Laser-Shield II is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10,60 microns) or KTP (532 nm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthesia gases or to overcome emergency obstruction of an airway.

Device Description

Xomed Laser-Shield II is an endotracheal tube provided sterile with laser resistant overwraps of aluminum and fluoroplastic covering the silicone elastomer shaft. The tube is fitted with an inflatable cuff designed to provide tracheal seal. The inflation assembly/balloon contains dry methylene blue that mixes with a liquid inflation media (sterile normal saline) to provide visible detection of inadvertent cuff rupture by the laser. Sterile cottonoid patties are also provided for wetting and placement around the positioned and inflated cuff for additional heat sink.

AI/ML Overview

The provided text is related to a 510(k) submission for a modification to an existing medical device, the Laser-Shield® II Tracheal Tube. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use. However, it does not contain the detailed study information needed to fully address your request regarding acceptance criteria and device performance studies.

Here's a breakdown of what can be extracted based on the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document implies that the acceptance criterion for the modified device is "substantial equivalence" to the predicate device. This is a regulatory standard, not a performance metric with specific thresholds (e.g., >95% accuracy). The modification itself is described as "extension of the aluminum wrap under a portion of the cuff and covering of this extension with a flexible silicone sleeve." The key phrase is "The intended use and claims for the modified device remains unchanged and no new materials are being used." This suggests that the modified device should perform as safely and effectively as the original.
Reported Device Performance: The text does not report specific quantitative performance metrics (e.g., laser resistance levels, cuff integrity under specific conditions) for either the original or the modified device. It merely states that the modification does not change the intended use or claims, implying that the performance is expected to be equivalent to the previously cleared device.

Acceptance Criteria (Implied)	Reported Device Performance
Substantially Equivalent to predicate device (Laser-Shield® II) for all types of surgical procedures involving CO2 or KTP laser use.	The modified device's intended use and claims remain unchanged; no new materials are used. Performance is assumed to be equivalent to the predicate. Specific performance metrics are not provided in this document.
The modification (extended aluminum wrap, silicone sleeve) does not negatively impact safety or efficacy.	(Not explicitly stated in terms of performance data, but implied by the "substantial equivalence" determination.)

Missing Information:

Specific numerical or qualitative performance metrics (e.g., "withstanding X joules of laser energy for Y seconds").
A direct comparison of the modified device's performance against the predicate device using quantitative data.

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

The provided 510(k) summary does not describe a clinical or performance "test set" in the context of typical AI/diagnostic device studies. This submission is for a device modification of an existing physical medical device (an endotracheal tube), not a software algorithm. Therefore, concepts like "test set" in the machine learning sense, "country of origin," or "retrospective/prospective" studies do not apply in this document.

Missing Information: This entire section is not applicable or not present for this type of device submission.

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

Again, this submission is for a physical medical device. The concept of "ground truth" established by experts for a test set (e.g., for image interpretation or diagnosis) is not relevant here. The evaluation involves engineering principles, material science, and safety testing (e.g., biocompatibility guidance, laser resistance testing as per established standards for endotracheal tubes), not expert interpretation of outputs.

Missing Information: This section is not applicable or not present.

4. Adjudication Method for the Test Set

As there is no "test set" in the given context (no diagnostic performance study), an adjudication method is not described or relevant.

Missing Information: This section is not applicable or not present.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This document describes a physical medical device (an endotracheal tube), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.

Missing Information: This section is not applicable or not present.

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

This is not an algorithm or software device. This question is not applicable.

Missing Information: This section is not applicable or not present.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this type of physical device, "ground truth" would be established through a combination of:

Engineering specifications and standards: The device is expected to meet certain physical and chemical properties.
Performance testing: Laboratory tests demonstrating laser resistance, cuff integrity, etc. (though specific results are not in this summary).
Biocompatibility data: Ensuring the materials are safe for human contact.
Pre-clinical safety data: If animal or bench testing was done (not described in detail here).

The document states "The modified Xomed Laser-Shield II is identical to the current device with the exception of the extension of the aluminum wrap... The intended use and claims for the modified device remains unchanged and no new materials are being used." This implies that the ground truth for acceptability relies on the established safety and efficacy of the predicate device and the assessment that the modification does not alter this.

Missing Information: Specific details of technical performance studies that would constitute "ground truth" development for a physical device are not included in this high-level summary.

8. The Sample Size for the Training Set

This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the AI sense.

Missing Information: This section is not applicable or not present.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI model, this question is not applicable.

Missing Information: This section is not applicable or not present.

In summary, the provided 510(k) summary is for a physical medical device modification and focuses on demonstrating substantial equivalence to a predicate device. It does not contain the type of detailed performance study information, acceptance criteria, or ground truth establishment relevant to AI/diagnostic device submissions that your questions primarily target.

Summary

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K993582

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

1.0 Date Prepared October 14, 1999
2.0 Submitter (Contact) Rov Berens Xomed Surgical Products Jacksonville, FL Telephone: 904-296-645

3.0 Device Name

Proprietary Name: Laser-Shield® II Tracheal Tube, Endotracheal Tube Common Name(s): Classification Name: Tracheal Tube

4.0 Device Classification

Product Code 73BTR Class II Tier II Tracheal Tube 21 CFR 868.5730

5.0 Device Description

6.0 Intended Use

Xomed Laser-Shield II is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10.60 microns) or KTP (532 mm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthesia gases or to overcome emergency obstruction of an airway.

7.0 Substantial Equivalence

The modified Xomed Laser-Shield II is identical to the current device with the exception of the extension of the aluminum wrap under a portion of the cuff and covering of this extension with a flexible silicone sleeve. The intended use and claims for the modified device remains unchanged and no new materials are being used.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 0 2000

Mr. Roy Berens Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216-0980

Re: K993582 Modification to Laser-Shield® II Endotracheal Tube Requlatory Class: II (two) Product Code: 73 BTR October 20, 1999 Dated: October 22, 1999 Received:

Dear Mr. Berens:

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 leqally 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, Druq, 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 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 (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 Failure to comply with the GMP regulation may result in assumptions. requlatory 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. Roy Berens

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 regulation (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,

Joanna VA Westerhausen for,

Celia 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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Premarket Notification [510(k)] for Modification to Laser-Shield® II

Intended Use Statement

993582 510(k) Number (if known): K

Device Name: Modification to Laser-Shield II

Indications for Use: Laser-Shield II is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10,60 microns) or KTP (532 nm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthesia gases or to overcome emergency obstruction of an airway.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

io.Aulestschen

51 : Kki Numt

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).