Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula

K142296 · Covidien · JOH · Feb 24, 2015 · Anesthesiology

Device Facts

• Record ID: K142296
• Device Name: Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula
• Applicant: Covidien
• Product Code: JOH · Anesthesiology
• Decision Date: Feb 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The device is intended to be used to provide an artificial airway in order to provide access to the patient's airway for airway management. When inserted in a tracheotomy stoma, the device is secured in place with a neck strap around the patient's neck which is attached to an integral neck plate, thereby providing for a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.

Device Story

Dual cannula tracheostomy tube; disposable inner cannula; provides artificial airway for spontaneous breathing or mechanical ventilation/anesthesia. Used in clinical environments (critical/non-critical care, long-term care, home). Inserted into tracheotomy stoma; secured via neck strap or suture holes in flange. Features: radiopaque PVC outer cannula; pliable neck plate; tapered tip for percutaneous insertion; integrated 15mm connector. TaperGuard cuff version includes low-pressure cuff with inflation line/luer valve/pilot balloon to seal airway and minimize tracheal damage. Translucent inner cannula allows inspection/maintenance. Physician/clinician-operated; facilitates airway access; benefits patient by maintaining secure airway.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including ISO 5356-1:2004, ISO 5366-1:2009, ISO 5361:2012, biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, subchronic toxicity), and performance testing (cuff pressure mapping, flange tie, air leak, inflation line pull, cuff puncture, insertion/removal, percutaneous compatibility).

Technological Characteristics

Materials: Medical grade PVC with citrate/DEHT plasticizers; Polymethylpentene (TPX) 15mm connector; Polypropylene obturator; Cotton tie strap. Design: Dual cannula, flexible molded flange, tapered tip. Energy: None (passive). Connectivity: None. Sterilization: Validated cycle (SAL 10E-6). Standards: ISO 5366-1:2009, ISO 5356-1:2004, ISO 5361:2012.

Indications for Use

Indicated for adult patients requiring an artificial airway for tracheal access and airway management. The TaperGuard cuff version is also indicated for use with Cook Percutaneous Dilatational Tracheotomy (PDT) procedures.

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™ Tracheostomy Tubes (K962173)
• Shiley™ DCT Adult Cuffed Percutaneous Tracheostomy Tubes (K963732)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes coiled around it, and a stylized human figure.

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

February 24, 2015

Covidien Brianna Reynolds Regulatory Affairs Specialist 6135 Gunbarrel Avenue Boulder, CO 80301

Re: K142296

> Trade/Device Name: Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube with TaperGuardTM Cuff, Disposable Inner Cannula Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: January 22, 2015 Received: January 23, 2015

Dear Ms. Reynolds,

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.

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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 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Teiashri 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 Statement

K142296 510(k) Number (if known):

Device Name:

Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula

Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner Cannula

## Indications for Use:

- Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula is ● intended for use in providing tracheal access for airway management.
- . Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner Cannula is intended for use in providing tracheal access for airway management.
- Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner . Cannula is also intended for use with Cook® Percutaneous Dilatational Tracheotomy (PDT) procedures.
- o The Shiley™ Disposable Inner Cannula is intended to be used with the appropriate Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff or Cuffless to provide tracheal access for airway management.

Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

> (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

# CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

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Image /page/3/Picture/0 description: The image contains the word "COVIDIEN" in a sans-serif font. The word is in blue and is positioned to the right of a blue and white square logo. The logo consists of a dark blue square with a light blue vertical line and a white rectangle in the center.

## 510(k) Summary

Date summary prepared 23 February 2015

## 510(k) Submitter/Holder

Covidien IIc 6135 Gunbarrel Avenue Boulder, CO 80301

### Contact

Danielle Mueller Regulatory Affairs Manager Phone: [phone] Fax: [phone]

### Name of Device

| Trade Name: | Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula<br>Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable<br>Inner Cannula |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog Numbers: | xUNxx and xCNxx |
| Common Name: | Tube Tracheostomy and Tube Cuff |
| Classification Name: | JOH, Tube Tracheostomy and Tube Cuff (21 CFR 868.5800) Class II, 73-<br>Anesthesiology |

## Purpose of Submission

The purpose of this submission is to introduce the Covidien Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula and Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula. The subject and predicate device have the submission is to notify the FDA of the following changes:

- Updated the materials used in the Tracheostomy tubes to a Medical Grade PVC ● with a citrate and DEHT based plasticizer
- . Addition of the Covidien taper-shaped cuff referred to as TaperGuard
- Tapered tracheostomy tube tip compatible with percutaneous insertion ●
- Line extension to include 3 intermediate sizes for cuffed and cuffless .
- Integrated ISO compliant 15 mm connector
- Flexible molded flange ●

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## Predicate Device

The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula and the Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula were compared and found to be substantially equivalent to the following products of comparable type in commercial distribution:

| Trade Name: | Shiley ™ Tracheostomy Tubes |
|---------------------|----------------------------------------------------------|
| Device Common Name: | Tube Tracheostomy and Tube Cuff |
| 510(k) Number: | K962173 |
| Manufacturer: | Covidien, formerly Tyco Healthcare |
| Trade Name: | Shiley™ DCT Adult Cuffed Percutaneous Tracheostomy Tubes |
| Device Common Name: | Tube Tracheostomy and Tube Cuff |
| 510(k) Number: | K963732 |
| Manufacturer: | Covidien, formerly Tyco Healthcare |

## Intended Use

The device is intended to be used to provide an artificial airway in order to provide access to the patient's airway for airway management. When inserted in a tracheotomy stoma, the device is secured in place with a neck strap around the patient's neck which is attached to an integral neck plate, thereby providing for a secure artificial ainway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.

## Indications for Use

- . Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula is intended for use in providing tracheal access for airway management.
- Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner . Cannula is intended for use in providing tracheal access for airway management.
- . Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff. Disposable Inner Cannula is also intended for use with Cook® Percutaneous Dilatational Tracheotomy (PDT) procedures.
- The Shiley™ Disposable Inner Cannula is intended to be used with the appropriate Shiley™ . Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff or Cuffless to provide tracheal access for airway management.

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### De vice De scription

The Shiley ™ Adult Flexible Tracheostomy Tube Cuffless is a dual cannula tracheostomy tube with a disposable inner cannula. The device is used to provide an artificial ainway in order to provide access to the patient's airway for airway management. It contains an integrated 15 mm connector for use with standard ventilation and anesthesia equipment. The tracheostomy tube has a radiopaque outer cannula constructed of polyvinyl chloride. A pliable neck plate allows conformity to individual neck anatomies and contains two suture holes. The tapered tracheostomy tube tip is compatible with percutaneous insertion. The smooth, rounded tip obturator facilitates insertion. The disposable inner cannula is translucent for easy inspection and allows for airway maintenance. This tracheostomy tube can be used with or without the disposable inner cannula included in the package however, use of the inner cannula is recommended.

The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff is a dual cannula tracheostomy tube with a disposable inner cannula. The device is used to provide an artificial airway in order to provide access to the patient's airway management. It contains an intecrated 15 mm connector for use with standard ventilation and anesthesia equipment. The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff has a radiopaque outer cannula constructed of polyvinyl chloride. A pliable neck plate allows conformity to individual neck anatomies and contains two suture holes. The tapered tracheostomy tube tip is compatible with percutaneous insertion. The smooth, rounded tip obturator facilitates insertion. The disposable inner cannula is translucent for easy inspection and allows for airway maintenance. The tracheostomy tube has a taper-shaped, low-pressure cuff to provide an effective air and fluid seal and minimize tracheal wall damage. The cuff inflation line has a luer valve with an integral pilot balloon. The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff can be used with or without the disposable inner cannula included in the package however, use of the inner cannula is recommended.

When inserted in a tracheotomy stoma, the device may be secured in place with a neck strap around the patient's neck which is attached to an integral neck plate. It also may be secured in place by using the suture holes in the flange of the tracheostomy tube, thereby providing for a secure artificial ainway for spontaneous breathing or direct connection to ventilation or anesthesia equipment.

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| | Subject Device: | Predicate Device | Predicate Device |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Shiley ™ Adult Flexible Tracheostomy Tube<br>Cuffless, Disposable Inner Cannula and Shiley ™<br>Adult Flexible Tracheostomy Tube with<br>TaperGuard™ Cuff, Disposable Inner Cannula | Shiley ™ Tracheostomy Tubes<br>(K962173)<br>(Cuffless and Cuffed) | Shiley ™ DCT Adult Cuffed Percutaneous<br>Tracheostomy Tubes (K963732) |
| | | | |
| Indications for<br>Use | Shiley ™ Adult Flexible Tracheostomy Tube<br>Cuffless, Disposable Inner Cannula is intended for<br>use in providing tracheal access for airway<br>management. | This device is intended for use in providing<br>tracheal access for airway management. | This device is intended for use in providing<br>tracheal access for airway management.<br>The device is primarily intended for use in |
| | Shiley ™ Adult Flexible Tracheostomy Tube with<br>TaperGuard™ Cuff, Disposable Inner Cannula is<br>intended for use in providing tracheal access for<br>airway management. | | conjunction with Percutaneous Dilatational<br>Tracheostomy and is inserted into the patient<br>using the introducer provided with the<br>Percutaneous kit. |
| | The Shiley ™ Disposable Inner Cannula is<br>intended to be used with the appropriate Shiley ™<br>Adult Flexible Tracheostomy Tube with<br>TaperGuard™ Cuff or Cuffless to provide<br>tracheal access for airway management. | | |
| | Shiley ™ Adult Flexible Tracheostomy Tube with<br>TaperGuard™ Cuff, Disposable Inner Cannula is<br>also intended for use with Cook® Percutaneous<br>Dilatational Tracheotomy (PDT) procedures. | | |
| Intended Use | The device is intended to be used to provide and<br>artificial airway in order to provide access to the<br>patient's airway for airway management. When<br>inserted in a tracheotomy stoma, the device is<br>secured in place with a neck strap around the<br>patient's neck which is attached to an integral neck<br>plate, thereby providing for a secure artificial<br>airway for spontaneous breathing or direct hook-<br>up to ventilation or anesthesia equipment. | The device is intended to be used to provide and<br>artificial airway in order to provide access to the<br>patient's airway for airway management. When<br>inserted in a tracheotomy stoma, the device is<br>secured in place with a neck strap around the<br>patient's neck which is attached to an integral<br>neck plate, thereby providing for a secure artificial<br>airway for spontaneous breathing or direct hook-<br>up to ventilation or anesthesia equipment | The device is intended to be used to provide<br>and artificial airway in order to provide access to<br>the patient's airway for airway management.<br>When inserted in a tracheotomy stoma, the<br>device is secured in place with a neck strap<br>around the patient's neck which is attached to<br>an integral neck plate, thereby providing for a<br>secure artificial airway for spontaneous<br>breathing or direct hook-up to ventilation or<br>anesthesia equipment |
| Device class | Class 2 | Class 2 | Class 2 |
| Product code | JOH | JOH | JOH |
| Patient<br>Population | Adult patients requiring an artificial airway | Adult patients requiring an artificial airway | Adult patients requiring an artificial airway |
| Environment of<br>Use | The product shall be used in a clinical environment<br>such as critical care units of a hospital, non-critical<br>care units of a hospital, long term care facilities<br>and home care. | The product shall be used in a clinical<br>environment such as critical care units of a<br>hospital, non-critical care units of a hospital, long<br>term care facilities and home care. | The product shall be used in a clinical<br>environment such as critical care units of a<br>hospital, non-critical care units of a hospital,<br>long term care facilities and home care. |
| Invasive / Non-<br>Invasive | Invasive | Invasive | Invasive |
| Sterilization | Sterile: The SAL is 10E-6 utilizing the existing<br>equivalent validated cycle 2. | Sterile: The SAL is 10E-6 utilizing the existing<br>validated cycle 66. | Sterile: The SAL is 10E-6 utilizing the existing<br>validated cycle 66. |
| Shelf Life | 2-year shelf life | 5-year shelf life | 5-year shelf life |
| Materials | | | |
| Cannula | Medical Grade PVC with a citrate Based plasticizer | Medical Grade PVC | Medical Grade PVC |
| Neck Plate | Medical Grade PVC with a citrate based plasticizer | Medical Grade PVC | Medical Grade PVC |
| 15 MM connector | Polymethylpentene - TPX | Medical Grade PVC | Medical Grade PVC |
| Cuff if applicable<br>by product type | Medical Grade PVC with a DEHT based plasticizer | Medical Grade PVC | Medical Grade PVC |
| Inflation System | Medical Grade PVC with a citrate based plasticizer | Medical Grade PVC and<br>Acrylonitrile butadiene styrene (ABS) | Medical Grade PVC and<br>Acrylonitrile butadiene styrene (ABS) |
| Obturator | Medical Grade Polypropylene | Medical Grade Polypropylene | Medical Grade Polypropylene |
| Tie Strap | Cotton | Cotton | Cotton |

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| Subject Device | | | | Predicate Device | | | | Predicate Device | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------|---------|-------------------------------------------------------------------|---------|---------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------|-------------|---------|---------|------------------|-------------|--|
| Shiley ™ Adult Flexible Tracheostomy Tube<br>Cuffless, Disposable Inner Cannula and Shiley ™<br>Adult Flexible Tracheostomy Tube with<br>TaperGuard ™ Cuff, Disposable Inner Cannula | | | | Shiley ™ Tracheostomy Tubes<br>(K962173)<br>(Cuffless and Cuffed) | | | | Shiley ™ DCT Adult Cuffed Percutaneous<br>Tracheostomy Tubes (K963732) | | | | | | |
| Sizes | | | | Cuffless: | | | | | | | | | | |
| | REF | ID (mm) | OD (mm) | Length (mm) | REF | ID (mm) | OD (mm) | Length (mm) | REF | ID (mm) | OD (mm) | Length (mm) | Flange (mm) | |
| | 4UN65A | 6.5 | 9.4 | 62 | 4DCT | 5.0 | 9.4 | 62 | 6PERC | 6.4 | 10.8 | 74 | 24.1 | |
| | 5UN70A | 7.0 | 10.1 | 68 | 6DCT | 6.4 | 10.38 | 74 | 8PERC | 7.6 | 12.2 | 79 | 27.2 | |
| | 6UN75A | 7.5 | 10.8 | 74 | 8DCT | 7.6 | 12.2 | 79 | | | | | | |
| | 7UN80A | 8.0 | 11.4 | 77 | 10DCT | 8.9 | 13.8 | 79 | | | | | | |
| | 8UN85A | 8.5 | 12.2 | 79 | | | | | | | | | | |
| | 9UN90A | 9.0 | 12.7 | 79 | Cuffed: | REF | ID (mm) | OD (mm) | Length (mm) | Flange | | | | |
| | 10UN10A | 10.0 | 13.8 | 79 | | | | | | | | | | |
| | Cuffed: | | | | | | | | | | | | | |
| | REF | ID (mm) | OD (mm) | Length (mm) | | | | | | | Flange | | | |
| | 4CN65A | 6.5 | 9.4 | 62 | | | | | | | 20.6 | | | |
| | 5CN70A | 7.0 | 10.1 | 68 | | | | | | | 25.4 | | | |
| | 6CN75A | 7.5 | 10.8 | 74 | 25.4 | 4DCFS | 5.0 | 9.4 | 62 | 20 | | | | |
| | 7CN80A | 8.0 | 11.4 | 77 | 25.4 | 6DCFS | 6.4 | 10.38 | 74 | 24 | | | | |
| | 8CN85A | 8.5 | 12.2 | 79 | 28.6 | 8DCFS | 7.6 | 12.2 | 79 | 27 | | | | |
| | 9CN90A | 9.0 | 12.7 | 79 | 28.6 | 10DCFS | 8.9 | 13.8 | 79 | 29 | | | | |
| | 10CN10A | 10.0 | 13.8 | 79 | 28.6 | Percutaneous<br>Compatible Size | Cuffed:<br>-4CN65<br>-5CN70<br>-6CN75<br>-7CN80<br>-8CN85 | | | | NA | 6 PERC<br>8 PERC | | |
| Percutaneous<br>Compatible Size | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | Cuffless:<br>-4UN65<br>-5UN70<br>-6UN75<br>-7UN80<br>-8UN85 | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| Use | Single Patient Use | | | Single Patient Use | | | | Single Patient Use | | | | | | |
| Design | Tracheostomy Tube Design | | | Tracheostomy Tube Design | | | | Tracheostomy Tube Design | | | | | | |
| Standards met | ISO 5366-1:2009 Anesthetic and Respiratory<br>Equipment -- Tracheostomy Tubes -- Part 1: Adult<br>Tracheostomy Tubes | | | 5356 (1987)<br>5366 (1985) | | | | 5356 (1987)<br>5366 (1985) | | | | | | |
| | ISO 5356-1:2004 Anesthetic and respiratory<br>equipment - Conical connectors: Part 1: Cones<br>and sockets | | | | | | | | | | | | | |
| | ISO 5361: 2012<br>Anesthetic and respiratory equipment-Tracheal<br>tubes and connectors | | | | | | | | | | | | | |

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## Technological Characteristics

The Covidien Shiley™ Adult Flexible Tracheostomy Tube Cuffless. Disposable Inner Cannula and the Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula have technological characteristics that differ from its predicates.

The materials used in the Covidien Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula and the Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula have been updated to a Medical Grade PVC with a Citrate and DEHT plasticizer. The subject device includes the addition of the Covidien taper-shaped cuff referred to as TaperGuard. A flexible molded flange with an integrated 15mm connector was designed into the tracheostomy tube. A one piece disposable inner cannula was designed to facilitate use of the tracheostomy tube both with and without the inner cannula in place. Finally, a product line extension has been added to include 3 intermediate sizes of cuffed and cuffless product. All other fundamental technological characteristics are identical to the predicate devices.

## Non-Clinical Data

The following types of non-clinical testing were performed to establish substantial equivalence to the predicates:

- -ISO 5356-1:2004
- ISO 5366-1:2009 -
- -ISO 5361:2012
- Biocompatibility: -
- Cytotoxicity o
- Sensitization O
- Irritation o
- Acute systemic toxicity O
- Genotoxicity O
- Subchronic toxicity implantation O
- Chemical characterization O
- Risk assessment O
- Performance testing:
- O Cuff pressure mapping
- Flange tape tie O
- Air leak O
- Inflation line pull tests O
- Cuff puncture & air seal tests O
- Insertion/removal tests O
- Percutaneous compatibility O

The results of these non-clinical tests show that the subject device can be considered substantially equivalent to the legally marketed predicate and no new questions of safety and efficacy have been raised.

# Clinical Data

-

Not required to show substantial equivalence.

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### Substantial Equivalence

The Covidien Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula and the Shiley ™ Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula have the same fundamental technology and design of the predicate Shiley ™ Tracheostomy Tubes (K962173) and the Shiley™ DCT Adult Cuffed Percutaneous Tracheostomy Tubes (K963732). The materials on the tracheostomy tube have been updated to include a medical grade PVC with citrate and DEHT based plasticizer. A tapered tracheostomy tube tip is compatible with percutaneous insertion has been included. The subject device also includes the addition of the Covidien taper-shaped cuff referred to as TaperGuard.

The changes in the Covidien Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula and the Shiley™ Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula do not impact the safety or effectiveness of the finished device.

## Conclusion

Substantial equivalence of the subject device is shown through performance testing, as stated above. The subject and predicate devices have similar indications, size range, intended use, environment of use, and patient population. The subject and predicate devices differ in number of sizes available, taper shape, materials and enhanced basic design. No new questions of safety and effectiveness have been raised. From the evidence presented in the Premarket Notification, the subject device can be considered substantially equivalent.