(275 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a standard medical device (endobronchial tube) and do not mention any computational or algorithmic features indicative of AI/ML.
Yes
The device is used for "one lung ventilation or one lung anesthesia," which are therapeutic interventions. While it also serves a diagnostic/surgical purpose ("one lung isolation for surgery"), its primary function as described in the intended use directly supports therapeutic procedures by enabling selective ventilation.
No
The device is used for isolating a lung for ventilation or anesthesia during surgery, not for diagnosing a condition. Its function is therapeutic/interventional.
No
The device description clearly states it is a physical tube made of PVC and includes accessories and a stylet, indicating it is a hardware device. The performance studies also focus on physical properties like bonding strength and cuff characteristics.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Rusch Endobronchial Tube is a medical device used to physically isolate and ventilate a patient's lung during surgery or anesthesia. It is inserted directly into the body.
- Intended Use: The intended use is for surgical procedures and anesthesia, not for analyzing biological samples.
The description clearly indicates a device used in vivo (within the living body) for a procedural purpose, not for in vitro (in glass/outside the body) diagnostic testing.
N/A
Intended Use / Indications for Use
Rusch Endobronchial Tubes are used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Patient Population: Patients requiring one lung isolation
Environment of use: Hospitals - OR and ICU
Product codes (comma separated list FDA assigned to the subject device)
CBI
Device Description
The Rusch 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. The Endobronchial tube is sold with or without accessories, contains a stylet and is available in Robertshaw, Carlens and White styles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung, trachea, bronchus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals - 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 related to:
- Connector bonding strength: Tested by applying an axial separation force to the connector, referencing ISO 5356.
- Cuff resting diameter: Measured when the cuff is inflated to a reference pressure to remove creases but minimize stretching of its walls, referencing ISO 5361.
- Tube collapse: Patency of the Endobronchial tube airway lumen tested by passing a steel ball through the lumen with the cuff inflated within a transparent tube, referencing ISO 5361.
- Cuff herniation: Tendency of the cuff to herniate beyond the plane perpendicular to the long axis of the tube at the nearest edge of the bevel tested by applying an axial force with the cuff inflated within a transparent tube, referencing ISO 5361.
- Cuff Burst Evaluation: Designed to ensure the cuff will not burst or rupture when inflated inside the trachea.
- Cuff Bond Strength: Evaluates the strength needed to separate the cuff from the tube.
- Side arm bonding strength: Evaluates 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15, 2015
Teleflex Medical, Inc. Lori Pfohl Senior Regulatory Affairs Specialist 2917 Weck Dr. Research Triangle Park, NC 27709
Re: K141888
Trade/Device Name: Rusch Endobronchial Tubes Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: Class II Product Code: CBI Dated: March 13, 2015 Received: March 16, 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.
1
Page 2 - Ms. 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 (800) 638-2041 or (301) 796-7100 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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. Division 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)
Device Name Rusch Endobronchial Tubes
Indications for Use (Describe)
Rusch Endobronchial Tubes are used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Patient Population: Patients requiring one lung isolation
Environment of use: Hospitals - OR and ICU
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) SUMMARY March 4, 2015
Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-491-8960 Fax: 919-433-4996
Contact Person
Lori Pfohl Senior Regulatory Affairs Specialist
Device Name
Trade Name: Rusch Endobronchial Tubes
Common Name: Bronchial Tube
Classification Name: Tube, Trachael/Bronchial, Differential Ventilation (w/wo connector) (Class II per 21 CFR 868.5740, Product Code CBI)
Predicate Devices
K051522 Silbroncho Double Lumen Tube K092886 Well Lead Endobronchial Tubes
Device Description
The Rusch 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. The Endobronchial tube is sold with or without accessories, contains a stylet and is available in Robertshaw, Carlens and White styles.
Intended Use
Rusch Endobronchial Tubes are used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Patient Population: Patients requiring one lung isolation
Environment of use: Hospitals - OR and ICU
Teleflex Medical
4
510(k) SUMMARY March 4, 2015
Contraindications
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.
Substantial Equivalence Comparison to Predicates
| Features | Teleflex Medical
Endobronchial Tube
(proposed) | Fuji Systems Silcobronch
(K051522) | Well Lead
EndobronchialTube
(K092886) |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------|
| Classification Name | Tube, Trachael/Bronchial, Differential
Ventilation (w/wo connector) | Same | Same |
| Product Code | CBI | Same | Same |
| Regulation Number | 868.5740 | Same | Same |
| Indications for Use | Rusch Endobronchial Tubes are used to
isolate the left or right lung of a patient
for surgery, one lung ventilation or one
lung anesthesia | Same | Same |
| Environment of Use | Hospital - OR and ICU | Same | Not stated |
| Patient Population | Patients requiring one lung isolation | Same | Not stated |
| Contraindications | 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 | Not Stated | Not Stated |
| Design Features | Double lumen shaft, 2 cuffs, Stylet | Same | Same |
| Single Use | Yes | Same | Same |
| Size Range | 26-41 French | 33-39 French | 28-41 French |
| Cuffed | Yes | Same | Same |
| Radiopaque | Yes | No | Yes |
| Connection to
ventilation source | 15 mm connector | Same | Same |
| DLT Materials | PVC | Silicone | PVC |
The proposed device is substantially equivalent to the predicate devices:
- Indications for Use-The indications for use are identical for the proposed device when 9 compared to the predicates. Each device is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
- Technology and construction The design, fabrication, shape, size, etc. are equivalent to the . predicates. The designs of the propose and predicate devices consist a double lumen tube with
5
510(k) SUMMARY March 4, 2015
cuffs on each lumen, and corresponding side arm assemblies to inflate the cuffs.
- Environment of use Identical to predicate. Hospital OR and ICU .
- Patient Population Identical to predicate. Patients requiring one lung isolation _
- Materials -All patient contacting materials are in compliance with ISO 10993-1. Testing 0 included cytotoxicity, sensitization and intracutaneous activity.
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 same materials as the K092886 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 |
|-------------------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Connector
bonding strength | ISO 5356 | 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 | The resting diameter of the cuff is measured when the cuff
is inflated to a reference pressure which is intended to
remove creases but minimize stretching of its walls |
| Tube collapse | ISO 5361 | The patency of the Endobronchial tube airway lumen is
tested by passing a steel ball through the Endobronchial
tube lumen with the cuff inflated within a transparent tube |
| Cuff herniation | ISO 5361 | The tendency of the cuff to herniate beyond the plane
perpendicular to the long axis of the tube at the nearest
edge of the bevel is tested by applying an axial force with
the cuff inflated within a transparent tube. A cuff which
protrudes excessively at its patient end may partially or
completely occlude the orifice at the patient end |
| 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 Rusch Endobronchial Tubes have the same indications for use, patient population and technology of construction as the predicate devices. 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.