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.

AI/ML Overview

This document describes the 510(k) submission for the Shiley Extended Length, Disposable Cannula, Tracheostomy Tube. The device is intended to provide an artificial airway for adults.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (CEN Standard Requirements)	Reported Device Performance (Modified Device Test Results)	Notes on Predicate Device Performance
Tie Strap Hole Strength	No requirement for this test parameter	45.8 lbs force	26.7 lbs force (SCT)
Outer cannula body to Trach Head Base Bond Strength	No requirement for this test parameter	55.0 lbs force	143.0 lbs force (SCT)
Trach Head Base-to-Head Cap Bond	No requirement for this test parameter	90.5 lbs force	N/A
Cuff Burst Strength	No requirement for this test parameter	6.6 lbs force	8.3 lbs force (SCT)
15mm Connector Disconnect Force	No requirement for this test parameter	19.4 lbs force	19.1 lbs force (SCT)
Neck Plate to Trach Tube Body Attachment Strength	minimum 11.3 lbs force	27.7 lbs force	42.1 lbs force (DCT)

Summary of Device Performance against Acceptance Criteria:

For tests with no specified CEN standard requirement, the device performance is reported without a direct "pass/fail" criterion. However, the performance is presented to demonstrate its physical integrity and generally favorable or comparable results to predicate devices.
For the "Neck Plate to Trach Tube Body Attachment Strength" test, the modified device's performance (27.7 lbs force) exceeds the specified minimum CEN standard requirement (11.3 lbs force), thus meeting this acceptance criterion.

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

Sample Size: The document does not explicitly state the sample size used for each "in-vitro performance data" test. It provides single values for "Modified Device Test Results" and "Predicate Device Test Results," implying these are representative or average values from testing, but the number of units tested is not specified.
Data Provenance: The data is generated from in-vitro performance testing, meaning it was conducted in a laboratory setting. There is no information regarding country of origin of the data provided, nor whether it's retrospective or prospective, as it's not clinical data.

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

Not Applicable: This study relies on in-vitro performance data for medical device mechanical properties, not expert-derived "ground truth" observations from cases (e.g., image interpretation). Therefore, no human experts were involved in establishing ground truth for the test set in the conventional sense of clinical or diagnostic studies.

4. Adjudication Method for the Test Set

Not Applicable: As stated above, this is an in-vitro performance study focusing on physical integrity, not a study involving human interpretation or clinical adjudication.

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

No, an MRMC comparative effectiveness study was not done. The study explicitly states: "Clinical data was not necessary, since device performance can be adequately assessed by in-vitro testing." Therefore, there is no effect size reported for human readers with or without AI assistance.

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

Not Applicable: This is a study on a physical medical device (tracheostomy tube), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply here.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on objective measurements of physical and mechanical properties of the device (e.g., force, strength) in a laboratory setting, compared against established engineering standards (CEN Standard Requirements where applicable) or direct comparison to predicate device performance. It is an objective, quantifiable measurement of the device's physical integrity and functional parameters.

8. The Sample Size for the Training Set

Not Applicable: This document describes a 510(k) submission for a physical medical device and its in-vitro performance. It does not involve machine learning or AI, and therefore there is no concept of a "training set" in this context.

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

Not Applicable: As explained above, there is no training set for this type of device submission.

Summary

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Appendix F
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510(k) Class II SUMMARY

Date Submitted:	April 2, 1997
Submitter:	Mallinckrodt Medical, Inc.Owner/Operator Number #1925021,675 McDonnell Blvd.St. Louis, MO 63134
Contact Person:	Michael Schoeck, Regulatory Affairs AssociateMallinckrodt Medical, Inc.675 McDonnell Blvd.St. Louis, MO 63134 (corporate offices)(314) 895-2318 (phone) or (314) 895-2344 (fax)
Device Name:	Shiley Extended Length, Disposable Cannula, Tracheostomy Tube
Common Name and Classification:	Tracheostomy Tube and tube cuff. 21 CFR 868.5800

Predicate Devices:

Predicate Device Names	Product Designations	510(k) Number
1.	Smiths Industries Medical Systems(SIMS), Profile TracheostomyTubes with Portex Flexible InnerCannulas.	"100/528/xxx" for 'Profile' TracheostomyTube with Flexible Inner Cannula"100/522/xxx" for Separate Flexible InnerCannulas (sold separate from Tracheostomytubes )(where "xxx" is the O/D size)	Marketed in Europesince approx. 1992 (seeproduct literature inAppendix C). No510(k) filed in USA(Mallinckrodt owns theU.S. patent).
2.	Specialized Tracheostomy Tubes	"MODIFIED xxx" (where xxx is theusual product designation of the modifiedtube)	K890194A, 7/20/89
3.	Shiley Disposable Cannula, LowPressure, Cuffed TracheostomyTube with Soft Swivel Neck Flangefeature.	DCT and DIC (standard Disposable InnerCannula included with DCT TracheostomyTube)	K962173, 10/4/96
4.	Shiley Sleep Apnea Cuffed andCuffless Tracheostomy Tubes	SLP (cuffed)SCS (cuffless)	K861463, 5/6/86K861462, 5/6/86
5.	Shiley Single CannulaTracheostomy Tube	SCT	K810106, 2/2/81

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Predicate Device Names	Product Designations	510(k) Number
6. Mallinckrodt Cuffed Tracheal Tube	Hi-Lo Tracheal Tubes	K871204, 4/21/87
7. Mallinckrodt Critical CareBroncho-Cath Right EndobronchialTube with CPAP Valve	85815, 85816, 85817, and 85818	K912230, 8/22/91

Device Description:

The intended use of the modified devices will continue to be provision of tracheal Intended Use: access for airway management in adults.

Comparison of Technological Characteristics of Subject Versus Predicate Devices:

Similarities:

. The new devices will be available in extended lengths, up to 105mm (compared to the standard Shilev DCT). These lengths are comparable to the predicate Shiley Specialized Tracheostomy Tubes.
.
. The new devices will be available in cuffed and uncuffed versions.
Like predicate Shiley tracheostomy tubes, each Extended Length tracheostomy tube will be packaged . with an obturator and neckstrap.
Soft Swivel Neck Flange: This feature was found to be substantially equivalent to the current stiff . swivel neck flange design in 510(k) #K962173 (cleared 10/4/96).
The new devices' inflation cuffs will utilize the same material used in the Mallinckrodt Broncho-Cath . Endobronchial Tube.

Differences:

. Non-arcuate tracheostomy tube shapes (compared to the arcuate standard Shiley DCT): The Extended Length Tracheostomy Tubes devices will vary in tube length along the proximal end of the tube (before the curvature of the tube) or along the distal end of the tube (after the curvature of the

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tube), in order to accommodate unique anatomical needs. Comparable non-arcuate trach tube shapes are currently available in the predicate Shiley Specialized Trach Tubes and the Shiley Sleep Apnea Trach Tubes.

Flexible extended length, disposable Inner Cannula. In order to accommodate the extended proximal . and distal section lengths of these new devices, it was necessary to develop a more flexible Disposable Inner Cannula. The new flexible Extended Length Inner Cannula ("XIC") has a "corrugated" appearance which allows the inner cannula increased lateral flexibility, while maintaining appropriate column strength. The predicate SIMS Profile device a flexible disposable Inner Cannula.
. The new XIC Disposable Inner Cannula terminates in an integral 15mm push-lock Connector (current 15mm connectors on standard Disposable Inner Cannulae (DIC) feature an integral snap-lock connector design).
. More flexible Outer Cannula body than the standard Shiley DCT (comparable to the predicate Mallinckrodt Hi-Lo Tracheal Tubes).

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)	45.8 lbs force	No requirement for thistest parameter
Outer cannula body to Trach HeadBase Bond Strength	143.0 lbs force(SCT)	55.0 lbs force	No requirement for thistest parameter
Trach Head Base-to-Head CapBond	N/A	90.5 lbs force	No requirement for thistest parameter
Cuff Burst Strength	8.3 lbs force(SCT)	6.6 lbs force	No requirement for thistest parameter
15mm Connector Disconnect Force	19.1 lbs force(SCT)	19.4 lbs force	No requirement for thistest parameter
Neck Plate to Trach Tube BodyAttachment Strength:	42.1 lbs force(DCT)	27.7 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 proposed modifications to these devices do not impact safety or effectiveness.

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Summary:

The data presented demonstrate that the proposed modifications (extended proximal and distal lengths, flexible spiral inner cannula design) 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.

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Image /page/4/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

SEP 2 5 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Michael B. Schoeck Mallinckrodt Inc. 675 McDonnell Boulevard P.O. Box 5840 St. Louis, Missouri 63134

Re: K971267 Shiley Extended Length, Disposable Cannula, Tracheostomy Tubes (Models XCS-D, XCS-P, XLT-D, and XLT-P) Regulatory Class: II (two) Product Code: 73 JOH Dated: July 25, 1997 Received: July 28, 1997

Dear Mr. Schoeck:

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 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). 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 assumptions. Failure to comply with the GMP regulation may result in regulatory 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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Paqe 2 - Mr. Michael B. Schoeck

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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Calyahan, Ph.D Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K971267 510(k) Number (if known): ______________________________________________________________________________________________________________________________________________________________________________

Device Name: Shiley Extended Length, Disposable Cannula, Tracheostomy Tubes (Models XCS-D, XCS-P, XLT-D, and XLT-P)

Indications for Use:

To provide tracheal access for airway management.

(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)
	OR
Over-The-Counter Use
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices	(Optional Format 1-2-96)
510(k) Number

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.