SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES

K962173 · Mallinckrodt Medical · JOH · Oct 4, 1996 · Anesthesiology

Device Facts

• Record ID: K962173
• Device Name: SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
• Applicant: Mallinckrodt Medical
• Product Code: JOH · Anesthesiology
• Decision Date: Oct 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Tracheostomy tubes provide artificial airway for spontaneous breathing or mechanical ventilation/anesthesia. Inserted via tracheotomy incision; secured via tiestrap attached to swivel neck plate/flange. Subject devices modify existing Shiley tracheostomy tubes by replacing rigid polycarbonate swivel neck plate/flange with soft, contoured version. New design utilizes rigid copolyester core for structural strength, overmolded with soft PVC for patient comfort and neck anatomy conformity. Used in clinical settings by healthcare providers. Modification improves patient comfort without altering primary function or clinical application.

Clinical Evidence

No clinical data. Bench testing only. In-vitro performance testing compared tie strap hole strength and neck plate-to-tube attachment strength against predicate devices and CEN standard requirements. Results demonstrated sufficient mechanical strength for the modified design.

Technological Characteristics

Tracheostomy tube with swivel neck plate/flange. Neck plate construction: rigid copolyester core overmolded with soft PVC. Predicate devices used rigid polycarbonate. Dimensions, cannula bend, and fenestration specifications remain identical to predicates. Non-electronic, mechanical device.

Indications for Use

Indicated for adults requiring artificial airway access for respiratory disease treatment or airway management.

Regulatory Classification

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.

Predicate Devices

• Shiley Low Pressure, Cuffed Tracheostomy Tube (K792222, K811033)
• Shiley Fenestrated, Low Pressure, Cuffed Tracheostomy Tube (K812302)
• Shiley Cuffless Tracheostomy Tubes (pre-amendment)
• Shiley Laryngectomy Tube (K821993)
• Shiley Disposable Cannula, Low Pressure, Cuffed Tracheostomy Tube (K811447)
• Shiley Disposable Cannula, Fenestrated, Low Pressure, Cuffed Tracheostomy Tube (K843729, K865061)
• Shiley Disposable Cannula, Cuffless Tracheostomy Tubes (K880614)
• Shiley Pediatric/Neonatal Tracheal Tubes (K945513)
• Shiley Single Cannula Tracheostomy Tube (K810106)

Submission Summary (Full Text)

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K962173

Appendix E

Page 1 of 3

OCT 4 1996

# 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)
[phone] (phone) or [phone] (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, 12/18/79
K811033, 5/13/81 |
| 2. Shiley Fenestrated, Low Pressure, Cuffed Tracheostomy Tube | FEN | K812302, 9/8/81 |
| 3. Shiley Cuffless Tracheostomy Tubes | CFS (non-fenestrated)
CFN (fenestrated) | pre-amendment |
| 4. Shiley Laryngectomy Tube | LGT | K821993, 8/12/82 |
| 5. Shiley Disposable Cannula, Low Pressure, Cuffed Tracheostomy Tube | DCT | K811447, 6/26/81 |
| 6. Shiley Disposable Cannula, Fenestrated, Low Pressure, Cuffed Tracheostomy Tube | DFEN | K843729, 10/19/84
K865061, 1/15/87 |
| 7. Shiley Disposable Cannula, Cuffless Tracheostomy Tubes | DCFS (non-fenestrated)
DCFN (fenestrated) | K880614, 3/9/88 |
| 8. Shiley Pediatric/Neonatal Tracheal Tubes | PED
NEO | K945513, 1/13/95 |
| 9. Shiley Single Cannula Tracheostomy Tube | SCT | K810106, 2/2/81 |

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Appendix E
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## Device Description:

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.

| 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, Cuffed Tracheostomy 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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Appendix E
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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 Device Test Results | Modified Device Test Results | CEN Standard Requirements |
| --- | --- | --- | --- |
| Tie Strap Hole Strength: | 26.7 lbs force (SCT) | 32.1 lbs force | No requirement for this test parameter |
| Neck Plate to Trach Tube Body Attachment 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.

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