom
Page 1 of 1