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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Rusch Endobronchial Tubes." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical acceptance criteria through a comparative effectiveness study or AI-related metrics.

Therefore, many of the requested categories in your prompt are not applicable to this document. This submission does not involve AI, machine learning, or complex diagnostic performance evaluation against an established ground truth in the way your prompt implies.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted to demonstrate substantial equivalence to predicate devices, focusing on physical and mechanical properties. It doesn't present "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for a diagnostic algorithm, nor does it provide specific numerical "reported device performance" against those criteria. Instead, it describes the principle of the test to ensure the device functions as intended and is safe.

| Test | Principle of Test | Acceptance Criteria (Implied) | Reported Device Performance |
|-------------------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Connector bonding strength | The security of the attachment of the connector to the Endobronchial tube is tested by applying an axial separation force to the connector | Must meet specified force without separation (per ISO 5356) | Meets requirements for safe and effective use. |
| Cuff resting diameter | 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 | Must fall within acceptable diameter range (per ISO 5361) | Meets requirements for safe and effective use. |
| Tube collapse | 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 | Steel ball must pass without obstruction (per ISO 5361) | Meets requirements for safe and effective use. |
| Cuff herniation | 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 protrusion must be within acceptable limits to prevent occlusion (per ISO 5361) | Meets requirements for safe and effective use. |
| 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 must not burst or rupture under specified inflation pressure inside the trachea. | Meets requirements for safe and effective use. |
| Cuff Bond Strength | To evaluate the strength needed to separate the cuff from the tube | Cuff must remain bonded to the tube under specified force. | Meets requirements for safe and effective use. |
| Side arm bonding strength | To evaluate the retention force of the inflation line connection to the Endobronchial tube | Inflation line connection must be retained under specified force. | Meets requirements for safe and effective use. |

Note: The phrase "Meets requirements for safe and effective use" is an interpretation based on the "Substantial Equivalence Conclusion" stating that "Performance test results demonstrate that the proposed device meets its intended use." Specific numerical results for each test are not provided in this summary.

The following sections are NOT applicable to the provided document, as it pertains to a traditional medical device (endobronchial tube) and not an AI/ML powered device or diagnostic tool.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. Physical device testing typically involves a set number of manufactured units, not a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. "Ground truth" in the context of diagnostic interpretation by experts is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process is described for this type of device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is explicitly for AI-assisted diagnostic studies, which this is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For mechanical testing, the "ground truth" is typically the physical measurement against a standard or specification.
8. The sample size for the training set
- Not applicable. There is no "training set" for this type of device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" or corresponding ground truth.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known)

K141888

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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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

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

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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 MedicalEndobronchial Tube(proposed)	Fuji Systems Silcobronch(K051522)	Well LeadEndobronchialTube(K092886)
Classification Name	Tube, Trachael/Bronchial, DifferentialVentilation (w/wo connector)	Same	Same
Product Code	CBI	Same	Same
Regulation Number	868.5740	Same	Same
Indications for Use	Rusch Endobronchial Tubes are used toisolate the left or right lung of a patientfor surgery, one lung ventilation or onelung 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 inpatients with obstructions or stenosis inthe left main bronchus. The right sidedversions are contraindicated in patientswith obstructions or stenosis in the rightmain bronchus. The versions with acarina hook are contraindicated for allprocedures 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 toventilation 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

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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 toStandard (ifapplicable)	Principle of Test
Connectorbonding strength	ISO 5356	The security of the attachment of the connector to theEndobronchial tube is tested by applying an axial separationforce to the connector
Cuff restingdiameter	ISO 5361	The resting diameter of the cuff is measured when the cuffis inflated to a reference pressure which is intended toremove creases but minimize stretching of its walls
Tube collapse	ISO 5361	The patency of the Endobronchial tube airway lumen istested by passing a steel ball through the Endobronchialtube lumen with the cuff inflated within a transparent tube
Cuff herniation	ISO 5361	The tendency of the cuff to herniate beyond the planeperpendicular to the long axis of the tube at the nearestedge of the bevel is tested by applying an axial force withthe cuff inflated within a transparent tube. A cuff whichprotrudes excessively at its patient end may partially orcompletely occlude the orifice at the patient end
Cuff BurstEvaluation	N/A	The cuff restrained burst test is designed to ensure the cuffwill not burst or rupture when inflated inside the trachea
Cuff BondStrength	N/A	To evaluate the strength needed to separate the cuff fromthe tube
Side armbonding strength	N/A	To evaluate the retention force of the inflation lineconnection 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.

Regulation Number and Section

§ 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).