(273 days)
Not Found
Not Found
No
The device description details a physical medical device (endotracheal tube) with no mention of software, algorithms, or any components that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
The device is indicated for airway management by oral intubation, which is a supportive function, not a therapeutic treatment.
No
The device is an endotracheal tube, indicated for airway management by oral intubation of the trachea. Its function is to facilitate breathing, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly details a physical, hardware-based medical device (endotracheal tube) made of silicone and stainless steel, with no mention of software as a component or the primary function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The ILM Endotracheal Tube is a device used for airway management by being inserted directly into the trachea. It is a physical device used within the body to maintain an open airway.
- Intended Use: The intended use clearly states "airway management by oral intubation of the trachea." This is a direct intervention on the patient's anatomy, not a diagnostic test performed on a sample.
The description of the device and its function aligns with a Class II or Class III medical device used for direct patient care, not an IVD.
N/A
Intended Use / Indications for Use
The ILM ETT is indicated for airway management by oral intubation of the trachea.
Product codes (comma separated list FDA assigned to the subject device)
73 BTR
Device Description
The ILM ETT is a straight, cuffed, wire-reinforced tracheal tube, with a Murphy Eye. It is available in a three sizes with internal diameters of 7.0mm, 7.5mm and 8.0mm. The airway tube is made from silicone and features a stainless steel reinforcing wire to prevent kinking or occlusion of the tube. The tip of the tube is molded from a softer grade of silicone for passage through the vocal cords. The airway tube features an inflatable silicone cuff for sealing the tube in the trachea. The tip of the ILM ETT is beveled in two directions to aid passage of the tube through the trachea. Depth markings are printed on the airway tube (in centimeters). These indicate the distance to the distal tip of the tube. The tube also has a printed black line to indicate its caudal surface. The ILM ETT features a small diameter silicone tube connected to a pilot balloon with a luer check valve for inflation of the cuff. The ILM ETT can be connected to the anesthesia circuit by a removable 15mm standard male connector which conforms to ISO5356-1 (1987). A connector is supplied with each ILM ETT. The ILM ETT is designed to be compatible with the LMA-Fastrach (an oropharyngeal airway). To ensure compatibility, a marker line indicates when the tube passes through the LMA-Fastrach. In addition, the inflation line is mounted close to the rear of the ILM ETT to ensure unobstructed passage of the tube through the LMA-Fastrach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Euromedical™ ILM (Intubating Laryngeal mask) 100% Silicone Wire-Reinforced Endotracheal Tube
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
§ 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
Attachment 1
510(k) Summary
8807.92(a)(1)
Submitter's Name: C.L. McIntosh & Associates for The Laryngeal Mask Company Ltd.
Submitter's Address: 12300 Twinbrook Parkway Suite 625 Rockville, MD 20852
Submitter's Telephone Number: (301) 770-9590
Contact Person: Robert L. Sheridan
Date of Preparation: April 5, 1999
8807.92(a)(2)
Trade/Proprietary Name: ILM Endotracheal Tube (ILM ETT)
Common/Usual Name: Endotracheal Tube
Classification Name: Tracheal Tube
8807.92(a)(3)
Legally Marketed Predicate Device:
Euromedical™ ILM (Intubating Laryngeal mask) 100% Silicone Wire-Reinforced Endotracheal Tube
8807.92(a)(4)
Description of Subject Device:
The ILM ETT is a straight, cuffed, wire-reinforced tracheal tube, with a Murphy Eye. It is available in a three sizes with internal diameters of 7.0mm, 7.5mm and 8.0mm.
1
The airway tube is made from silicone and features a stainless steel reinforcing wire to prevent kinking or occlusion of the tube. The tip of the tube is molded from a softer grade of silicone for passage through the vocal cords. The airway tube features an inflatable silicone cuff for sealing the tube in the trachea. The tip of the ILM ETT is beveled in two directions to aid passage of the tube through the trachea.
Depth markings are printed on the airway tube (in centimeters). These indicate the distance to the distal tip of the tube. The tube also has a printed black line to indicate its caudal surface.
The ILM ETT features a small diameter silicone tube connected to a pilot balloon with a luer check valve for inflation of the cuff.
The ILM ETT can be connected to the anesthesia circuit by a removable 15mm standard male connector which conforms to ISO5356-1 (1987). A connector is supplied with each ILM ETT.
The ILM ETT is designed to be compatible with the LMA-Fastrach (an oropharyngeal airway). To ensure compatibility, a marker line indicates when the tube passes through the LMA-Fastrach. In addition, the inflation line is mounted close to the rear of the ILM ETT to ensure unobstructed passage of the tube through the LMA-Fastrach.
$807.92(a)(5)
Statement of Intended Use:
The ILM ETT is indicated for airway management by oral intubation of the trachea.
8807.92(a)(6)
Comparison with Predicate Device:
The ILM ETT and the Euromedical Silicone Wire-Reinforced Endotracheal Tube have identical performance, and with the exception of the labeling, they are the same device. The two devices use the same materials and are dimensionally identical. They are molded and assembled in the same manufacturing plant to the same specifications (except for the labeling). The differences in the labeling are limited to changes in the company details, product names and attempts to make the Instructions for Use more readable.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. Inside the circle is a stylized symbol of three human figures in profile, arranged in a row and connected by flowing lines, representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 4 2000
Mr. Robert L. Sheridan The Laryngeal Mask Company Ltd. c/o C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, MD 20852
Re: K991580 ILM Endotracheal Tube Regulatory Class: II (two) Product Code: 73 BTR November 5, 1999 Dated: Received: November 8, 1999
Dear Mr. Sheridan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Robert L. Sheridan
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may. be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
feran A Winteragher (res)
elia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 3
Indications for Use Statement
| Applicant: | The Laryngeal Mask Company Ltd |
|---|---|
| 510(k) Number (if known): | |
| Device Name: | ILM Endotracheal Tube |
| Indications for Use: | The ILM Endotracheal Tube is indicated for airway management by oral intubation of the trachea. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
leAN Andh
vision Sign-Off) vision of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K99 580
$\downarrow$ Prescription Use
(Per 21 CFR 801.109)