The SealGuard Evac Endotracheal tube is indicated for airway management by oral/nasal intubation of the trachea, and for evacuation or drainage of the subglottic space.

The SealGuard Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.

Device Description

The SealGuard™ and the SealGuard™ Oral Evac Tracheal Tubes are sterile, single-use devices supplied with a standard 15mm connector. On the Evac tubes, in addition to the main lumen, the tube has a separate Evac lumen which has a dorsal opening above the cuff. Access to the lumen is accomplished via a clear connecting tube with a capped Luer connector. The tube features a unique ultra thin high volume low pressure cuff and self sealing valve with attached pilot balloon. The unique cuff material of the SealGuard products ideally gives an improved sealing performance over historical PVC cuffed product. The tube incorporates a Magill curve, a hooded tip with Murphy Eye and a Tip-To-Tip™ radiopaque line to assist in radiographic visualization.

AI/ML Overview

This document is a 510(k) summary for the SealGuard Endotracheal Tube and SealGuard Evac Endotracheal Tubes. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about a study proving the device meets specific acceptance criteria in the way one might expect for a novel AI/software medical device.

Therefore, many of the requested sections (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment, training set size) are not applicable or cannot be extracted from the provided text, as the submission is for a physical medical device (endotracheal tube) and its performance is typically evaluated through bench testing and clinical equivalence, not machine learning model evaluation.

Here's an analysis based on the provided text, addressing the applicable points and noting where information is not present:

Acceptance Criteria and Device Performance Study

The document does not explicitly present a table of "acceptance criteria" with quantitative metrics for performance and corresponding study results in the context of a software or AI device. Instead, the submission for this physical device focuses on demonstrating substantial equivalence to existing predicate devices (Hi-Lo Cuffed Tracheal Tube K871204 and Hi-Lo Evac Endotracheal Tubes K965132). This means the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate device(s) for the stated indications for use.

The primary differences between the proposed and predicate devices are:

Cuff material: PU (polyurethane) for SealGuard vs. PVC (polyvinylchloride) for predicate.
Cuff shape: Tapered for SealGuard vs. barrel shape for predicate.

The study that "proves" the device meets the acceptance criteria (i.e., is substantially equivalent) would typically involve a combination of:

Bench testing: To compare physical characteristics, sealing ability, and other performance metrics against the predicate devices.
Biocompatibility testing: To ensure the new cuff material is safe.
Design verification and validation: To confirm the device consistently performs as intended.

However, the provided text does not include the details of these studies or their specific results, nor does it list quantitative acceptance criteria. It only states that the device "maintain the same intended use as the predicate device" and "consist of the same fundamental technology." The FDA's letter confirms substantial equivalence based on the submitted information.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in a quantitative table format within the provided text. The overall acceptance criterion is "substantial equivalence" to the predicate devices. This implies meeting the same safety and effectiveness standards, likely through performance testing related to sealing, material properties, and functionality consistent with an endotracheal tube.
Reported Device Performance: Not detailed in a quantitative table within the provided text. The document describes the device's features (e.g., "unique ultra thin high volume low pressure cuff," "improved sealing performance over historical PVC cuffed product") but does not provide specific performance data or a direct comparison to predicate device data.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/not provided as the submission is not for an AI/software device that typically utilizes "test sets" of data for performance evaluation. The "study" mentioned is likely a set of engineering tests and possibly small-scale clinical equivalence evaluations (though not detailed here) for a physical medical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. Ground truth in the context of AI/software refers to the expert-labeled data used to evaluate algorithm performance. For a physical device, performance is typically assessed through direct measurement, mechanical testing, and observation, often against established standards or predicate device performance, rather than expert-labeled "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. Adjudication methods are relevant for resolving discrepancies in expert labeling for ground truth in AI studies.

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 information is not applicable/not provided. An MRMC study is specific to evaluating diagnostic performance with and without AI assistance for tasks involving human interpretation of medical images or data. This is not relevant to an endotracheal tube.

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

This information is not applicable/not provided. "Standalone performance" refers to the performance of an algorithm without human intervention, which is not relevant for a physical medical device like an endotracheal tube.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/not provided. For a physical medical device, "ground truth" relates more to whether the device physically functions as intended and meets specifications (e.g., does the cuff inflate and seal effectively? Is the material biocompatible?). This is confirmed through engineering tests and material analysis rather than establishing "ground truth" from experts or pathology in the AI sense.

8. The sample size for the training set

This information is not applicable/not provided. A "training set" is used to develop and train machine learning models, which is irrelevant for this physical medical device submission.

9. How the ground truth for the training set was established

This information is not applicable/not provided for the same reasons as point 8.

Summary

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KORAS20

OCT 02 2008

Special 510(k) Summary

1. Company Identification

Covidien, (formerly Nellcor Puritan Bennett, Inc.) 6135 Gunbarrel Avenue Boulder, CO 80301

Establishment Registration: 2936999

2. Contact Person

Scott Dickerhoff Director, Regulatory Affairs Phone: (303) 305-2382 Fax: (303) 305-2212 Email: scott.dickerhoff(@covidien.com

510(k) Preparation Date

July 15, 2008

4. Device Name

SealGuard Endotracheal Tube and SealGuard Evac Endotracheal Tubes. Trade Name: Common Name: Endotracheal Tube, Tracheal Tube

5. Device Classification

Class II per 21 CFR 878.5730

6. Indications for Use

The SealGuard Evac Endotracheal tube is indicated for airway management by oral/nasal intubation of the trachea, and for evacuation or drainage of the subglottic space.

The SealGuard Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.

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7. Description of Device

SealGuard™ Endotracheal Tube (5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10mm)

SealGuard™ Evac Endotracheal Tube - Oral (6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm)

8. Substantial Equivalence

The predicate devices to which we claim equivalence are the Hi-Lo Cuffed Tracheal Tube (K871204), and the Hi-Lo Evac Endotracheal Tubes (K965132).

The SealGuard Endotracheal tube and the SealGuard EVAC Endotracheal tubes maintain the same intended use as the predicate device. It is a device inserted into the trachea through the mouth or nose to facilitate breathing.

The SealGuard Endotracheal tube & SealGuard EVAC Endotracheal tubes and the predicate device consist of the same fundamental technology.

The SealGuard Endotracheal tube and the SealGuard EVAC Endotracheal tubes differ from the predicate device in that the cuff material is PU (polyurethane) and the predicate device cuff is PVC (polyvinylchloride). In addition, the shape of the cuff is modified from a barrel shape to a tapered shape.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 02 2008

Mallinckrodt Medical C/O Mr. Scott Dickerhoff Director, Regulatory Affairs Covidien 6135 Gunbarrel Avenue Boulder, Colorado 80301

Re: K082520

Trade/Device Name: ScalGuard Tracheal Tubes and SealGuard Evac Tracheal Tubes Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: August 29, 2008 Received: September 2, 2008

Dear Mr. Dickerhoff:

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.

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Page 2 - Mr. Dickerhoff

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

MAnuels Sedimts foell

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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Indications for Use

510(k) Number: _

Device Name: SealGuard Tracheal Tubes and SealGuard Evac Tracheal Tubes

Indications for Use:

The SealGuard Evac Endotracheal tube is indicated for airway management by oral/nasal intubation of the trachea, and for evacuation or drainage of the subglottic space.

The SealGuard Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.

fr. Aciup.

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080620

Prescription Use _ X (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)

Covidien

Page 114 of 185

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).