These devices are used to provide an artificial airway, in order to assist in the treatment of a variety of respiratory diseases and airway management in adults. After insertion in place through a tracheotomy incision in the patient's neck and trachea, the devices are then secured in place with a tiestrap around the patient's neck. which is attached to the tracheostomy tube's swivel neck plate/flange. Once in place, these devices provide a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.

Each device described in this present notification will be essentially identical to an existing Shiley Tracheostomy Tube. The only modification to each of these nine marketed devices will be replacement of the current stiff swivel neck plate/flange with a soft, contoured swivel neck plate/flange to facilitate conformity to individual neck anatomies and, thus. improve patient comfort.

AI/ML Overview

This report describes the acceptance criteria and the study that proves the enhanced Shiley Tracheostomy Tubes meet the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (CEN Standard Requirements)	Reported Device Performance (Modified Device Test Results)
Tie Strap Hole Strength	No specific requirement	32.1 lbs force
Neck Plate to Trach Tube Body Attachment Strength	Minimum 11.3 lbs force	22.7 lbs force

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

The document does not explicitly state the sample sizes used for the in-vitro performance tests. The data provenance is also not specified, though it can be inferred that the testing was conducted internally by the manufacturer, Mallinckrodt Medical, Inc., as part of their 510(k) submission. These tests are in-vitro performance data (bench testing), not clinical data from patients.

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

This section is not applicable. The "ground truth" for this device modification is based on engineering performance standards (CEN Standard Requirements) and internal testing results, not on expert consensus from clinical cases.

4. Adjudication Method for the Test Set

This section is not applicable. The "adjudication" is based on direct comparison of the modified device's performance against established engineering standards and a predicate device, not on expert review of clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not an AI-based device, nor is it a diagnostic device that would involve human readers interpreting results. Therefore, an MRMC comparative effectiveness study was not performed and is not relevant to this submission.

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

This is not an algorithm or AI-based device. Therefore, a standalone algorithm performance study was not done and is not relevant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the in-vitro performance tests is based on engineering performance standards and comparison to predicate device performance. Specifically, for the "Neck Plate to Trach Tube Body Attachment Strength," the ground truth is a "minimum 11.3 lbs force" derived from CEN Standard Requirements. For "Tie Strap Hole Strength," there was no specific ground truth requirement, but the modified device's performance was reported alongside the predicate device's performance.

8. The Sample Size for the Training Set

This section is not applicable. This is not an AI/ML device that requires a training set.

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

This section is not applicable, as there is no training set for this device.

Summary

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K962123

OCT 4 1996

Appendix E Page 1 of 3

510(k) Class II SUMMARY

Date Submitted: May 31, 1996

Submitter: Mallinckrodt Medical, Inc. Establishment Registration Number 2029387, 18691 Jamboree Road Irvine, CA 92715
Contact Person: Michael Schoeck, Regulatory Affairs Associate Mallinckrodt Medical, Inc. 675 McDonnell Blvd. Hazelwood, MO 63134 (corporate offices) (314) 895-2318 (phone) or (314) 895-2355 (fax)
Device Name: Shiley Tracheostomy Tubes

Common Name and Classification: Tracheostomy Tube and tube cuff, 21 CFR 868.5800

Predicate Devices:

	Predicate Device Name	Product Designation	510(k) Number
1.	Shiley Low Pressure, Cuffed Tracheostomy Tube	LPC	K792222, 12/18/79K811033, 5/13/81
2.	Shiley Fenestrated, Low Pressure, Cuffed TracheostomyTube	FEN	K812302, 9/8/81
3.	Shiley Cuffless Tracheostomy Tubes	CFS (non-fenestrated)CFN (fenestrated)	pre-amendment
5.	Shiley Disposable Cannula, Low Pressure, CuffedTracheostomy Tube	DCT	K811447, 6/26/81
6.	Shiley Disposable Cannula, Fenestrated, Low Pressure,Cuffed Tracheostomy Tube	DFEN	K843729, 10/19/84K865061, 1/15/87
7.	Shiley Disposable Cannula, Cuffless TracheostomyTubes	DCFS (non-fenestrated)DCFN (fenestrated)	K880614, 3/9/88
8.	Shiley Pediatric/Neonatal Tracheal Tubes	PEDNEO	K945513, 1/13/95
9.	Shiley Single Cannula Tracheostomy Tube	SCT	K810106, 2/2/81

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Device Description:

	Products Which will Incorporate the new Soft Swivel Neck Plate/flange	Product Designation)
1.	Shiley Low Pressure, Cuffed Tracheostomy Tube	LPC
2.	Shiley Fenestrated, Low Pressure, Cuffed Tracheostomy Tube	FEN
3.	Shiley Cuffless Tracheostomy Tube (non-fenestrated)	CFS
4.	Shiley Cuffless Tracheostomy Tube (fenestrated)	CFN
5.	Shiley Laryngectomy Tube	LGT
6.	Shiley Disposable Cannula, Low Pressure, Cuffed Tracheostomy Tube	DCT
7.	Shiley Disposable Cannula, Fenestrated, Low Pressure, CuffedTracheostomy Tube	DFEN
8.	Shiley Disposable Cannula, Cuffless Tracheostomy Tube (non-fenestrated)	DCFS
9.	Shiley Disposable Cannula, Cuffless Tracheostomy Tube (fenestrated)	DCFN

Intended Use:

The intended use of the modified devices with continue to be provision of tracheal access for airway management in adults.

Comparison of Technological Characteristics of Subject Versus Predicate Devices:

Similarities:

The modified tracheostomy tubes will be identical to their respective predicate devices in intended use, . indications for use, ID, OD, length, # of fenestrations, location and size of fenestrations, cannula bend, and in their packaged accessories.
. The modified trach tubes will feature a soft (not rigid) neck plate design like the predicate PED/NEO and SCT devices.
All materials used in the modified tracheostomy tubes and their packaged accessories will remain the ● same as the predicate devices. Only the configuration and materials of the swivel neck plate/flange on each device will change.
The product designations (i.e., model #'s) for each of the modified Trach Tubes will remain the same. .

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Since the soft swivel neck plate/flange is used clinically in the same way as the previous rigid swivel . neck plate/flange, it will be unnecessary to modify the Instructions for Use.

Differences:

The swivel neck plate/flanges have changed from a uniformly rigid polycarbonate design to a . configuration which combines both rigid and soft biocompatible plastic materials.
The new neck plate/flange will feature a rigid copolyester core for strength. The pins upon which the neck plate/flange swivels (after connection to the main body of the Trach tube) are part of this rigid inner core.

Soft PVC will then be overmolded around the rigid core to form the outer surface of the swivel neck plate/flange. Thus, the outer surface of the neck plate will be soft and flexible along the edges.

. The soft swivel neck plate/flange will also be slightly larger and more contoured than the current design to facilitate patient comfort.

Performance/Clinical Data:

A. In-vitro performance data:

Test	Predicate DeviceTest Results	Modified Device TestResults	CEN StandardRequirements
Tie Strap Hole Strength:	26.7 lbs force(SCT)	32.1 lbs force	No requirement for thistest parameter
Neck Plate to Trach Tube BodyAttachment Strength:	42.1 lbs force(DCT)	22.7 lbs force	minimum 11.3 lbs force

B. Clinical Data: Clinical data was not necessary, since device performance can be adequately assessed by in-vitro testing.
In conclusion, the similarities to the predicate devices, in conjunction with the physical integrity test results, demonstrate that the soft swivel neck plate/flange modification to these devices does not impact safety or effectiveness.

Summary:

The data presented demonstrate that the proposed modification (soft swivel neck plate/flange) to Shiley Tracheostomy Tubes does not impact device performance characteristics and, thus, does not raise new safety and efficacy questions. This information supports the conclusion that the modified Shiley Tracheostomy Tubes and accessories are substantially equivalent in intended use, operation, and characteristics, as compared to existing legally marketed devices.

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.