SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T

K122531 · Covidien · JOH · Oct 9, 2012 · Anesthesiology

Device Facts

• Record ID: K122531
• Device Name: SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T
• Applicant: Covidien
• Product Code: JOH · Anesthesiology
• Decision Date: Oct 9, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The device is intended to be used to provide and 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

Single cannula tracheostomy tube; includes neck strap and obturator. Inserted into tracheotomy stoma; secured via integral neck plate and neck strap. Provides artificial airway for spontaneous breathing or connection to ventilation/anesthesia equipment. Used in clinical environments (neonatal/pediatric/critical care units, long-term care, home care) by healthcare professionals. Benefits patient by maintaining airway patency. Constructed from medical-grade PVC with citric-based non-phthalate plasticizer.

Clinical Evidence

No clinical data. Bench testing performed to confirm compliance with ISO 5366-3:2001/Cor:2003, ISO 5356-1:2004, and ISO 5366-1:2000. Biocompatibility testing satisfied ISO 10993-1:2009 requirements.

Technological Characteristics

Single cannula tracheostomy tube. Materials: Medical-grade PVC with citric-based non-phthalate plasticizer (cannula, neck plate, 15mm connector); medical-grade polypropylene (obturator); cotton (tie strap). Standards: ISO 5366-1:2000, ISO 5366-3:2001/Cor:2003, ISO 5356-1:2004. Sterilization: Sterile (SAL 10E-6) via validated cycle 66.

Indications for Use

Indicated for neonatal and pediatric patients requiring an artificial airway for tracheal access and 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 Pediatric and Neonatal Tracheostomy Tubes (K945513)
• Bivona Tracheostomy Tube Tracheostomy Tubes (K083641)

Submission Summary (Full Text)

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# COVIDIEN

#### K122531 510(k) Summary

Date summary prepared 21-September-2012

# 510(k) Submitter/Holder

Covidien IIc 6135 Gunbarrel Avenue Boulder, CO.80301

#### Contact

Ted Kuhn Sr. Regulatory Affairs Product Specialist Office: 303-305-2272 Mobile: [phone] Fax: [phone] email address: [e-mail]

#### Name of Device

| Trade Name: | Shiley Neonatal, Pediatric, Pediatric Long Tracheostomy Tube Cuffless |
|----------------------|--------------------------------------------------------------------------------------|
| Catalog Numbers: | NEF, PEF, PELF |
| Common Name: | Tube Tracheostomy and Tube Cuff |
| Classification Name: | JOH, Tube Tracheostomy and Tube Cuff (21 CFR 868.5800) Class II, 73<br>Anestesiology |

# Purpose of Submission

The purpose of this submission is to introduce the Covidien Shiley Neonatal, Pediatric Long Cuffless Tracheostomy Tube. The subject and predicate device have the equivalent Indications for Use, Intended Use, fundamental technology, and design. This submission is to notify the FDA of the following changes:

- . Pediatric and Neonatal Tracheostomy tubes size line extension of the previously cleared Shiley Pediatric and Neonatal Tracheostomy tubes
OCT

9 2012

- Updated the materials used in the Tracheostomy tubes to a Medical Grade PVC ● with a Citric based non-phthalate plasticizer
- Update to the Manufacturing process .

#### Predicate Device

The Shiley Neonatal, Pediatric, Pediatric Long Tracheostomy Tube Cuffless was compared and found to be substantially equivalent to the following products of comparable type in commercial distribution:

| Trade Name: | Shiley Pediatric and Neonatal Tracheostomy Tubes |
|---------------------|--------------------------------------------------|
| Device Common Name: | Tube Tracheostomy and Tube Cuff |
| 510(k) Number: | K945513 |
| Manufacturer: | Covidien, formerly Tyco Healthcare |

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| Trade Name: | Bivona Tracheostomy Tube Tracheostomy Tubes |
|---------------------|---------------------------------------------|
| Device Common Name: | Tube Tracheostomy and Tube Cuff |
| 510(k) Number: | K083641 |
| Manufacturer: | Smiths Medical ASD, Inc. |

#### Intended Use

The device is intended to be used to provide and 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.

#### Indications for Use

This device is intended for use in providing tracheal access for airway management.

### Device Description

The Shiley Neonatal, Pediatric, Pediatric Long Tracheostomy Tube Cuffless tube is a single cannula tracheostomy tube which also contains a neck strap and obturator. The device is intended to be used to provide and artificial airway in order to provide access to the patient's airway for airway management. 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, thereby providing for a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.

# Technological Characteristics

The Shiley Neonatal, Pediatric, Pediatric Long Tracheostomy Tube Cuffless tube has technological characteristics that differ from its predicates. The Shiley Pediatric and Neonatal Tracheostomy Tubes (K945513) are comprised of a Medical Grade Polyvinylchloride (PVC) and BIVONA Tracheostomy Tubes (K083641) is comprised of Silicone and Acrylonitrile butadiene styrene (ABS) materials. Shiley Neonatal, Pediatric Long Tracheostomy Tube Cuffless tube is comprised of a Medical Grade PVC with a Citric Based non-phthalate plasticizer. All other fundamental technological characteristics are identical to the predicate devices.

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| Subject Device: | Predicate Device | Predicate Device | |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shiley Neonatal,<br>Pediatric, Pediatric<br>Long Tracheostomy<br>Tube Cuffless | Shiley Neonatal,<br>Pediatric, Pediatric<br>Long Tracheostomy<br>Tube (K945513) | BIVONA<br>Tracheostomy Tubes<br>(K083641) | |
| Indications for Use | This device is intended<br>for use in providing<br>tracheal access for<br>airway management. | This device is intended<br>for use in providing<br>tracheal access for<br>airway management. | The Bivona<br>Tracheostomy Tube is<br>intended to provide<br>direct airway access<br>for a tracheotomized<br>patient for up to 29<br>days. It may be<br>reprocessed for a<br>single-patient use up to<br>5 times for pediatric<br>sizes. |
| Intended Use | This device is intended<br>for use in providing<br>tracheal access for<br>airway management. | This device is intended<br>for use in providing<br>tracheal access for<br>airway management. | Unknown |
| Device class | Class 2 | Class 2 | Class 2 |
| Product code | JOH | JOH | JOH |
| Patient Population | Neonatal and Pediatric<br>patients requiring an<br>artificial airway | Neonatal and Pediatric<br>patients requiring an<br>artificial airway | Pediatric patients<br>requiring an artificial<br>airway |
| Environment of Use | The product shall be<br>used in a clinical<br>environment such as the<br>neonatal, pediatric or<br>critical care units of a<br>hospital, non-critical care<br>units of a hospital, long<br>term care facilities and<br>home care. | The product shall be<br>used in a clinical<br>environment such as the<br>neonatal, pediatric or<br>critical care units of a<br>hospital, non-critical care<br>units of a hospital, long<br>term care facilities and<br>home care. | Unknown |
| Invasive / Non-<br>Invasive | Invasive | Invasive | Invasive |
| Sterilization | Sterile : The SAL is 10E-6<br>utilizing the existing<br>validated cycle 66. | Sterile : The SAL is 10E-6<br>utilizing the existing<br>validated cycle 66. | Sterile with Ethylene<br>Oxide |
| Shelf Life | 1-year Minimum shelf life | 5-year shelf life | Unknown |
| Materials | | | |
| | Subject Device: | Predicate Device | Predicate Device |
| | Shiley Neonatal,<br>Pediatric, Pediatric<br>Long Tracheostomy<br>Tube Cuffless | Shiley Neonatal,<br>Pediatric, Pediatric<br>Long Tracheostomy<br>Tube (K945513) | BIVONA<br>Tracheostomy Tubes<br>(K083641) |
| Cannula | Medical Grade PVC<br>with a Citric Based non-<br>phthalate plasticizer | Medical Grade PVC | Silicone |
| Neck Plate | Medical Grade PVC<br>with a Citric Based non-<br>phthalate plasticizer | Medical Grade PVC | Silicone |
| 15 MM connector | Medical Grade PVC<br>with a Citric Based non-<br>phthalate plasticizer | Medical Grade PVC | Acrylonitrile butadiene<br>styrene (ABS) |
| Obturator | Medical Grade<br>Polypropylene | Medical Grade<br>Polypropylene | Medical Grade<br>Polypropylene |
| Tie Strap | Cotton | Cotton | Cotton |
| Biocompatibility | ISO 10993-1:2009 | ISO 10993-1:2009 | ISO 10993-1:2009 |
| Sizes | 2.5 NEF to 4.5 NEF<br>2.5 PEF to 5.5 PEF<br>5.0 PELF to 6.5 PELF | 3.0 NEO to 4.5 NEO<br>3.0 PED to 5.5 PED<br>5.0 PDL to 6.5 PDL | 2.5 to 4.0<br>Neonatal<br>2.5 to 5.5<br>Pediatric |
| Use | Single Patient Use | Single Patient Use | Single Patient Use |
| Design | Tracheostomy Tube<br>Design | Tracheostomy Tube<br>Design | Tracheostomy Tube<br>Design |
| | Subject Device: | Predicate Device | Predicate Device |
| | Shiley Neonatal,<br>Pediatric, Pediatric<br>Long Tracheostomy<br>Tube Cuffless | Shiley Neonatal,<br>Pediatric, Pediatric<br>Long Tracheostomy<br>Tube (K945513) | BIVONA<br>Tracheostomy Tubes<br>(K083641) |
| Standards met | ISO 5366-1:2000<br>Anesthetic and<br>respiratory equipment —<br>Tracheostomy tubes Part<br>1: Tubes and connectors<br>for use in adults<br><br>ISO 5366-3:2001 /<br>Cor:2003 Anesthetic and<br>Respiratory Equipment --<br>Tracheostomy Tubes --<br>Part 3: Pediatric<br>Tracheostomy Tubes<br><br>ISO 5356-1:2004<br>Anesthetic and<br>respiratory equipment -<br>Conical connectors: Part<br>1: Cones and sockets<br><br>(The key product<br>standards used to<br>develop this product<br>range are ISO 5366 Part<br>3and ISO 5356-1. The<br>PDL model encompasses<br>a 6.5mm Tracheostomy<br>tube. The 6.5mm tube is<br>beyond the scope of ISO<br>5366 Part 3. Therefore<br>ISO 5366 Part 1 is also<br>used to guide the<br>development of the<br>product range) | 5356 (1987)<br>5366 (1985) | ISO 5366-3:2001<br><br>ISO 5366-3:2001<br>Second edition 2001-<br>08-15<br><br>ISO 5356-1<br>Third<br>edition 2004-05-15 |

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### Non-Clinical Data

Bench testing was performed to confirm that the Shiley Neonatal, Pediatric Long Tracheostomy Tube Cuffless meets the requirements of ISO 5366-3 [2001/Cor:2003[, ISO 5356-1:2004 and ISO 5366-1:2000 for Tracheostomy Tubes. Biocompatibility testing was performed on the Shiley Neonatal, Pediatric Long Tracheostomy Tube Cuffless which satisfied all of the requirements of ISO 10993-1:2009.

# Clinical Data

Not Required

# Substantial Equivalence

The predicate devices to which we claim equivalence are the Shiley Pediatric and Neonatal Tracheostomy Tubes (K945513) and BIVONA Tracheostomy Tubes (K083641). The basic design elements and their assemblies are identical to the cleared predicate device. The Indications for Use of the proposed devices are equivalent to the cleared predicate devices.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

OCT
9
2012

Covidien, Limited Liability Company Mr. Ted Kuhn Senior Regulatory Affairs Product Specialist Respiratory & Monitoring Solutions 6135 Gunbarrel Avenue Boulder, Colorado 80021

Re: K122531

Trade/Device Name: Shiley Neonatal Tracheostomy Tube Cuffless Shiley Pediatric Tracheostomy Tube Cuffless Shiley Pediatric Tracheostomy Tube Long Cuffless

Regulation Number: 21 CFR 686.5800

Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: September 21, 2012 Received: September 24, 2012

Dear Mr. Kuhn:

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 device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number (if known): K122531

Device Name:

Shiley Neonatal Tracheostomy Tube Cuffless Shiley Pediatric Tracheostomy Tube Cuffless Shiley Pediatric Tracheostomy Tube Long Cuffless

#### Indications for Use:

This device is intended for use in providing tracheal access for airway management.

AND/OR Over-The-Counter Use × Prescription Use (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)

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Ancolnoons. Devices

1225

**510(k) Number:**