(276 days)
Not Found
No
The 510(k) summary describes a standard medical device (endobronchial tube) and does not mention any AI or ML components, image processing, or data-driven performance metrics.
No
The device is used for intubation and ventilation during thoracic surgery and other procedures, which are supportive functions rather than direct therapeutic treatment of a disease or condition.
No
This device is an Endobronchial Tube used for intubation and ventilation, not for diagnosing conditions. Its intended uses involve surgical procedures and anesthesia administration, not detection or analysis of diseases.
No
The device description clearly states it is a physical tube made of PVC, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures and ventilation within the body (specifically the main stem bronchus). IVDs are used to examine specimens outside the body to provide information about a patient's health.
- Device Description: The description details a tube inserted into the trachea for ventilation, which is a medical device used for treatment/support, not for diagnostic testing of samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the SHERIDAN® Endobronchial Tube is a medical device used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
main stem bronchus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital - OR and ICU
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Comparative Performance Testing
Tests performed:
15mm machine end Connector separation strength: The security of the attachment of the connector to the Endobronchial tube is tested by applying an axial separation force to the connector.
Cuff resting diameter (Reference to Standard: ISO 5361): Verify that diameter size marked on pouch matches the diameter of the product.
Cuff herniation (Reference to Standard: ISO 5361): Verify cuff is not going to distort beyond the nearest bevel.
Cuff Burst Evaluation: The cuff restrained burst test is designed to ensure the cuff will not burst or rupture when inflated inside the trachea.
Cuff Bond Strength: To evaluate the strength needed to separate the cuff from the tube.
Side arm bonding strength: To evaluate the retention force of the inflation line connection to the Endobronchial tube.
Key results: Performance test results demonstrate that the proposed device meets its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 3015 Carrington Mills Bvld Morrisville, NC 27560 USA Phone: 919-491-8960 Fax: 919-433-4996
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
Sheridan Endobronchial Tube
(proposed) | Teleflex Medical
Rusch Endobronchial Tube
(predicate) |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | Tube, Trachael/Bronchial, Differential Ventilation
(w/wo connector) | Same |
| Product Code | СВІ | Same |
| Regulation Number | 868.5740 | Same |
| Indications for 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. | Rusch Endobronchial Tubes are used to isolate
the left or right lung of a patient for surgery, one
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
contraindicated in patients with stenosis or
obstruction of the main stem bronchus that will
inhibit or prohibit accurate tube placement. | Left sides versions are contraindicated in patients
with obstructions or stenosis in the left main
bronchus. The right sided versions are
contraindicated in patients with obstructions or
stenosis in the right main bronchus. The versions
with a carina hook are contraindicated for all
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
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
5
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
Standard (if
applicable) | Principle of Test |
|---------------------------------------------------------|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 15mm machine
end Connector
separation
strength | N/A | The security of the attachment of the connector to the
Endobronchial tube is tested by applying an axial separation
force to the connector |
| Cuff resting
diameter | ISO 5361 | Verify that diameter size marked on pouch matches the diameter
of the product |
| Cuff herniation | ISO 5361 | Verify cuff is not going to distort beyond the nearest bevel |
| Cuff Burst
Evaluation | N/A | The cuff restrained burst test is designed to ensure the cuff will not
burst or rupture when inflated inside the trachea |
| Cuff Bond
Strength | N/A | To evaluate the strength needed to separate the cuff from
the tube |
| Side arm
bonding strength | N/A | To evaluate the retention force of the inflation line
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.