RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE

K132415 · Teleflexmedical, Inc. · BTR · Jun 6, 2014 · Anesthesiology

Device Facts

• Record ID: K132415
• Device Name: RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE
• Applicant: Teleflexmedical, Inc.
• Product Code: BTR · Anesthesiology
• Decision Date: Jun 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Rusch tracheal tubes are indicated for airway management by oral or nasal intubation of the trachea.

Device Story

Rusch Safety Silk Tracheal Tube Series is a sterile, single-use device for airway management. It consists of a PVC tube (formulated without DEHP) featuring a cuff, inflation line, pilot balloon, one-way valve, and a radiopaque line. Available in oral (Super Safety Silk) and nasal (Nasal Safety Silk) versions with Murphy or Magill styles. The device is inserted by a clinician into the patient's trachea via the mouth or nose to maintain an open airway. It connects to a ventilation source via a 15mm connector. The device facilitates mechanical ventilation or oxygenation, benefiting patients requiring airway support. It is intended for use in any clinical environment where endotracheal intubation is performed.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility (cytotoxicity, sensitization, intracutaneous activity, implantation, genotoxicity), cuff leak evaluation, tube curvature, tube collapse, cuff herniation, and bonding strength testing (ISO 5361).

Technological Characteristics

Materials: Non-DEHP PVC, Polyamide connector, Barium Sulfate radiopaque marker. Design: Cuffed tracheal tube with inflation line, pilot balloon, one-way valve, 15mm connector. Dimensions: 5.0mm - 10.0mm ID. Sterilization: Ethylene Oxide (10^-6 SAL). Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for airway management via oral or nasal intubation in adults. Used in clinical settings where endotracheal intubation is performed.

Regulatory Classification

Identification

A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

Predicate Devices

• Teleflex Medical's Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy (K993786)
• Teleflex Medical's Rusch Oral/Nasal Tracheal Tube Cuffed, Magill/Murphy (K961837)

Submission Summary (Full Text)

{0}------------------------------------------------

# JUN 0 6 2014

# 510(k) SUMMARY

### Rusch Safety Silk Tracheal Tube Series

### 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

Lori Pfohl Regulatory Affairs Specialist

## Date Prepared

6/3/2014

### Device Name

Trade Name: Rusch Safety Silk Tracheal Tube Series

Common Name: Tracheal Tube

Classification Name: Tube, Tracheal (Class II per 21 CFR 868.5730, Product Code BTR)

# Predicate Devices

Teleflex Medical's Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy - K993786

Teleflex Medical's Rusch Oral/Nasal Tracheal Tube Cuffed, Magill/Murphy -K961837

# Device Description

The proposed Teleflex Medical Super Safety Silk and Nasal Safety Silk tracheal tubes are sterile, single use devices that are made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" = < 0.1% DEHP w/w). The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the tracheal tube. Each tracheal tube is supplied with an appropriately sized 15mm connector.

Teleflex Medical

Page 1 of 5

{1}------------------------------------------------

The oral version of the device (Super Safety Silk) will be sold in both Murphy eye and Magill styles.

The nasal version of the device (Nasal Safety Silk) will be offered in the Murphy eye style only.

# Indications for Use

- Rusch tracheal tubes are indicated for oral or nasal intubation for airway . management.
Intended Population

- Adults
Intended Environment of Use

- Locations where ET intubation may be performed. .
# Contraindications

None

# Substantial Equivalence

The proposed device is substantially equivalent to the predicate devices:

| | Teleflex Medical<br>Safety Silk Series<br>Oral / Nasal<br>acheal | Teleflex Medical<br>Oral / Nasal Tracheal Tube<br>atety Clear Plus) | Teleflex Medical<br>al / Nasal Tracheal |
|-------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Classification Name | Tube, Trachea<br>(w/wo connector) | Same | Same |
| Product Code | 73 BTR | Same | Same |
| Regulation Number | 868.5730 | Same | Same |
| Indications for Use | Rusch tracheal<br>tubes are indicated<br>for oral or nasal<br>intubation for<br>airway<br>management. | Rusch Oral / Nasal Trachea<br>Tube, Cuffed,<br>Magill/Murphy is a device<br>inserted into a patient's<br>trachea via the nose or<br>mouth and used to maintain<br>an open airway. | Oral or nasal<br>intubation and airway<br>management |
| | Teleflex Medical<br>Safety Silk Series<br>Oral / Nasal<br>Tracheal Tube<br>(proposed) | Teleflex Medical<br>Oral / Nasal Tracheal Tube<br>(Safety Clear Plus)<br>(K993786) | Teleflex Medical<br>Oral / Nasal Tracheal<br>Tube<br>(K961837) |
| Features | | | |
| Environment of Use | Locations where ET<br>intubation may be<br>performed | Not stated | Not stated |
| Patient Population | Adults | Not stated | Not stated |
| Contraindications | None | Same | Same |
| Single Use | Yes | Same | Same |
| Size Range | $5.0 mm - 10.0 mm$ | $2.0 mm - 4.0 mm$ | $4.5 mm - 11.0 mm$ |
| Cuffed | Yes | Same | Same |
| Radiopaque | Yes | Same | Same |
| Connection to<br>ventilation source | 15 mm connector | Same | Same |
| Method of<br>Sterilization | Ethylene Oxide 10-6<br>SAL | Same | Same |
| Biocompatibility | Materials have been<br>tested per ISO<br>10993 | Same | Same |
| No-DEHP | Yes | No | No |
| Packaging<br>Configuration | Ten (10) individual<br>units in a shelf box.<br>Ten shelf boxes in a<br>shipper | Same | Same |
| Sterile | Yes | Same | Same |
| Eye | Murphy and Magill | Same | Same |
| Tip | Beveled | Same | Same |
| Graduations | Multiple cm<br>markings | Same | Same |
| Shaft | PVC | Same | Same |
| Cuff | PVC | Same | Same |
| Pilot Balloon | PVC | Same | Same |
| Inflation Valve | PVC | Same | Same |
| Inflation Tube | PVC | Same | Same |
| X-Ray Marker,<br>Stripe | PVC with Barium<br>Sulfate | Same | Same |
| Connector | Polyamide | Polypropylene | Polypropylene |

Teleflex Medical

{2}------------------------------------------------

.

·

-

{3}------------------------------------------------

# Comparison to Predicate Device:

The proposed Safety Silk series tracheal tubes are substantially equivalent to the predicate devices with respect to indications for use, technology and construction. The proposed device is designed with different materials than the predicate. These proposed device materials are Non-DEHP.

#### Indications for Use -.

The indications for use are substantially equivalent for the proposed device when compared to the predicates. Each device is indicated for Oral or Nasal use in airway management.

#### Technology and construction -.

The design, fabrication, shape, size, etc. are substantially equivalent to the predicates. This design includes the disposable tracheal tube, cuff side arm assembly and 15mm connector.

#### . Environment of use -

While not specifically stated, the environments of use are equivalent to predicates

#### . Patient Population -

While not specifically stated, the patient population is equivalent to the predicate

#### Materials -.

All patient contacting materials are in compliance with ISO 10993-1. Testing included Cytotoxicity, sensitization, intracutaneous activity, implantation and genotoxicity testing.

| Test | Reference to<br>Standard (if<br>applicable) | Principle of Test | Acceptance Criteria |
|---------------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Cuff Bonding<br>Leak Evaluation | N/A | To perform a visual check at<br>the welding point of the cuff | No leak around the<br>welding area |
| Tube Curvature<br>Test | 150 5361 | To measure the curvature of<br>the tube | Must meet the product<br>requirement of 140mm<br>± 20mm |
| Tube Collapse | ISO 5361 | The patency of the ET tube<br>airway lumen is tested by<br>passing a steel ball through<br>the tracheal tube lumen with<br>the cuff inflated within a<br>transparent tube | The steel ball (OD =<br>75% of the stated ID)<br>must pass through the<br>lumen freelv. |
| Cuff Resting<br>Diameter | ISO 5361 | The resting diameter of the<br>cuff is measured when the<br>cuff is inflated to a reference<br>pressure which is intended to<br>remove creases but minimize<br>stretching of its walls | The cuff resting<br>diameter shall be within<br>± 15% of specification<br>for each individual size |
| Test | | Reference to Principle of Test | Acceptance Criteria |

## Performance Testing

Teleflex Medical

Page 4 of 5

{4}------------------------------------------------

| | Standard (if .<br>applicable) | | |
|----------------------------------------|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cuff Herniation | ISO 5361 | The tendency of the cuff to<br>herniate beyond the plane<br>perpendicular to the long axis<br>of the tube at the nearest<br>edge of the bevel is tested by<br>applying an axial force with<br>the cuff inflated within a<br>transparent tube. A cuff which<br>protrudes excessively at its<br>patient end may partially or<br>completely occlude the orifice<br>at the patient end | No abnormality or<br>defect on the cuff (any<br>part of the inflated cuff<br>reaches beyond the<br>nearest edge of the<br>bevel will be considered<br>as defect). No<br>abnormalitv on the<br>configuration of the cuff<br>during deflating the cuff<br>over a period of not less<br>than 10s (any<br>abnormality will be<br>considered as defect)." |
| Side Arm<br>Bonding Strength | N/A | To evaluate the retention<br>force of the inflation line<br>connection to the Tracheal<br>tube | Must be able to sustain<br>a minimum of 15N |
| Connector<br>Bonding Strength | N/A | The security of the<br>attachment of the connector<br>to the tracheal tube is tested<br>by applying an axial<br>separation force to the<br>connector | Tube-Connector<br>bonding must meet the<br>minimum specification<br>to 50N |
| Tube<br>Compression<br>Evaluation | N/A | To measure the rigidity of the<br>tube | Must be within the<br>range of current data |
| Cuff Unrestrained<br>Burst Evaluation | N/A | To determine minimum cuff<br>burst pressure under<br>unrestrained conditions | Must be within the<br>range of current data |
| Cuff Restrained<br>Burst Evaluation | N/A | To determine cuff burst<br>volume under restrained<br>conditions to simulate<br>conditions in the trachea | Must be within the<br>range of current data |
| Cuff Sealing<br>Pressure<br>Evaluation | N/A | To determine the minimum<br>cuff pressure required to seal<br>the corrugated tube | Must be within the<br>range of current data |

The Rusch Safety Silk Tracheal Tube Series has the same indications for use, technological characteristics and construction as its predicates. Performance test results demonstrate that the proposed device is substantially equivalent.

Teleflex Medical

{5}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

June 6, 2014

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

Re: K132415

Trade/Device Name: Rusch Safety Silk Tracheal Tube Series Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: II Product Code: BTR Dated: May 05, 2014 Received: May 06, 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.

{6}------------------------------------------------

Page 2 - Ms. 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.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/Resourcesfor You/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

{7}------------------------------------------------

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K132415

Device Name

Rusch Super Safety Silk Tracheal Tubes

Indications for Use (Describe)

Rusch tracheal tubes are indicated for airway management by oral or nasal intubation of the trachea.

Intended Population: Adults

Intended Environment of Use: Locations where ET intubation may be performed

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)

# Please do not write below this line – continue on a separate page if needed.

A FREE FOR FOR FOREDA USE ONLY AND ANNE AND ANNA ANDREA ASSA Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Todd D. Courtney -S 2014.06.05 15:19:37 -04

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the I he buroen time to this collection of intromation in the data needed and complete line to review that delons, occirculy of comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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