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.

AI/ML Overview

The provided text is a 510(k) summary for the ILM Endotracheal Tube (ILM ETT) and a subsequent FDA approval letter. It outlines the device's description, intended use, and comparison to a predicate device. However, it does not contain any information regarding specific acceptance criteria, a scientific study, device performance metrics, sample sizes, expert involvement, or statistical methods.

The core of the submission for the ILM ETT is a claim of substantial equivalence to an existing legally marketed predicate device, the Euromedical™ ILM (Intubating Laryngeal mask) 100% Silicone Wire-Reinforced Endotracheal Tube. The document explicitly states:

"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)."

Therefore, the "acceptance criteria" and "study" are implicitly tied to demonstrating this substantial equivalence, rather than a de novo performance study against concrete numerical thresholds.

Here's an analysis based on the provided text, highlighting what's missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion	Reported Device Performance
Mechanical/Physical Equivalence to Predicate Device:
Identical materials	Confirmed: "The two devices use the same materials"
Dimensionally identical	Confirmed: "and are dimensionally identical."
Molded and assembled to same specifications (except labeling)	Confirmed: "They are molded and assembled in the same manufacturing plant to the same specifications (except for the labeling)."
Functional Equivalence to Predicate Device:
Identical performance	Confirmed: "The ILM ETT and the Euromedical Silicone Wire-Reinforced Endotracheal Tube have identical performance..."
Compatibility with LMA-Fastrach:
Marker line indicates tube passage	Confirmed: "a marker line indicates when the tube passes through the LMA-Fastrach."
Inflation line mounted close to rear to ensure unobstructed passage	Confirmed: "the inflation line is mounted close to the rear of the ILM ETT to ensure unobstructed passage of the tube through the LMA-Fastrach."

Critically Missing: The document does not provide specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum leak rate, specific airflow resistance) nor quantitative performance data for the ILM ETT itself. Its performance is asserted as being identical to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable in the context of a de novo performance study. The "test" for substantial equivalence relied on a direct comparison of specifications and manufacturing processes to the predicate device.
Data Provenance: Not applicable. No clinical or performance data is presented. The equivalence claim is based on manufacturing and design documents.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts: Not applicable. No dedicated expert panel was used to establish ground truth for a test set, as no performance study data is presented. The FDA reviewers are the "experts" who evaluate the substantial equivalence claim based on the provided technical documentation.
Qualifications of Experts: N/A for establishing ground truth data. The FDA reviewers fall under "Division of Cardiovascular, Respiratory, and Neurological Devices." The approval letter is signed by an "Acting Director" with "Ph.D., M.D." qualifications, indicating medical and scientific expertise.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. There was no test set requiring multi-reader adjudication. The process was a regulatory review of documentation for substantial equivalence.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

MRMC Study: No. The provided document makes no mention of an MRMC study. This is a 510(k) submission based on substantial equivalence, not a comparative clinical trial.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Not applicable. This is a medical device, an endotracheal tube, not an algorithm or AI system. Its "performance" is inherently human-in-the-loop during its use for intubation.

7. The Type of Ground Truth Used:

Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness profile of the predicate device. The applicant's submission relies on the assertion that the ILM ETT is materially and functionally identical to this already approved device. Therefore, the ground truth is the regulatory acceptance and historical performance of the predicate device.

8. The Sample Size for the Training Set:

Sample Size: Not applicable. There is no AI component or "training set" for this device.

9. How the Ground Truth for the Training Set was Established:

Ground Truth Establishment: Not applicable, as there is no training set.

Summary of the "Study" (in the context of a 510(k) based on substantial equivalence):

The "study" here is essentially the comparison and verification of design specifications, materials, and manufacturing processes between the proposed ILM ETT and the legally marketed predicate device, the Euromedical™ ILM (Intubating Laryngeal mask) 100% Silicone Wire-Reinforced Endotracheal Tube.

The applicant provided documentation to the FDA asserting that the two devices are:

Identical in performance.
Made from the same materials.
Dimensionally identical.
Molded and assembled in the same manufacturing plant to the same specifications (except for labeling changes, which were minor administrative updates).

The FDA reviewed this documentation and, based on the submitted evidence, concluded that the ILM Endotracheal Tube was "substantially equivalent" to the predicate device. This substantial equivalence effectively "proves" that the device meets the (implicit) acceptance criteria of being as safe and effective as a device already on the market. There was no independent performance study conducted, or at least, none is described in this summary.

Summary

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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.

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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.

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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.

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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

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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)

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vision Sign-Off) vision of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K99 580

$\downarrow$ Prescription Use

(Per 21 CFR 801.109)

Regulation Number and Section

§ 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).