Sheridan Endobronchial Tubes

K180253 · Teleflex Medical · CBI · Nov 2, 2018 · Anesthesiology

Device Facts

• Record ID: K180253
• Device Name: Sheridan Endobronchial Tubes
• Applicant: Teleflex Medical
• Product Code: CBI · Anesthesiology
• Decision Date: Nov 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5740
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SHERIDAN® Endobronchial Tube is intended for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The SHERIDAN® Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.

Device Story

Sheridan Endobronchial Tube is a sterile, single-use PVC double-lumen tube (DLT) designed for selective ventilation of one lung. Device is inserted into the trachea via the mouth; features two cuffs and side-arm assemblies for independent inflation/deflation of either lung. Used in hospital OR and ICU settings by clinicians for thoracic surgery, bronchospirometry, and anesthesia administration. Output is the physical isolation and ventilation of a single lung, enabling surgical access or diagnostic procedures. Benefits include controlled lung collapse/ventilation, facilitating thoracic procedures. Device is radiopaque for visualization.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including cuff burst evaluation, cuff bond strength, side arm bonding strength, 15mm connector separation strength, and cuff herniation testing per ISO 5361. Biocompatibility testing (cytotoxicity, sensitization, intracutaneous activity, particulate/inorganic matter, and VOC) was performed per ISO 10993-1.

Technological Characteristics

Double-lumen tube constructed of PVC. Features two cuffs, stylet, and 15mm connectors. Radiopaque. Sterile, single-use. Dimensions: 28-41 French. Compliant with ISO 5361 for cuff performance and ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for patients requiring one-lung isolation, main stem bronchus intubation, and selective lung ventilation during thoracic surgery, bronchospirometry, or anesthesia. Contraindicated in patients with stenosis or obstruction of the main stem bronchus.

Regulatory Classification

Identification

A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.

Predicate Devices

• Rusch Endobronchial Tubes (K141888)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Teleflex Medical Lori Pfohl Senior Regulatory Affairs Specialist 3015 Carrington Mills Blvd Morrisville, North Carolina 27560

Re: K180253

Trade/Device Name: Sheridan Endobronchial Tubes Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: Class II Product Code: CBI Dated: October 3, 2018 Received: October 5, 2018

Dear Lori 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Todd D. Courtney -S

for Tina Kiang, Ph.D. 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

510(k) Number (if known) K180253

Device Name Sheridan Endobronchial Tubes

Indications for Use (Describe)

The SHERIDAN® Endobronchial Tube is intenced for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The SHERIDAN® Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.

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

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 3015 Carrington Mills Bvld Morrisville, NC 27560 USA Phone: [phone] Fax: [phone]

### Contact Person

Lori Pfohl Senior Regulatory Affairs Specialist

#### Device Name

Trade Name: Sheridan Endobronchial Tubes

Common Name: Bronchial Tube

Classification Name: Tube, Tracheal/Bronchial, Differential Ventilation (w/wo connector) (Class II per 21 CFR 868.5740. Product Code CBI)

#### Predicate Device

K141888 Rusch Endobronchial Tubes

#### Device Description

The Sheridan Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung.

#### Intended Use

The SHERIDAN® Endobronchial Tube is intended for use in thoracic surgery. bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The SHERIDAN® Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.

#### Contraindications

SHERIDAN® Endobronchial Tubes are contraindicated in patients with stenosis or obstruction of the main stem bronchus that will inhibit or prohibit accurate tube placement.

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# Substantial Equivalence Comparison to Predicate

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

| Features | Teleflex Medical<br>Sheridan Endobronchial Tube<br>(proposed) | Teleflex Medical<br>Rusch Endobronchial Tube<br>(predicate) |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | Tube, Trachael/Bronchial, Differential Ventilation<br>(w/wo connector) | Same |
| Product Code | СВІ | Same |
| Regulation Number | 868.5740 | Same |
| Indications for Use | The SHERIDAN® Endobronchial Tube is intended<br>for use in thoracic surgery, bronchospirometry,<br>administration of Endobronchial anesthesia and<br>other uses commonly requiring Endobronchial<br>intubation. The<br>SHERIDAN® Endobronchial tube is indicated for<br>main stem bronchus intubation and allows for<br>selective inflation or deflation of either lung. | Rusch Endobronchial Tubes are used to isolate<br>the left or right lung of a patient for surgery, one<br>lung ventilation or one lung anesthesia |
| Environment of Use | Hospital - OR and ICU | Same |
| Patient Population | Patients requiring one-lung isolation | Same |
| Contraindications | SHERIDAN® Endobronchial Tubes are<br>contraindicated in patients with stenosis or<br>obstruction of the main stem bronchus that will<br>inhibit or prohibit accurate tube placement. | Left sides versions are contraindicated in patients<br>with obstructions or stenosis in the left main<br>bronchus. The right sided versions are<br>contraindicated in patients with obstructions or<br>stenosis in the right main bronchus. The versions<br>with a carina hook are contraindicated for all<br>procedures in the region of the carina |
| Design Features | Double lumen shaft, 2 cuffs, Stylet | Double lumen shaft, 2 cuffs, Stylet |
| Single Use | Yes | Yes |
| Size Range | 28-41 French | 26-41 French |
| Cuffed | Yes | Yes |
| Radiopaque | Yes | Yes |
| Connection to<br>ventilation source | 15 mm connector | 15 mm connector |
| DLT Materials | PVC | PVC |

- Indications for Use The indications for use are considered to be identical. ● While the Sheridan indications for use is a bit more descriptive, both include identical uses.
- Technology and construction The design, fabrication, shape, size, etc. is ● equivalent to the predicate. The designs of the proposed and predicate device consists of a double lumen tube with cuffs on each lumen, and corresponding side arm assemblies to inflate the cuffs.
- Environment of use Identical for the proposed and predicate devices. ●

# Teleflex Medical

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#### K180253 510(k) SUMMARY January 25, 2018

- . 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, particulate matter, inorganic matter and VOC testing.

# Comparison to Predicate Device:

The proposed Endobronchial 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. Additionally, the proposed device is made with the similar materials as the K141888 predicate.

### 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 |
|---------------------------------------------------------|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 15mm machine<br>end Connector<br>separation<br>strength | N/A | The security of the attachment of the connector to the<br>Endobronchial tube is tested by applying an axial separation<br>force to the connector |
| Cuff resting<br>diameter | ISO 5361 | Verify that diameter size marked on pouch matches the diameter<br>of the product |
| Cuff herniation | ISO 5361 | Verify cuff is not going to distort beyond the nearest bevel |
| Cuff Burst<br>Evaluation | N/A | The cuff restrained burst test is designed to ensure the cuff will not<br>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 Endobronchial tube |

#### Substantial Equivalence Conclusion

The Sheridan Endobronchial Tubes have 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 proposed device can be found substantially equivalent.