The subject devices are single patient use tracheostomy tubes that are intended to provide an artificial airway for airway management. It is available in multiple neonatal and pediatric sizes, all of which are available either cuffless or with a TaperGuard™ cuff. The products have a radiopaque tube with a clear flange and standard 15mm connector for direct connection to standard ventilation and anesthesia equipment. The products are not made with natural rubber latex or DEHP.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the Shiley™ Neonatal/Pediatric Tracheostomy Tube. It details the device's characteristics, intended use, and comparisons to predicate devices, along with the performance testing conducted to demonstrate substantial equivalence.

However, the document specifically states "N/A - Clinical evidence was not necessary to show substantial equivalence." This means that the submission did not include a clinical study in the traditional sense, especially not one involving human subjects that would typically require the establishment of an AI model's performance against human readers or a ground truth derived from expert consensus or pathology for a diagnostic or AI-driven device.

Therefore, many of the requested elements for AI model evaluation (like multi-reader multi-case studies, expert adjudication, training set details, etc.) are not applicable to this 510(k) submission as it concerns a physical medical device (tracheostomy tube) and not an AI/software device.

I can, however, extract information regarding the acceptance criteria and the studies that were performed to prove the device met those criteria for this type of medical device.

Acceptance Criteria and Device Performance for the Shiley™ Neonatal/Pediatric Tracheostomy Tube

This 510(k) submission focuses on demonstrating substantial equivalence of a physical medical device (tracheostomy tube) to existing predicate devices based on design, materials, and performance through non-clinical testing. It does not involve an AI model or diagnostic performance evaluation that would necessitate clinical studies, multi-reader analyses, or expert ground truth establishment in the way described in the prompt's questions.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria (Tests Performed) and Reported Device Performance:

Acceptance Criteria (Test Category)	Specific Tests/Standards (Implicit Acceptance Criteria: Compliance)	Reported Device Performance (Compliance)
Biocompatibility	Cytotoxicity, Sensitization, Acute Systemic Toxicity, Genotoxicity, Subchronic Toxicity, Material Mediated Rabbit Pyrogen, Implantation, Chemical Characterization, Risk Assessment (in accordance with ISO-10993 and FDA Guidance)	Conducted and found acceptable (implicitly means device meets biological safety requirements).
Sterilization & Packaging Validation	Sterility (ISO 11135-1, ISO 10993-7), Packaging Integrity (ISO 11607-1)	Validation conducted to ensure sterility and packaging integrity are acceptable.
MRI Compatibility	MRI Safety and Compatibility, MR Compatibility Labeling (FDA guidance, ASTM F2503-13)	Product designated MR Conditional (cuffed) and MR Safe (cuffless), indicating successful testing compliance.
Bench Testing (Functional Performance)	ISO 5366-3, ISO 5356-1, Internal bench testing for cuff performance, connector mechanical performance, and cannula bend.	Testing conducted in accordance with specified ISO standards and internal protocols (implicitly means device meets functional requirements).
Design/Material Equivalence	Intended Use, Patient Population, Environment of Use, Single Patient Use, Sterilization Method, Shelf Life, Device Design to ISO standards, Size Range, Flange design, Connector design, Cannula Angle, Cannula Wall, Radiopaque Cannula, Cuff Type, Inflation System, Obturator & Neck Strap, Material composition (PVC, ABS, Polypropylene, Cotton).	Subject device demonstrated to be identical or equivalent (with explained changes like one-piece flange/connector and non-DEHP PVC material changes) to predicate devices on all listed parameters.

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

Sample Size: Not explicitly stated for each test, but standard for medical device bench testing and biocompatibility involves a sufficient number of samples to ensure statistical validity and representativeness of the manufacturing process. These are typically small, controlled batches for verification.
Data Provenance: Laboratory test results from internal or contracted testing facilities for the subject device. These are prospective tests performed specifically for this 510(k) submission, not retrospective patient data. The country of origin for the testing itself is not specified, but the applicant (Covidien) is based in Boulder, CO, USA.

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

N/A. The testing conducted for this device is physical and material performance testing, not a diagnostic or AI evaluation requiring expert-established ground truth from clinical images or patient data. The "ground truth" here is compliance with engineering specifications, material standards, and regulatory guidelines, verified by laboratory measurements.

4. Adjudication Method for the Test Set:

N/A. This concept applies to human reader studies or AI performance evaluations, not to the bench and material testing performed for this device. Test results are objective measurements against pre-defined specifications.

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

No. As explicitly stated in the summary, "N/A - Clinical evidence was not necessary to show substantial equivalence." An MRMC study is a type of clinical study used for diagnostic devices, particularly those involving image interpretation by human readers.

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

No. This device is a physical tracheostomy tube, not a software algorithm.

7. The Type of Ground Truth Used:

For this device, the "ground truth" is defined by engineering specifications, international consensus standards (e.g., ISO 10993, ISO 11135, ISO 11607, ISO 5366, ISO 5356), and FDA guidance documents. Compliance with these established objective criteria serves as the basis for performance evaluation and substantial equivalence determination.

8. The Sample Size for the Training Set:

N/A. This device does not involve a "training set" in the context of machine learning or AI.

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

N/A. As no training set for an AI model was used, this question is not applicable.

Summary

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510(k) SUMMARY K182861

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 Shiley™ Neonatal/Pediatric Tracheostomy Tube.

Submitted By:	Covidien6135 Gunbarrel AvenueBoulder, CO 80301
Date:	February 19, 2019
Contact Person:	Yaara BasevitchRegulatory Affairs Manager(720) 891-0214
Proprietary Name:	Shiley™ Neonatal/Pediatric Tracheostomy Tube
Common Name:	Tracheostomy Tube & Tube Cuff
Device Classification Regulation:	21 CFR 868.5800 – Class II
Device Product Code & Panel:	JOH
Predicate Devices:	Shiley™ Neonatal/Pediatric Tracheostomy Tube Cuffless(K122531)Shiley™ Neonatal/Pediatric Tracheostomy Tube withTaperGuard™ Cuff (K142298)
Reference Device:	Shiley™ Neonatal/Pediatric long Tracheostomy Tube(K945513)Shiley™ cuffed Pediatric long Tracheostomy Tube(K955680)

Device Description

Indications for Use/Intended Use

The device is intended for use in providing tracheal access for airway management.

Technological Characteristics Comparison

The subject device is identical in intended use, basic design, functionality, and size range to the predicate devices. The subject device features a few design and material changes compared to the predicates. The

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cannula angle of the subject device features a more narrowed angle range in comparison to the predicate device. The subject device features a one-piece flange with integrated 15mm connector; whereas, the predicate featured a two-piece design. The materials of the subject device cannula, 15mm connector and flange, and cuff were changed to a different grade of non-DEHP PVC in comparison to the predicate device. A comparison table is provided below.

		SUBJECT	PREDICATE
		Shiley™ Neonatal/PediatricTracheostomy Tube(cuffed & cuffless)	Shiley™Neonatal/PediatricTracheostomy Tube –cuffed [K142298]	Shiley™Neonatal/PediatricTracheostomy Tube –cuffless [K122531]
Intended Use		Providing tracheal access forairway management	Identical	Identical
Patient Population		Neonatal & pediatric	Identical	Identical
Environment of Use		Hospitals, long-term carefacilities, home care	Identical	Identical
Use		Single patient	Identical	Identical
Sterilization		Ethylene oxide	Identical	Identical
Shelf Life		5 years	Identical	Identical
MR Compatibility		MR Conditional (cuffed);MR Safe (cuffless)	Not specified	Not specified
DESIGN
Device Design		Per ISO 5366-1, ISO 5366-3,ISO 5356-1	Per ISO 5366-1, ISO 5366-3, ISO 5356-1	Per ISO 5366-1, ISO 5366-3, ISO 5356-1
	Neonatal	2.5 - 4.5	Identical	Identical
Size Range	Pediatric	2.5 - 6.5	Identical	Identical
		Transparent flexible materialwith integrated connector	Transparent flexiblematerial; 2-piece design	Transparent flexiblematerial; 2-piece design
Flange
Connector		Flexible, integrated withflange (1-piece design)	Rigid 15mm cap molded toflange (2-piece design)	Rigid 15mm cap moldedto flange (2-piece design)
Cannula Angle		120° (105-120°)	120°	120°
	Cuffed	Lumen present	Identical	N/A
Cannula Wall	Cuffless	No lumen	N/A	Lumen present
Radiopaque Cannula		Yes	Yes	Yes
Cuff		Taper-shaped, low-pressure	Identical	N/A
Inflation System		Inflation line, pilot balloon,inflation valve, luer guard	Identical	N/A
Obturator & Neck Strap		Identical to predicate	Identical	Identical
MATERIALS
Cannula		Non-DEHP PVC	Non-DEHP PVC	Non-DEHP PVC
Flange		Non-DEHP PVC	Non-DEHP PVC	Non-DEHP PVC
15mm Connector		Non-DEHP PVC	ABS	ABS
Cuff		Non-DEHP PVC	Non-DEHP PVC	N/A
InflationSystem	Inflationline	Non-DEHP PVC	Identical	N/A
	Pilotballoon	Non-DEHP PVC	Identical
	Inflation valve	PVC housing with metal spring and nitrile gasket	Identical
	Luer guard	Non-DEHP PVC	Identical
Obturator		Polypropylene	Identical	Identical
Neck Strap		Cotton	Identical	Identical

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Substantial Equivalence - Summary of Performance Testing

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility testing

The biocompatibility evaluation was conducted in accordance with FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The tests included are cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, subchronic toxicity, material mediated rabbit pyrogen, implantation, chemical characterization, and risk assessment.

Sterilization and Packaging Validation

Validation was conducted to ensure the subject device product sterility to the end user for ISO 11135-1 and ISO 10993-7 is acceptable. Packaging validation was in accordance with ISO 11607-1.

MRI Compatibility

MRI safety and compatibility and MR compatibility labeling for the subject devices in accordance with FDA guidance "Establishing Safety and Compatibility of Passive Implants in the MR Environment", and ASTM F2503-13.

Bench Testing

Bench testing on the subject device was conducted in accordance with ISO 5366-3, ISO 5356-1. In addition, internal bench testing to assess the cuff performance, connector mechanical performance and cannula bend were performed.

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.

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Indications for Use

510(k) Number (if known) K182861

Device Name

Shiley Neonatal/Pediatric Tracheostomy Tube

Indications for Use (Describe)

The device is intended for use in providing tracheal access for airway management.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Covidien Yaara Basevitch Regulatory Affairs Manager 6135 Gunbarrel Ave Boulder, Colorado 80301

Re: K182861

Trade/Device Name: Shiley Neonatal/Pediatric Tracheostomy Tube Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube And Tube Cuff Regulatory Class: Class II Product Code: JOH Dated: February 19, 2019 Received: February 21, 2019

Dear Yaara Basevitch:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.