The subject device is an oral/hasal cuffless pediatric endotracheal tube with Murphy eye. The tube incorporates a Maqill curve, radiopaque line, and ISO 15mm connector. It is manufactured from materials without latex or DEHP.

AI/ML Overview

This document describes the Mallinckrodt™ Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye, and its substantial equivalence to a predicate device. The information provided focuses on the device's design and non-clinical testing.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving it:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the subject device met all acceptance criteria for verification testing per ISO 5361:2012. However, it does not provide a detailed table outlining specific acceptance criteria values and the device's reported performance against each criterion from the ISO 5361:2012 standard. It only broadly states that the criteria were met.

For example, a typical table would look like:

Acceptance Criteria (from ISO 5361:2012)	Required Performance	Reported Device Performance
(Specific physical dimension, e.g., connector size)	(e.g., 15mm +/- tolerance)	(e.g., 15.02mm)
(Specific mechanical property, e.g., tensile strength)	(e.g., > X MPa)	(e.g., Y MPa)
(Specific sterility requirement)	(e.g., Sterility Assurance Level of 10^-6)	(e.g., Passed SAL testing)
... and so on for all relevant clauses of ISO 5361:2012

The document mentions several qualities the device shares with the predicate, which can be inferred as design or performance requirements, but not explicit acceptance criteria with numerical values:

Cuffless
Standard 15mm connector
Magill curve
Murphy eye
Similar size range (2.0 - 7.0mm for subject device, 2.0 - 9.0mm for predicate)
Similar material composition (Medical grade PVC with a non-DEHP plasticizer for subject, Medical grade PVC for predicate)

Biocompatibility Testing: The device met all biocompatibility requirements for its intended use, according to ISO 10993-1:2009.
DEHP Content: Solvent extraction testing confirmed DEHP is less than 0.1% w/w.

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

The document refers to "verification testing per ISO 5361:2012" and "biocompatibility testing per ISO 10993-1:2009." However, it does not specify the sample size used for these tests.
The data provenance is not explicitly stated in terms of country of origin, but it is a regulatory submission to the US FDA, implying testing was conducted to meet US regulatory standards, likely by the manufacturer (Covidien). The studies are inherent to the product development and regulatory submission process, thus they would be prospective in nature for this specific device.

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

This information is not provided. The testing refers to adherence to international standards (ISO 5361:2012 for performance, ISO 10993-1:2009 for biocompatibility), which typically involve standardized laboratory measurements and analyses, not expert consensus on qualitative data in the way a medical image interpretation study might.

4. Adjudication Method for the Test Set:

This concept of adjudication (e.g., 2+1, 3+1) is not applicable to the type of engineering and biocompatibility testing described in the document. These tests rely on objective measurements and established protocols rather than subjective interpretations requiring multiple expert adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "N/A - Clinical evidence was not necessary to show substantial equivalence." This type of study would involve human readers (e.g., clinicians) evaluating cases, often with and without AI assistance, which is not relevant to a tracheal tube.

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

No. This device is a physical medical device (tracheal tube), not a software algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used:

The "ground truth" here is adherence to specified technical standards.

For performance, the ground truth is defined by the requirements of ISO 5361:2012 (Anesthesiology and respiratory equipment - Tracheal tubes and connectors).
For biocompatibility, the ground truth is defined by the requirements of ISO 10993-1:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).
For DEHP content, the ground truth is the chemical composition confirmed by solvent extraction testing, verifying it's less than 0.1% w/w.

These are engineering standards and chemical analyses, not pathology, outcomes data, or expert consensus in the typical sense of clinical trials.

8. The Sample Size for the Training Set:

This information is not applicable. The device is an endotracheal tube, not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 11, 2015

Covidien Danielle Mueller Regulatory Affairs Manager 6135 Gunbarrel Ave Boulder, CO 80301

Re: K151381

Trade/Device Name: Mallinckrodt™ Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: November 9, 2015 Received: November 10, 2015

Dear Danielle Mueller:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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 (if known) K151381

Device Name

Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye

Indications for Use (Describe)

The oral/nasal cuffless non-DEHP pediatric endotracheal tube with Murphy eye is indication of the trachea for airway management.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a 510(k) Summary for the use of the Mallinckrodt™ Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye.

Submitted By:	Covidien6135 Gunbarrel AvenueBoulder, CO 80301
Date:	December 10, 2015
Contact Person:	Danielle MuellerRegulatory Affairs Manager(303) 305-2603
Proprietary Name:	Mallinckrodt™ Oral/Nasal Tracheal Tube Cuffless,Non-DEHP, Murphy Eye
Common Name:	Tracheal Tube
Device Classification Regulation:	21 CFR 868.5730 - Class II
Device Product Code & Panel:	BTR
Predicate Devices:	BEVER™ Endotracheal Tube (K111401)

Device Description

Indications for Use/Intended Use

The oral/nasal cuffless non-DEHP pediatric endotracheal tube with Murphy eye is indicated for oral or nasal intubation of the trachea for airway management.

Technological Characteristics Comparison

The subject device is substantially equivalent to the predicate in terms of technological characteristics. Both devices are designed in accordance with ISO 5361 and have the following features in common: cuffless, standard 15mm connector, Magill curve, Murphy eye, similar size range, and similar material composition.

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	SUBJECT	PREDICATE
	Mallinckrodt™ Oral/NasalTracheal Tube Cuffless, Non-DEHP, Murphy Eye	BEVER™ Oral/Nasal EndotrachealTube Cuffless [K111401]
Intended Use	Oral or nasal intubation of thetrachea for airway management.	Oral or nasal intubation of thetrachea for airway managementduring mechanical ventilation andanesthesia.
PatientPopulation	Pediatrics	Pediatrics, Adults
Use	Single patient	Single patient
DEVICE DESIGN
Tube Design	Per ISO 5361:2012	Per ISO 5361:1999
Magill Curve	Yes	Yes
Murphy Eye	Yes	Yes
Radiopaque Line	Yes	Yes
Size Range	2.0 - 7.0mm	2.0 - 9.0mm
Sterilization	EtO	EtO
Shelf Life	5 years	4 years
Tube Material	Medical grade PVC with a non-DEHP plasticizer	Medical grade PVC

Substantial Equivalence - Non-Clinical Evidence

The subject device met all acceptance criteria for verification testing per ISO 5361:2012; therefore, it can be considered substantially equivalent to the predicate in terms of performance. Additionally, biocompatibility testing was performed per ISO 10993-1:2009 including the following: cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic toxicity, implantation, chemical characterization, and toxicological risk assessment. The device met all biocompatibility requirements for its intended use. Solvent extraction testing was performed to confirm the content of DEHP is less than 0.1% w/w in the device.

Substantial Equivalence - Clinical Evidence

N/A - Clinical evidence was not necessary to show substantial equivalence.

Substantial Equivalence – Conclusions

No new questions of safety and effectiveness have been raised. From the evidence presented in the premarket notification, the subject devices can be considered substantially equivalent.

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).