The Rüsch Easy Tube is a sterile single patient use, combination esophageal/tracheal tube intended to be used for emergency intubation, difficult intubation or general anesthesia intubation. The device will provide sufficient ventilation whether the airway is placed into the esophagus or into the trachea.

Device Description

The Rüsch Easy Tube consists of a 28 Fr (Small) or 41 Fr (Large), clear, twin lumen tube with a radiopaque stripe and graduated centimeter markings. The 28 Fr size is for use with patients 90 - 130 cm in height. The 41 Fr size is for use with patients over 130 cm in height. The device is designed to occlude the oro- and nasopharynx. The tube has a PVC high volume, low pressure, inflatable distal esophageal cuff and a larger proximal oropharyngeal cuff. Both cuffs are provided with self-sealing luer connector valves. A color-coded pilot balloon is provided for each of the color coding facilitates identification of the cuff/pilot balloon relationship. The clear pilot balloon corresponds with the clear distal cuff. The blue pilot balloon corresponds with the green proximal cuff. The shaft for the proximal cuff is also color-coded with a matching blue sleeve.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the Rüsch Easy Tube, which is a medical device (tracheal tube). This document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a clinical study or AI model.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI device is largely not applicable to this document.

However, I can extract the information that is present:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the context of an AI/algorithm's performance. Instead, it compares the Rüsch Easy Tube to a predicate device (Kendall Combitube - K844746) based on design and performance characteristics to establish substantial equivalence.

Comparison Point	Predicate Device (Kendall Combitube - K844746)	Rüsch Easy Tube (Reported Characteristics)
Intended Use	To be used for emergency, difficult or general anesthesia intubation. The device will provide sufficient ventilation whether the airway is placed into the esophagus or into the trachea.	To be used for emergency, difficult or general anesthesia intubation. The device will provide sufficient ventilation whether the airway is placed into the esophagus or into the trachea.
I.D. Size	Small Adult - 37Fr, Regular - 41Fr	Small - 28Fr, Large - 41Fr
Cuff Style	High Volume, Low Pressure	High Volume, Low Pressure
Pilot Balloons - Color Coded	Yes	Yes (Clear Pilot Balloon for clear distal cuff, Blue Pilot Balloon for green proximal cuff)
Tube Available Separately	Yes	Yes
Graduations	No	Yes
Radiopaque Marker	No	Yes
Inflation Valve Type	Luer Activated	Luer Activated
Sterile	No	Yes (Sterile single patient use)

Regarding the device meeting acceptance criteria: The document states, "All materials used in the fabrication of the Rüsch Easy Tube were evaluated through biological qualification safety tests as outlined in ISO 10993 Part 1 'Biological Evaluation of Medical Devices'. Comparative testing was performed. The materials used were also tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." This indicates that biological safety and material specifications were met according to established standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided because this is a 510(k) submission for a physical medical device, not an AI/algorithm-based diagnostic or treatment device that typically involves a "test set" in the sense of AI evaluation. The "comparative testing" mentioned refers to testing of materials and likely functional aspects against industry standards and the predicate device, not a data-driven test set.

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 as typically understood for AI models (e.g., expert consensus on medical images) is not relevant for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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 device is a tracheal tube, not an AI-assisted diagnostic tool that would involve human "readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" implicitly refers to established material safety standards (ISO 10993 Part 1) and industry-recognized test methods for physical characteristics. For substantial equivalence, the "ground truth" is the performance and characteristics of the legally marketed predicate device (Kendall Combitube).

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Teleflex Medical. The logo is in black and white. The word "Teleflex" is in a bold, sans-serif font, and the word "MEDICAL" is in a smaller, sans-serif font below the word "Teleflex."

JAN - 7 2005

K043205

Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, IL 60015 USA 847-572-8002 Phone: Fax: 847-572-8001 www.teleflex.com

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Rüsch Easy Tube

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, IL 60015 USA Phone: 847-572-8002 Fax: 847-572-8001

B. Contact Person

Lori Hays Senior Manager, Regulatory Affairs

C. Date Prepared

November 18, 2004

D. Device Name

Trade Name: Rüsch Easy Tube

Common Name: Tracheal Tube

Classification Name: Tube, Tracheal (w/wo Connector)

Product Code: BTR

Regulation Number: 868.5730

Class: Il

E. Device Description

A Division of Teleflex Incorporated

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The device is designed to occlude the oro- and nasopharynx. The tube has a PVC high volume, low pressure, inflatable distal esophageal cuff and a larger proximal oropharyngeal cuff. Both cuffs are provided with self-sealing luer connector valves. A color-coded pilot balloon is provided for each of the color coding facilitates identification of the cuff/pilot balloon relationship. The clear pilot balloon corresponds with the clear distal cuff. The blue pilot balloon corresponds with the green proximal cuff. The shaft for the proximal cuff is also color-coded with a matching blue sleeve.

F. Intended Use

G. Substantial Equivalence

The Rüsch Easy Tube is substantially equivalent to the Kendall Combitube (K844746) in intended use, design and components, materials, and performance characteristics. See Table 1.

Comparison Point	Easy Tube	Kendall Combitube -K844746
Intended Use	To be used for emergency,difficult or general anesthesiaintubation. The device willprovide sufficient ventilationwhether the airway is placedinto the esophagus or into thetrachea.	To be used for emergency,difficult or general anesthesiaintubation. The device willprovide sufficient ventilationwhether the airway is placedinto the esophagus or into thetrachea.
I.D. Size	Small - 28FrLarge - 41Fr	Small Adult - 37Fr,Regular - 41Fr
Cuff Style	High Volume, Low Pressure	High Volume, Low Pressure
Pilot Balloons -Color Coded	Yes	Yes
Tube AvailableSeparately	Yes	Yes
Graduations	Yes	No
Radiopaque Marker	Yes	No
Inflation Valve Type	Luer Activated	Luer Activated
Sterile	Yes	No

Table 1

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H. Summary of Testing

All materials used in the fabrication of the Rüsch Easy Tube were evaluated through biological qualification safety tests as outlined in ISO 10993 Part 1 "Biological Evaluation of Medical Devices". Comparative testing was performed. The materials used were also tested in accordance with industry recognized test methods and were found to be acceptable for the intended use

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2005

Ms. Lori Hays Senior Manager, Regulatory Affairs Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, Illinois 60015

Re: K043205

Trade/Device Name: Rüsch Easy Tube Regulation Number: 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: November 18, 2004 Received: November 19, 2004

Dear Ms. Hays:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Hays

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. or the rest of mply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instills (1) CF CF CF 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) rine reter notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rf you contact the Office of Compliance at (301) 594-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Suitte Michael OMD. for DR. CHIU LIN

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for Teleflex Medical. The logo is in black and consists of the word "Teleflex" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font size underneath. The logo is simple and modern, and it is likely used to represent the company's brand identity.

Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, IL 60015 USA Phone: 847-572-8002 847-572-8001 Fax: www.teleflex.com

Indications for Use

510(k) Number (if known):

Rüsch Easy Tube Device Name:

Indications For Use:

The Rüsch Easy Tube is a sterile, single use, combination esophageal/ tracheal tube intende to be used for emergency intubation, difficult intubation or general anesthesia intubation. Th to be adou for entilation whether the airway is placed into the esophagus or in the trachea

Jan K. Lemille Smichaelo MD

FOR

sthesiology, General Hospital, ion Control, Dental

510(k) Number:_Koy3205

AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use _ X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

A Division of Teleflex Incorporated

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
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.(b)
Classification. Class II (performance standards).