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

K150844 · Covidien · JOH · Jul 14, 2015 · Anesthesiology

Device Facts

• Record ID: K150844
• Device Name: Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula
• Applicant: Covidien
• Product Code: JOH · Anesthesiology
• Decision Date: Jul 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Shiley™ Adult Flexible Tracheostomy Cuff, Reusable Inner Cannula is intended to provide tracheal access for airway management. The Shiley™ Adult Flexible Tracheostomy Tube Cuffless. Reusable Intended to provide tracheal access for airway management. The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures. The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.

Device Story

Single patient-use dual cannula tracheostomy tubes; provide artificial airway for airway management. Line extension of existing Shiley flexible tubes; introduces reusable inner cannula option. Device consists of outer cannula, reusable inner cannula, flange, 15mm connector, and optional TaperGuard cuff. Used in hospitals, long-term care facilities, and home care settings. Operated by clinicians for airway maintenance. Provides tracheal access; cuffless or taper-shaped cuff options available. Reusable inner cannula allows for cleaning and reuse within a single patient. Benefits include established airway access and flexibility for patient-specific management.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including insertion/removal force, lock/pinch force, cleaning validation per AAMI TIR 30, EtO residual testing per ISO 10993-7, and biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, systemic toxicity, genotoxicity, subchronic toxicity, chemical characterization).

Technological Characteristics

Dual cannula tracheostomy tube. Materials: Medical grade PVC (outer cannula, flange, cuff, inflation system), high-density polyethylene (inner cannula), polymethylpentene (15mm connector), polypropylene (obturator), cotton (tie strap). Sterilization: Ethylene Oxide. Shelf life: 2 years. Standards: ISO 5366-1:2009, ISO 5361:2012, ISO 10993-7:2008, ISO 10993-1:2009, AAMI TIR 30.

Indications for Use

Indicated for adult patients requiring tracheal access for airway management, including use during 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™ Adult Flexible Tracheostomy Tube, Disposable Inner Cannula (K142296)
• Shiley™ Tracheostomy Tubes (K962173)

Submission Summary (Full Text)

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

July 14, 2015

Covidien Danielle Mueller Regulatory Affairs Manager 6135 Gunbarrel Ave Boulder, CO 80301

Re: K150844

Trade/Device Name: Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: Class II Product Code: JOH Dated: June 10, 2015 Received: June 11, 2015

Dear Ms. Mueller:

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,

Tejashri 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

510(k) Number (if known)

K150844

#### Device Name

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

#### Indications for Use (Describe)

The Shiley™ Adult Flexible Tracheostomy Cuff, Reusable Inner Cannula is intended to provide tracheal access for airway management.

The Shiley™ Adult Flexible Tracheostomy Tube Cuffless. Reusable Intended to provide tracheal access for airway management.

The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.

The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------|--------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## 510(k) SUMMARY

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 use of the Shiley™ Adult Flexible Tracheostomy Tube, Reusable Inner Cannula.

| Submitted By: | Covidien<br>6135 Gunbarrel Avenue<br>Boulder, CO 80301 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | July 10, 2015 |
| Contact Person: | Danielle Mueller<br>Regulatory Affairs Manager<br>[phone] |
| Proprietary Name: | Shiley™ Adult Flexible Tracheostomy Tube with<br>TaperGuard™ Cuff, Reusable Inner Cannula<br>Shiley™ Adult Flexible Tracheostomy Tube Cuffless,<br>Reusable Inner Cannula |
| Common Name: | Tracheostomy Tube & Tube Cuff |
| Device Classification Regulation: | 21 CFR 868.5800 – Class II |
| Device Product Code & Panel: | JOH |
| Predicate Devices: | Shiley™ Adult Flexible Tracheostomy Tube, Disposable<br>Inner Cannula (K142296)<br>Shiley™ Tracheostomy Tubes (K962173) |

### Device Description

The subject devices are single patient-use dual cannula tracheostomy tubes that are intended to provide an artificial airway for airway management. The subject device represents a line extension introducing the option of a reusable inner cannula.

### Indications for Use/Intended Use

The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is intended to provide tracheal access for airway management.

The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is intended to provide tracheal access for airway management.

The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is also intended for use with percutaneous Dilatational Tracheotomy (PDT) procedures.

The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is also intended for use with percutaneous Dilatational Tracheotomy (PDT) procedures.

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# Technological Characteristics Comparison

The subject device is identical to the predicate Shiley™ Adult Flexible Tracheostomy Tube, Disposable Inner Cannula (K142296) with the exception of the inner cannula material and reuse status.

| | SUBJECT | PREDICATE | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| | Shiley™ Adult Flexible Tube,<br>Reusable Inner Cannula | Shiley™ Adult Flexible Tube,<br>Disposable Inner Cannula<br>[K142296] | Shiley™ Tracheostomy Tubes<br>[K962173] |
| Intended Use | Intended for use in providing<br>tracheal access for airway<br>management. Also intended for<br>use with Percutaneous<br>Dilatational Tracheotomy (PDT)<br>procedures. | Identical | Intended for use in providing<br>tracheal access for airway<br>management in adults. |
| Patient<br>Population | Adults | Identical | Identical |
| Environment of<br>Use | Hospitals, long-term care<br>facilities, home care | Identical | Identical |
| Use | Single patient | Identical | Identical |
| Inner Cannula<br>Use | Reusable within single patient | Disposable | Reusable & disposable options<br>available |
| Cuff | Cuffless or taper-shaped cuff | Identical | Cuffless or barrel-shaped cuff |
| Size Range | ID: 6.5mm-10.0mm<br>OD: 9.4mm-13.8mm<br>Length: 62mm-79mm | Identical | ID: 5.0 - 8.9mm<br>OD: 9.4 - 13.8mm<br>Length: 65 - 81mm |
| Sterilization | Ethylene Oxide | Identical | Identical |
| Shelf Life | 2 years | Identical | 5 years |
| MATERIALS | | | |
| Outer cannula | Medical grade PVC with citrate-<br>based plasticizer | Identical | Medical grade PVC |
| Inner cannula | High density polyethylene | Low density polyethylene | Reusable: polycarbonate &<br>polypropylene<br>Disposable: polypropylene & PVC |
| Flange | Medical grade PVC with citrate-<br>based plasticizer | Identical | Medical grade PVC |
| 15mm<br>Connector | Polymethylpentene | Identical | Medical grade PVC |
| Cuff | Medical grade PVC with DEHT-<br>based plasticizer | Identical | Medical grade PVC |
| Inflation System | Medical grade PVC with citrate-<br>based plasticizer | Identical | Medical grade PVC |
| Obturator | Medical grade polypropylene | Identical | Identical |
| Tie Strap | Cotton | Identical | Identical |

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### Substantial Equivalence - Non-Clinical Evidence

Product performance testing, including insertion/removal force, lock & pinch force, and tests per ISO 5366-1:2009 and ISO 5361:2012 were performed with the conclusion that the subject devices can be expected to perform as well as the predicate and can be considered substantially equivalent. The cleaning methods for the reusable inner cannula were validated in accordance with AAMI TIR 30. The results from ethylene oxide residual tests on the EtO-sterilized device demonstrated compliance to ISO 10993-7:2008 for the device's intended use. Additionally, biocompatibility testing was performed per ISO 10993-1:2009 including the following: cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, subchronic toxicity implantation, chemical characterization, and risk assessment. The device met all biocompatibility requirements for its intended use.

### 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.