RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET

K122235 · Teleflexmedical, Inc. · JOH · Sep 6, 2013 · Anesthesiology

Device Facts

• Record ID: K122235
• Device Name: RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
• Applicant: Teleflexmedical, Inc.
• Product Code: JOH · Anesthesiology
• Decision Date: Sep 6, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

Rusch TracFlex Plus is a sterile, single-patient-use tracheostomy tube set designed for airway management in hospital, surgery center, and home care environments. The device consists of a stainless steel spiral-reinforced PVC tube (Non-DEHP) available in sizes 7-11mm, with cuffed or uncuffed options. Accessories include a disposable inner cannula, obturator, and various caps. The tube is inserted into a tracheotomy incision to provide an artificial airway. The device features an adjustable flange for neck securement and a pressure-indicating pilot balloon for cuffed versions. It is operated by healthcare professionals or patients/caregivers in home settings. The device provides a stable airway, facilitating patient breathing. It is a mechanical device with no electronic or software components.

Clinical Evidence

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

Technological Characteristics

Materials: Non-DEHP PVC (resin < 0.1% DEHP), stainless steel spiral reinforcement, polyethylene inner cannula. Design: Cuffed/uncuffed, 7-11mm sizes, adjustable flange, 15mm connector (ISO 5356-1). Sterilization: Ethylene Oxide. Mechanical sensing: Spring return luer-operated valve for cuff inflation. Radiopaque.

Indications for Use

Indicated for airway management in adult tracheostomized patients. Contraindicated in patients with abnormal upper airway anatomy or pathology, and during radiation therapy or magnetic resonance imaging.

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 Ultra TracheoFlex Teleflex Medical, Inc (K964056)

Submission Summary (Full Text)

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

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

#### Contact Person

SEP 06 2013

Lori Pfohl Regulatory Affairs Specialist

#### Device Name

Trade Name: Rusch TracFlex Plus 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 Device

Rusch Ultra TracheoFlex Teleflex Medical, Inc - K964056

#### Device Description and Changes to Predicate

The Rusch TracFlex Plus Tracheostomy Tube Set is a sterile, single patient use tracheotomy tube, available in sizes 7-11mm 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, in order to provide access to the patient's airway. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The TracFlex Plus 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.

#### Indications for Use

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

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- This device is intended for use on adult patients o
Intended Environment of Use –

- This device is intended for use in hospital and hospital-type facilities, surgery o centers and home care environments.
The product is single patient, multi-use

## Contraindications

Use of the Rusch TracFlex Plus is contraindicated in patients having abnormal upper airway or pathology and for patients during radiation therapy and magnetic resonance imaging

## Substantial Equivalence Comparison to Predicates

The proposed device is substantially equivalent to the predicate device:

| Features | Proposed (TracFlex Plus) | Predicate (Ultra Tracheoflex) K964056 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Device | Rusch TracFlex Plus Tracheostomy Tube Set | Rusch Ultra Tracheoflex Tracheostomy Kits K964056 |
| Indications for use | The Rusch TracFlex Plus tracheostomy tube set is used in airway management of tracheostomized patients | Tracheostomy tube kits intended for airway management in a tracheostomized patient |
| FDA Product Code | JOH 868.5800 | Same |
| Environment of Use | Home, Hospital, Sub-acute Institutions | Same |
| Patient Population | Adult | Same |
| Contraindications | Use of the TrachFlex Plus Tracheostomy Set is contraindicated in patients having abnormal upper airway anatomy or pathology<br>For patients during radiation therapy and magnetic resonance imaging | Use of the Rusch Ultra Tracheoflex Tracheostomy Set is contraindicated in patients having abnormal upper airway anatomy or pathology |
| Sizes | 7 to 11 mm | 6-11 mm |
| Fenestrated | No | Yes and No |
| Cuff (if present) | Low Pressure | Same |
| Available in sets | Yes | Yes |
| Pilot balloon (cuffed version) | Pressure indicating | same |
| Flange | Adjustable | Fixed |
| Low pressure cuff inflation system | Spring return luer operated valve | same |
| Radiopaque | Yes | Yes |
| Stainless steel spiral reinforced tube | Yes | Yes |
| Method of Sterilization | Ethylene Oxide | Same |
| Packaging Material | Thermoformed tray with Tyvek Lid | Same |

Teleflex Medical

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| Features | Proposed (TracFlex Plus) | Predicate (Ultra Tracheoflex) K964056 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------|
| Inner cannula | Disposable | same |
| Tube Components | 15 mm connector<br>Flange<br>Neck Plate<br>Introducer / obturator<br>Cuffed/Uncuffed<br>Pilot balloon | Same |
| Accessories | yes | yes |
| 15 mm connector<br>compliant to ISO<br>5356-1 | yes | yes |

- Indications for Use The indications for use are identical for the proposed . device when compared to the predicate - K964056. Each device is indicated for use in airway management of tracheostomized patients.
- Technology and construction The design, fabrication, shape, size, etc. are o equivalent to the predicate - K964056. This design includes the disposable inner cannula, obturator, shower cap, cough cap and sealing cap. They are available in sizes from 7.0 to 11.0 mm OD.
- Environment of use The environments of use are identical to predicate -. K964056
- Patient Population -The patient population is equivalent to the predicate -. K964056
- 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 essence of this change is to add a Non-DEHP PVC version of the previously cleared PVC tracheostomy tube. This change also changes the inner cannula material from polyurethane to polyethylene. The proposed device is substantially equivalent in intended use, design, performance and principles of operation to the identified predicate devices cleared under K964056. The differences between the Rusch TracFlex Plus and the predicate device are minor and raise no new issues of safety and efficacy.

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# Non-clinical Comparative Performance Testing

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 5366-1<br>Section 6.1<br>Machine end | 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 5366-1<br>Section 6.2.<br>Neck-plate | 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 5366-1<br>Section 6.4.3 | The resting diameter of the cuff is measured when the cuff is<br>inflated to a reference pressure which is intended to remove<br>creases but minimize stretching of its walls |
| Tube collapse | ISO 5361 section<br>4.5 for cuff tests | The patency of the ET tube airway lumen is tested by passing<br>a steel ball through the tracheal tube lumen with the cuff<br>inflated within a transparent tube |
| Cuff herniation | ISO 5361 section<br>4.5 for cuff tests | The tendency of the cuff to herniate beyond the plane<br>perpendicular to the long axis of the tube at the nearest edge<br>of the bevel is tested by applying an axial force with the cuff<br>inflated within a transparent tube. A cuff which protrudes<br>excessively at its patient end may partially or completely<br>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 the<br>tube |
| Side arm bonding<br>strength | N/A | To evaluate the retention force of the inflation line connection<br>to the Tracheostomy tube |
| Ink adhesion | N/A | To ensure the printing remains legible after the aging and<br>sterilization processes and being wiped with a solvent |
| DEHP testing | ISO 10993-17<br>and 10993-18 | Extractions are performed to determine the content of DEHP<br>in the total device |
| Dimensional<br>evaluation (Inner<br>cannula) | N/A | To verify the inner cannula component meets the engineering<br>drawing |
| Dimensional<br>evaluation<br>(Silicone stopper<br>ring) | N/A | To verify the silicone stopper ring component meets the<br>engineering drawing |
| Inner Cannula<br>tensile strength<br>after silicone<br>coating | N/A | To determine the tensile strength of the inner cannula after<br>the coating process |
| Ink Adhesion Test | N/A | To ensure the ink adheres to the inner cannula surface |
| Assembly Bonding<br>Strength | N/A | To determine the bond strength between the stopper and the<br>inner cannula |
| Kinking Test | N/A | To ensure the patency of the inner cannula during use |
| Biocompatibility | ISO 10993-1 | To demonstrate biocompatibility of the materials used.<br>Testing included cytotoxicity, sensitization, intracutaneous |

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## Substantial Equivalence Conclusion

The Rusch TracFlex Plus has the same indications for use, technological characteristics and construction as its predicate. Performance test results demonstrate that the proposed device is substantially equivalent and because pass/fail criteria has been met, the devices can be found substantially equivalent.

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing shapes. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gib09 Silver Spring, MI) 20993-0002

September 6, 2013

Teleflex Medical. Incorporated Ms. Lori Pfohl Regulatory Affairs Specialist 2917 Weck Drive RESEARCH TRIANGLE PARK NC 27709

Re: K122235

Trade/Device Name: Rusch Tracflex Plus Tracheostomy Tube Set Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff . Regulatory Class: II Product Code: JOH Dated: August 7, 2013 Reccived: August 8, 2013

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 10 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 gencral 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Image /page/6/Picture/7 description: The image contains a logo on the left side and some text on the right side. The text reads "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID". The text is stacked vertically, with the name at the top, followed by the title, and then the organization name. The image is of low resolution and the text is slightly blurry.

Kwame Ulmer M.S. Acting Division 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

Page 1 of 1

510(k) Number:

4122235

Device Name:

Rusch TracFlex Plus Tracheostomy Tube Set

Indications for Use:

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

Prescription Use XX (Part 21 CFR 801 Subpart D)

t

Over-the-counter use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tejashri S. Purohitsheth -S
Clinical Deputy Director,
DAGRID
2013.09.06 15:44:03-04'00'

(Division Sign-Off) tsion of Anesthestology, General Hospital ..ection Control, Dental Devices

510(k) Number: K122235