RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET

K133173 · Teleflexmedical, Inc. · JOH · May 23, 2014 · Anesthesiology

Device Facts

• Record ID: K133173
• Device Name: RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
• Applicant: Teleflexmedical, Inc.
• Product Code: JOH · Anesthesiology
• Decision Date: May 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Rusch TracFlex Plus Pediatric Tracheostomy Tube Set is used in airway management of tracheostomized patients.

Device Story

The Rusch TracFlex Plus Pediatric Tracheostomy Tube Set is a sterile, single-patient-use device designed to provide an artificial airway via a tracheotomy incision. The tube is constructed from non-DEHP PVC resin and features stainless steel spiral reinforcement to prevent collapse. It is available in cuffed and uncuffed versions (sizes 3-6mm). The set includes accessories such as a disposable inner cannula, obturator, and various caps (shower, cough, sealing). The device is used in hospital, sub-acute, and home environments by clinicians or caregivers to maintain airway patency. The flange secures the tube to the patient's neck via a strap. By providing a stable, reinforced airway, the device facilitates ventilation and respiratory support for pediatric patients, reducing the risk of airway obstruction.

Clinical Evidence

Bench testing only. Performance testing included connector bonding strength, flange bonding strength, cuff resting diameter, tube collapse resistance, cuff herniation, cuff burst evaluation, cuff bond strength, side arm bonding strength, and ink adhesion. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous activity, genotoxicity, and implantation testing per ISO 10993-1.

Technological Characteristics

Materials: Non-DEHP PVC resin, silicone. Construction: Stainless steel spiral armored tube, radiopaque. Dimensions: 3-6mm OD. Connectivity: None. Sterilization: Ethylene Oxide. Standards: ISO 5366-3 (mechanical testing), ISO 5356-1 (15mm connector), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for airway management in pediatric patients (neonate to 21 years) in home, hospital, and sub-acute settings. Contraindicated for patients with insurmountable intubation obstruction or those undergoing radiation therapy or MRI.

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

• Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless (K023918)

Reference Devices

• Rusch TracFlex Plus Tracheostomy Tube Set (K122235)

Submission Summary (Full Text)

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K133173

#### Name, Address, Phone and Fax Number of Applicant

MAY 2 3 2014

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: [phone] Fax:

#### Contact Person

Lori Pfohl Regulatory Affairs Specialist

#### Device Name

Trade Name: Rusch TracFlex Plus Pediatric Tracheostomy Tube Set

Common Name: Tracheostomy Tube

Classification Name: Tube Tracheostomy and tube cuff (Class II per 21 CFR 868.5800, Product Code JOH)

#### Predicate Devices

K023918 - Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless K122235 - Rusch TracFlex Plus Tracheostomy Tube Set (Reference)

#### Device Description and Changes to Predicate

The Rusch TracFlex Plus Pediatric Tracheostomy Tube Set is a sterile, single patient use tracheotomy tube, available in sizes 3-6mm in 1 mm increments, with accessories which may be included in a set or sold separately. The device is used to provide an artificial airway. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The TracFlex Plus Pediatric tracheostomy tube is made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" = < 0.1% DEHP w/w), and is stainless steel spiral armored. It is available cuffed and uncuffed. Accessories included in the set are a disposable inner cannula, obturator, shower cap, cough cap and sealing cap. The tracheostomy tube is secured using the flange that is connected to the neck strap.

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The Rusch TracFlex Plus Pediatric Tracheostomy Tube Set is used in airway management of tracheostomized patients

Patient Population: Pediatric Patients

Environment of use: Home, Hospital and Sub-acute Institutions

## Contraindications

Insurmountable intubation obstruction

For patients during radiation therapy and magnetic resonance imaging

## Substantial Equivalence Comparison to Predicates

| Features | Proposed TracFlex Plus<br>Pediatric | Predicate Crystal Clear<br>K023918 | Predicate (for reference)<br>TracFlex Plus<br>K122235 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Device | Rusch TracFlex Plus<br>Pediatric Tracheostomy<br>Set | Rusch Crystal Clear<br>Tracheostomy Sets, Cuffed<br>and Cuffless | Rusch TracFlex Plus<br>Tracheostomy Tube Set |
| Indications for use | The Rusch TracFlex Plus<br>Pediatric Tracheostomy<br>Tube Set is used in airway<br>management of<br>tracheostomized patients | The Rusch Crystal Clear<br>Tracheostomy Sets, Cuffed<br>and Cuffless are intended<br>for airway management of<br>tracheostomized patients. | The Rusch TracFlex Plus<br>tracheostomy tube set is<br>used in airway<br>management of<br>tracheostomized patients |
| Environment of Use | Home, Hospital and Sub-<br>acute Institutions | Same | Same |
| Patient Population | Pediatric | Pediatric and adult | Adult |
| FDA Product Code | JOH 868.5800 | Same | Same |
| Contraindications | Insurmountable intubation<br>obstruction<br>For patients during<br>radiation therapy and<br>magnetic resonance<br>imaging | None | Same |
| Sizes | 3-6 | 3.5 - 10.5 mm | 7 to 11 mm |
| Fenestrated | No | Yes and No | No |
| Cuff (if present) | Low Pressure | Same | Same |
| Available in sets | Yes | Yes | Yes |
| Low pressure cuff | Spring return luer | same | Same |

## The proposed device is substantially equivalent to the predicate device:

Teleflex Medical

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| inflation system | operated valve | |
|-----------------------------------------------|-------------------------------------|------|
| Radiopaque | Yes | Yes |
| Stainless steel spiral<br>reinforced tube | Yes | Yes |
| Method of<br>Sterilization | Ethylene Oxide | Same |
| Packaging Material | Thermoformed tray with<br>Tyvek Lid | Same |
| Inner cannula | Disposable | same |
| Materials in patient<br>contact | PVC and Silicone | same |
| 15 mm connector<br>compliant to ISO<br>5356-1 | Yes | Same |
| Manufactured with<br>DEHP (Non-DEHP) | No | Yes |

- Indications for Use The indications for use are identical for the proposed device when . compared to the predicate - K023918. Each device is indicated for use in airway management of tracheostomized patients.
- . Technology and construction - The design, fabrication, shape, size, etc. are equivalent to the predicate - K023918. This design includes the disposable inner cannula, obturator, shower cap, cough cap and sealing cap. They are available in sizes from 3.0 to 6.0mm OD.
- Environment of use The environments of use are identical to predicate K023918 .
- . Patient Population -The patient population is identical to the predicate - K023918
- Materials -All patient contacting materials are in compliance with ISO 10993-1. Testing ● included cytotoxicity, sensitization, intracutaneous activity, genotoxicity and implantation testing.

### Comparison to Predicate Device:

The proposed TracFlex Plus Pediatric tracheostomy tubes are substantially equivalent to the predicate devices with respect to indications for use, technology and construction. The differences between the predicate and the proposed devices are minor and any risks have been mitigated through testing. The proposed device is designed with different materials than the main predicate, but essentially identical materials to the reference predicate. The proposed device is Non-DEHP.

## Non-clinical Comparative Performance Testing

# Teleflex Medical

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A brief summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in the table below:

| Test | Reference to<br>Standard (if<br>applicable) | Principle of Test |
|---------------------------------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Connector<br>bonding strength | ISO 5366-3 | The security of the attachment of the connector to the<br>tracheostomy tube is tested by applying an axial separation<br>force to the connector |
| Flange (neck-<br>plate) bonding<br>strength | ISO 5366-3 | The security of the attachment of the neck-plate to the<br>tracheostomy tube is tested by applying an axial separation<br>force to the neck-plate (flange) |
| Cuff resting<br>diameter | ISO 5366-3 | The resting diameter of the cuff is measured when the cuff<br>is inflated to a reference pressure which is intended to<br>remove creases but minimize stretching of its walls |
| Tube collapse | ISO 5366 | The patency of the tracheostomy tube airway lumen is<br>tested by passing a steel ball through the tracheostomy<br>tube lumen with the cuff inflated within a transparent tube |
| Cuff herniation | ISO 5366 | The tendency of the cuff to herniate beyond the plane<br>perpendicular to the long axis of the tube at the nearest<br>edge of the bevel is tested by applying an axial force with<br>the cuff inflated within a transparent tube. A cuff which<br>protrudes excessively at its patient end may partially or<br>completely occlude the orifice at the patient end |
| Cuff Burst<br>Evaluation | N/A | The cuff restrained burst test is designed to ensure the cuff<br>will not burst or rupture when inflated inside the trachea |
| Cuff Bond<br>Strength | N/A | To evaluate the strength needed to separate the cuff from<br>the tube |
| Side arm<br>bonding strength | N/A | To evaluate the retention force of the inflation line<br>connection to the Tracheostomy tube |
| Ink adhesion test | N/A | To ensure the printing remains legible after the aging and<br>sterilization processes and being wiped with a solvent |

### Substantial Equivalence Conclusion

The Rusch TracFlex Plus Pediatric has the same indications for use, patient population and technology of construction as the predicate device. Performance test results demonstrate that the proposed device meets its intended use. It is for these reasons that the devices can be found substantially equivalent.

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

May 23, 2014

Teleflex Medical, Incorporated Lori Pfohl Senior Regulatory Affairs Specialist 2917 Week Drive Research Triangle Park, NC 27709

Re: K133173

Trade/Device Name: Rusch TracFlex Plus Pediatric Tracheostomy Tube Set Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy tube and tube cuff. Regulatory Class: Class II Product Code: JOH Dated: April 24, 2014 Received: April 25, 2014

Dear Ms. Pfohl:

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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Page 2 - Lori Pfohl

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 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" (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/ReportalProblem/default.hum 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/Industrv/default.htm.

:

:

Sincerely yours.

Teiashri P

Erin 1. Keith. M.S. Acting 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133173

Device Name Rusch TracFlex Plus Pediatric Tracheostomy Tube Set

Indications for Use (Describe)

The Rusch TracFlex Plus Pediatric Tracheostomy Tube Set is used in airway management of tracheostomized patients.

Patient Population: Pediatric Patients per below:

| Pediatric Subgroup | Approximate Age Range |
|---------------------------|-----------------------|
| Neonate/Newborn | Birth to 28 days |
| Infant | 29 days to < 2 years |
| Child | 2 years to <12 years |
| Adolescent | 12 years to <18 years |
| Transitional Adolescent A | 18 years to <21 years |

Environment of use: Home, Hospital and Sub-acute Institutions

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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