Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

K150603 · Teleflexmedical, Inc. · BTR · Nov 27, 2015 · Anesthesiology

Device Facts

• Record ID: K150603
• Device Name: Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
• Applicant: Teleflexmedical, Inc.
• Product Code: BTR · Anesthesiology
• Decision Date: Nov 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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

Device Story

Sterile, single-use tracheal tube; PVC resin construction (non-DEHP); includes cuff, inflation line, pilot balloon, one-way valve, and radiopaque line. Supplied with 15mm connector. Available in Murphy eye and Magill styles. Used in clinical settings where endotracheal intubation is performed; operated by healthcare professionals. Device maintains open airway for ventilation. Benefits include pediatric-specific sizing and non-DEHP material composition.

Clinical Evidence

Bench testing only. Testing included biocompatibility per ISO 10993-1 (cytotoxicity, sensitization, intracutaneous activity, implantation, genotoxicity, extractables/leachables) and mechanical performance testing per ISO 5361 (tube curvature, collapse, cuff diameter, cuff herniation) and internal specifications (cuff bonding, tube compression, burst pressure, sealing pressure).

Technological Characteristics

Materials: PVC resin (non-DEHP <0.1% w/w), Polyamide connector, Barium Sulfate radiopaque marker. Dimensions: 3.0 mm – 4.5 mm ID. Sterilization: Ethylene Oxide (10-6 SAL). Biocompatibility: ISO 10993-1 compliant. Design: Cuffed, Murphy/Magill eye, beveled tip, multiple cm graduations.

Indications for Use

Indicated for airway management via oral or nasal intubation of the trachea in pediatric patients.

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

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

Reference Devices

• Rusch Safety Silk Series Oral/Nasal Tracheal Tube (132415)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, while "U.S. FOOD & DRUG" is in a slightly smaller font, and "ADMINISTRATION" is in an even smaller font below.

October 28, 2021

Teleflex Medical, Inc. Lori Pfohl Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709

Re: K150603

Trade/Device Name: Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: Class II Product Code: BTR

Dear Lori Pfohl:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on November 27, 2015. Specifically, FDA is updating this SE letter due to the clearance date not appearing on the original letter.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Todd Courtney, Office of Ophthalmic, Anesthesia, Respiratory, ENT and Devices, 301-796-6371, [e-mail].

Sincerely,

# Todd D. Courtney -S

Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

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

Re: K150603

Trade/Device Name: Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: Class II Product Code: BTR Dated: November 5, 2015 Received: November 6, 2015

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.

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

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

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/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,

Image /page/2/Picture/8 description: The image shows the FDA logo on the left side. On the right side, the text "Richard C. Chapman - S 2015.11.27 13:42:38 -05'00'" is displayed. The text appears to be a timestamp or signature related to the FDA logo.

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

for

Enclosure

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

# Indications for Use

510(k) Number (if known)

Device Name

Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

Indications for Use (Describe)

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

Intended Population: Pediatric

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

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

2 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.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send 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 PRAStaff(@fda.hhs.gov

"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."

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

# Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

### 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 Senior Regulatory Affairs Specialist

### Date Prepared

3/9/2015

### Device Name

## Trade Name: Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

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 Rusch Safety Silk Pediatric Tracheal Tube Series 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 radiopague line is incorporated into the full length of the tracheal tube. Each tracheal tube is supplied with an appropriately sized 15mm connector.

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.

# Teleflex Medical

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

# Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

# Indications for Use

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

- Pediatric patients ●
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:

| Features | Teleflex Medical<br>Safety Silk Series<br>Oral / Nasal<br>Tracheal Tube<br>(Proposed) | Teleflex Medical<br>Oral / Nasal Tracheal<br>Tube<br>(Safety Clear Plus)<br>(K993786) | Teleflex<br>Medical<br>Oral / Nasal<br>Tracheal Tube<br>(K961837) | Teleflex Medical<br>Safety Silk Series<br>Oral / Nasal Tracheal<br>Tube<br>(132415) |
|------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Classification<br>Name | Tube, Tracheal<br>(w/wo connector) | Same | Same | Same |
| Product Code | 73 BTR | Same | Same | Same |
| Regulation<br>Number | 868.5730 | Same | Same | Same |
| Indications for<br>Use | Rusch tracheal tubes<br>are indicated<br>for airway<br>management by oral<br>or nasal intubation<br>of the trachea | Rusch Oral / Nasal<br>Trachea Tube,Cuffed,<br>Magill/Murphy is a<br>device inserted into a<br>patient's trachea via<br>the nose or mouth<br>and used to maintain<br>an open airway. | Oral or nasal<br>intubation and<br>airway<br>management | Same |
| Environment of<br>Use | Locations where ET<br>intubation may be<br>performed | Not stated | Not stated | Same |
| Patient<br>Population | Pediatric | Not stated | Not stated | Adult |
| Contraindications | None | Same | Same | Same |
| Single Use | Yes | Same | Same | Yes |

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

| Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube |
|-------------------------------------------------------------|
|-------------------------------------------------------------|

| Features | Teleflex Medical<br>Safety Silk Series<br>Oral / Nasal<br>Tracheal Tube<br>(proposed) | Teleflex Medical<br>Oral / Nasal Tracheal<br>Tube<br>(Safety Clear Plus)<br>(K993786) | Teleflex<br>Medical<br>Oral / Nasal<br>Tracheal Tube<br>(K961837) | Teleflex Medical<br>Safety Silk Series<br>Oral / Nasal Tracheal<br>Tube<br>(Reference Predicate) |
|-------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Size Range | 3.0 mm – 4.5 mm | 2.0 mm - 4.0 mm | 4.5 mm - 11.0<br>mm | 5.0 mm – 10.0 mm |
| Cuffed | Yes | Same | Same | Same |
| Radiopaque | Yes | Same | Same | Same |
| Connection to<br>ventilation source | 15 mm connector | Same | Same | Same |
| Method of<br>Sterilization | Ethylene Oxide 10-6<br>SAL | Same | Same | Same |
| Biocompatibility | Materials have been<br>tested per ISO<br>10993 | Same | Same | Same |
| Made without<br>DEHP | Yes | No | No | Yes |
| Packaging<br>Configuration | Ten (10) individual<br>units in a shelf box.<br>Ten shelf boxes in a<br>shipper | Not stated | Ten (10)<br>individual units<br>in a shelf box. | Same |
| Sterile | Yes | Same | Same | Same |
| Eye | Murphy and Magill | Same | Same | Same |
| Tip | Beveled | Same | Same | Same |
| Graduations | Multiple cm<br>markings | Same | Same | Same |
| Shaft | PVC | Same | Same | Same |
| Cuff | PVC | Same | Same | Same |
| Pilot Balloon | PVC | Same | Same | Same |
| Inflation Valve | PVC | Same | Same | Same |
| Inflation Tube | PVC | Same | Same | Same |
| X-Ray Marker,<br>Stripe | PVC with Barium<br>Sulfate | Same | Same | Same |
| Connector | Polyamide | Polypropylene | Polypropylene | Same |

# 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 differences between the predicate and the proposed devices are minor and any risks have been mitigated through testing. The proposed device is designed with essentially the similar materials as the predicate, and identical materials to the reference predicate

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

# Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

#### 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, and Extractables/Leachables Testing.

| Test | Reference to<br>Standard (if<br>applicable) | Principle of Test | Acceptance Criteria |
|---------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cuff Bonding Leak<br>Evaluation | N/A | To perform a visual check at the welding<br>point of the cuff | No leak around the welding area |
| Tube Curvature<br>Test | ISO 5361 | To measure the curvature of the tube | Must meet the product requirement<br>of 140mm ± 20mm |
| Tube Collapse | ISO 5361 | The patency of the ET tube airway lumen<br>is tested by passing a steel ball through<br>the tracheal tube lumen with the cuff<br>inflated within a transparent tube | The steel ball (OD = 75% of the<br>stated ID) must pass through the<br>lumen freely. |
| Cuff Resting<br>Diameter | ISO 5361 | The resting diameter of the cuff is<br>measured when the cuff is inflated to a<br>reference pressure which is intended to<br>remove creases but minimize stretching<br>of its walls | The cuff resting diameter shall be<br>within ± 15% of specification for<br>each individual size |
| Cuff Herniation | ISO 5361 | The tendency of the cuff to herniate<br>beyond the plane perpendicular to the<br>long axis of the tube at the nearest edge<br>of the bevel is tested by applying an axial<br>force with the cuff inflated within a<br>transparent tube. A cuff which protrudes<br>excessively at its patient end may<br>partially or completely occlude the orifice<br>at the patient end | No abnormality or defect on the cuff<br>(any part of the inflated cuff reaches<br>beyond the nearest edge of the<br>bevel will be considered as defect).<br>No abnormality on the configuration<br>of the cuff during deflating the cuff<br>over a period of not less than 10s<br>(any abnormality will be considered<br>as defect). |

# Performance Testing

{8}------------------------------------------------

| Test | Reference to<br>Standard (if<br>applicable) | Principle of Test | Acceptance Criteria |
|----------------------------------------|---------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Tube<br>Compression<br>Evaluation | N/A | To measure the rigidity of the tube | Must be within the range of current<br>data |
| Cuff Unrestrained<br>Burst Evaluation | N/A | To determine minimum cuff burst<br>pressure under unrestrained conditions | Must be within the range of current<br>data |
| Cuff Restrained<br>Burst Evaluation | N/A | To determine cuff burst volume under<br>restrained conditions to simulate<br>conditions in the trachea | Must be within the range of current<br>data |
| Cuff Sealing<br>Pressure<br>Evaluation | N/A | To determine the minimum cuff pressure<br>required to seal the corrugated tube | Must be within the range of current<br>data |

# Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

The Rusch Safety Silk Pediatric Tracheal Tube Series has the same indications for use,

technological characteristics and construction as its predicates. Performance test results demonstrate that the proposed device meets its intended use. It is for these reasons that the proposed device can be found substantially equivalent.